Research Involving Persons with 

Mental Disorders That May Affect 

Decisionmaking Capacity

VOLUME II

COMMISSIONED PAPERS BY THE

NATIONAL BIOETHICS ADVISORY COMMISSION

MARCH 1999
National Bioethics Advisory Commission, 6100 Executive Boulevard, Suite 5B01, Rockville, Maryland 20892-7508

Telephone: 301-402-4242 Facsimile: 301-480-6900 Website: www.bioethics.gov
Research Involving 

Persons with 

Mental Disorders 

That May Affect 

Decisionmaking Capacity

Commissioned Papers

March 1999

NATIONAL BIOETHICS ADVISORY 

COMMISSION

Table of Contents

PAPER ONE

Decisionally Impaired Research Subjects

Paul S. Appelbaum, M.D. 1

The Nature of Disorders that Affect Decisionmaking Ability 1

The Promise of Research with Disorders that Cause 

Decisional Impairments 3

PAPER TWO

Research Involving Persons with Mental 

Disabilities: A Review of Policy Issues 

and Proposals

Rebecca Dresser, J.D. 5

Introduction 5

Historical Context 6

Capacity Assessment 9

Conclusion 27

PAPER THREE

Relational Ethics and Research with 

Vulnerable Populations

Celia B. Fisher, Ph.D. 29

Philosophical Premises Guiding Ethics-in-Science 

Decision Making 29

Relational Ethics and Co-Learning 32

Questioning Value Assumptions and Striving for Common 

Conceptions of the Good 36

Challenging Scientistic Assumptions 37

Relational Ethics and Informed Consent 41

Conclusion: Power and Partnership 45

PAPER FOUR

Critical Issues Concerning Research 

Involving Decisionally Impaired Persons

Jonathan D. Moreno, Ph.D. 51

Introduction 51

Should the individual’s informed consent always be 

required for research participation? 52

Should the individuals be able to execute substantive

advance research directives? 52

Should the patient’s legally authorized representative be 

empowered to make research participation decisions,

and on what basis should he or she decide? 53

Should legally authorized surrogates be empowered to make 

research participation decisions, and on what basis 

should they decide? 54

Should those who are decisionally impaired and at high risk 

for decisional incapacity be excluded from research? 55

Should the patient who decides to participate in research 

be required to have appointed a legally authorized 

representative to make subsequent medical care decisions? 55

Should those who are decisionally incapacitated be excluded

from research? 55

Should research involving the decisionally impaired or 

incapacitated be limited to that which is relevant to a 

medical problem from which the patient is suffering? 56

Should investigators be required to notify individuals that 

they have been found to be decisionally incapacitated 

and that they are to be entered into a research project 

without their consent? 56

Should consent auditors ever be required? 56

Should “reconsent” procedures ever be required? 56

Should “wraparound” studies ever be required? 57

Should placebo arms ever be prohibited? 57

Should the National Bioethics Advisory Commission 

promulgate new regulations concerning the participation 

in research of those who are decisionally impaired, or 

should it rather offer guidance for potential subjects,

their physicians, clinical investigators, institutional 

review boards, and other policymaking bodies? 57

PAPER FIVE

Competency to Decide on Treatment and 

Research: The MacArthur Capacity Instruments

Elyn R. Saks 59

Introduction 59

The Nature of the MacArthur Treatment Instruments 61

Normative Judgments Required When Designing 

Competency and Capacity Instruments 63

Evaluating the MacArthur Instruments 65

Importing the MacArthur Instruments into the 75

Research Context

What recommendations should the National Bioethics 

Advisory Commission make to institutional review 

boards regarding competency evaluations? 77

Conclusion 78

PAPER ONE DECISIONALLY IMPAIRED

RESEARCH SUBJECTS

Disorders and Research Promises

The Nature of Disorders that Affect 

Decisionmaking Ability

Any disorder that alters mentation may adversely affect decisionmaking ability. When such a disorder is present in an early

or mild phase, the resulting impairment may not rise to the

level at which a potential research subject would be considered

unable to consent to research participation, although extra care

in the informed consent process may be required. More

advanced or severe forms of disorder, however, may render the

subject incapable of independent choice. Thus, identification

of a potential subject as suffering from a disorder that may

impair mentation does not obviate the need for an individualized assessment of the person’s decisionmaking abilities.

A relatively small body of research has documented the

effects of various disorders on decisionmaking capacity per se,

but this is supplemented in many cases by data on cognitive

functioning in general and by a good deal of clinical experience

with these populations.

Dementia

Dementias are characterized by multiple cognitive deficits,

most prominently impairment of memory. The best known of

these conditions is dementia of the Alzheimer’s type, a progressive disorder whose cause is presently unknown, the incidence of which increases with age, from 2 to 4 percent in the

population over 65 years old to 20 percent or more in persons

over 85 years old.1 Dementias may also be caused by vascular

infarcts of the brain, head trauma, HIV infection, and other

neurological conditions, such as Parkinson’s disease and Huntington’s disease.

Study of decisionmaking impairment in persons with

dementia has focused on Alzheimer’s disease. Even patients

with mild Alzheimer’s dementia may evidence deficits in

understanding relevant information and reasoning sufficient to

call their capacities into question, although the choices they

make about treatment and research may not differ at this point

from non-impaired populations. As dementia progresses to the

moderate stage, however, the range and magnitude of deficits

Paul S. Appelbaum, M.D.

A.F. Zelesnik Professor and Chairman

Department of Psychiatry

University of Massachusetts Medical Center

55 Lake Avenue North

Worcester, Massachusetts 01655

1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental 

Disorders, 4th ed. (DSM-IV). Washington, DC: APA, 1994.
expands, and many more persons fail even the simplest tests of

decisionmaking capacity.2 The co-occurrence of other disorders, such as delirium or depression, may exacerbate the impact

of dementia on the ability to make decisions.

Delirium

Like dementia, delirium involves alterations in cognition, but

usually evolves over hours to days. Disturbances of consciousness and attention are prominent. Delirium is most often

caused by systemic medical conditions, side effects of medications, intoxication with or withdrawal from psychoactive

agents, or toxins.3 Studies demonstrating high rates of decisional impairment in severely ill, hospitalized patients are probably detecting the effects of delirium secondary to the underlying conditions and, in some cases, the treatments being administered.4 In contrast, other work suggests that serious medical

illness that does not directly impair brain function, even when

it results in hospitalization, is not likely, by itself, to result in

limitations on decisionmaking abilities.5

Schizophrenia

Schizophrenia is a severe psychiatric disorder marked by delusions, hallucinations, disorganized speech or behavior, and

diminished affect and initiative. A variety of cognitive dysfunctions, including several related to processing information, have

been associated with the disorder. Its onset typically occurs in

early adulthood and, although its course is variable, symptoms

often wax and wane, with the result that functional impairment

fluctuates over time.6 Many of its manifestations can be

reduced with antipsychotic medication, but residual symptoms

are frequent and relapse is not uncommon.

As many as one-half of acutely hospitalized patients with

schizophrenia may have substantially impaired decisionmaking

abilities, including understanding, appreciation, and reasoning.7 Since many of these impairments appear to be related to

active symptoms, the prevalence of reduced capacity is likely to

be lower among outpatient groups.8 Lack of insight into the

presence of illness and need for treatment is common among

persons with schizophrenia;9 this may make it especially difficult for them to anticipate consequences of their decisions

related to the risk of future relapse.

Depression

Symptoms of major depression include: depressed mood; feelings of worthlessness; diminished interest and pleasure in most

activities; changes in appetite, sleep patterns, and energy levels;

and difficulties in concentration.10 Cognitive impairments may

exist in information processing11 and reasoning,12 among other

functions. It has also been suggested that decreased motivation

to protect their interests may reduce depressed patients’ abilities

to make decisions,13 and alter the nature of those decisions.14

Less clear is the extent to which these consequences of depression impede decision making. One study suggested that hospitalized depressed patients may manifest problems roughly half

as often as patients with schizophrenia, that is, in about onequarter of cases.15 But it is likely that the degree of impairment

relates to the intensity of depressive symptoms, and thus will

vary across populations.

Other Disorders

Although less subject to formal study in the context of consent

to treatment or research, there is good reason to believe that

other conditions may also predispose to impaired decisional

functions. Mental retardation, affecting as it does a range of

cognitive abilities, is more likely to impair capacities as severity

increases. Bipolar disorder results in alternating states of

depression and mania, the latter comprising elevated mood,

increased impulsivity, and reduced attention, among other features; manic patients are notorious for making poor decisions

about money and personal affairs, and it is probable that this

deficit extends into research decision making for some subset of

this group. Other psychotic disorders involve some of the

symptoms seen in schizophrenia, including delusions and hallucinations, and probably have some of the same consequences

2 NATIONAL BIOETHICS ADVISORY COMMISSION

DECISIONALLY IMPAIRED RESEARCH SUBJECTS: DISORDERS AND RESEARCH PROMISES

2 Marson, Ingram, Cody, and Harrell. “Assessing the competency of patients with Alzheimer’s disease under different legal standards,” Archives of Neurology 52 (1995): 949–54; Stanley B,

Guido J, Stanley M, and Shortell D. “The elderly patient and informed consent.” Journal of the American Medical Association 252 (1984): 1302–1306.

3 American Psychiatric Association, DSM-IV, op. cit.

4 Cohen, McCue, and Green. “Do clinical and formal assessment of the capacity of patients in the intensive care unit to make decisions agree?” Archives of Internal Medicine 153 (1993):

2481–85.

5 Appelbaum and Grisso. “Capacities of hospitalized, medically ill patients to consent to treatment,” Psychosomatics 38 (1997): 119–25.

6 American Psychiatric Association, DSM-IV, op. cit.

7 Grisso and Appelbaum. “The MacArthur Treatment Competence Study, III: Abilities of patients to consent to psychiatric and medical treatment,” Law and Human Behavior 19 (1995):

149–74.

8 Rosenfeld, Turkheimer, and Gardner. “Decision making in a schizophrenic population,” Law and Human Behavior 16 (1992): 651–62.

9 Amador, Strauss, Yale, and Gorman. “Awareness of illness in schizophrenia,” Schizophrenia Bulletin 17 (1991): 113–32.

10 American Psychiatric Association, DSM-IV, op. cit.

11 Hartlarge, Alloy, Vazquez, and Dykman. “Automatic and effortful processing in depression,” Psychological Bulletin 113 (1993): 247–78.

12 Baker and Channon. “Reasoning in depression: impairment on a concept discrimination learning task,” Cognition and Emotion 9 (1995): 579–97.

13 Elliott. “Caring about risks: are severely depressed patients competent to consent to research?” Archives of General Psychiatry 54 (1997): 113–16.

14 Lee and Ganzini. “Depression in the elderly: Effect on patient attitudes toward life-sustaining therapy,” Journal of the American Geriatrics Society 40 (1992): 983–88.

15 Grisso and Appelbaum, op. cit.
for decision making. Substance use disorders, including use of

alcohol and illegal drugs, result in states of intoxication and

withdrawal that resemble delirium in their effects on attention,

cognition, and other mental functions.

This list, while highlighting the major conditions that impact

decisionmaking ability, is by no means exhaustive.

The Promise of Research with Disorders that 

Cause Decisional Impairments

Psychiatric, neurological, and other disorders that may render

persons decisionally impaired account for enormous morbidity, with associated human and economic costs. Of the ten leading causes of disability in the world, according to a recent World

Health Organization report, five were psychiatric conditions:

unipolar depression, alcohol use, bipolar affective disorder,

schizophrenia, and obsessive-compulsive disorder.16 It has been

estimated that direct and indirect costs of mental illness and

substance abuse in the United States totaled more than $313

billion in 1990.17 Alzheimer’s disease now afflicts approximately

4 million people in this country and, with the number of persons over 65 years of age expected to double by the year 2030,

the resulting morbidity will grow proportionately.

Given the scope of these disorders, when treatments can be

identified that mitigate their impact, the benefits are substantial. Since 1970, the cumulative savings to the U.S. economy

from the introduction of lithium as a treatment for bipolar disorder is estimated at $145 billion. No dollar figure can be put

on the benefits to patients and families spared the anguish of

manic and depressive episodes, which often tear apart the fabric of family life and social relationships. Similarly, the introduction of clozapine for treatment of schizophrenia has been

estimated to have yielded savings of $1.4 billion per year since

1990.18 Thus, every incentive exists to improve our understanding of disorders affecting brain function and to develop more

effective treatments for them.

Research on these conditions falls into two broad categories:

studies aimed at elucidating the underlying pathophysiologic

bases of the disorders; and studies intended to develop or test

new treatments for them. Among the most powerful approaches to examining basic aspects of brain function and dysfunction

are new techniques that allow imaging of the working brain.

Positron emission tomography (PET), fast magnetic resonance

imaging (fMRI), single photon emission computer tomography

(SPECT), and related devices facilitate identification of the

anatomic location of brain areas involved in cognitive and

affective functions.19 Comparisons of normal and afflicted

populations permit localization of regions affected by the disease process. These techniques also allow monitoring of the

effects of treatment regimens at the level of the brain.20

Medications are the mainstay of treatment for severe psychiatric and neurologic disorders—although behavioral interventions can be useful adjuncts—and thus are the primary focus of

treatment-oriented research. Development of new medications

is being facilitated by studies of brain neurotransmitter receptors, which allow new molecules to be created that have the

desired therapeutic effects with minimal side effects. More

innovative approaches still on the drawing boards include

insertion of new genes to correct identified defects underlying

brain disorders (“gene therapy”), and use of immunologic therapies, like the recent successful inoculation of rats against the

psychostimulant effects of cocaine.21

Some basic research (e.g., on brain receptor mechanisms) can

be performed with animal subjects rather than with humans.

But when disease processes themselves are under study, the

absence of animal models for most psychiatric and neurologic

syndromes means that research on both underlying mechanisms of disease and on promising treatments must involve

human subjects. Moreover, unless research is to be limited to

the mildest forms of the disorders—which may differ substantively from more chronic or severe forms—persons whose decisionmaking capacities may be impaired are likely to be

involved. From this reality flows the central dilemma of designing appropriate protections in research on decisionally

impaired populations: protection of subjects from harm must

be balanced against the potential for benefit to subjects themselves, and to other persons with their disorders, that may arise

from research participation.

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DECISIONALLY IMPAIRED RESEARCH SUBJECTS: DISORDERS AND RESEARCH PROMISES

16 World Health Organization. The Global Burden of Disease. Cambridge, MA: Harvard University Press, 1997.

17 American Psychiatric Association. Opening Windows into the Future: Psychiatric Research in the 21st Century. Washington, DC: APA, 1997.

18 Testimony of Steven Hyman, Director, National Institute of Mental Health, U.S. Senate Appropriations Subcommittee Hearings, 1997; Meltzer, Cola, Way, Thompson, Bastani, Davies,

and Snitz. “Cost effectiveness of clozapine in neuroleptic-resistant schizophrenia,” American Journal of Psychiatry 150 (1993): 1630–38.

19 Andreasen, O’Leary, and Arndt. “Neuroimaging and clinical neuroscience: basic issues and principles,” in Oldham, Riba, and Tasman (eds.), American Psychiatric Press Review of Psychiatry, Vol. 12. Washington, DC: American Psychiatric Press, 1993.

20 Baxter, Schwartz, Bergman, Szuba, Guze, Mazziotta, Alazraki, Selin, Ferng, Munford, and Phelps. “Caudate glucose metabolic rate changes with both drug and behavior therapy for

obsessive-compulsive disorder,” Archives of General Psychiatry 49 (1992): 681–89.

21 American Psychiatric Association, Opening Windows, op.cit.

PAPER TWO RESEARCH INVOLVING 

PERSONS WITH MENTAL 

DISABILITIES

A Review of Policy Issues and Proposals

Introduction 

Developing a federal policy to govern research involving adults

with cognitive impairment poses numerous challenges. Some

challenges are related to the diverse abilities and situations of

individuals in this population. Due to this diversity, relatively

detailed standards and procedures are required to discern

which persons are capable of independent decisions to enter

and remain in a study, and which need the assistance of another to act as research decision maker. Challenges also arise from

the effort to show respect for the varied present and former

preferences of decisionally incapable persons. Additional challenges are posed by the lack of clear consensus concerning 

the acceptable balance of risk and expected benefit in studies

involving incapable subjects.

Practical challenges face those creating federal policy on

research involving adults with mental disabilities as well. Some

proposals in the literature may be too complex for real-world

application. Federal policy must be reasonably attainable by,

and conveyed in language comprehensible to, Institutional

Review Board members, researchers, clinicians, and lay persons.

I begin by describing the historical context of the current

debate over research involving adults with mental disabilities.

Then, with the goal of delineating the choices before you, I discuss six basic concepts relevant to potential policy. Though the

concepts merit separate analysis, they often are combined in

various policy proposals. For example, some proposals favor a

higher standard for capacity to enter a research study when the

risks of participation are significant; other suggest that higherrisk studies for incapable subjects should be permitted only as

long as the subject affirmatively assents or previously consented while competent to participate.

The following is a list of basic questions to be addressed in

the deliberations on appropriate federal policy for research

involving adults with mental disabilities:

n What capacity standard(s) should apply to persons deciding about research participation?

(Should a lower standard be applied to persons

designating a research proxy decision maker?)

n What procedures, if any, should be required to

ensure that an individual’s decision to enter 

(and remain in) research is capable, informed,

and voluntary? Should special procedures be

Rebecca Dresser, J.D.

John Deaver Drinko-Baker & Hostetler Professor 

Case Western Reserve University

School of Law

Professor, Center for Biomedical Ethics

School of Medicine

Mailing Address:

Case Western Reserve University

School of Law

11075 East Boulevard

Cleveland, Ohio 44106

Telephone: (216) 368-6071

E-mail: rsd2@po.cwru.edu
required only in certain cases, such as research

presenting no prospect of direct benefit? When,

if ever, should an independent monitor be

involved in such evaluations?

n Should federal policy encourage or require specific qualifications for persons making research

decisions for incapable individuals (e.g., legal

guardianship, prior designation as research or

health care proxy, legislative authorization to

make health care decisions)? 

n Should substantive standards be adopted for

decisions by subject representatives (e.g., choose

according to subject’s prior express wishes or

general values and preferences, or subject’s best

interests)?

n Should requirements be adopted for education

and screening of subject representatives? (If so,

who should perform these tasks?)

n Should affirmative subject assent (always/sometimes/never) be required? Should research ever be

permitted when subjects appear partially or completely incapable of assent? If so, when? What

constitutes an objection sufficient to block continued participation? When, if ever, may research

proceed despite an incapable subject’s objection? 

n What procedures should be applied to monitor

an incapable subject’s continued willingness to

participate in research? When, if ever, should an

independent monitor be required?

n Should research advance directives be encouraged or required? If so, what constitutes informed

advance consent to research participation? How

should the subject’s right to withdraw be respected

in this situation? When, if ever, should a research

directive be a permissible basis for conducting

research presenting greater risk to an incapable

subject than is ordinarily permitted?

n Should policy specify the appropriate direct benefits, indirect benefits, and risks to be weighed in

evaluating studies involving incapable subjects? 

n Should policy incorporate the concepts of “minimal risk” and “a minor increase over minimal

risk”? If so, should the concepts be defined with

greater precision than in current federal policy?

n Should limits be placed on the degree of risk 

permissibly presented in research involving 

incapable subjects? What prospect of direct benefit to subjects or benefit to society is sufficient to

justify various degrees of research risks? Should a

national review process be adopted to consider

the justification for certain categories of research

with risk-expected benefit ratios unfavorable to

incapable or questionably capable subjects?

n Should monitoring procedures be required to

ensure that acceptable risk-expected benefit 

standards are observed in ongoing research?

n Should IRBs be required to include representatives of relevant subject groups when reviewing

studies involving mentally disabled persons?

Should policy direct IRBs or investigators to

arrange for notice to, and consultation with,

representatives of affected communities regarding proposed, ongoing, and completed research? 

Historical Context

International Developments

The subject’s informed and voluntary consent is the strongest

basis for enrollment in a research study. Certain persons diagnosed with psychiatric disorders, developmental disabilities,

dementia, and other conditions associated with mental disability possess the necessary cognitive abilities and are sufficiently

independent of others to provide informed and voluntary consent. Many others, however, are not. A basic moral and policy

question is whether these individuals should ever be involved 

in research.

The Nuremberg Code, the first international document on

human subjects research, appears to forbid such research.

According to the Code, “[t]he voluntary consent of the human

subject is absolutely essential.” Adequate consent requires the

subject’s: (1) “legal capacity to consent”; (2) ability “to exercise

free power of choice without the intervention of any element of

force, fraud, deceit, duress, or over-reaching, or other ulterior

form of constraint or coercion”; and (3) “sufficient knowledge

and comprehension of the elements of the subject matter

involved,” including “the nature, duration, and purpose of

the experiment; the method and means by which it is to be 

conducted; all inconveniences and hazards reasonably to be

expected; and the effects upon his health or person which may

possibly come from his participation in the experiment.”1

Absent from the Code is any provision authorizing surrogate

consent to research on behalf of subjects incapable of producing a decision that meets these criteria.

Later research codes and policies have rejected the Nuremberg Code’s apparent position that informed and voluntary

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RESEARCH INVOLVING PERSONS WITH MENTAL DISABILITIES: A REVIEW OF POLICY ISSUES AND PROPOSALS

1 United States v. Karl Brandt, reprinted in Katz, Experimentation with Human Beings (1972): 292, 305.
consent is an absolute prerequisite to a human subject’s research

participation. Two justifications are offered for this rejection.

One rests on an interpretation of the Code in light of its historical origins. The Code was formulated in response to the

Nazi experiments conducted on competent subjects without

their consent. The judges issuing the Code may not have

intended to take a specific position on research involving incapable subjects.2 The second justification for rejecting a ban 

on research involving incapable subjects is based on moral 

considerations. Because new treatments must eventually be

tested in persons suffering from the relevant condition, a policy totally excluding incapable subjects from research would

preclude the development of improved treatment for persons

with serious psychiatric disorders, dementia, and other mentally debilitating conditions.

The next major international research code reflects these

views. The World Medical Association’s Declaration of

Helsinki, first issued in 1964, provides for limited research

involvement of incapable human subjects. The most recent 

version of the Declaration states, “[i]n the case of legal incompetence, informed consent should be obtained from the legal

guardian in accordance with national legislation.”3 The 

Declaration divides research into two categories: “therapeutic”

and “non-therapeutic.” The Declaration appears to rule out 

the participation of incapable subjects in research that fails 

to offer them the possibility of direct benefit. When research

has the advancement of knowledge for the benefit of others 

as its sole objective, the Declaration states, “[t]he subjects

should be volunteers ....”

Two other recent documents address research involving incapable human subjects. The International Ethical Guidelines for

Biomedical Research, issued in 1993 by the Council for International Organizations of Medical Sciences (CIOMS) and the

World Health Organization (WHO), allow an incapable individual’s research participation to be authorized by a “legal

guardian or other duly authorized person.” The guidelines 

permit research involving incapable subjects only if “the 

degree of risk attached to interventions that are not intended 

to benefit the individual subject is low” and “interventions ...

intended to provide therapeutic benefit are likely to be at least

as advantageous to the individual as any alternative.” Incapable

subjects’ objections to participation must be respected; the 

sole exception would be the rare case in which “an investigational intervention is intended to be of therapeutic benefit to a

subject, ... there is no reasonable medical alternative, and local

law permits overriding the objection.”4

Last November, the Council of Europe’s Committee of

Ministers adopted the Convention for the Protection of Human

Rights and Dignity of the Human Being With Regard to the

Application of Biology and Medicine. This document allows

persons without the capacity to consent to be involved in

research if all the following conditions are met: (1) “the results

of the research have the potential to produce real and direct

benefit to his or her health”; (2) “research of comparable 

effectiveness cannot be carried out on individuals capable of

giving consent”; (3) participation is authorized by the incapable person’s “representative or an authority or a person or

body provided by law”; and (4) the incapable person does not

object to participation.

The document also permits research that fails to offer subjects potential direct health benefit if the study meets conditions two through four, above, and: (1) is designed to produce

knowledge for the benefit of persons with the same condition;

and (2) “entails only minimal risk and minimal burden for 

the individual concerned.”5

U.S. Policy Development

In the aftermath of Tuskegee and other disturbing studies by

U.S. researchers, Congress enacted legislation establishing the

National Commission for the Protection of Human Subjects 

in 1974. Besides its work addressing the ethics of human subjects research in general, the commission produced analyses of

the ethical and legal issues raised by the involvement of certain

groups deemed especially vulnerable to inappropriate research

practices. These groups included children, who are legally

incompetent to make independent decisions, and persons 

institutionalized as mentally infirm, whose mental impairment 

and institutionalized status can prevent them from making

informed and voluntary decisions to participate in research.6

In its 1977 Report and Recommendations on Research

Involving Children,7 and its 1978 Report and Recommendations on Research Involving Those Institutionalized as Mentally Infirm,8 the commission rejected both the Nuremberg

Code’s complete ban and the Helsinki Declaration’s limitation

on the involvement of incapable subjects. The commissioners

believed a less restrictive approach was justified to avoid harm

to incapable persons as a group:

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RESEARCH INVOLVING PERSONS WITH MENTAL DISABILITIES: A REVIEW OF POLICY ISSUES AND PROPOSALS

2 McCormick, Proxy Consent in the Experimentation Situation, Perspectives in Biology and Medicine 18 (Autumn, 1974): 2.

3 World Medical Association, Declaration of Helsinki, Journal of the American Medical Association 277 (1997): 927.

4 CIOMS/WHO, International Ethical Guidelines for Biomedical Research Involving Human Subjects 22 (1993).

5 Council of Europe, Convention on Human Rights and Medicine (Nov. 1996). Member states will be invited to ratify or otherwise respond to this document.

6 Some infamous incidents of human subjects use in the U.S. involved children with developmental disabilities (the Willowbrook State School hepatitis study and the radiation study at

Fernald State School) and debilitated elderly adults (the cancer study at the Jewish Chronic Disease Hospital). See Advisory Committee on Human Radiation Experiments, Final Report

(1995): 342-46; Bein, “Surrogate Consent and the Incompetent Human Subject,” Food Drug Cosmetic Law Journal 46 (1991); 739, 756–57.

7 National Commission, Report and Recommendations, Research Involving Children (1977) [hereinafter Report on Children].

8 National Commission, Report and Recommendations, Research Involving Those Institutionalized as Mentally Infirm (1978) [hereinafter Report on Institutionalized Persons].
since some research involving the mentally

infirm cannot be undertaken with any other

group, and since this research may yield significant knowledge about the causes and treatment

of mental disabilities, it is necessary to consider

the consequences of prohibiting such research.

Some argue that prohibiting such research might

harm the class of mentally infirm persons as a

whole by depriving them of benefits they could

have received if the research had proceeded.9

The commissioners concluded that the dual goals of benefiting the class of mentally infirm persons and protecting 

individual subjects from undue harm could be met by a third

approach: incapable subjects could be involved in studies offering them potential direct benefit, as well as studies failing to

offer potential direct benefit, as long as the burdens and risks 

of research participation did not exceed a certain level.

Based on this general approach, the commission created a

framework for evaluating research involving incapable subjects. The commissioners’ proposals regarding children and

institutionalized persons with mental impairments were similar, though with some variation. The proposals had in common

the following: (1) a requirement to justify the involvement of

these subject groups rather than alternative, less vulnerable

subject populations; (2) a hierarchy of research categories

establishing more rigorous substantive and procedural standards for proposals presenting more than minimal risk to 

incapable subjects; and (3) a mechanism for incapable subjects to provide input in the form of “assent” or objection to

study participation.

Differences in the recommendations on children and institutionalized persons were based on the commissioners’ recognition that some adults institutionalized as mentally infirm 

retain the ability to issue an informed and voluntary decision.

Because of concerns about the vulnerability of institutionalized persons, however, the commission recommended that

IRBs be given discretion to appoint “an auditor to observe 

and assure the adequacy of the consent process for research”

presenting greater than minimal risk. Moreover, the commissioners believed such auditors should be required in 

projects presenting no prospect of direct benefit and more 

than minimal risk to subjects. The commission’s proposals 

also gave incapable adults more authority than children to

block study participation.10 Finally, because incapable adults

lack the clear legal guardian that most children have, the 

commission noted that in some cases a court-appointed

guardian would be required to provide adequate authority for

research participation.

In response to the commission’s work, the Department of

Health, Education and Welfare (DHEW) proposed regulations

to govern research on the two populations. The regulations on

research involving children were adopted by the Department 

of Health and Human Services (DHHS) in June, 1983.11 Proposed regulations on persons institutionalized as mentally 

disabled were never adopted, however.12

The Secretary of DHHS attributed the government’s failure

to issue final regulations on research involving institutionalized

persons to “a lack of consensus” on the proposed regulatory

provisions and to a judgment that the general regulations 

governing human subjects participation sufficiently incorporated the commission’s recommendations.13 Robert Levine

blames the reported lack of consensus on DHEW’s earlier 

failure to adhere to the commission’s recommendations. The

agency’s proposed regulations indicated that consent auditors

might be mandatory for all research involving institutionalized,

mentally disabled persons. Moreover, they suggested that the

authorization of an additional person, assigned the role of

independent advocate, might be necessary before an incapable

person could become a research subject. During the public

comment period, many responded negatively to these additional procedural requirements, presumably on the belief that 

they were unnecessary and overly burdensome to research.14

Current U.S. Regulations

At this time, no special regulations govern research involving

adults diagnosed with a condition characterized by mental

impairment. Such research is governed by the “Common

Rule,”15 the general federal provisions governing human subjects research. A few Common Rule provisions address research

involving persons with mental disabilities. The rule identifies

“mentally disabled persons” as a vulnerable population. Institutional review boards are directed to include “additional

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9 Id., 58.

10 The commission required explicit court authorization to involve an objecting institutionalized person in research. In contrast, the group recommended that parents be permitted to

authorize research over a child’s objection if the study presents a prospect of direct benefit to subject not available outside the research context.

11 Protection of Human Subjects, Additional DHHS Protections for Children Involved as Subjects in Research, 48 Fed. Reg. 9818 (Mar. 8, 1983).

12 Protection of Human Subjects, Proposed Regulations on Research Involving Those Institutionalized as Mentally Disabled, 43 Fed. Reg. 53950 (Nov. 17, 1978).

13 President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Implementing Human Research Regulations (1983): 23–29.

14 Levine, “Proposed Regulations for Research Involving Those Institutionalized as Mentally Infirm: A Consideration of Their Relevance in 1996,” IRB (Sept.-Oct. 1996): 1. See also 

Bonnie, “Research With Cognitively Impaired Subjects,” Archives of General Psychiatry 54 (1997): 105, 107 (debate over proposed regulations provoked division between scientists 

concerned that safeguards, especially consent auditors and subject advocates, would significantly hinder research and advocates for mentally disabled persons, concerned about 

subjects’ vulnerability). Bonnie also refers to opposition to special regulations for persons with mental illness on grounds that such an approach would foster negative stereotypes

about such individuals.

15 Federal Policy for the Protection of Human Subjects, 56 Fed. Reg. 28012 (1991).
[unspecified] safeguards ... to protect the rights and welfare” of

mentally disabled research subjects; IRBs are also advised to

ensure that “subject selection is equitable,” and that mentally

disabled persons are not involved in research that could be 

conducted on a less vulnerable group.16 Finally, “[i]f an IRB

regularly reviews research that involves a vulnerable category 

of subjects, such as ... mentally disabled persons, consideration

should be given to the inclusion of one or more individuals

who are knowledgeable about and experienced in working with

these subjects.”17 The rule allows an incapable individual’s

“legally authorized representative” to give valid consent to the

individual’s research participation,18 but provides no definition

of incapacity, no guidance on the identity or qualifications of

a subject representative, and no statement on acceptable riskexpected benefit ratios for research involving decisionally 

incapable subjects.

In the 1980s and 1990s, numerous groups and individuals

expressed dissatisfaction with gaps in the existing regulations.

These included the Advisory Committee on Human Radiation

Experiments, which reviewed eight studies conducted in the

early 1990s involving adult subjects with questionable decisionmaking capacity. Four of these studies required that subjects

undergo diagnostic imaging that offered them no prospect of

direct benefit, and two appeared to present greater than minimal risk. Yet, as the Committee noted, “there was no discussion

in the documents or consent form of the implications for the

subjects of these potentially anxiety-provoking conditions.

Nor was there discussion of the subjects’ capacity to consent or

evidence that appropriate surrogate decision makers had given

permission for their participation.”19 Inquiries into studies

involving medication withdrawal from persons diagnosed with

schizophrenia also have raised questions about the adequacy of

existing federal policy.20

Dissatisfaction with the current regulatory system also has

driven many organizations and individuals to offer proposals

for additional provisions to govern research on mentally disabled persons in general, as well as on particular subgroups,

such as persons with dementia and persons diagnosed with

psychiatric disorders. These proposals, and their underlying

positions on the major ethical issues, are discussed in the

remainder of this paper.

Capacity Assessment

Determining the proper standards and procedures to govern

capacity assessment poses a major challenge in formulating

policy on research involving subjects with mental disabilities.

Persons with mental disabilities vary widely in their ability to

engage in independent decision making. Persons with psychiatric disorders may retain such capacity, possess it intermittently, or be permanently unable to make decisions for themselves.

Individuals with dementia frequently retain decisionmaking

capacity early in the course of the illness, but with time they

become intermittently, and then permanently, unable to make

their own decisions. Some individuals with developmental 

disabilities are capable of making many choices for themselves;

others completely lack such capacity.21

Incorrect capacity determinations are problematic because 

of their moral consequences. A judgment that a capable person

is incapable of exercising autonomy is disrespectful, demeaning, and stigmatizing to that individual. Conversely, a judgment that an incapable person is capable leaves that individual unprotected and vulnerable to exploitation by others.22

The presence of many “borderline” cases among members of

the relevant populations triggers concern about the adequacy 

of subject capacity assessments. Although it is important to

accord due respect to mentally disabled persons capable of

autonomous choice, it is also important to recognize that 

investigators seeking to enroll subjects may be too willing to

label prospective subjects capable when this will advance their

research objectives.23

Existing federal policy fails to provide guidance to investigators and IRBs on the appropriate substantive and procedural

standards applicable to capacity determinations in research

involving mentally disabled subjects. In the current situation,

individual IRBs determine how investigators are to address

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16 Sec. ___.111 (a)(3) and (b).

17 Sec. ___.107(a).

18 Sec. ___.116 

19 Final Report, supra, 706–07.

20 Office for Protection from Research Risks, Evaluation of Human Subject Protections in Schizophrenia Research Conducted by the University of California, Los Angeles (1994). See also

Shamoo and Keay, “Ethical Concerns About Relapse Studies,” Cambridge Quarterly of Healthcare Ethics 5 (1996): 373 (in review of 41 U.S. studies involving relapse published between

1966 and 1993, authors found frequent lack of attention to capacity assessment, subject or proxy consent, risk reduction and justification, and monitoring to avoid harm to subjects

after studies were initiated).

21 See generally Thomasma, “A Communal Model for Presumed Consent for Research on the Neurologically Vulnerable,” Accountability in Research 4 (1996): 227; Sachs, et al., “Ethical

Aspects of Dementia Research: Informed Consent and Proxy Consent,” Clinical Research 42 (1994): 403.

22 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human

Subjects of Research (1979) [hereinafter Belmont Report].

23 See, e.g., Marson, et al., Journal of the American Geriatrics Society 45 (1997): 453, 455 (“researchers increasingly desire and encourage” patients with Alzheimer’s disease (AD) to participate in research, but at the same time, “the progressive cognitive impairment characteristic of the disease relentlessly erodes decision-making capacity and makes AD patients vulnerable to coercion and exploitation”); Shamoo and Keay, supra, (1996) 373 (expressing concern about researchers’ assumptions of subject capacity, for example, in one study authors

asserted that all 28 acutely psychotic subjects with schizophrenia “were capable of informed consent and entered voluntarily”).
these matters. The likely result is substantial variation in the 

criteria and safeguards applied to this form of research.24 Most

of the commentary supports more systematic and specific 

federal direction on capacity assessment.25 Greater guidance is

needed on defining decisional capacity in the research context,

and procedures for assessing such capacity.

Substantive Requirements for Research Decision Making 

An autonomous choice to enter a research study is both

informed and voluntary. To be capable of informed choice, it 

is generally agreed that a prospective subject should demonstrate the ability “to understand the nature of the research participation; appreciate the consequences of such participation;

exhibit ability to deliberate on alternatives, including the 

alternative not to participate in the research; and evidence 

ability to make a reasoned choice.”26 Subjects also should 

“comprehend the fact that the suggested intervention is in fact

research (and is not intended to provide therapeutic benefit

when that is the case),” and that they may decide against participation “without jeopardizing the care and concern of health

care providers.”27

There is consensus that decisional capacity requires a certain level of cognitive ability. Less agreement exists on whether

subjects should be judged incapable if they lack affective 

appreciation of the choice before them. In a recent article, Carl

Elliott argues that some depressed persons “might realize that 

a protocol involves risks, but simply not care about the risks,” or

“as a result of their depression, may even want to take risks.”28

Elliott believes that judgments on a person’s capacity to consent to research should take into account such emotional 

attitudes. He also proposes that subjects failing to exhibit a

“minimal degree of concern for [their] welfare” should be

deemed incapable of independent decision making. Others

oppose this position, contending that such an approach could

yield excessive paternalism toward persons diagnosed with

mental disorders, insufficient data exist on the extent of incapacitating emotional impairment among depressed persons,

affective impairment is difficult to assess, and normative consensus is lacking on “how much impairment we as a society are

willing to tolerate before we consider someone incompetent.”29

It is generally agreed that a prospective subject’s capacity to

decide whether to participate in a particular research project

cannot be determined through a general mental status assessment.30 Instead, investigators must present the specific material

relevant to that project and evaluate the prospective subject’s ability to understand and appreciate that information.31

Some commentators endorse a “sliding-scale” approach to

decisional capacity in the research setting. This approach

demands an increasing level of understanding and appreciation as study risks increase and potential benefits to subjects

decrease.32 Similarly, some suggest that many prospective subjects incapable of independent research decision making

remain capable of selecting a research proxy, since “the decisionmaking capacity that is required to designate a proxy is far less

than the capacity required to understand a detailed protocol.”33

Besides being informed, a decision to enter research should

be voluntary. The Nuremberg Code provides descriptive characteristics of a voluntary decision.34 The National Commission’s Belmont Report characterizes a voluntary decision as

“free of coercion and undue influence.” According to the 

report, “[c]oercion occurs when an overt threat of harm is

intentionally presented by one person to another in order 

to obtain compliance. Undue influence ... occurs through an

offer of an excessive, unwarranted, inappropriate or improper

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24 Bonnie, supra, 109.

25 E.g., id.

26 High, et al., “Guidelines for Addressing Ethical and Legal Issues in Alzheimer Disease Research: A Position Paper,” Alzheimer Disease and Associated Disorders 8 (Supp. 4, 1994); 66, 69.

In discussing decisional capacity in the research context, many writers also cite the President’s Commission’s requirements for treatment decisionmaking capacity: (1) possession of a

set of values and goals; (2) ability to communicate and comprehend information; and (3) ability to reason and deliberate about the choice at hand. President’s Commission for the

Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in

the Patient-Practitioner Relationship (1982): 60.

27 Melnick, et al., “Clinical Research in Senile Dementia of the Alzheimer Type,” Journal of the American Geriatrics Society 32 (1984): 531, 533.

28 Elliot, “Caring About Risks,” Archives of General Psychiatry 54 (1997): 113.

29 Appelbaum, “Rethinking the Conduct of Psychiatric Research, “Archives of General Psychiatry 54 (1997): 117, 119. See also Hirschfeld, et al., “Protecting Subjects and Fostering

Research,” Archives of General Psychiatry 54 (1997): 121.

30 High, et al., supra; Marson, “Determining the Competency of Alzheimer Patients to Consent to Treatment and Research,” Alzheimer Disease and Associated Disorders 8 (Supp. 4, 1994): 5.

31 According to the Common Rule, prospective subjects should understand: (1) that the study involves research; (2) the purposes of the research; (3) the expected length of time of

research participation; (4) the procedures to be performed and which, if any, are experimental; (5) reasonably foreseeable risks and discomforts; (6) reasonably expected benefits to

subjects or others; (7) alternatives, including treatment, that could benefit the individual more than research participation; (8) the level of confidentiality protecting any identifiable

information recorded on the subject; (9) whether compensation and medical treatment will be available for injuries resulting from research; (10) the identity of the person(s) to 

notify if the subject has questions or suspects research-related injury; and (11) that participation is voluntary, refusal will not be penalized, and participation may cease at any time

without penalty. 56 Fed. Reg. sec. ___.116(a). Additional information must be disclosed and understood when relevant to a particular study, such as any additional costs subjects 

may incur as a result of study participation. Id., sec. ___.116(b).

32 Elliott, “Mentally Disabled and Mentally Ill Persons: Research Issues,” in Encyclopedia of Bioethics, rev. ed., W.T. Reich (ed.) (1995): 1760; Appelbaum, “Drug-Free Research in Schizophrenia: An Overview of the Controversy,” IRB (Jan.-Feb. 1996): 1; Annas and Glantz, “Rules for Research in Nursing Homes,” New England Journal of Medicine 315 (1986): 1157.

33 Sachs, et al., supra, 410.

34 See p. 5, above.
reward or other overture in order to obtain compliance.”

In addition, the report notes, an inducement that is not overly

persuasive to most adults could unduly influence the judgment of vulnerable subjects. The commissioners acknowledged that unjustifiable external influence cannot always be

precisely defined, but that “undue influence would include

actions such as manipulating a person’s choice through the

controlling influence of a close relative and threatening to 

withdraw health services to which an individual would be 

otherwise entitled.”35

Due to its limited congressional mandate, the National 

Commission considered only the potential pressures on institutionalized persons to enroll in research. Recent commentary

favors expanding this concern, on grounds that persons with

mental disabilities are especially vulnerable to such pressures

no matter where they reside.36 Prospective subjects living in 

the community frequently rely heavily on the assistance of

professionals and family members and may perceive research

participation as essential to maintaining the approval of their

caregivers.37 Some support also remains for providing special

protections to persons in residential facilities, due to their 

near-complete dependence on the goodwill of the staff.38

A final element of decisional capacity, implicit in the above

discussion, is the subject’s ongoing ability to make a voluntary

and informed choice to participate. Some persons with psychiatric disorders and dementia can issue an adequately informed

and voluntary consent to participate in a study, but subsequently lose their capacity for independent choice. As a result,

they become unable to exercise their right to withdraw from 

a study. Studies involving subjects with fluctuating or declining decisional capacity must include mechanisms to ascertain

and address this possibility, including provision for appointment of a representative for subjects who become incapable.39

Procedures for Capacity Assessment 

and Information Disclosure

Existing federal regulations acknowledge that mentally disabled

persons may be vulnerable to undue influence or coercion, but

leave the adoption of special safeguards up to individual IRBs.

The regulations also fail to provide guidance on the process that

should govern capacity assessments and information disclosure.

Shortcomings in the process of capacity assessment were

cited in a recent New York appellate court decision invalidating

state regulations governing nonfederally funded research

involving incapable adult residents of facilities operated and

licensed by the New York State Office of Mental Health. Plaintiffs in the case were involuntarily hospitalized individuals

deemed incapable of making treatment decisions who feared

they would also be labeled incapable of research decision 

making and then “forced” to participate in greater than minimal risk studies.

The New York regulations gave the IRB “complete discretion in designating the individual or individuals who will make

the assessment [of subject] capacity and who will thereafter

review the researcher’s initial assessment.” This flexibility,

together with the absence of “appropriate and specific provisions for notice to the potential subject that his or her capacity

is being evaluated and for appropriate administrative and 

judicial review of a determination of capacity” contributed to

the court’s conclusion that the regulations violated the due

process requirements of the New York State Constitution and

the Fourteenth Amendment to the U.S. Constitution.40 This

decision raises questions about the constitutional status of

the existing federal regulations as well, since they closely resemble the invalidated New York regulations.41

A variety of approaches to capacity assessment are endorsed

in the literature on research involving adults with cognitive

impairment. Most commentators believe that IRBs should 

at minimum require investigators to specify the method by

which prospective subjects’ decisional capacity will be evaluated and the criteria for identifying incapable subjects.42 A major

point of contention, however, is whether capacity assessment

and information disclosure should be conducted by an individual not otherwise connected with the research project.

The National Commission recommended that IRBs have 

discretion to require an independent “consent auditor” for 

projects presenting greater than minimal risk to persons institutionalized as mentally infirm. The auditor would observe 

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35 Belmont Report, supra, 6.

36 Bonnie, supra; Levine, Proposed Regulations, supra.

37 Relatives may view research participation as improving their own chances for avoiding conditions that appear genetically linked or as a means to reduce their caregiving burdens. Keyserlingk, et al., “Proposed Guidelines for the Participation of Persons With Dementia as Research Subjects,” Perspectives in Biological Medicine 38 (1995): 319.

38 Elliott, supra; High and Doole, “Ethical and Legal Issues in Conducting Research Involving Elderly Subjects,” Behavioral Sciences and the Law 13 (1995): 319. See also American College

of Physicians, “Cognitively Impaired Subjects,” Annals of Internal Medicine 111 (1989): 843 (recommending that IRB “consider asking a committee composed mostly of representative

residents of, for example, a nursing home, to review proposed research projects to be conducted at the facility).

39 Appelbaum, Drug-Free Research, supra.

40 T.D. v. N.Y. State Office of Mental Health, 650 N.Y.S. 2d 173 (App. Div. 1996).

41 See Capron, “Incapacitated Research,” Hastings Center Report (Mar.-Apr. 1997): 25.

New York’s highest court has agreed to hear plaintiff’s appeal of T.D. Plaintiffs argue that the intermediate appellate court’s decision should apply to all research involving greater than

minimal risk (including studies presenting a prospect of direct benefit) and to federally funded research. The appeal will involve the court in a direct evaluation of the existing federal

policy.

42 E.g., Bonnie, supra; Melnick, et al., supra.
and verify the adequacy of the consent and assent process,

and in appropriate cases observe the conduct of the study to

ensure the subject’s continued willingness to participate.43 The

commission recommended that such auditors be required for 

projects presenting greater than minimal risk and no prospect

of direct benefit to subjects. The DHEW regulations contemplated mandating auditors for all projects involving this subject population, but opposition to this proposal reportedly 

was one reason the regulations never became final.

More recent commentary includes a spectrum of views 

on the need for an independent consent auditor. Some echo 

the National Commission’s view that a requirement for an

independent evaluator becomes increasingly justified as net

research risks to subjects increase. A Canadian group took 

this position in its recent recommendations on dementia

research.44 According to this group, the role of consent assessor/monitor ordinarily can be filled by a researcher or consultant “familiar with dementias and qualified to assess and

monitor competence and consent in such subjects on an 

ongoing basis.” This individual should be knowledgeable about

the project and its risks and potential benefits. On the other

hand, if the research team lacks a person with these qualifications, if there is “a real danger of conflict of interest” for team

members who might evaluate and monitor capacity, or if the

project involves greater than minimal risk and no prospect 

of direct benefit to subjects, an independent assessor/monitor

should be appointed.45

Others appear open to general use of outside observers and

examiners. Recent guidelines adopted by the Loma Linda University IRB state, “[c]onsent observers who are independent of

the investigator and of the institution will be required by the

IRB in those conditions where the potential subject’s decisionmaking capacity is suspect.”46 In testimony before the National

Bioethics Advisory Commission, representatives of Citizens for

Responsible Care in Psychiatry and Research recommended that

“[a]n independent psychiatrist ... determine the capacity of [the]

potential participant to comprehend the risks and benefits of

enrolling in the proposed research study.”47 Recent articles also

endorse the participation of a “special research educator” in the

disclosure and decision process, particularly to ensure that

prospective subjects understand that advancement of general

knowledge is the primary goal of the project at hand.48

A 1991 article makes a strong case for an independent, federally employed patient-advocate’s involvement in capacity

determinations, as well as in assisting and monitoring decision

making by family surrogates for incapable persons. Philip Bein

notes that courts have demanded relatively strict procedural

safeguards in the context of imposed psychiatric treatment 

and sterilization for persons with mental disabilities. He 

makes the following argument for a similar approach in the

research context:

As with psychotropic medication and sterilization,

several distinct features of experimentation suggest 

the need for special protections. First, the history of

medical experimentation has been characterized by

significant incidents of abuse, particularly where 

members of vulnerable populations have been enlisted

as subjects. Second, the interests of medical researchers

in securing participation in the experiment often conflicts with their duties as treating physicians to inform,

advise, and act in the best interests of their patients.

Third, experimentation is inherently highly intrusive

and dangerous, as the nature and magnitude of risks

involved are largely unknown and unknowable.49

In contrast, Bein suggests that courts have not demanded

such safeguards for decisions on life-sustaining treatment, based

on an absence of the above features in the treatment setting.

He also argues that an IRB-administered system of patientadvocates would provide inadequate oversight because such a

system would be too responsive to institutional interests.50

Other recent commentary proposes more diverse methods

for ensuring against inappropriate capacity determinations.

Bonnie opposes a federal requirement for any specific procedure, rather “the regulations should provide a menu of safeguards” from which IRBs could choose, including “specially 

tailored follow-up questions to assess subject understanding,

videotaping or audiotaping of consent interviews, second 

opinions, use of consent specialists, or concurrent consent by 

a family member.”51

Many groups advise the involvement of a trusted family

member or friend in the disclosure and decisionmaking

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43 The commission discussed the auditor’s observation of ongoing research as a means to ensure continued assent, but the mechanism could also be adopted to monitor a capable subject’s continued consent, especially if a decline in capacity is possible.

44 Keyserlingk, et al., supra.

45 Id., 343–44. See also Melnick, et al., supra.

46 Orr, “Guidelines for the Use of Placebo Controls in Clinical Trials of Psychopharmacologic Agents,” Psychiatric Services 47 (1996): 1262.

47 Shamoo and Sharev, “Unethical Use of Persons With Mental Illness in High Risk Research Experiments,” BioLaw 2 (1997): S:23.

48 DeRenzo, “The Ethics of Involving Psychiatrically Impaired Persons in Research,” IRB (Nov.-Dec. 1994). In a study of this approach, researchers found that the participation of a

trained educator increased the comprehension of psychiatric patients asked to enroll in research. Appelbaum, et al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report (April 1987): 20.

49 Bein, supra, 748–49.

50 Id., 762.

51 Bonnie, supra, 110.
process. Capable subjects reportedly are often willing to permit

such involvement. Dementia researchers frequently adopt a

mechanism called “double” or “dual” informed consent when

the capacities of prospective subjects are uncertain or fluctuating.52 This approach has the virtue of providing a concerned

back-up listener and questioner who “may help the cognitively

impaired individual understand the research and exercise a

meaningful informed consent.”53 On the other hand, the presence of a caregiving relative could, in some cases, put pressure

on subjects to enter a research study.54

Another suggestion is to require the use of a two-part consent

process. In this process, information about a study is presented

to a prospective subject and a questionnaire administered to

determine the individual’s comprehension. The subject is then

provided with a copy of the questionnaire to refer to as needed.

If the individual initially fails to demonstrate an adequate

understanding of the material, written or oral information is

presented again, and the subject retested. This process is likely

to yield more accurate judgments of subject capacity than a 

less systematic and rigorous inquiry.55

Finally, numerous ideas have been offered to make information more accessible to subjects capable of exercising independent choice. Simple perceptual aids, such as increasing the

type size of printed material, may enhance the ability of elderly 

subjects to comprehend the necessary information. Information can be delivered through videotape, slides, or pictorial 

presentations. A creative suggestion is for investigators to ask 

representatives of the affected population to critique drafts of

information materials prior to their actual research use.56

The literature offers fewer suggestions for ensuring adequate

voluntariness. The Helsinki Declaration includes a provision

advising “the physician obtaining informed consent for the

research project [to] be particularly cautious if the subject is 

in a dependent relationship or him or her may consent under

duress.” In these circumstances, “informed consent should be

obtained by a physician who is not engaged in the investigation

and who is completely independent of this official relationship.”57 To guard against pressure from family or other caregivers, someone should talk separately with consenting subjects

on their reasons for participating. Again, the issue is whether a

research team member, independent evaluator, or IRB representative should be given this responsibility.

Research Decisions for Persons Incapable 

of Independent Choice

Many persons diagnosed with mentally disabling conditions

are unable to make their own decisions on research participation. Others may become incapable while they are participating

in a study. In these circumstances, persons other than the 

incapable individual must make the choice for or against that

individual’s research involvement. Decisions on the permissible

conditions for enrolling and retaining incapable subjects must

be made at the policy level, as well as by IRBs and the subject’s

personal representative.

Existing federal policy is largely silent on these matters.

According to the Common Rule, the risks presented by any 

proposal to involve human subjects must be reduced to the

minimum necessary to obtain the desired data, and must be

“reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably

be expected to result.”58 No additional limits or criteria for

evaluating permissible risk in research involving incapable 

subjects are included in the rule. Special DHHS regulations

establish such conditions for research involving children, but

research involving incapable adults is governed solely by the

Common Rule’s general provisions.

Existing federal policy also gives little direction on who

should act as the incapable subject’s personal representative in

making decisions on research participation. The Common Rule

simply provides that “[i]nformed consent will be sought from

each prospective subject or the subject’s legally authorized 

representative.”59 The rule fails to address the desirable qualifications of a representative or the substantive criteria that

should guide that person’s choices. The Belmont Report simply

states that third-party decision makers “should be those who

are most likely to understand the incompetent subject’s situation and act in that person’s best interest.”60

Improvements in current policy will require attention to five

areas: (1) selection of an incapable subject’s representative; (2)

substantive criteria governing the subject representative’s decision making; (3) the incapable subject’s assent or objection to

research participation; (4) the incapable subject’s preferences

while capable; and (5) permissible levels of risk in research

involving incapable subjects. Although these areas are discussed

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52 High, et al., supra. See also Bonnie, supra, 110 (“participation of surrogate decisionmakers can be a useful safeguard even if the subject has the requisite capacity to provide legally 

valid consent”).

53 Karlawish and Sachs, “Research on the Cognitively Impaired: Lessons and Warnings from the Emergency Research Debate,” Journal of the American Geriatrics Society 45 (1997): 474, 477.

54 Id.

55 Ratzan, “Technical Aspects of Obtaining Informed Consent from Persons with Senile Dementia of the Alzheimer’s Type,” in Alzheimer’s Dementia: Dilemmas in Clinical Research 123

(Melnick and Dubler, eds., 1985) (citing Miller and Willner, “The Two-Part Consent Form,” New England Journal of Medicine 290 (1974): 964.

56 Melnick, et al., supra.

57 World Medical Association, supra.

58 Sec. ___.111(a).

59 Sec. ___.111(4).

60 Belmont Report, supra, 6.
in separate sections, they are significantly related, and are likely

to be combined in any policy revision.

The Incapable Subject’s Representative

The Common Rule’s use of the phrase “legally authorized 

representative” leaves many unanswered questions. State laws

contain general provisions on the standards and procedures

governing appointment of guardians for persons declared legally incompetent. Guardianship requires a judicial proceeding

and ordinarily authorizes someone to make financial decisions,

personal decisions, or both types of decisions for the incompetent person. Limited guardianships covering a narrower area of

decisionmaking responsibility are also possible.

Relatively few states have laws specifically addressing the area

of research decision making by legal guardians. Existing state

legislation limits the involvement of incapable subjects in

research in various ways; a number of laws require guardians to

obtain specific court authorization to make decisions on a

ward’s research participation.61

Federal research policy is not intended to preempt or otherwise affect state or local laws applying to research, including

those conferring additional protection on subjects.62 Thus,

investigators and IRBs in jurisdictions with specific law governing the identity and authority of research decision makers for

incapable subjects must comply with that law. Yet in the many

states without clear law, it will be left to federal policy, investigators, and IRBs to determine who may act as an incapable subject’s surrogate decision maker in research.

The literature indicates that at present legal guardianship is

rarely, if ever, mandated in the research setting. Instead, close

family members, who may or may not have formal guardianship status, are the customary decision makers when the

research participation of incapable adults is sought.

Should federal policy require formal legal guardianship? The

underlying question is whether such a requirement is necessary

or sufficient to provide adequate protection against inappropriate research use of a vulnerable population to advance the

interests of others. The National Commission recommended

that the permission of either a legal guardian or a judge be

required to authorize the research participation of subjects

institutionalized as mentally infirm in the following situations:

(1) the incapable subject objects to participation; or (2) the

subject is incapable of assent (see below) and the research presents more than minimal risk to subjects.63

Later commentary questions whether formal legal proceedings are necessary to provide adequate protection for incapable

subjects, particularly those not residing in an institutional setting. As one writer notes, IRBs requiring legal guardianship 

“to be on the safe side” could end up contributing to a deprivation of general decisionmaking rights of subjects.64 Moreover,

the guardian appointment process ordinarily will not address

research participation issues in any explicit way. In most cases,

a judicial decision to confer guardianship status on a particular

person is made without consideration of that person’s suitability as a research decision maker.

Dissatisfaction with a requirement for legal guardianship 

has led to proposals of alternative mechanisms for granting

authority to act as an incapable person’s representative in

research decision making. One option is to allow decisionally

capable persons to authorize in advance a specific individual 

to make decisions on research participation during a future

period of incapacity. This device, which is modeled on the

durable power of attorney (DPA) for health care, has the 

virtue of promoting the capable individual’s autonomous 

views on who is best suited to act on his or her behalf in the 

research context.

The primary advantage of the research DPA is the explicit

authority granted by the subject, who presumably will choose

someone likely to express her values and protect her welfare.

Intramural research at the National Institutes of Health (NIH)

Clinical Center is governed by a policy that encourages this

approach.65 The American College of Physicians and numerous

others express support for use of these devices.66 As a practical

matter, however, it is unclear whether many individuals will 

be interested in or willing to complete such a document.67

Moreover, the device cannot be applied to the population of

persons with mental disability who are currently incapable 

and not expected to recover capacity.68

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61 See Appendix for brief descriptions of existing state legislation.

62 Common Rule, Sec. ___.101(f).

63 National Commission, Report on Institutionalized Persons, supra, 11–20. At least one commentator supports a requirement for explicit judicial authorization prior to an incapable 

subject’s enrollment in research if relatives are unwilling to act as subject representatives or if a subject-advocate questions a family surrogate’s good faith or decisionmaking capacity.

Bein, supra. Others have criticized this view as intrusive, unnecessarily adversarial, and too great an impediment to research. Berg, “Legal and Ethical Complexities of Consent with

Cognitively Impaired Research Subjects: Proposed Guidelines,” Journal of Legal and Medical Ethics 24 (1996): 18; Kapp, “Proxy Decision Making in Alzheimer Disease Research:

Durable Powers of Attorney, Guardianship, and Other Alternatives,” Alzheimer Disease and Related Disorders 8 (Supp. 4, 1994): 28.

64 Office for Protection from Research Risks, Protecting Human Research Subjects: Institutional Review Board Guidebook (1993): 6–30. See also High and Doole, supra, 328 (guardianship

process may produce rights deprivation and “is often intrusive, humiliating, expensive, and time-consuming”).

65 Fletcher and Wichman, “A New Consent Policy for Research With Impaired Human Subjects,” Psychopharmaceutical Bulletin 23 (1987): 382; NIH Clinical Center, Consent Process in

Research Involving Impaired Human Subjects (Mar. 30, 1987). If no relative or friend is available, prospective subjects may designate the Center’s patient representative or a chaplain 

or social worker not assigned to the research unit.

66 American College of Physicians, supra. See also Kapp, supra; Melnick, et al., supra.

67 See High and Doole, supra.

68 See pp. 40–51, below for further discussion of the research DPA.
A second potential source of authority is an existing health

care power of attorney. In this situation, the now-incapable

subject previously exercised an autonomous choice to delegate

medical decision making to a particular person. The question is

whether an individual’s choice of a friend or relative to make

treatment decisions in the event of incapacity is defensibly

interpreted as an authorization for research decision making as

well. The NIH Clinical Center policy allows previously chosen

health care proxies to make research decisions for subjects.69

A third alternative is to regard state legislation authorizing

family members to make certain treatment decisions on behalf

of relatives as conferring authority for research decisions as

well. It might be argued that such legislation embodies a recognition that important health-related decisions for decisionally

incapacitated persons are properly assigned to relatives. Most

reasonable would be to extend the laws’ application to a close

relative’s decision regarding research offering potential health

benefit to an incapable subject.70 Others believe that these laws

should not be interpreted so expansively and that amendments

or new legislation would be required to provide explicit statutory authority for delegation of research decision making to relatives.71

The final possible option is to assign research decisionmaking

authority based on the simple status of being a close relative.

Support for this alternative comes from the long-held tradition

in health care of relying on families to make decisions for incapable persons, as well as from the belief that relatives are most

likely to make decisions in accord with the incapable person’s

values, preferences, and interests.72 This approach also is easy to

administer; moreover, it apparently has been, and continues to

be, a common practice in the actual research setting.73

Each of the above options presents advantages and drawbacks. Requiring judicial involvement raises the costs of

research and does not necessarily advance respect for, and protection of, incapable persons. Requiring explicit DPAs for

research poses practical difficulties, since relatively few persons

have, or can be expected to complete, these documents. Another question is whether the power of DPAs to accept research

risks to an incapable individual should be equal to the power of

competent adult subjects to consent to such risks for themselves

(see below). New legislation authorizing relatives to make

research decisions for incapable persons would require action

by the states; such legislation would emerge slowly and in some

states, not at all.

All of these alternatives also raise questions about the accuracy with which incapable subjects’ values and preferences as

competent persons will be expressed by formal or informal representatives.74 The problem of potential conflicts of interest

between subjects’ interests and those of their representatives

exist as well. Those most likely to act as representatives are family members, who may see the subject’s research participation

as an avenue “that may lighten the burden of caregiving or lead

to treatment from which the family member may benefit.”75

Two empirical studies found some family members willing to

allow an incapable relative to be entered in a research study

even though they thought the relative would refuse if competent. Some family members also stated they would allow an

incapable relative to become a subject even though they would

refuse to enroll in such a study themselves.76

One response to the above concerns is to conduct screening

and education of subject representatives, with the goal of ascertaining inappropriate decision makers and enhancing the likelihood that representatives will make choices that adequately

respect the subject’s competent preferences and current interests.77 Adopting a requirement for screening and training

would raise the further question of whether this procedure

should be conducted by a member of the research team, the

IRB, or someone otherwise independent of the project.78

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69 NIH Clinical Center, supra.

70 Bonnie, supra, 110.

71 Kapp, supra.

72 This position is endorsed in policy guidelines adopted by Alzheimer Disease Centers in the U.S. See High, et al., (“[u]nless there is statutory or case law to the contrary, family members

should be recognized as having surrogate authority without prerequisite appointment as guardians or proxies through the use of instruments such as durable powers of attorney”).

73 Kapp, supra; High and Doole, supra.

74 See Sachs, “Advance Consent for Dementia Research,” Alzheimer Disease and Related Disorders 8 (Supp. 4 1994): 19 (“I think it is fair to assume that most proxies [in the current 

consent process] know very little about their demented relative’s preferences regarding research participation”).

75 Keyserlingk, et al., supra, 346.

76 Sachs, et al., supra; Warren, et al., “Informed Consent by Proxy,” New England Journal of Medicine 315 (1986): 1124. There were also cases in which family members would not allow 

an incapable subject’s participation even though they thought the subject would consent if competent or the family members would enter such a study themselves.

77 See, e.g., High and Doole, supra 328 (“family members may be disqualified to serve as surrogates for a variety of reasons, including lack of capacity, inattention to the subject’s wellbeing, self-interested motives, or unavailability”); American College of Physicians, supra, 844 (“researchers must inform [proxies and surrogates] of the standards for decisionmaking”).

Some concerns about the quality of third-party decisions are raised by empirical studies of parents consenting to their children’s’ research participation. For example, a recent 

study of 64 parents whose children had participated in a clinical trial found that only a small number recognized that drug trials are designed to test safety as well as efficacy, while 

the majority believed such trials posed either no risk or low risk. Fewer than half realized that they had the right to withdraw their children from the trial at any time. Harth and

Thong, “Parental Perceptions and Attitudes About Informed Consent in Clinical Research Involving Children,” Social Science and Medicine 41 (1995): 1647.

78 For contrasting views on this point, see Berg, supra, 26 (investigator or IRB could prepare document for subject representatives on substantive standards for decision making, and 

giving examples of how to apply them; in complex protocols, neutral educator could be assigned to explain relevant information) and Bein, supra, 761 (independent, governmentemployed patient-advocate could present information to and advise family-surrogates on research decisions for incapable relatives; advocate questioning surrogate’s “good faith 

or ability to make a proper decision” could initiate court proceedings to resolve whether incapable person should participate in study).
An alternative or additional approach is to limit the authority of any third party to consent to research participation by an

incapable subject. Three forms of substantive limitations are

commonly endorsed. One is to allow guardians, proxies, and

informal surrogates to give valid consent to studies if the incapable subject assents or fails to object to initial or ongoing

research participation. The second is to require that third parties make research decisions consistent with the incapable 

subject’s prior instructions issued while competent. The third is

to permit subject representatives to authorize the involvement

of incapable subjects only in studies that meet certain riskpotential benefit standards. Many of the recommendations on

research involving persons with mental disabilities apply each

of these limits, but combine them in a variety of ways.

The Incapable Subject’s Research Preferences

According to the Belmont Report, respect for persons incapable

of fully autonomous choice “requires giving them the opportunity to choose to the extent they are able, whether or not 

to participate in research.”79 Consistent with this view, the

National Commission recommended that under specified 

conditions, researchers should obtain assent to research participation from subjects incapable of independent decision making. According to the commissioners, persons are capable of

assent if they “know what procedures will be performed in 

the research, choose freely to undergo these procedures, communicate this choice unambiguously, and [know] that they 

may withdraw from participation.”80

The commission recommended that an incapable subject’s

overt objection to initial or ongoing participation should rule

out research involvement unless the study offers the subject a

prospect of direct benefit and a court specifically authorizes the

subject’s participation. The commissioners also stated that an

objecting incapable subject should be involved in research presenting a prospect of direct benefit and more than minimal risk

only when the benefit is available solely in the research context.

The commissioners recommended procedural mechanisms

to ensure application of these substantive provisions. They stated that IRBs should have discretion to appoint an independent

auditor to verify the subject’s assent or lack of objection. They

also recommended that independent auditors be required to

monitor the incapable subject’s initial and ongoing assent in

research presenting more than minimal risk and no prospect of

direct benefit to subjects; if subjects object at any time to this

category of research, they should be removed from the study.

Not all incapable individuals can provide assent as defined 

by the National Commission. Some persons may satisfy certain elements of the standard, but not all of them.81 Should 

the physical or verbal indications of persons incapable of

assent be considered in research decision making? A related

question is “whether the failure to actively object to participation in a protocol is enough to be interpreted as a tacit or

implied form of assent or whether some more affirmative

agreement is necessary.”82 According to the National Commission, “mere absence of objection” ought not be interpreted 

as assent.83 The commission recommended requiring the consent of a subject’s legal guardian to authorize more than 

minimal risk research involving nonobjecting subjects incapable of assent. Whether this situation might be adequately

addressed through less formal procedural safeguards, or by

imposing special limits on research risks, remains unsettled 

in the existing literature.

There is general agreement that the sole potential justification for imposing research interventions on actively resisting

subjects would be to advance the goal of protection; that is, to

provide a potential material health benefit unavailable outside

the study. Recent commentary generally supports a requirement for subject assent, or at minimum, lack of objection,

except in the unusual case when research participation offers

the subject direct benefits not otherwise obtainable in the clinical setting.84 Yet not all commentators agree that potential

direct benefit should be sufficient to override the incapable

subject’s behavioral resistance to research participation.

A Canadian group considering research involving persons

with dementia recently noted:

Faced with an objection by a patient of impaired

capacity, the justification advanced for nevertheless

imposing the investigational intervention is that it

holds out the prospect of direct (therapeutic) benefit.

However, it is normally not legitimate to impose even

established therapy on a patient refusing it. The case

for proceeding may be stronger regarding the incom16 NATIONAL BIOETHICS ADVISORY COMMISSION

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79 Belmont Report, supra, 6.

80 Report on Institutionalized Persons, supra, 9.

81 An empirical study found that many dementia patients incapable of independent decision making were nevertheless “able to provide useful information on their values and preferences

that was pertinent to making research enrollment decisions.” Sachs, et al., supra, 410.

82 Kapp, supra, 34.

83 Report on Mentally Disabled Persons, supra, 14.

What constitutes a recognizable objection is another question. Subjects might exhibit a transient unwillingness to participate, due to temporary fatigue or distraction. Should any sign

of unwillingness suffice as grounds to remove the subject from research, or may the investigators be given another opportunity to seek the subject’s cooperation? See Keyserlingk,

supra, 341 (should not assume that “transient lack of cooperation always signifies an objection”; instead, “[d]ecisions as to whether a patient is clearly or probably objecting will obviously be a matter of judgment”). A related issue is whether such judgments should be made by an investigator, independent evaluator, the subject’s representative, or an IRB representative.

84 E.g., Berg, supra; High and Doole, supra; High, et al., supra; Melnick, et al., supra.
petent ... patient who objects, but it is difficult to

equate an intervention which is investigational in

nature—whatever its potential for direct (therapeutic)

benefit—with an intervention “which would be

ordered in a purely therapeutic context.”85

This group was “not fully persuaded” that potential therapeutic benefit provides ethical justification for compelling an

objecting subject’s research participation. In their view, this 

“is at best a position in need of further debate.”86

Draft legislation under consideration in Maryland completely bars investigators from conducting research involving 

a decisionally incapable individual “who refuses to perform 

an action related to the research.”87 The T.D. case labeled 

constitutionally deficient New York’s provision allowing the

involvement of an objecting incapable subject in potentially

therapeutic research because the state regulations failed to 

provide patients or their representatives notice and an opportunity to challenge this involvement.88

The Incapable Subject’s Preferences While Competent 

Various groups and individual commentators have explored the

relevance of advance decision making in the research context.

Two types of research advance directives are discussed.

Through an instruction directive, a competent person may consent to or refuse future research involvement during a period 

of temporary or permanent incapacity. Through a proxy directive (also known as a research DPA), a competent individual

may choose someone else as her research decision maker if she

subsequently loses decisional capacity.

As in the treatment area, advance research decision making 

is supported as a means of extending respect to the autonomous choices of capable individuals. Advance decision making 

is also seen as protective in that it can prevent a surrogate from

authorizing an incapable subject’s involvement in research the

subject previously deemed unacceptable. The primary issues

raised by research advance directives are: (1) whether advance

decisions can be adequately informed; (2) how to safeguard the

subject’s right to withdraw from research; and (3) whether

advance choice is a morally defensible basis for permitting 

otherwise prohibited levels of risks and burdens in research

involving incapable subjects.

The concept of advance research decision making was initially discussed in the 1980s. In his volume on clinical research,

Robert Levine discussed the “research living will” as an avenue

for competent persons to authorize future research involvement while incompetent.89 In 1987, the NIH Clinical Center

adopted a policy in which persons “who are or will become cognitively impaired” are asked to complete a durable power of

attorney (DPA) document appointing a proxy research decision

maker.90 Such proxies may authorize an incapable subject’s 

participation in research presenting greater than minimal risk

to subjects. In such cases, an ethics consultation is conducted 

to verify the proxy’s capacity to understand information relevant to the research decision. If no DPA exists, the consent of

a court-appointed family guardian is required. The Clinical

Center policy deems a subject’s prior exercise of choice an

acceptable basis for permitting higher risk research than is 

otherwise permitted for subjects lacking court-appointed 

family guardians.91

In 1989, the American College of Physicians (ACP) gave 

qualified endorsement to instruction and proxy mechanisms

permitting competent persons to register advance consent to

research. According to the ACP, investigators seeking advance

consent would be required to disclose to the competent person

the usual information on a study’s purpose, methods, risks,

and potential benefits. Moreover, the ACP recognized a need 

for more caution regarding advance research decisions than

advance treatment decisions:

In nonexperimental care, advance directives are generally used by patients to indicate their intent to refuse

procedures ... which they believe will be contrary to

their interests. Respect for autonomy creates a strong

presumption for adherence to instructions for nonintervention. In contrast, advance directives for research

purposes would authorize interventions that do not

benefit the subject in the case of nontherapeutic

research, or that may not benefit the subject in the case

of therapeutic research.92

Accordingly, this group took the position that research

advance directives “may be abrogated if it is later determined

that the proposed research would unduly threaten the subject’s welfare.”93

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85 Keyserlingk, et al., supra, 342, quoting Melnick, et al., supra.

86 Id., 342.

87 Office of the Maryland Attorney General, Second Report of the Attorney General’s Research Working Group (May, 1997).

88 T.D., 650 N.Y.S. 2d, 193.

89 R. Levine, Ethics and Regulation of Clinical Research 270–74 (rev. ed. 1986).

90 Subjects “not seriously impaired” are viewed as capable of completing a research DPA. If a prospective subject is “so seriously impaired as to be incapable of understanding the intent

or meaning of the DPA process, a next of kin surrogate may be chosen by the physician.” In addition, if a prospective subject has a previously completed health care DPA or a courtappointed guardian, no research DPA is sought. NIH Clinical Center, supra.

91 Research presenting greater than minimal risk is not permitted for subjects lacking a DPA or court-appointed family guardian.

92 American College of Physicians, supra, 844.

93 For example, the proxy decision maker should withdraw an incapable subject from a study if risks or burdens increase due to changes in research methods, changes in the subject’s

physical condition, or the incapable subject’s lack of cooperation with study procedures. Id., 844.
Despite these cautions and restrictions, the ACP deemed an

incapable subject’s prior consent an acceptable basis for 

allowing that subject’s involvement in higher risk research than

is permitted for other incapable subjects. The position paper

states that incapable subjects with informal proxies should 

not be involved in greater than minimal risk research offering no prospect of direct benefit. In contrast, subjects with

advance directives may be involved in such studies, as long as

the above limitations are observed.

Other groups and commentators have expressed general 

support for advance research decision making without addressing the concept in detail.94 Four articles published between

1994 and 1996 present more lengthy analyses of advance

research directives and are discussed below.

In reviewing the advance directive’s potential application to

dementia research, Greg Sachs suggests it is unlikely that many

individuals will prepare research directives. He notes that 

relatively few person make treatment directives, even though

many fear overtreatment at the end of life. Even fewer will 

make research directives, he predicts, because “the fear of missing out on being a subject in a promising dementia study, or 

of being inappropriately volunteered by one’s relatives, is 

simply not a prevalent or powerful concern.”95

Federal policy establishes stringent disclosure requirements

for investigators recruiting competent persons for research.

An individual considering whether to authorize future research

participation ought to be informed about a prospective study 

as well. But problems in information delivery are posed by 

the time lapse between a capable individual’s decision to enter

a future study and the onset of actual participation. As a Canadian group points out, “[t]he research intervention, process,

or technology may have evolved; the risk of harm may have

increased beyond what was originally predicted; the patient’s

medical conditions, relationships, level of family support,

and daily routine may have changed and deteriorated.”96

In light of these possibilities, commentators agree that a

third-party decision maker should be appointed to withdraw

the subject from a study if previously unrecognized risks 

and burdens become apparent.97 They differ, however, on the

standard third parties should apply when exercising the 

subject’s right to withdraw from research the subject previously authorized.

Some writers favor withdrawal only when the factual circumstances become materially different from what the individual

agreed to in a directive.98 Others contend that withdrawal

should also occur if it becomes apparent to others that research

participation threatens the incapable subject’s welfare. According to this position, a research proxy’s or surrogate’s obligation to respect the person’s prior wishes is limited by the 

obligation to protect the person. The function of the [thirdparty decision maker] is to promote what subjects think are

their best interests, which necessarily excludes consenting to

being intentionally harmed or to being unreasonably exposed

to the risk of harm.99

This dispute is related to disagreement on the appropriate

scope of a competent person’s advance consent to research.

Commentators are divided on whether policy should permit an

incapable subject to be exposed to otherwise impermissible 

levels of research risks and burdens based on the subject’s prior

instructions. Moorhouse and Weisstub contend that directives

should be restricted to authorizing research “with a negligible

or less than substantial risk.”100 Their position is based on the

belief that capable individuals cannot predict with complete

accuracy how they will experience research as incapable subjects. These authors also argue that the competent individual’s

freedom to volunteer for research to advance the interests 

of others is qualified by society’s responsibility to protect vulnerable individuals from material harm.

A Canadian group addressing dementia research proposes

that research directives should apply to studies offering no

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94 E.g., Melnick, et al., supra (endorsing research directives and implying that such documents could authorize otherwise questionable research presenting more than minimal risk 

and no prospect of direct therapeutic benefit to subjects); Annas and Glantz (competent person diagnosed with disorder expected to produce incapacity could designate proxy 

decision maker; such document could authorize participation in otherwise prohibited nontherapeutic studies posing “any risk of harm,” but should be used only if instructions 

are specific and address “reasonably well defined” research, and subject retains right to withdraw even after he or she becomes incapable).

95 Sachs, “Advance Consent,” supra. Sachs refers to unpublished survey data finding that while 16 of 21 ethicists expressed enthusiasm for advance research directives, only eight 

out of 74 investigators agreed that directives would be a workable approach. In a different survey of healthy elderly persons, many respondents indicated they would be unwilling 

to complete “blank checks” authorizing participation in a wide range of future studies. Respondents were more positive about advance directives authorizing research offering 

a reasonable prospect of direct benefit, but only if interventions were restricted to the specific procedures, pain, and discomfort set forth in the document. Keyserlingk, et al.,

supra, 347.

96 Keyserlingk, et al., supra 347.

97 See, e.g., Moorhouse and Weisstub, “Advance Directives for Research: Ethical Problems and Responses,” International Journal of Law and Psychiatry 19 (107): 135 (“in the event 

of the development of unforeseen risks, a change in the subject’s condition, or an objection expressed by the incapable subject or a concerned third party,” subject’s surrogate 

decision maker must have power to remove subject from study).

98 Berg, supra, 22 (surrogate has responsibility to withdraw subject only if research or risk-benefit ratio changes substantially from what subject consented to).

99 Moorhouse and Weisstub, 135. See also Shamoo and Sharev, supra, S:29 (advance directives should not bind a subject to research participation).

An intermediate position is presented in Keyserlingk, et al., supra, 352 (advance directive should be overridden if “no direct benefit is anticipated for the subject and it becomes 

apparent that enrollment or continued participation would seriously endanger that subject’s welfare to an extent not foreseen by the subject, or even if foreseen, to an extent 

judged by the substitute [decisionmaker] to be socially or morally unacceptable”).

100 Moorhouse and Weisstub, supra, 134.
direct benefit to subjects only if the risk is minimal or a minor

increase over minimal.101 They suggest one exception to this

limit, however: “[i]f a subject who provides a directive specifying a willingness to undergo a higher risk level also provides

evidence of having already experienced a similar level of physical or psychological pain or discomfort in another research 

setting, then the cap of allowable risk for that subject could 

be raised accordingly.”102

Berg supports full implementation of advance research

instructions without regard to the risk level. She argues,

“[b]ecause competent subjects do not have limits placed on the

types of research in which they can participate while they

remain competent (as long as the protocol is approved by an

appropriate review board), they should not have limits placed

on the types of research in which they can consent, in advance,

to participate should they become incompetent.”103 Conversely,

when an advance directive refuses research participation, Berg

suggests that the subject’s refusal could be overridden if a study

offers possible direct benefit unavailable in the clinical setting.

She fails to explain why concern for the incapable subject’s 

best interests justifies disregarding a directive in one situation

and not the other.

A few public policy developments are relevant to this topic 

as well. In 1996, the Food and Drug Administration and 

NIH adopted new regulations governing research involving

incapable subjects in the emergency setting.104 The new regulations allow research to proceed in the absence of consent by 

a subject or subject representative if a number of conditions 

are met. One such condition is that investigators cannot reasonably obtain prospective consent from competent individuals likely to be candidates for later study enrollment.105

The regulations and agency comments do not address the

rationale for, or implementation issues raised by, prospec tive

consent. The commentary implies that the ordinary disclosure

requirements for informed consent govern advance research

decision making.106 According to agency officials, when IRBs

determine that investigators can reasonably identify and seek

prospective consent from persons likely to become eligible for a

study, “[t]hose individuals who either did not make a decision

or who refused would be excluded from participation in the

investigation.”107 In response to a public comment describing

“the difficult task for potential subjects to imagine the kind of

research they would want should they suffer a catastrophic illness,” officials acknowledged possible difficulties in implementing the prospective decisionmaking process, but suggested that

IRBs could adequately address these matters.108 The New York

court decision invalidating regulations governing research at

the state’s mental health facilities also expressed support for

prospective decision making on research participation. In T.D.,

the appellate court took the position that without an incapable

subject’s previous consent or the consent of someone the subject specifically chose as her research decision maker, “[i]t may

very well be that ... there is at present no constitutionally

acceptable protocol for obtaining the participation of incapable

individuals” in studies posing greater than minimal risk and no

prospect of therapeutic benefit.109 By implication, then, the

court deemed advance consent or the consent of a specifically

authorized research proxy a constitutionally adequate basis for

an incapable subject’s participation in research posing more

than minimal risk and no prospect of direct benefit to subjects.

The court’s position was based on earlier New York decisions

addressing surrogate decision making on life-sustaining treatment for incapable patients. These decisions established a rule

that “in the absence of specific legislation, and where there is no

evidence of personal intent, a surrogate has no recognized right

to decide ... that treatment should be withheld....”110 Because

“participation in studies involving greater than minimal risk

exposes the subjects to possible harmful, and even fatal, side

effects,” the court determined that explicit legislation or the

subject’s prior expression of intent should be required in the

research context as well.111

The state of Maryland has initiated a third policy effort relevant to advance research decision making. Draft legislation

includes a framework for third-party decisions on research for

decisionally incapacitated persons. Research is permitted with

consent of an incapable subject’s “legally authorized representative.” Unlike current federal policy, this proposal specifies who

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101 Keyserlingk, et al., supra, 351.

102 Id.

103 Berg, supra, 22.

104 Department of Health and Human Services, Food and Drug Administration, Protection of Human Subjects; Informed Consent, 61 Fed. Reg. 51498 (Oct. 2, 1996).

105 21 CFR 50.24 (a)(2)(iii).

106 The FDA’s comments on the regulations include as examples of when “prior informed consent” could be used, “use of a surgical procedure with a known severe consequence; administration of a drug product with a known serious adverse reaction; identification of a population with a particular disease or condition who are at an extremely high risk for a serious

event.” 61 Fed. Reg. 51511.

107 Id.

108 Id.

109 T.D., 650 N.Y.S. 2d, 177.

110 Id., 190.

111 Id., 191. This support for advance decision making also reflects the judges’ apparent view that requiring a prior choice shows respect for the competent person’s right of self-determination and provides better protection of incapable subjects than the state’s invalidated provisions on surrogate decision making. The opinion fails to discuss how to ensure that advance

decisions on research are adequately informed or how to implement the subject’s right to withdraw from a study.
ing priority order, (1) a research agent designated in an advance

directive for research; (2) a health care agent designated in an

advance directive for treatment; (3) a surrogate authorized by

statute to make health care decisions for an incapable person;

or (4) a monitor designated by the IRB to act as a research decision maker for an incapable person.112

The draft gives greater decisionmaking authority to third

parties expressly chosen by an incapable individual. In the

absence of an instruction directive, only research agents and

health care agents are authorized to consent to an incapable

subject’s involvement in research presenting a minor increase

over minimal risk and no expected direct benefit. Only a

research agent may authorize an individual’s involvement in

research presenting more than a minor increase over minimal

risk and no direct benefit.

The legislation also recognizes a limited role for instruction

directives. A monitor may consent to an incapable individual’s

participation in research presenting minimal risk and no direct

benefit if the individual’s advance directive explicitly authorizes

such participation. A research agent may permit an incapable

subject to be involved in research presenting more than a minor

increase over minimal risk only if “the research is unambiguously included in the individual’s advance directive authorizing

research participation.”113 Thus, otherwise prohibited research

risk is permitted based on the prior competent choice of a now

incapable subject.

The draft does not discuss the study information that must

be disclosed to a capable person making an advance research

directive. Withdrawal from research is addressed, however. Any

third party consenting to an incapable subject’s participation

must (1) take reasonable steps to learn whether the experience

of the individual in the research is consistent with the expectations of the legally authorized representative at the time that

consent was granted; and (2) withdraw consent if continued

participation would, considering all relevant circumstances be

detrimental to the well-being of the individual.114

In sum, advance research decision making has been widely

discussed in the literature and included in some recent policy

initiatives. Numerous conceptual and practical questions

remain unresolved, however. The number of persons willing to

prepare research directives may be small, especially if rigorous

standards for information disclosure are observed. Investigators

and IRBs face challenges in providing competent individuals

with up-to-date information on a future study. Finally, the literature reveals disagreement on the significance policy should

assign to the competent individual’s preferences about future

research participation posing more than minimal risk to incapable subjects.

Should federal policy regard the incapable subject’s past competent instructions as an acceptable basis for initial or ongoing

participation in studies that otherwise would be prohibited? To

answer this question, policy makers must first decide whether

certain types of studies are too risky or burdensome to conduct

on incapable subjects who have not prepared advance research

directives. This issue is discussed in the next section.

Balancing Risks and Expected Benefits in Research

Involving Incapable Subjects 

A generally accepted principle is that research risks to human

subjects must be justified by expected benefits to subjects, to

others, or to both. The Common Rule directs IRBs to ensure

that research risks are minimized and are “reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to

result.”115 These provisions govern all research involving

human subjects. Many commentators and organizations, as

well as the international documents described above, favor

placing additional constraints on acceptable risks in research

involving decisionally incapable subjects.

As was noted earlier, the National Commission proposed a

research review framework in which greater substantive and

procedural demands would be applied to research presenting

relatively high risks to children and incapable individuals institutionalized as mentally infirm. The current DHHS regulations

governing research involving children incorporate such a

framework.116 The regulations classify research using the somewhat controversial concept of “minimal risk.” According to the

Common Rule, a study presents minimal risk if “the probability and magnitude of harm or discomfort anticipated in the

research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of

routine physical or psychological examinations or tests.”117

The DHHS regulations on research involving children permit

IRBs to approve research presenting no more than minimal risk

as long as requirements for parental permission and child

assent are satisfied. Studies presenting greater than minimal

risk must meet additional requirements. If a study in this category also offers a prospect of direct benefit to subjects, criteria

for IRB approval include: (1) a finding that the risk is justified

by the prospective direct benefit; and (2) a finding that the

research presents at least as favorable a risk-expected benefit

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112 Office of the Maryland Attorney General, supra.

113 Id., 15.

114 Id., 16.

115 Sec. ___.111(a).

116 45 CFR 46 (1991). See appendix for a copy of the regulations.

117 Sec. ___.102(i).
ratio for subjects as that presented by available alternatives in

the clinical setting.

If a study presenting more than minimal risk offers no

prospect of direct benefit to child subjects, criteria for IRB

approval include: (1) a finding that the research presents a

minor increase over minimal risk; (2) a finding that “the intervention or procedure presents experiences that are reasonably commensurate with those inherent in their actual or

expected medical, dental, psychological, social, or educational

situations;” and (3) a finding that the study is likely to produce

generalizable and vitally important information on the subjects’ condition.

The regulations also provide for a special review process to

address an otherwise unapprovable study determined by an

IRB to offer “a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.” The Secretary of DHHS

may approve such a study if, after consultation with experts in

relevant fields and the opportunity for public review and 

comment, he or she concurs with the IRB’s finding on research

significance and determines that “the research will be conducted in accordance with sound ethical principles.”118

These regulations, the National Commission’s recommendations on research involving children and institutionalized

persons, and the literature on research involving incapable

adults present the following policy matters for consideration:

(1) the appropriate definitions of risk and benefit to be adopted in policy on research involving incapable adult subjects; (2)

the appropriate limitations on risk for research involving this

population; and (3) the appropriate procedures for ensuring

that the chosen substantive standards are observed during the

research process.

Defining Risks and Benefits in Research Involving 

Incapable Subjects

Risks

Incapable subjects are vulnerable to a variety of possible 

harms when they participate in research. Risks to incapable

subjects “range from physical injury and pain at one extreme,

to discomfort and inconvenience at the other, including at 

various points along the continuum such effects as frustration,

dislocation, confusion, and shame.”119 The Common Rule’s

definition of minimal risk refers to “harm or discomfort,”

which seems clearly to include experiential burdens as well as

health risks.

The most thorough published analysis on risks and potential benefits in research involving incapable adults suggests 

that review committees should consider “physical, social,

psychological, and economic,” risks, including “foregone benefits, ... violations of privacy, ... effects upon the subject’s 

relationship with family members, [and] the new anxiety 

associated with being invited to participate in ... research before

having come to terms with one’s affliction.”120 Risk assessment also involves probability judgments: “[t]he quantification

of risk involves an examination of both the degree or magnitude of harm that could occur and the possibility that such

harm will occur.”121

Evaluating risks to incapable subjects requires familiarity

with how subjects in the relevant population may respond,

both generally and as individuals, to proposed research interventions and procedures. What may be a small inconvenience

to ordinary persons may be highly disturbing to some incapable subjects. Thus, for example, a diversion in routine can 

for some dementia patients, “constitute real threats to needed

order and stability, contribute to already high levels of frustration and confusion, or result in a variety of health complications.”122 Similarly, as the National Commission observed,

some subjects institutionalized as mentally infirm may “react

more severely than normal persons” to routine medical or 

psychological examinations.123

Because of this special vulnerability to harm and discomfort,

risk evaluation should incorporate reliable knowledge on the

range of anticipated reactions subjects may have to study 

procedures. Though conceding that precise risk and benefit

assessments rarely are attainable, the Belmont Report states,

“the idea of systematic, nonarbitrary analysis of risks and 

benefits should be emulated as far as possible.”124 The 

National Commission’s Report on Research Involving Children advised IRBs to assess risks from the following points of

view: “a common-sense estimation of the risk; an estimation

based upon investigators’ experience with similar interventions or procedures; any statistical information that is available regarding such interventions or procedures; and the situation of the proposed subjects.”125

Like the current DHHS regulations on research involving

children, many proposals on research involving incapable

adults employ the concepts of minimal risk and minor increase

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118 Apparently, to date, no study has been approved under these provisions.

119 Keyserlingk, et al., supra, 326.

120 Id., 326–27.

121 Berg, supra, 24.

122 Keyserlingk, et al., supra, 324.

123 Report on Institutionalized Persons, supra, 8–9.

124 Belmont Report, supra, 7.

125 Report on Children, supra, 8–9.
over minimal risk. Giving substance to these concepts poses 

difficulties, however.

The Common Rule’s minimal risk definition is tied to the

risks of ordinary life and medical care. The minimal risk concept is praised for its flexibility: “[i]t is inescapable and even

desirable that determinations of risk level (and its acceptability when balanced with benefit consideration) are matters 

of judgment rather than detailed definition, judgments which

are patient-specific, context-specific, and confirmed after consideration and debate from many points of view.”126 In addition, the concept’s reference to “risks of everyday life” is 

supported as conveying a defensible normative judgment that

the sorts of risks society deems acceptable in other contexts

may be acceptable in research as well.127

In contrast to the minimal risk concept’s reference to the 

life and medical experiences of ordinary persons, the DHHS

regulations’ concept of minor increase over minimal risk is 

tied to the prospective subject’s individual situation. Because

persons with psychiatric and other disorders undergo treatment and tests involving some discomfort and risk, a study 

presenting similar procedures and potential for harm may

qualify as presenting a minor increase over minimal risk to

them.128 For subjects not accustomed to or in need of such

medical interventions, however, the same study would present

a higher level of risk.

In its Report on Research Involving Children, the majority of

National Commission members defended this approach on

grounds that it permitted no child to be exposed to a significant

threat of harm. Further, they noted that the approach simply

permits children with health conditions to be exposed in

research to experiences that for them are normal due to the

medical and other procedures necessary to address their health

problems. One member was highly critical of this approach,

however, contending that it was wrong to take a more permissive approach to research risk in children with health problems than in other children. He argued that the only morally

defensible differential treatment of sick and healthy children

would be one that was more permissive about research risks to

healthy children than to children already burdened by their

health problems.129

Commentators have criticized both the Common Rule’s

“minimal risk” definition, and the DHHS regulations’ term

“minor increase over minimal risk.” Loretta Kopelman provides the most detailed critique. First, she finds the risks of

ordinary life too vague a notion to provide a meaningful comparison point for research risks. Ordinary life is filled with a

variety of dangers, she notes, but “[d]o we know the nature,

probability, and magnitude of these ‘everyday’ hazards well

enough to serve as a baseline to estimate research risk?” Second,

though the comparison to routine medical care furnishes helpful guidance regarding minimal risk, it fails to clarify whether

procedures such as “X rays, bronchoscopy, spinal taps, or cardiac puncture,” which clearly are not part of routine medical

care, could qualify as presenting a minor increase over minimal risk for children with health problems who must undergo

these risky and burdensome procedures in the clinical setting.

Kopelman argues that the phrase minor increase over minimal risk should be replaced or supplemented by a clearly

defined upper limit on the risk IRBs may approve for any 

child subject.130

A few empirical studies indicate that there is a real possibility of variation in how IRBs and investigators classify protocols using the current federal risk categories. For example, a

1981 survey found differences in how pediatric researchers 

and department chairs applied the federal classifications to a

variety of procedures commonly used in research.131 Similarly,

there was substantial disparity in how the nine members of a

special NIH review panel applied the federal classifications to 

a trial of human growth hormone in which healthy short 

children were subjects.132 A survey asking research review committee members and chairs in Canada to classify four different

dementia studies “confirmed that there is considerable disagreement and uncertainty about what risks and benefits 

mean and about what is to be considered allowable risk.”133

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126 Keyserlingk, et al., supra, 329.

127 Freedman, Fuks, and Weijer, in “Loco Parentis: Minimal Risk as an Ethical Threshold for Research Upon Children,” Hastings Center Report (Mar.-Apr. 1993): 13, 17–18. According 

to the National Commission, “where no risk at all or no risk that departs from the risk normal to childhood (which the Commission calls ‘minimal risk’) is evidenced, the research 

can ethically be offered and can ethically be accepted by parents and, at the appropriate age, by the children themselves.” Report on Children, supra, 137.

128 The DHHS regulations on children in research provide that studies may be approved as presenting a minor increase over minimal risk as long as the risks and experiences “are 

reasonably commensurate with those inherent” in the child subjects’ actual or anticipated medical or other situations.

129 Report on Children, supra, 146 (dissenting statement of Commissioner Turtle).

130 Kopelman, “Research Policy: Risk and Vulnerable Groups,” in Encyclopedia of Bioethics (W. Reich (ed.), rev. ed. 1995): 2291, 2294–95; Kopelman, “When Is the Risk Minimal Enough 

for Children to Be Research Subjects?” in Children and Health Care: Moral and Social Issues (Kopelman and Moskop (eds.), 1989): 89–99. See also Berg, supra, 24 (noting possible 

interpretations of minimal risk and concluding that “[i]t clearly does not mean only insignificant risk, but its exact scope is unclear”).

The Maryland draft legislation adopts a definition of minimal risk similar to that in the Common Rule. It also refers to minor increase over minimal risk, which is defined as 

“the probability and magnitude of harm or discomfort anticipated in the research, including psychological harm and loss of dignity, are only slightly greater in and of themselves 

than those ordinarily encountered in the daily life of the potential research subjects or during the performance of routine physical or psychological examinations or tests.” Office 

of the Maryland Attorney General, supra, 4.

131 Janofsky and Starfield, “Assessment of Risk in Research on Children,” Journal of Pediatrics 98 (1981): 842.

132 See Tauer, “The NIH Trials of Growth Hormone for Short Stature,” IRB (May-June 1994): 1.

133 Keyserlingk, et al., supra, 326.
In sum, if policy on research involving incapable adults

incorporates the concepts of minimal risk and minor increase

over minimal risk without providing further guidance to 

investigators and IRBs, the concepts may be interpreted in

materially different ways. A study classified as minimal risk at

one institution could be classified as higher risk at another.

Also needed is more discussion and clarification of acceptable risk in research involving incapable adults whose health

problems expose them to risks in the clinical setting. Incapable persons accustomed to certain procedures may experience fewer burdens when undergoing them for research 

purposes. Thus, it is defensible to classify the risks to them as

lower than they would be for someone unfamiliar with the 

procedures. On the other hand, some procedures entail 

material burdens each time they are administered. Procedures

of this sort ought not be classified as lower risk for subjects 

who have had the misfortune of enduring them in the treatment setting.134

One way to reduce variance in risk classification would be to

provide examples of studies that ordinarily would be expected

to present a certain level of risk to members of a certain

research population. The discussion could also include general

considerations relevant to risk classification. For example, one

author proposes that lumbar punctures and positron emission

tomography “can be reasonably viewed as having greater than

minimal risk for persons with dementia because 1) both procedures are invasive, 2) both carry the risk of pain and discomfort during and after, and 3) complications from either

procedure can require surgery to correct.”135 The Maryland

draft legislation states that an IRB may not classify a study as

presenting minimal risk if the study would expose incapable

subjects to “a loss of dignity greater than that ordinarily 

experienced by individuals who are not decisionally incapacitated during the performance of routine physical or psychological examinations or tests.”136 The draft legislation also 

prohibits IRBs from applying the minimal risk or minor

increase over minimal risk categories to studies exposing 

incapable subjects to possible “severe or prolonged pain or 

discomfort” or “deterioration in a medical condition.”137

Another document lists as minimal risk for dementia 

patients “routine observation, data collection, answering a

questionnaire, epidemiological surveys, venipuncture, and

blood sampling,” as well as neuropsychological testing.138

Though some reportedly classify lumbar punctures and bone

marrow biopsies as presenting a minor increase over minimal

risk, this document suggests that such procedures may present

“greater risks for some patients with dementia who are unable

to understand or tolerate the pain or discomfort” accompanying the interventions.139 Finally, the document notes that

repeated performance of procedures ordinarily qualifying as

minimal risk could at some point create sufficient burdens to

subjects to merit a higher risk classification.

Benefits

Research involving incapable adults may yield three types of

benefit: direct benefit to subjects, indirect benefit to subjects, and benefit to others. Direct benefit to subjects includes

health improvements which may or may not be related to the

disorder responsible for the subject’s incapacity.140 The 

National Commission stated that research offering potential

benefits to persons institutionalized as mentally infirm includes

studies to improve existing methods of biomedical or behavioral therapy, or to develop new educational or training methods. The studies may evaluate somatic or behavioral therapies,

such as research designed to determine differential responsiveness to a particular drug therapy, or to match particular clients

with the most effective treatment. Studies may also assess the

efficacy of techniques for remedial education, job training,

elimination of self-destructive and endangering behaviors, and

teaching of personal hygiene and social skills.141

According to the commission, “[t]o be considered ‘direct,’ the

possibility of benefit to the subject must be fairly immediate

[and t]he expectation of success should be well-founded scientifically.”142 A more recent statement on dementia research 

limits direct benefit to:

a short- or long-range improvement, or a slowing of

a degenerative process, in the specific medical condition of the relevant subject, whether in the patient’s

condition of dementia, a medical symptom associated

with dementia, or another physical or mental condition unrelated to dementia. Such direct benefits

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134Prior exposure to procedures could actually increase the fear and anxiety for some incapable subjects. Incapable adults with memory impairment may not recall undergoing procedures; for them, each procedure will be experienced as a new one.

135 DeRenzo, supra, 540.

136 Office of Maryland Attorney General, supra, 7.

137 Id.

138 Keyserlingk, et al., supra, 330.

139 Id., 330.

140 Keyserlingk, et al., supra, 327.

141 Report on Institutionalized Persons, supra, 31.

142 Id., 13.

Berg also emphasizes the need to weigh the likelihood of direct benefit to subjects. In clinical trials, for example, “the benefit calculation must take into account how probable it is that

a particular subject will get the experimental medium as well as the probability that, once received, the intervention will help.” Berg, supra, 25.
include those resulting from diagnostic and preventative measures.143

Subjects may obtain other forms of benefit from research

participation. As the National Commission noted, “[e]ven in

research not involving procedures designed to provide direct

benefit to the health or well-being of the research subjects, ...

there may be incidental or indirect benefits.”144 Examples of

indirect benefits are, “diversion from routine, the opportunity

to meet with other people and to feel useful and helpful,

or ... greater access provided to professional care and support.”145 According to one group, indirect benefit may be

acknowledged, but should not be assigned the same weight as

direct benefit in research review and discussions with prospective subjects and their representatives.146

The T.D. decision criticized New York’s failure to include a

more precise definition of direct subject benefit in the regulations the court invalidated. The regulations referred to “direct

benefit that is important to the general health or well being 

of the subject and is available only in the context of the

research.” Because otherwise applicable limitations and safeguards could be waived if a study offered potential direct 

benefit to subjects,147 the court seemed to favor a narrow 

definition encompassing only expected benefits produced by

the research procedure, related to the incapable subject’s 

psychiatric condition, and reasonably equivalent to those 

provided by currently available treatments.148

The court’s response supports, at minimum, a need to scrutinize investigators’ characterizations of research offering potential direct benefit to subjects.149 Such claims require careful

scrutiny by IRBs and other reviewers. Specific definitions of

direct and indirect benefit, and a statement on the relative 

significance of the two, could assist investigators and reviewers

in evaluations of the benefits anticipated from particular studies. The decision also questions the justification for a policy

adopting less rigorous limits and safeguards for studies offering prospective direct benefit to subjects, if direct benefit is

defined as broadly as it was in the New York regulations.

Research benefit to others encompasses benefit to a subject’s

family or other caregivers, to persons with the same disorder as

subjects, and to persons diagnosed with the disorder in the

future. This category of research presents the greatest challenge

for those seeking the appropriate balance between subject 

protection and the welfare of others. As one group noted,

when such research is invasive and presents no realistic possibility of direct health benefit, it “poses in the most dramatic

form the conflict between the societal interest in the conduct 

of important and promising research and the interests of the

potential subject.”150

Acceptable Risk-anticipated Benefit Ratios in 

Research Involving Incapable Subjects

Proposed policies on research involving incapable adults 

generally engage in a balancing of risks and potential benefits 

to determine when such research is acceptable. Most proposals

take the position that incapable adults may be involved in 

studies presenting little or no risk to them, as long as requirements for third party consent are met and the research offers 

a reasonable prospect of advancing knowledge or benefiting 

the subject, or both. There is substantial support, however,

for adopting additional restrictions and review requirements

for studies presenting higher risk, particularly for higher 

risk studies failing to offer subjects a reasonable prospect of

direct benefit.

Research presenting more than low risk to subjects is generally classified into one of two categories. The first category 

is research offering subjects a reasonable prospect of direct 

benefit. Though the moral justification for such research is

enhanced by the potential for improving subjects’ health or

welfare, most proposals incorporate the view that limits on 

risk are still needed to provide adequate protection to incapable individuals.

Greater than Minimal Risk Research Offering 

Direct Subject Benefit

The general view is that it is permissible to include incapable

subjects in potentially beneficial research projects as long as 

the research presents a balance of risks and expected direct benefits similar to that available in the clinical setting.151 This 

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143 Keyserlingk, et al., supra, 327. This group notes that currently direct benefits to subjects in dementia research are limited to symptom control. There may be disagreement on whether

research with the potential to extend life for someone in the later stages of a progressive dementia ought to be seen as offering the prospect of direct benefit to subjects.

144 Report on Institutionalized Persons, supra, 31.

145 Keyserlingk, et al., supra, 327.

146 Thus, indirect benefit ought not be deemed sufficient to enter an incapable subject in studies presenting more than a “minor increment over minimal risk.” Id., 333–34. The group

characterized indirect benefits as “by nature difficult to predict with any accuracy and ... often very person-specific.” Id., 327.

147 The regulations permitted the involvement of incapable subjects in greater than minimal risk research with the prospect of direct benefit without otherwise applicable requirements 

for an absence of subject objection and a finding that the study could not be conducted without the participation of incapable subjects. T.D., 650 N.Y.S. 2d, 187–88, 193.

148 Id.

149 Capron, supra.

150 Melnick, et al., supra, 535.

151 The standard is similar to the general demand for clinical equipoise when human subjects participate in clinical trials. Freedman, “Equipoise and the Ethics of Clinical Research,”

New England Journal of Medicine 317 (1987): 141.
position is adopted in current DHHS regulations on research

involving children.152 It is also endorsed in most of the proposals on incapable adults.

The American College of Physicians’ document allows surrogates to consent to research involving incapable subjects 

only “if the net additional risks of participation (including 

the risk of foregoing standard treatment, if any exists) are not

substantially greater than the risks of standard treatment (or 

of no treatment, if none exists).” In addition, there should be

“scientific evidence to indicate that the proposed treatment is

reasonably likely to provide substantially greater benefit than

standard treatment (or no treatment, if none exists).”153

The Maryland draft legislation deems “expected medical 

benefit” research permissible if an agent or surrogate,“after taking into account treatment alternatives outside of the research,

... concludes that participation is in the individual’s medical

best interest.”154 The NIH Clinical Center permits greater than

minimal risk research offering a prospect of direct subject 

benefit with the consent of a DPA or court-appointed family

guardian, following an ethics consultation to ensure that the

third-party decision maker understands the relevant information. For subjects without a DPA or court-appointed

guardian, this form of research is permitted, “if the situation is

a medical emergency, when a physician may give therapy,

including experimental therapy, if in the physician’s judgment

it is necessary to protect the life or health of the patient.”155

Greater than Minimal Risk Research Offering 

No Reasonable Prospect of Direct Subject Benefit

The American College of Physicians and other groups take 

the position that greater than minimal risk research offering

subjects no reasonable prospect of direct benefit should be 

permitted only when authorized by a research advance directive156 or after review and approval at the national level,

through a process resembling that set forth in the current 

regulations governing research involving children.157 The

National Commission also recommended a national review

process for studies that could not be approved under its other

recommendations on research involving persons institutionalized as mentally infirm. However, others see this position as

either too liberal or too restrictive.

On one hand, some favor an absolute prohibition on moderate or high-risk research offering no benefit to subjects but

great promise of benefit to others, based on the Nuremberg

Code’s and Helsinki Declaration’s “conviction that vulnerable

and unconsenting individuals should not be put at undue risk

for the sake of patient groups or society.”158 Supporters of this

position contend that when these documents were created, “it

was presumably well understood that a price of that prohibition

would be that some important research could not proceed,

some research answers would be delayed, and some promising

therapies and preventive measures would for the time being

remain untested and unavailable.”159 Some writers explicitly

label this stance the most ethically defensible position.160

A position paper representing federally funded Alzheimer

Disease Centers adopts a somewhat different view: “[r]esearch

that involves potential risks and no direct benefit to subjects

may be justified if the anticipated knowledge is vital and the

research protocol is likely to generate such knowledge.”161 This

group also believes that a national review process is not necessarily the best way to decide whether to permit research presenting no potential direct benefit and more than minimal risk

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152 See pp. 52–54, above.

153 American College of Physicians, supra, 845. A limited exception is permitted for incapable individuals who consented to higher risk through an advance directive.

154 Office of Maryland Attorney General, supra, 11.

Commentators take a similar position. See, e.g., Berg, supra, 25 (approving this category of research if “no alternative treatment is available of at least equal value, and the experimental

treatment is not available through any other source”).

Much of the recent controversy over trials involving medication withdrawal for persons with serious psychiatric disorders concerns whether sufficient potential direct benefit exists

to justify allowing subjects of questionable capacity to enter or remain in such trials. See Appelbaum, supra; Gilbert, et al., “Neuroleptic Withdrawal in Schizophrenic Patients,” Archives

of General Psychiatry 52 (1995): 173. The Loma Linda IRB Guidelines for use of placebos in studies involving persons with psychiatric illness present specific exclusion and inclusion

criteria for such studies. Enrollment is limited to persons whose use of standard treatment has produced responses or side effects deemed unacceptable by the patient or an independent psychiatrist. Orr, supra, 1263. Similarly, Appelbaum endorses a requirement for an independent clinician to screen prospective subjects with the goal of excluding those facing a

high risk of harm from psychotic deterioration. Appelbaum, supra, 4.

155 NIH Clinical Center, supra.

156 Even in this case, the ACP would rule out research that “would unduly threaten the subject’s welfare.” See pp. 41–42, above.

The Maryland draft legislation would permit research presenting more than a minor increase over minimal risk and no reasonable prospect of direct benefit only when subjects

appointed a research agent and “the research is unambiguously included in the [incapacitated] individual’s advance directive authorizing research participation.” Office of Maryland

Attorney General, supra, 15. Berg proposes that high-risk research offering little or no prospect of direct subject benefit should be prohibited unless there is clear evidence that a 

subject’s competent preferences would support participation. Berg, supra, 28.

157 American College of Physicians, supra, 846. See also Melnick, et al., supra, 535 (advising national ethics review prior to any decision to permit studies in this category).

158 Keyserlingk, et al., supra, 334.

159 Id.

160 Id., 334. The group would accept this form of research for a small group of incapable subjects who previously consented to it in an advance directive, however. See pp. 45–46, above.

Annas and Glantz also contend that without previous competent and specific consent, incapable nursing home residents should not be enrolled in “nontherapeutic experimentation

that carries any risk of harm with it.” Annas and Glantz, supra, 1157. See also Shamoo and Sharev, supra (calling for “moratorium on all nontherapeutic, high risk experimentation

with mentally disabled persons which is likely to cause a relapse); Thomasma, supra, 228 (incapable persons should not be involved in research failing to offer direct benefit if study

presents more than “very mild risk”).

161 The group does not explicitly address whether limits on risk should be applied to this form of research. High, et al., supra, 72–73.
to incapable subjects. They acknowledge that “there may 

be some advantages” to national review, but contend that

“immediate and direct monitoring of such research and on-site

assurance of its humane ethical conduct are at least as important as the process of evaluation and approval of any proposed research.”162

In sum, there is a range of opinion on how federal policy

should address risks to incapable subjects in studies conducted

solely for the benefit of others. The literature presents at least

three options: (1) adopt an absolute risk limit, such as minimal

risk or minor increase over minimal risk; (2) require approval

at the national level for studies exceeding a specific risk level;

or (3) preserve the status quo and allow IRBs to determine

acceptable risk levels. If the decision to limit risks is made,

consideration should be given to providing more specific 

definitions than exist in current policy provisions on minimal

risk and minor increase over minimal risk.

Maintaining Acceptable Risk-expected Benefit Ratios 

in the Research Process

In the initial review process, IRBs evaluate a research proposal’s

risks and expected benefits based on predictions of subject

response. In many cases, a range of responses among subjects will be predicted. In some cases, predictions may prove

inaccurate as research progresses, for some or even all subjects.

As a result, subjects’ health status and experiences must be 

evaluated on an ongoing basis to ensure that subjects can be

removed if risks become excessive.

The need for subject monitoring is widely acknowledged.

The Common Rule directs IRBs to ensure that “[w]hen appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”163

Commentators also refer to the importance of monitoring.164

The major question is how to implement this task. A central

issue is whether, and if so, when, monitoring should be conducted by a person independent of the research team.

After evaluating human subject protections in schizophrenia

research conducted at the University of California at Los Angeles (UCLA), the U.S. Office of Protection from Research Risks

(OPRR) required the institution to “establish one or more 

independent Data and Safety Monitoring Boards ... to oversee [DHHS]-supported protocols involving subjects with

severe psychiatric disorders in which the research investigators

or co-investigators are also responsible for the clinical management of subjects.”165 The institution was directed to submit 

to federal officials a proposal on creating and operating the

monitoring boards.

Detailed provisions on monitoring are included in Loma

Linda University IRB guidelines on psychopharmacology

research in which placebos are administered. Investigators must

specify how often subjects will be assessed for deterioration or

improvement during studies. Validated quantitative instruments must be used for assessment and subjects must be withdrawn if their condition deteriorates to a level “greater than 

that expected for normal clinical fluctuation in a patient with

that diagnosis who is on standard therapy,” if they exhibit previously specified behaviors indicating possible danger to self

or others, or if no signs of improvement in their condition are

evident after a specified time.166

Other documents assign monitoring responsibility to the

incapable subject’s representative as well. According to the Belmont Report, the representative “should be given an opportunity to observe the research as it proceeds in order to be able to

withdraw the subject from the research, if such action appears

in the subject’s best interest.”167 The Maryland draft legislation

directs subject representatives to “take reasonable steps to learn

whether the experience of the individual in the research is 

consistent with the expectations of the legally authorized representative at the time that consent was granted.”168

The general policy question is whether research team members and subject representatives can provide sufficient protection to incapable subjects. Research team members face a

conflict between protecting subjects and maintaining the study

population.169 It is unlikely that subject representatives will be

present during every part of an incapable subject’s research

involvement; in addition, lay persons might not recognize 

every indication of increased risk to subjects. Federal policy

should provide guidance to IRBs on potential approaches to

monitoring harms and benefits to individual subjects and 

criteria for determining when the involvement of an independent clinician is needed.170

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RESEARCH INVOLVING PERSONS WITH MENTAL DISABILITIES: A REVIEW OF POLICY ISSUES AND PROPOSALS

162 High, et al., supra, 72. Another statement questions the assumption that a national review body would be particularly qualified to determine “whether the research in question is

indeed extremely important to society or to a class of patients—sufficiently so that standard research norms could be put aside.” Keyserlingk, et al., supra, 335.

163 Sec. ___.111(a)(6).

164 See, e.g., Appelbaum, supra, 4 (noting importance of close monitoring to detect early symptoms of relapse so that medication can be resumed to minimize deterioration); Keyserlingk,

et al., supra, 324 (researchers “must have in place at the start the needed mechanism to monitor subjects, not only as regards the research question, but also in order to identify and

prevent unanticipated complications and harms, both physical and psychological”).

165 Office for Protection from Research Risks, supra, 27.

166 Orr, supra, 1263.

167 Belmont Report, supra, 6.

168 Office of Maryland Attorney General, supra, 16.

169 In the UCLA schizophrenia research, subjects received clinical care from psychiatrists who also were co-investigators for the study. There was concern that such a conflict of interest

could lead psychiatrists to be insufficiently responsive to signs of possible relapse in patient-subjects.

170 See Shamoo and Sharev, supra, S:29 (researchers and IRBs should be held accountable for monitoring to ensure welfare of subjects protected; physician not associated with research 

or institution where research conducted should help decide whether subjects’ interests served by continued participation).
Subject Representation in Research Design and Review

Increased subject representation in the review and conduct of

research is another commonly-endorsed strategy for improving

research decisions affecting persons with mental disabilities.

Representation is generally viewed as a means of enhancing 

the likelihood that decisions will be responsive to the interests

of affected groups.

The Common Rule directs IRBs frequently reviewing

research involving a vulnerable subject group to consider

including as reviewers persons with knowledge of and experience working with the relevant subject group. The current 

provision is advisory only; moreover, it refers to the involvement of expert professionals, not persons representing vulnerable subject groups.

After evaluating schizophrenia studies at UCLA, the OPRR

directed the School of Medicine’s IRB to “engage one or more

subject representatives as IRB members who will assist the IRB

in the review of issues related to the rights and welfare of subjects with severe psychiatric disorders.”171 This requirement 

was imposed even though the IRB already had a psychiatrist

and a psychologist as members.172

New federal policy creating an exception to informed consent

requirements for certain research in the emergency setting

directs IRBs approving such research to arrange for consultation “with representatives of the communities in which the

clinical investigation will be conducted and from which the

subjects will be drawn.”173 The regulations also instruct IRBs 

to ensure that plans for and results of such studies be disclosed

to the relevant communities.174

A third relevant development is the increased involvement 

of affected persons in the planning of clinical research on their

conditions. The phenomenon first arose in the context of

HIV research; it is now evident in other areas of clinical

research as well.175 It would be possible for federal policy on

research involving persons with mental disabilities to promote

the involvement of subject representatives in planning clinical

studies of the relevant conditions.

If enhanced subject representation is adopted as a policy 

goal, several issues merit consideration. First, should policy set

forth specific qualifications for representatives of affected

groups? Should policy include a preference for persons diagnosed with the relevant condition? Under what circumstances

may family members or members and employees of advocacy

organizations act as representatives? Should investigators be

required to demonstrate to IRBs that representatives of the

affected group were consulted in the planning process? Specific

responses to these issues would assist IRBs asked to implement

federal policy concerning this relatively unexplored area.

Conclusion

The aim of this analysis has been to highlight the important

issues and concepts meriting enhanced attention in federal

research policy and to describe various reforms endorsed in 

the literature. An improved federal policy would address,

through regulation or enhanced guidance and education for

IRBs and investigators, the following matters:

n identification of the population of persons with

mental disabilities at risk of decisional incapacity; and 

n appropriate standards and procedures for determining which individuals are capable of independent decisions to enter and to remain in a

research study.

For individuals identified as incapable of independent 

decision making, the following topics need attention:

n identification of a proper surrogate decision maker;

n screening, education, and substantive decisionmaking standards for surrogate decision makers;

n definition of subject assent and determination of

when it is required;

n definition of subject objection and determination of when it rules out subject participation;

n the role and significance of research advance

directives;

n the acceptable risk-expected benefit ratios for

research involving incapable subjects;

n the definition of any designated limits on 

risk for research involving incapable subjects;

n standards and procedures for waiving the customary limits on acceptable risk (e.g., with

explicit prior consent, consent of previously 

designated surrogate, or permission of national

advisory body); and 

n monitoring procedures to ensure continued consent, assent, absence of objection, adherence to

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171 Office for Protection from Research Risks, supra, 21–22.

172 See also Shamoo and Sharev, supra, S:29 (IRBs reviewing proposals to involve mentally disabled subjects should include at least two patient-representatives).

173 21 CFR 50.24 (a)(7).

174 Id.

175 See Erikson, “Breast Cancer Activists Seek Voice in Research Decisions,” Science 269 (1995): 1508.
advance directive terms, and adherence to permissible risk-expected benefit ratio.

Provisions on consumer representation in IRBs and in planning and conducting research on affected populations should

also be considered.

28 NATIONAL BIOETHICS ADVISORY COMMISSION

RESEARCH INVOLVING PERSONS WITH MENTAL DISABILITIES: A REVIEW OF POLICY ISSUES AND PROPOSALS
PAPER THREE RELATIONAL ETHICS 

AND RESEARCH WITH 

VULNERABLE POPULATIONS

Researchers applying the scientific method to describe,

explain, and enhance the status of individuals with physical,

psychological, and social vulnerabilities are encountering 

ethical dilemmas to which current federal regulations offer

incomplete answers. In such work, scientific and ethical duties

often appear to have mutually exclusive goals. Whereas scientific responsibility involves a search for truth through experimental controls, ethical duties are directed toward protecting

participant welfare through means that often seem to jeopardize such controls (Fisher, 1993). When the goals of science and

ethics appear to conflict, investigators studying vulnerable populations draw upon their own moral compass, the advice of

colleagues, and recommendations of institutional review

boards (IRBs) to make decisions about ethical procedures that

have immediate and possibly long-term impact on participants, their families, and the communities they represent.

Since 1974, the federal government, through regulations

requiring the establishment of the institutional review board

(IRB) system, has formally recognized the inadequacy of ethical procedures which rely solely on the professional judgment

of individual scientists (Benson and Roth, 1988). However,

ethical evaluations drawn from the consensus of IRB members

can also represent a restricted moral view. IRBs typically

include ethicists, academic scholars, practitioners, and scientists who judge the ethicality of a research proposal through the

application of federal and professional guidelines, abstract

moral principles, and values situated within the cultures of

academia, institutionalized medicine, or science. The perspectives of those who participate in research are typically given

only superficial consideration through the appointment of a

community member who cannot realistically represent perspectives of the diverse individuals who will be called upon to

participate in various research projects conducted by members

of the institution. Children and adolescents at psychosocial 

or physical risk, individuals from diverse economic and cultural backgrounds, and adults with cognitive deficits react differently to controlled procedures, and their perspectives and the

perspectives of their family members can differ from those of

well-meaning IRB decision makers.

Public reactions to past and recent revelations concerning 

the government-sponsored Tuskegee Syphilis Study (Jones,

1993), the human radiation experiments (ACHR, 1996), and

the NIMH Violence Initiative (Leavy, 1992) have lead to 

Celia B. Fisher, Ph.D.

Professor

Director of the Doctoral Specialization 

in Applied Developmental Psychology

Fordham University

Bronx, New York 10458 

Telephone: (718) 817-3793

Fax: (212) 759-2009

E-mail: Fisher @ Murray.Fordham.edu 

This work benefited from the insightful 

comments of Bart Collopy, Gary Fisher,

and Margaret Walker.
concerns that current federal guidelines do not adequately 

protect the interests of our most vulnerable citizens and that

diminished public trust in human subjects research may jeopardize research participation. In response to public concern, the

President has appointed the National Bioethics Advisory Commission to review the adequacy of current federal guidelines 

for the protection of human subjects. This paper argues that 

to insure such protections are adequate, revised research regulations need to reflect a relational approach that encourages

moral discourse between scientists and participants as an essential means of constructing the best scientific and ethical procedures possible within each unique research context.

Philosophical Premises Guiding Ethics-in-Science

Decision Making

Consequential and Deontic Frameworks

Since the Nuremberg Code (1946), federal regulations (DHHS,

1991) and professional guidelines for research (e.g., American

Psychological Association [APA], 1992), have primarily drawn

upon the utilitarian or consequential meta-ethical position

(Beauchamp, Faden, Wallace, and Walters, 1982) to solve ethical problems when actions that would protect the rights and

welfare of research participants threaten the internal validity 

of an experiment. According to utilitarianism, the morally 

right action is the one that produces the most pleasing consequences (Mill, 1861/1957). Applied to ethics-in-science 

decision making, when a conflict between scientific rigor and

participant welfare arises, the investigator’s obligation to a

small group of research participants may be superseded by 

her or his responsibility to produce reliable data that can potentially provide future benefits to members of society at large or

to the participants’ particular social group. Utilitarianism thus

encourages a value structure in which potential benefits of

science to society can receive higher moral priority than concrete and measurable risks to research participants.

Although consequentialism does not rule out consideration

of participant values about, and idiosyncratic sensitivity to,

specific types of harm and benefit, in practice those adopting

this framework conceptualize risk and benefit as tangible entities with universal value subject to rational analyses by those

other than the participant. Utilitarianism can thus promote an

ethical orientation in which an abstract risk/benefit calculus

guides moral action independent of the particular values and

priorities a subject might place on the specific risks and benefits under consideration.

Equally important in philosophical circles, but less pervasive

in ethics-in-science decision making, is the deontological

approach in which the moral rightness of an action is evaluated without regard to the consequences and is carried out only

if one would will that that action should be universal law 

(Kant, 1785/1958; Levine, 1986). Following deontic moral

premises, an investigator would never treat a participant simply as a means to advance scientific knowledge and would only

select research procedures she or he could apply across all

research contexts. The Kantian tradition’s inherent respect for

the dignity of persons would appear to encourage scientists to

incorporate participant perspectives into their ethical decision

making. In practice, however, its focus on the universality of

moral principles, and its indifference to particular relations 

and particular persons (Carroll, Schneider, and Wesley, 1985;

Williams, 1981), often leads investigators and IRBs to believe

they can determine which research procedures are ethical without consulting members of the population under study.

Although both utilitarianism and deontology are important

philosophical resources for ethics-in-science decisions, applied

in isolation from a participant’s own understanding of the

research context, these moral frameworks have the potential 

to minimize a scientist’s special relationship, and subsequent

moral obligations, to individual research participants, fostering a psychological distance between scientist and subject

(Fisher, 1994).

A Relational Ethic Derived from a Justice-Care Perspective

Moral arguments for the duty to consider participant perspectives in ethics-in-science decision making derive from a synthesis of principle-based justice ethics and relational-based care

ethics. The justice perspective emphasizes moral agency based

upon principles of mutual respect, beneficence, and fairness

(Kohlberg, 1984). It stresses impartiality and distance from

both the scientist’s own interests and her or his connectedness

to participants. The ethics of care emphasizes the duty to interact with research participants on their own terms in response 

to their needs (Gilligan, 1982). It stresses attention to the interpersonal situation and a narrative of relationships that extends

over time.

In recent years there has been growing recognition in 

philosophical and scientific circles that morality based on justice can and does coexist with morality based on interpersonal

obligations (Baier, 1988; Dillon, 1992; Higgins, 1989; Killen,

1996; Waithe, 1989). For example, efforts have been made to

integrate the two perspectives into a single moral orientation

toward individual identity. Those advancing the justice perspective have traditionally taken individual identity as fundamental, viewed care as a choice, focused deliberations on how

one can fulfill obligations to others without violating their

autonomy, and emphasized the development of moral injunctions to protect identity. In contrast, those advancing the care

perspective have traditionally taken relationships as fundamental, viewed care as an obligation, focused on how one can

achieve individual freedom without violating moral obligations

to others, and stressed the construction of moral injunctions 

to protect relationships (Clement, 1996). By integrating the 

two philosophical orientations, a justice-care position assumes:

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(a) individuality is a product of ongoing interactions between 

a person and her or his social environment; (b) respect for individuality need not threaten a sense of community; and (c) one

cannot care for others without recognizing and being responsive to their individuality.

Research Vulnerability as a Relational Construct 

A justice-care orientation conceptualizes vulnerability as a relational construct. Research vulnerability is defined in terms of

a susceptibility to harm that does not rest solely upon the physical, psychological, or social characteristics that society views 

as disadvantageous, but upon the degree to which an individual’s welfare is dependent upon the specific actions of scientists within a specific experimental context. In relational ethics,

the obligation to protect the vulnerable also resides within the

context of dependency and not in the charitable inclinations 

of the moral agent (Goodin, 1985). From this perspective both

the specific susceptibility to research risks and the specific ability of scientists to help alleviate these risks defines an obligation

that is not voluntary but morally binding (Goodin, 1985).

When an individual labeled by society as vulnerable is the

focus of scientific inquiry, the investigator must consider the

special life contexts that render this person more or less susceptible to the harms associated with recruitment procedures and

participatory requirements for each particular experimental

design. For example, susceptibility to coercion and exploitation

may be a particular risk for those whose age, mental status,

or sociopolitical standing have limited their experience in 

making independent choices or for whom acquiescence to

authority has been a means of survival. It is not unusual for

individuals with mental retardation to assume permission from

a nondisabled guardian is required when they seek or are

offered treatment (Ficker-Terrill and Rowitz, 1991; Ellis, 1992).

For these persons, recruitment and consent procedures drawing upon institutional authority or the influence of legal

guardians may increase their vulnerability to undue persuasion

and involuntary participation. On the other hand, relationships between vulnerable persons and their family members,

practitioners, or community leaders may be a positive life feature that investigators can draw upon to reduce susceptibility 

to research risk.

A relational concept of vulnerability also implies harm is 

not predetermined. From this perspective, protecting the vulnerable entails reducing if not eliminating the probability of

threatened harms (Goodin, 1985). As a consequence, morally

responsible scientists must take actions which go beyond simply protecting cognitively impaired persons from established

risks associated with research participation. They must be 

willing to reconfigure experimental procedures to reduce or

eliminate research vulnerability. This may include re-conceptualizing traditional assumptions regarding the standards by

which an individual is considered competent to give informed

consent and the role of guardians in consent decisions. It may

also include new ethical responsibilities, including an obligation to educate prospective participants about concepts associated with the conduct of human subjects research and to

inform them of the value orientations driving the research.

From a relational perspective, the investigator sees such efforts

not in terms of paternalism (Goodin, 1985), but as contextually defined obligations of the research contract.

Principles, Consequences, Community, and Care 

A justice-care perspective accepts respect, beneficence, justice,

and integrity as fundamental ethical principles that guide the

moral actions of scientists. The translation of these principles

into moral actions is not, however, assumed to be achieved 

simply through a scientist’s moral reflections, but must derive

from expressions of mutual accommodation among scientist,

participant, and caring others integrated into concrete practices (Ricoeur, 1990; Widershoven and Smits, 1996). In addition, connectedness with, and caring for, those who participate

in research need to be viewed as moral ends in their own right,

rather than simply as a means to facilitate recruitment or 

maintain participant cooperation.

While accepting the deontic principle that research participants should not simply be used as a means to achieving

research goals, relational ethics conceives personhood and

autonomy as social constructions which can best be respected

through mutual understanding and dialogue between scientist

and subject. Respecting research participants thus involves

responding to them on the basis of their own self-conceptions.

A justice-care perspective proposes such ethical principles as

beneficence, respect, and justice can and should guide research

design and ethics-in-science practices, but that the investigator’s interpretation of these principles should not be prioritized

over the moral perspectives of participants and their families.

A justice-care perspective includes an evaluation of the 

moral rightness of ethics-in-science decisions in terms of consequences. However, relational ethics also draws attention to

contextual factors that may influence how a specific moral goal

may be achieved and perceived. Such factors include the recognition that scientists and participants may differ in their understanding of the rightness of the consequences of a particular

form of scientific inquiry. A relational approach to ethical decision making also rejects sole reliance on a rational calculation

of risk to benefits, recognizing that scientists and prospective

research participants may differ in how they evaluate particular

harms and goods, and whether or not they view the weighing 

of costs and benefits itself as a morally right action.

Ethical relationalism is not ethical relativism. An emphasis 

on the contextual nature of ethical judgments based upon 

scientist-participant dialogue is not meant to imply an ethical

relativism. Relational ethics does not assume basic foundational moral principles can be derived from group consensus. It sees

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embeddedness within a moral community composed of

scientists, participants, and their families as an essential starting point but not an end point in the search for the good (MacIntyre, 1984). Thus, the exchange of views between scientist 

and participant is aimed at illuminating rather than eliminating the moral values of each and creating a research enterprise

that can accommodate rather than subjugate these values. As

discussed more fully below, participant perspectives must inform

but not dictate a scientist’s moral judgments. Similarly, the value

orientations of scientists can not be perceived to outweigh

those who will be the focus of scientific inquiry. When applying

a relational ethic, an investigator must be prepared to abandon

a research project if its implementation compromises or usurps

scientific, participant, or community values.

Relations between partners, not strangers. Relational ethics

draws upon features of communitarianism (Rawls, 1971). It

promotes reliance on compassionate and reciprocal empathy

for the feelings of others and encourages scientists and prospective participants to uphold the common good rather than 

individualistic notions of the good life (Prilleltensky, 1997;

Sugden, 1993). Rawls (1971) proposes that just actions in a

society composed of members with different levels of resources

and power can be guided by imagining oneself in an “original

position” behind a veil of ignorance that would conceal one’s

actual social status. However, as Toulman (1981) points out, a

system of justice based upon imagining a veil of ignorance may

well be fair, but will also be an ethics for relations between

strangers. In relational ethics, such imaginings, if based solely

upon rational and abstract reasoning abilities, are seen to result

in false perceptions irretrievably embedded in the rational 

scientist’s own subjectivity. At its very core, relationalism

assumes that the ability to understand the perspective of individuals who differ in life experiences, world views, needs,

power, social status, culture, and material and personal

resources requires a process of bidirectional teaching and learning. This dialectic is operationalized in investigator-participant

co-learning procedures wherein the moral perspective of

prospective participants is viewed as an essential element of

ethics-in-science decision making.

Relationalism and Participant Perspectives 

A relational ethic based upon a justice-care perspective (Farr

and Seaver, 1974; Sullivan and Dieker, 1973; Veatch, 1987;

Wilson and Donnerstein, 1976), supports several moral arguments for including the views of prospective research participants, their families, and their communities in ethics-in-science

decision making (Fisher and Fyrberg, 1994; Hillerbrand, 1987;

LaFromboise and Foster, 1989; Ponterotto and Casas, 1990).

First, formulating regulations and ethical judgments solely on

the bases of opinions expressed by experts in the scholarly 

community and IRB members risks treating subjects as

“research material” rather than as moral agents with the right to

judge the ethicality of investigative procedures in which they

participate. Second, failure to consider prospective participants’ points of view encourages singular reliance on scientific

inference or professional logic that can lead to research procedures causing significant participant distress. The University 

of California IRB approval of consent procedures that failed 

to disclose the full nature of experimental risk involving 

medication withdrawal from participants with recent-onset

schizophrenia (OPRR, 1994) is an unfortunate example of what

happens when ethics-in-science decisions are not based upon

honest and open dialogue among scientists, prospective participants, and families.

Third, failure to draw upon participant perspectives can 

also lead to the rejection of potentially worthwhile scientific

procedures that participants and their families would perceive

as benign and/or worthwhile. For example, in the every day

practice of science, investigators often find that guidelines

designed to protect vulnerable children from experimental 

psychopharmacological treatments inadvertently create institutional obstacles that limit participants’ autonomy and access 

to research protocols that may advance scientific understanding and treatment of their disorders (Jensen, Hoagwood, and

Fisher, 1996). Fourth, consistent with the community consultation model advanced by ethicists and investigators concerned

with ethical practices and policies for clinical research on

HIV/AIDS and other life threatening and potentially socially

stigmatizing disorders, engaging prospective participants’

partners in the design and implementation of research: (a)

assures adequate consideration of the ethical values of beneficence, respect, and justice; and (b) increases the probability of

community support and cooperation (Levine, Neveloff Dubler,

and Levine, 1991; Melton, Levine, Koocher, Rosenthal, and

Thompson, 1988).

Relational Ethics and Co-Learning 

For the past two decades, ethical decisions regarding research

with human subjects have been guided by the three fundamental principles set forth by the Belmont Report (DHEW, 1978):

respect for persons, beneficence, and justice. Although few dispute the importance of these principles, there is no consensus

on how to prioritize one’s obligations when specific ethical

problems place the principles in conflict. From a relational

standpoint, achieving such consensus might actually decrease

the adequacy of moral procedures. Consensus among IRBs,

bioethicists, and investigators risks promoting universal application of a presumed hierarchy of values across contexts differing in their moral requirements that would reflect the values 

of the scientific and scholarly communities without consideration of participant values. Co-learning approaches can help situate decisions surrounding conflicting ethical principles within

specific research contexts and the perspectives of the specific

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population considered for investigation.

A major assumption of relational ethics is that co-learning

enhances the moral development of scientists and participants

through a better understanding of the reciprocal relationship

between the participant’s expectations and the researcher’s

obligations. Relational ethics views scientist and participant

alike as moral agents joined in partnership to construct

research goals and procedures that produce knowledge carrying

social value and scientific validity. In viewing autonomy as a

social construction, it proposes that respect for personhood

must be rooted in scientist-participant dialogues aimed at discovering shared and unshared values in a process of mutual

influencing through which fair and caring ethical procedures

are derived.

Teaching and Learning 

A relational ethic seeks to develop methods of ethics-in-science

decision making sensitive to both the justice-based dimension

of equality and inequality and the care-based dimension of

attachment and detachment (Clement, 1996). It assumes both

scientist and participant come to the research enterprise as

experts: The researcher brings expertise about the scientific

method and extant empirical knowledge base and the prospective participant brings expertise about the fears, hopes, and

wishes the community brings towards the prospect of research.

A cornerstone of relational ethics is that the roles of teacher

and student are assumed by both investigator and participant

throughout the process of exchanging views. For example, to

begin a dialogue by asking prospective participants open-ended

questions concerning research ethics is sometimes problematic

since it asks individuals to provide spontaneous and decontextualized responses to moral questions which require informed

deliberation on issues of scientific concern that most participants have not previously considered. Investigators can use colearning procedures to share with prospective participants their

views on how and why it is important to apply the scientific

method to examine questions of societal import and to debates

underlying areas of current ethical concern. In turn, the

prospective participants, their families, or community representatives can apply their moral perspectives to critique the scientific and social value of a proposed study and share with

investigators the value orientations guiding their reactions to

the planned procedures.

Through the uncovering of common and unshared dimensions of ethical attitudes toward the integrity of scientific

research, co-learning joins scientist, prospective participants,

and community members in partnership to discover previously unidentified areas of moral concern and to construct a scientific enterprise based upon mutual respect, accommodation,

and trust. Researchers employing co-learning welcome differing points of views as checks against the risk of confusing scientific self-interest with social beneficence. They forge ongoing

partnerships with prospective participants, gaining community

input at the design, implementation, interpretation, and dissemination stages of research (Higgins-D’Alessandro, Fisher,

and Hamilton, 1998).

Debriefing as Part of the Ongoing Process of Co-Learning 

A foundational assumption of relational ethics is that co-learning is an ongoing process involving scientist and community

members in moral discourse throughout each step of human

subjects research including: the research design, informed consent, project implementation, data interpretation, and knowledge dissemination phases. It therefore requires greater attention to debriefing procedures, an ethics-in-science practice that

has received scant attention outside of ethical discourse on

deceptive research practices. Debriefing has been viewed traditionally as a unidirectional activity that allows the scientist to

correct any misconception or supply information, purposely

withheld, in a sensitive and educational manner so that the participant can understand and accept the reasons offered, and be

satisfied with the experience (Keith-Spiegel and Koocher,

1985). As a consequence, in practice, especially in non-treatment research, debriefing is typically conducted in a cursory

fashion, void of an exchange of views, sometimes consisting

simply of a promise (often unfulfilled) to send participants a

summary of the findings when the research is completed.

From a relational standpoint, debriefing is a critical phase

during which the congruence between the participant’s expectations and the scientist’s obligations, presumably obtained

during informed consent, can truly be assessed (Scott-Jones

and Rosnow, in press). Debriefing thus needs to be constructed

as a bi-directional activity in which investigator and participant

openly share their views on: (a) the nature of and reaction to

the research experience; (b) the adequacy of information provided during informed consent; and (c) the scientific validity

and social value of the data collected. From this exchange, participants become more educated critics and consumers of scientific knowledge and investigators become more educated

about participant perspectives that can improve future ethical

procedures, research design, and interpretation and communication of research results.

Confidentiality in Research with Vulnerable 

Populations: A Case Example of Co-Learning

The principle of respect has generated numerous ethical 

guidelines for protecting participant privacy through the 

maintenance of confidentiality. Intricate procedures have 

been developed for keeping data sheets free of identifying 

information and for keeping records secure. Maintaining 

confidentiality presents few ethical challenges when science 

is characterized by laboratory studies devoid of information about individual differences or when individuals with 

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previously identified disorders are the focus of study. The 

ethical obligations are more complex when scientists study the

probability of impairment in populations judged to be at risk

for disorders or health-compromising behaviors. Such studies

have the potential to tap previously unidentified sources of psychopathology, developmental delay, cognitive deficits, abuse,

addictions, criminal activities, and other socially stigmatizing

characteristics and behaviors (Fisher, 1993, 1994; Fisher and

Rosendahl, 1990).

Does an investigator have a moral duty to help a research 

participant if a previously unidentified problem is revealed

during the course of research? Does this moral obligation 

override the duty to protect participant confidentiality? The

scientific community has traditionally been reluctant to act

upon information about individuals uncovered during the

course of nonintervention research out of a healthy skepticism

that inferences drawn from tests designed to evaluate differences between groups of individuals may not have diagnostic

validity when applied to a particular research participant 

(Fisher and Brennan, 1992). A second source of reluctance is

scientists’ awareness that sharing information with someone

who can help the research participant can sometimes create

stressful or harmful consequences for the participant, especially if such individuals react to information with punitive measures (Fisher, 1993).

A third element of caution against acting when researchderived information indicates that participants are in jeopardy

is rooted in the scientist-citizen dilemma (Veatch, 1987).

Acting to help a research participant may threaten the internal

validity of an experiment (especially in longitudinal designs) 

or jeopardize the trust and participation of others involved in

the research (Fisher and Brennan, 1992; Fisher, Higgins, et al.,

1996; Fisher, Hoagwood, and Jensen, 1996). Applying the 

rule-utilitarian framework, when a conflict emerges between

participant welfare and scientific rigor, investigators have often

valued the production of well-controlled data that can benefit

society over their duty to facilitate or procure services for 

individual participants.

Adolescent Perspectives on Risk and Confidentiality 

The study of risk in adolescent populations highlights ethical

issues surrounding confidentiality, both because of the potential dangers the risks pose to each particular teenager’s well

being and because of this age group’s ambiguous status with

respect to decisional capacities (Holder, 1981; Koocher and

Keith-Spiegel, 1990; Melton, Koocher, and Saks, 1993).

Research on risk-related characteristics or behavior can reveal a

particular adolescent participant may have: suicidal ideation, is

engaging in health compromising behaviors, is involved in illegal and/or harmful behaviors, or is living in abusive circumstances. An implicit assumption underlying the failure to assist

adolescents who indicate potential problems during the course

of risk research is that teenagers value autonomy and would 

feel betrayed by an experimenter disclosing confidential information to protect them. Blind faith in this assumption has 

prevented scientists from asking two critical questions: What

moral role does an adolescent research participant expect of

an investigator and what are the consequences of failing to fulfill

this role? 

Applying a co-learning procedure, my colleagues and I (Fisher, Higgins, et al., 1996) asked these questions of high school

students living in a low-income urban environment. Students

(who self-identified as predominantly Hispanic) were provided

with a brief overview of the scientific method and scientists’

concerns regarding confidentiality. They were then asked to

give opinions concerning different ethical strategies an investigator could follow if during the course of research an adolescent participant indicated she or he was in danger or engaged

in high-risk behaviors. The investigator could: (1) keep the

information confidential and take no action; (2) talk to the

teenager and assist her or him in finding a referral source; or (3)

tell a parent or another concerned adult. To avoid imposing our

own evaluations of risk severity, we asked the adolescents to

rate their perceptions of how problematic they considered the

following: use of alcohol, illegal drugs, and cigarettes; physical

and sexual abuse; suicidal ideation; sexually transmitted diseases; truancy; vandalism; theft; violence; and shyness.

Influencing the Lives We Examine

“Those of us who study lives are aware that we influence

the lives we examine—perhaps very little, perhaps a great

deal” (Josselson, 1996, p. 80).

Perhaps, not surprisingly, adolescents of all ages viewed 

self-referrals most favorably. However, probably the most

important finding of this co-learning approach was that

teenagers often viewed the maintenance of confidentiality negatively, especially in situations in which an investigator learns

that a research participant is a victim of, or engaged in, behaviors adolescents themselves perceive as problematic. Students’

responses thus indicated that they saw the investigator as having

a moral role in relationship to their problems. The advocacy role

that teenagers assumed was a scientist’s obligation was thus in

direct contradiction to the role of impartial observer assumed

by the majority of investigators currently conducting adolescent risk research.

A process of co-learning can illuminate the impact of both

action and inaction on the life trajectories of those studied. The

responses of adolescents alerted us to the disconcerting probability that even when teenagers have been promised confidentiality under traditional informed consent procedures, they

nonetheless expect to be helped when they tell an adult interviewer they are a victim of violence or involved in high-risk

behaviors. An investigator’s failure to help a teenager may have

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an iatrogenic effect on how the teenager conceptualizes her or his

own behaviors and the fiduciary responsibility of adults. Adolescents may interpret the scientist’s lack of action as an indication that their problem is unimportant, appropriate services are

unavailable, or that knowledgeable adults can not be depended

upon to help children in need (Fisher, 1993, 1994; Fisher, Higgins, et al., 1996). Thus, the preservation of confidentiality in

adolescent risk research in particular and research with other

vulnerable populations in general, assumed by many scientists

to be a moral good, may in some cases actually result in harm.

Avoiding the Fallacy of “Is to Ought”

In working with vulnerable populations, ethics-in-science decisions must reflect a balance between the need for communion

between scientist and participant and the obligation of individual moral agency. Relational ethic’s emphasis on autonomous

mutual accommodation guards against the temptation to use

the co-learning process to follow the fallacy of “is to ought”

(Sidgwick, 1902). The fiduciary nature of the scientist-participant relationship obliges the investigator to take ultimate

responsibility for decisions that impact the rights and welfare of

research participants. Accordingly, prospective participant perspectives must inform, but not dictate, the scientist’s ethical

decisions (Fisher and Fyrberg, 1994). In developing ethical procedures for human subjects research, scientists must assume the

responsibility to apprehend and respect the views of research participants without relinquishing their obligation to apply their own

knowledge, training, and values to the pursuit of the moral act.

For example, although they rated sexually transmitted diseases (STDs) as a serious problem, most teenagers we interviewed did not believe an investigator should report STDs to

concerned adults. While providing teenagers with a referral to 

a health clinic may respect their autonomy, given the lifethreatening nature of some of these diseases, an investigator 

has to evaluate teenagers’ preferences against the ability of

those in this age group to understand the personal implications of the disease, adolescents’ ability to obtain appropriate

assistance in this circumstance, and the risk to their health if

they do not follow through on the referral and the problem

remains unreported.

Constructing ethical procedures based upon mutual accommodation. How does a relational ethic address conflicts 

between the principles of respect and beneficence? Instead of

simply complying with or overriding the adolescents’ preferences, a relational-based approach calls for the development 

of ethical procedures that can accommodate (a) the scientist’s

fiduciary responsibility to protect participant autonomy and

welfare and produce reliable information according to 

accepted principles of research practice; (b) the adolescents’

expectations for confidentiality and concern; and (c ) the participants’ and guardians’ right to know the exact nature of

the investigator’s confidentiality and reporting policy.

In this specific situation, an understanding of adolescent 

and guardian expectations, combined with a recognition of

the investigator’ fiduciary responsibility, leads to the following

guidelines for confidentiality and disclosure procedures in 

adolescent risk research:

n Prior to initiating a study, the investigator 

should determine the adequacy of school and

community services for the risk behaviors and

disorders under investigation, the general ability

of prospective participants at different stages of

adolescence to utilize and benefit from these 

services with or without parental involvement,

and the extent to which different reporting

options conducive to the participants’ ability to

use existing services sustains or impairs the scientific validity of research procedures.

n The investigator then engages a small sample of

prospective participants and their guardians in discussion regarding the available reporting options

or draws upon previously acquired information

on adolescent and guardian perspectives.

n Based upon this information, the investigator

selects the reporting and referral procedures that

meet the adolescents’ and guardians’ expectations of the scientist’s role responsibilities, serve

the teenage participants’ autonomy and welfare,

and preserve the scientific integrity of the study.

n During the recruitment phase of the study, both

guardians and adolescents are informed about

the specific confidentiality, referral, or reporting

procedures to be implemented. This insures that

either can decline to give their permission/assent

for participation based on full knowledge of how

the investigator will respond to risk information

derived during the course of research.

n In addition, in recognizing that many adolescents’ assume that scientists have a moral 

obligation to assist participants who are at developmental risk, irrespective of the confidentiality

or reporting procedures selected for the study,

a list of neighborhood agencies specializing in

the problems under investigation is provided to

all those contacted, regardless of whether or not

they choose to participate in the study.

n If during the course of the study, an adolescent

participant meets conditions for referral or

reporting, the course of action outlined during

the consent procedures are reviewed with the

teenager, and then implemented.

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n At the completion of the study, participants are

asked to evaluate the adequacy of the ethical 

procedures and guardians and participants are

provided with a general summary of the scientific and ethical aspects of the study. These last

steps allow for continued mutual evaluation and

potential adjustment of future procedures.

Questioning Value Assumptions and Striving 

for Common Conceptions of the Good 

In the construction of its professional authority, the science

establishment has endorsed a set of ethical codes to police 

itself and allow others to police its members. These standards

can be said to largely reflect Eurocentric, rational-deductive,

libertarian conceptions of the good (Prilleltensky, 1997) 

which, preserved in federal regulations and professional codes,

become moral premises not amenable to challenge. The establishment’s definition of the good is embodied in assumptions

guiding scientific conduct (Beauchamp, et al., 1992; Freedman,

1975; Rosenwald, 1996; Veatch, 1987), among them:

n knowledge gathering is a fundamental and

unconditional good;

n knowledge generated by the scientific method is

and should be value free;

n scientists are entitled to use humans as material

for their pursuits;

n respect, beneficence, and justice are guiding

moral principles for ethical decision making in

human subjects research;

n cost-benefit analysis is an acceptable basis for

deciding how to prioritize these moral principles

and for guiding ethical decision making;

n informed consent is the primary means of

ensuring participants are not victims of an

imbalance in favor of greater risks than benefits;

n the right to make autonomous decisions regarding research participation is dependent upon 

the ability to weigh the risks and benefits of

the experimental procedures;

n principles of beneficence and justice can be subordinated to the principle of autonomy reflected

in informed consent policies;

n the absence of harm justifies the absence of

benefits if it leads to scientifically valid information; and

n science-in-ethics decision making is the province

of those with professional authority, be it scientists, bioethicists, IRB members, or policy makers.

Relational ethics poses several interrelated questions about

these traditional value premises: Do the values embodied in

current professional codes and federal regulations reflect the

moral visions of those asked to participate in research? Do scientists and participant groups have different conceptions of the

good life and therefore different evaluations of the ethical procedures aimed at producing knowledge to achieve the good? Do

standards of competency for consent to research decisions place

an unjust burden on those with identified mental impairments?

Would some individuals who consent to research participation

on the basis of information describing the immediate purpose

and nature of a study, decline to consent if they knew the value

orientations driving the scientific and ethical procedures?

Should scientists be required to communicate their conception

of the good and have their values exposed to participant evaluation? These questions take on ethical urgency when applied to

research with persons with cognitive deficits, individuals not

old enough to have the legal right to consent to research, and

members of historically oppressed populations.

Advocates for those who because of age or impairment have

traditionally been denied the right to consent to research, have

begun to challenge traditional standards for judging the moral

agency of those legally defined as incapable of consent. For

example, with the advent of de-institutionalization and the

principle of normalization into human services (Lindsey and

Luckasson, 1991; Wolfensberger, 1972), regulations for Intermediate Care Facilities (Conditions of Participation, 1988) and

recent court decisions guaranteeing the right of persons with

mental retardation to make their own treatment decisions

(Rennie v. Klein, 1982; Rogers v. Okin, 1982), a diagnosis of

mental retardation is no longer accepted as a presumption of

incompetence to consent to or refuse treatment (Dinnerstein,

1994). Similarly, state laws have increasingly granted adolescents the right to make decisions concerning treatment for

venereal disease, drug abuse, or emotional disorders without

guardian permission (Fisher, Hatashika-Wong, and Isman,

1999; Holder, 1981). However, federal guidelines regulating the

rights of these individuals in research have been vague in the

case of teenagers, and not formally articulated in the case of

individuals with cognitive deficits (Fisher, Hoagwood, and

Jensen, 1996; Bonnie, 1997). In the absence of clear guidelines,

individuals who have not reached the age of legal maturity, or

who because of disability do not have the legal right to make

autonomous decisions, have lost their claims to the moral

authority to make decisions about research participation.

Advocates for the rights of historically oppressed groups are

increasingly drawing attention to the possibility that established Eurocentric views of science may not be universal. Some

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argue that the value placed on the control and manipulation of

variables may reflect a materialistic, individualistic, power

dynamic inconsistent with the values of spirit, collectivity, and

harmony inherent in many ethnic minority cultures (Greenfield, 1994; Marcus and Kitayama, 1991; Parham, 1993; Triandis, 1990). Ethnic minority scholars are also espousing widely

held minority community beliefs that their members have been

“raped” by white researchers who engage in research without

understanding or caring for those they study, who use minority members as bargaining chips for the receipt of large federal

grants, and who treat them as the “human equivalent of lab

rats” (Mio and Iwamasa, 1993; Parham, 1990; Ponterotto,

1993).

Challenging Scientistic Assumptions

Is All Knowledge Worth Pursuing?

Science has traditionally attached ethical significance to 

methods but not topics (Rosenwald, 1996). This stance reflects

two assumptions inherent in a scientistic philosophy: (a) the

pursuit of knowledge is good regardless of its social and ethical

implications, and (b) consideration for the practical consequences of research will inhibit scientific progress and academic freedom (Scarr, 1988). From this perspective, statements

in the final paragraph of a journal article stating the limited

generalizability of one’s work to social application provide 

sufficient ethical safety mechanisms and/or alleviate the 

investigator of further moral responsibility against society’s

(mis)use of the products of her or his work (Fisher, et al., 1997;

Prilleltensky, 1997).

From a relational perspective, research is embedded in valuational contexts that make it impossible to claim the existence of

value-free information (Prilleltensky, 1997). Thus, a counterpoint to the scientistic view is that all research is value-laden

and sociopolitical in nature (Kurtines, Azmitia, and Gewirtz,

1992). This is particularly true when individuals with cognitive

deficits and minority group members are the focus of study

(Sampson, 1993; Zuckerman, 1990). In a society in which persons with cognitive impairments see their rights diminished

through protectionist laws and members of historically

oppressed communities have their rights degraded through discriminatory laws and practices, scientists must recognize that

any research on these and other politically vulnerable communities can directly impact public attitudes and policies directed

toward research participants and the populations they represent (Fisher, et al., 1997). That policy makers and nonscientist

citizens “are not likely to make the distinction between scientific

theory and what seems to be its political implications, or between

generalizations based on population statistics and their applications to individual members of a given group” (Zuckerman,

1990, p. 1301), argues for the importance of integrating participant perspectives into ethics-in-science decision making.

Group stigmatization. One community concern receiving 

little attention in ethics-in-science discourse is whether group

stigmatization should be considered in determining risks to

participants. Failure to give ethical attention to group depreciation as a research risk is rooted in the scientific ethos which

considers research morally permissible if the risks of the procedures are “reasonable” in relation to the benefits hoped for

(Beauchamp, et al., 1982). The “reasonableness” of risk has 

typically been determined by members of the majority establishment who, by definition of their intellectual, age, or racial

caste status, may overestimate the value of research and underestimate the risks of community stigmatization. According to

Cassell (1982), if harm/benefit cannot be accurately predicted 

it should not be applied. This may be especially true for the 

ethical evaluation of research on minority persons or those

with diminished legal rights, when they or their families do 

not have a voice in evaluating the “reasonableness” of collective

risks and benefits.

Many researchers have yet to recognize that racism and other

prejudices are not just abstract theoretical ideas, but rather real

conditions of discrimination and oppression in the lives of

ethnic minority individuals and those labeled as having cognitive deficiencies (Sue, 1993). Accordingly, failure to consider

group stigmatization as a potential cost of research participation may be asking politically disadvantaged members of

society to unjustly bear research risks. A relational ethic calls 

for researchers adhering to Eurocentric, scientistic philosophies

to question their individualistic and rational-deductive values

and consider the diverse world views held by members of ethnic minority and cognitively vulnerable communities.

In moving from a “discourse of power of the majority” to a

new form of dialectics between investigators and communities

(Ponterotto and Casas, 1990; Ivey, 1987), the science establishment must be prepared to ask questions that may challenge

foundational premises of scientism: Should government and

IRBs provide assurance of protection from group stigmatization and personal harm to physically, cognitively and 

politically vulnerable participants? Should the risk of group

stigmatization be communicated to participants and their 

families during informed consent procedures? Is collective

stigmatization a moral prohibition? 

Re-evaluating the Ethical Significance of 

Research Benefits

Secular scientific thinking holds an instrumental view of

reality. It values self-directed rational planning, self-determination, and autonomy. The notion of the good is constantly 

filtered through these values. In ethics-in-science decision 

making, the scholarly community grants moral priority to 

the ability to weigh the costs and benefits of an experiment,

but does not challenge whether a society based upon such 

calculations is worthwhile. A relational ethic emphasizes the

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importance of considering the authenticity of the cost-benefit

analysis to the moral lives of prospective research participants.

For example, might some adults with mental retardation prefer

to avoid unpleasant side effects associated with experimental

treatments for behavioral disorders, rather than take the chance

that their behavioral problems might or might not be reduced

by research participation? Are some individuals from historically oppressed populations unwilling to engage in any research

which may risk additional group stigmatization? 

Questioning the moral value of the cost-benefit analysis. The

acceptance of the balance of risks and benefits as a primary

means of ethical justification implies that beneficence, the

moral obligation to protect the welfare of research participants, does not take priority over other moral values in ethical

decisions for human subjects research. Some have questioned

whether efforts to ameliorate potential harm to vulnerable

populations is sufficient ethical justification for human experimentation. In human subjects research it is often considered

morally sufficient to conduct an experiment if the participants

are in no worse condition at the end than they were at the

beginning of a study. This emphasis on the principle of nonmaleficence—to do no harm—has lead to the acceptance of

an “ethical minimalism” (Rosenwald, 1996) in which research

participants are rarely direct beneficiaries of the knowledge

they helped produce. Such research is said to be valuable if it 

is conducted according to accepted scientific standards of

reliability and control and assumed to have social value. When

conducting research with historically stigmatized populations,

investigators need to be sensitive to how evaluations of social

benefits are culturally determined and pose the question:

Within whose historical tradition is this knowledge valued?

(Bermant, 1982).

Justice in its narrower sense is understood to be what is fair

and equal, and the just person is the person who takes only her

or his proper share. When research offers no direct benefits to a

participant or her or his community, how do we determine

what is the scientist’s proper share? Casas (1990) criticizes current ethical guidelines for human subjects research for their

emphasis on avoidance of harm rather than promotion of benefit to the community under investigation. Casas argues that an

emphasis on harm avoidance is an insufficient ethical justification for conducting research on vulnerable communities

because it shifts the ethical burden away from the investigator’s

obligation to demonstrate that research will result in any good

and towards the participant who must demonstrate that they

may be harmed. Casas’ comments raise the provocative possibility that the cost/benefit calculus, a traditionally cherished

means of evaluating ethical actions, may not be an acceptable

method of moral analyses for individuals holding values outside the Eurocentric and scientistic conceptions of the good.

Incentives for research participation. The absence of participant input on the risks and benefits of research inducements

can also lead to unfair practices. When applied to studies on

impoverished, institutionalized, or otherwise vulnerable populations, the decision to provide inducements creates a tension

between compensating individuals fairly for their time and

coercing them to assume extraordinary burdens because they

need the income (Levine, 1986). Unfortunately, little consensus

exists about what defines due and undue incentives for research

participation (Macklin, 1981).

Offering incentives should serve the principle of justice, by

enabling a balanced sampling of individuals from all segments of society and equitable distribution of both the burdens

and benefits of research participation (Fisher, 1993; Levine,

1986). However, varying economic circumstances can lead 

to varying perceptions of monetary inducements. To insure

that consent to participate in research is rational and voluntary, investigators and IRBs have warned against inducements

that might coerce individuals with limited economic power 

to participate in scientific procedures to which they might 

not otherwise consent. Unfortunately this approach sometimes leads to situations in which legal minors, adults with

mental retardation, or persons from lower socioeconomic

backgrounds are provided smaller compensation than economically advantaged individuals engaged in similar types of

research activities.

When is consideration of the economic, intellectual, developmental, or political status of individuals with respect to

research inducements justice or discrimination? Who should

decide? One response to this dilemma is to view research in

terms of the justice of exchange and the selection of incentives

as a means of establishing equality between goods exchanged.

The goods that participants bring to the research arena 

include: (a) the characteristics essential to answering a research

question; (b) the ability to engage in the experimental procedures; and (c) the motivation to participate honestly and to 

the best of their ability. Scientists bring to the research partnership: (a) the knowledge and training needed to construct

experimental problems of scientific and societal import; (b) the

ability and responsibility to protect the rights and welfare of

participants during the implementation of these procedures;

and (c) the willingness to share the benefits of research with

participants and/or society.

To determine a just exchange of research goods, investigators

can consult with prospective participants and their advocates to

determine the market value of the time, skill, and effort

required for participation within the context of the nonmonetary goods they may receive from research participation

(e.g., individual or community benefits of research-derived

knowledge). Inducements based upon this information can 

be set at levels sufficient to attract the desirable number and

diversity of research participants (Levine, 1986). Such an

approach reflects the position that economic justice belongs 

to the domain of obligation rather than charity (Goodin, 1985).

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The Sociopolitical Nature of Ethnic Minority Research

“Concepts of racial inferiority form what Horace Mann

Bond called “a crazy-quilt world of unreality” in a 

society that proclaimed equality, opportunity, and

democracy as goals while it “brutalized, degraded, and

dehumanized” African Americans “by every instrument

of the culture” (Tyack, 1995, p. 6).

Racism in American society has a long history marked by

social and political constructions of differences governed by 

the political and social interests of the ruling racial caste (Miles,

1989). Race-based research can and has been used to justify 

segregation, political subordination, and hostile and demeaning stereotypes (Laosa, 1984; Tyack, 1995). To many members

of racial and ethnic minority groups, federally funded research

represents another arm of a powerful racial caste system.

Although the recent federal regulation that requires justification for failing to include women and minorities in research is

laudable (DHHS, 1994), this policy does not address, and 

may even perpetuate, the questionable scientific validity and

ethicality of classifying humans into different “races” and the

practices of power and subordination that such classifications

represent in the United States (Tyack, 1995). In contemporary

science, terms such as “race” and “ethnicity” are used categorically with little scientific basis outside of historical folk beliefs

based upon pre-colonial era thinking about the inherent superiority and inferiority of populations along genetic lines (Chan

and Hune, 1995; Essed, 1991; Fisher, et al., 1997; Stanfield,

1991). Use of racial labels to categorize research participants

enables investigators to leave monolithic racial stereotypes

unquestioned and avoid examining the personal significance 

of these terms for research participants, scientists, and members of society (Cocking, 1994; Fisher, et al., 1997; Oboler,

1995; Ogbu, 1994; Stanfield, 1993). Socially constructed racial

labels can strip participants of their personal identity by 

studying them only in terms of racial or ethnic categorizations

(Heath, 1993). In their rush to label ethnic minority participants, researchers apply categories that may not reflect how

individuals see themselves.

Funding for research on ethnic minority populations is often

driven by economic and political concerns (e.g., urban crime,

welfare dependency) framed within the cultural lens of nonminority political leaders. Research designed to address minority “problems” may be viewed very differently by white

researchers and the minority communities they wish to study.

Desegregation policies (Tyack, 1995), the Bell Curve debate 

and associated IQ-based tracking movements in American 

education (Herrnstein and Murray, 1997; Jensen, 1991; Laosa,

1984), the Tuskegee syphilis study and government radiation

experiments which misinformed research participants about

information directly relevant to their health (Jones, 1993;

ACHR, 1996), the NIH-initiated studies on the biological bases

of violence (Leavy, 1992), and the California Adolescent Family

Life Program’s study of sexual abuse in African-American and

Latin-American adolescent mothers (Fisher, et al., 1997) are

examples of sociopolitically driven experimentation on

racial/ethnic minorities that have undermined trust in scientists as guardians of ethical treatment when prospective participants are minorities (Fisher, et al., 1997).

Who Speaks for Ethnic Minority Communities?

Some minority scholars have expressed the view that white

researchers do not understand the sociopolitical nature of

research involving questions of oppression, discrimination,

prejudice, racism, and dominate-subordinate relations (Sue,

1993). They argue researchers seeking to study minority communities, including investigators who are themselves members of the ethnic group(s) to be studied, should routinely 

seek advice of community leaders (J.F. Jackson, M.H. Bennett,

J. Dent, H. Fairchild, R. Jones, and P. Rhymer-Todman, personal communication, January 21, 1993). In response to these 

concerns, social scientists investigating high-risk behaviors 

in ethnic minority youth have formed community advisory

task forces comprised of ethnic minority scholars, practitioners, and community members charged with assisting in the

development of culture-fair research procedures and adequate

informed consent and debriefing procedures (Fisher, Hoagwood, and Jensen, 1996).

Relational ethics requires investigators to guard against

another form of paternalism: The unwarranted assumption

that opinions of minority scholars and community leaders

reflect or override those of the less educated and more vulnerable community members who may be the target of investigation. In response to concerns regarding the controversial 

NIH Violence Initiative (Wheeler, 1992), a panel of AfricanAmerican leaders was appointed to review the scientific 

adequacy and potential for group stigmatization and harm 

that would result from government-sponsored research on

pharmacological approaches to stemming the tide of urban

violence. However, absent from the dialogue was the voice of

African-American women and men living in impoverished

ghetto communities, whose sons, based on current statistics,

have a devastatingly high probability of entering the juvenile

justice system before they reach adulthood (Wordes, Bynum,

and Corley, 1994).

Federal guidelines that encourage the inclusion of guardians

of prospective participants might have situated the ethical

issues raised by the government initiative within the real-world

concerns and needs of those who would be most directly

impacted. For example, how would these individuals have

weighed the risk of group stigmatization against the chance

that experimental treatment might help them protect their 

sons from the sobering picture of adolescent risk characterizing

their communities? How might an understanding about their

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fears, hopes, and dreams for their children have influenced 

the research plans and goals supported by the initiative? How

might an honest dialogue between scientists and the parents of

prospective participants have shaped the recruitment procedures, experimental design, and dissemination plans in ways

that might impact positively on the reactions of those later

recruited for participation in the studies? 

From a relational perspective, investigators conducting 

multicultural research need to insure scientific and ethical 

procedures are derived from dialogue among scientists, community leaders, and representatives of the ethnic minority 

individuals who will directly participate in the research. Moreover, investigators need to insure discussions are bidirectional,

and that ethics-in-science decision making derived from such

discourse is based upon respect and mutual accommodation,

rather than compromise and coercion.

White Racial Identity and the Cultural Lens 

of Ethnic Minority Research

From a relational perspective, a scientist’s identity is in part

defined by the participants studied. When members of ethnic

minority groups are the focus of scientific inquiry, investigators should approach all research projects with the assumption that racial/ethnic bias is inherently present (Atkinson,

1993). A relatively ignored basis of unintentional racism is 

failure of white investigators to consider the impact of their

own racial identity on what research problems they choose 

to examine and the research methodologies they select (Ponterotto, 1993). According to Helms (1993), an inherent and

sometimes unconscious facet of white racial identity is that

white members of society are born the benefactors and beneficiaries of racism. Their attempt to deny, repress, or distort 

this fact can lead to research supporting racist ideologies.

From this perspective, racism in research can only truly be

overcome after white researchers attempt to become aware of

their role and status in a racist society and work to develop

non-racist definitions of whiteness. In relational ethics, this

goal can only be achieved through honest, caring, and ongoing

engagement of minority members in dialogue on value

assumptions driving race-relevant research.

Research implications of Helms’ stages of white racial identity.

Helms’ model of white racial identity includes six stages of

increasingly complex racial conceptualizations. In the first

stage, “contact,” a white researcher is considered naïve to the

sociopolitical implications of race in this country and erroneously assumes that data from research on predominantly

white samples pertain to people of all races. Researchers 

operating at this level may focus their investigations on social

characteristics such as income, education, and employment 

status rather than factors associated with minority status (e.g.,

discrimination) on the unsupported assumption that racial

group differences disappear when ethnic groups are of similar

demographic backgrounds (Fisher, et al., 1997; SlonimNevo, 1992).

In Helms’ second stage, “disintegration,” an investigator

becomes aware of race-related moral dilemmas and becomes

ambivalent about the inclusion of racial/ethnic minorities in

research. This may lead to unrealistic expectations for standards

in research excellence applied only to minority group investigations, resulting in a paucity of studies directly relevant to the

concerns of ethnic-minority communities. For example,

members of grant review panels operating at this level may 

give lower priority scores to research on newly immigrated,

lower-income, Spanish-speaking populations if the proposed

study does not include comparison groups defined by various combinations of individuals of different immigration 

histories, income levels, and language orientations. Such decisions can undermine research on ethnic minorities when there

is a lack of sufficient numbers of individuals representing each

of these groupings, when individuals who meet certain group

criteria are non-representative of Spanish-speaking residents 

of the United States, or when the rationale for inclusion is 

based upon empirically unsupported assumptions that these

factors comprise independent influences on behavior.

In attempts to deal with the personal disorientation emerging in the second stage, Helms describes a third level of white

racial identity development, “reintegration.” In this stage, white

researchers may seek re-equilibration by idealizing white 

culture as a standard for behavioral norms. This can lead to 

the assumption that ethnic minority research is only valuable

when whites are used as a control group, leading to comparative methodologies, which in turn result in deficitoriented approaches to understanding ethnic-minority 

behaviors and mental health issues (e.g., Banks, 1993; Graham,

1992; McAdoo, 1993).

At Helms’ next level, “pseudo-independence,” white

researchers substitute the ethnocentrism of the earlier stages 

for a liberalism that seeks to explain away racial-group differences in terms of cultural disadvantage, rather than looking

equally at both minority and white behaviors. This can lead 

to research supporting the paternalistic view that ethnic

minorities lack the ability or fortitude to play a role in alleviating adverse conditions impacting their lives (Parham and

McDavis, 1987). Research influenced by this level of white

racial identity development may also include assessments of

acculturation (adaptation to white social values) as an indicator

of psychological adjustment, when in fact some newly immigrated participants may experience the transfer of culture as a

source of intrapsychic and intrafamilial stress (e.g., Cooper,

1994; Gil, Vegas, and Dimas, 1994; Szapocznik and Kurtines,

1993), and traditional values or a bicultural orientation may 

in fact serve as buffers against psychological distress (Berry,

1980; Bettes, et al., 1990; LaFromboise, 1988). In the absence 

of information about what elements of majority culture are

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harmonious with the basic values and characteristics of

specific ethnic communities, white researchers operating at this

level of racial identity development risk legitimizing social prejudices into presumably value free “adaptive” and “maladaptive” categories of racial behavior (Fisher, et al., 1997;

Takanishi, 1994; Tharp, 1994).

According to Helms, those scientists attaining the fifth 

level of white racial identity, “immersion-emersion,” attempt 

to re-educate themselves and others by incorporating an 

understanding of white culture and racist sociopolitical history

in studies on both minority and white behaviors. This can

include scientific attention to the impact of racial discrimination in employment, housing, educational, and legal institutions as factors influencing family socialization patterns and

physical and psychological well-being (Boykin and Toms, 1985;

Fisher, et al., 1997, Gaines and Reed, 1995; Johnston, O’Malley,

and Backman, 1993; Sue, 1991). Such endeavors will fail to 

provide adequate explanation of factors influencing ethnicminority well-being if they do not incorporate the perceptions

and understanding that minorities have of their own social

realities, including perspectives of their immigration and life 

in the United States.

In Helms’ final stage, “autonomy,” white scientists, willing 

to abandon the benefits racism has provided them, recognize

the implicit cultural assumptions in their work and the need

not to impose these assumptions on other racial groups.

From a relational perspective, researchers can not develop a

mature white racial identity without giving ethnic minority

members a voice in the scientific enterprise designed to determine their identity and subjectivity (Fisher, et al., 1997;

Sampson, 1993). Incorporation of ethnic minority perspectives in white researchers’ exploration of their own racial biases

may challenge the extent to which their world view and 

conception of the good is sufficient or even appropriate for

studying racially diverse populations.

Relational Ethics and Informed Consent

Treating Adults with Cognitive Impairments as 

Members of the Moral Community

The scholarly and legal establishments have traditionally

defined partners in the moral community as “rational” persons

with whom one can have a shared understanding about 

what constitutes a moral action in a given situation. The “rational person” orientation has elevated certain levels of abstract

thinking to standards by which moral agency is judged. In 

the scientific community, adaptation of the utilitarian 

philosophy has led to ascribing what might be considered 

exultant status to the ability to weigh the costs and benefits of

research. For adults with cognitive impairments who may 

not make decisions based upon rational calculation, valuation

of cost-benefit analysis as a standard of moral agency can

deprive them of liberty of action and consensus making—

considered to be the rights of personhood.

The ability to rationally manipulate the costs and benefits 

of research and arrive at a “reasonable” outcome of choice is 

the most cognitively complex of several psycho-legal standards

of consent capacity (Appelbaum and Roth, 1982). The ability 

to respond to requests to participate in research can be also 

be evaluated at levels requiring less abstract reasoning skills

including: (1) expressing a choice concerning participation;

(2) demonstrating a factual understanding of the risks, benefits,

and alternatives associated with a research project; or (3) indicating the ability to appreciate the implications of the above

factors to one’s own circumstance and the voluntary nature of

participation (Appelbaum and Roth, 1982). Holding persons to

a standard which requires the calculation of costs and benefits

poses legal and ethical problems because it is difficult to

demonstrate that a person’s preference is directly related to 

the rational she or he may give, and rejection of an individual’s rational can justify widespread substitute decision 

making for those with cognitive impairments (Roth, Meisel,

and Lidz, 1977).

All persons with mental disabilities are unique individuals.

Those in the mild and moderate classifications of mental 

retardation and those with non-acute psychiatric disorders 

can often speak intelligibly, comprehend the speech of others,

and reason, and many have more in common with those with

typical mental abilities than with those classified with severe 

or profound mental retardation or acute psychosis. However,

many have characteristics, educational backgrounds, and 

social experiences that can negatively impact their ability to

make decisions affecting their lives. These can include deficits

in basic knowledge, difficulty with abstract reasoning and in

foreseeing the long-term consequences of a present act,

denial of disability, reduced ability to make and/or communicate a reasoned choice, limited experience in making 

independent choices, or difficulty in delaying gratification

(Ellis, 1992, Evans, 1981; Hayden, et al., 1992; Hill and Lakin,

1986; Wikler, 1996; Zetlin and Turner, 1984). The ethical challenge for scientists is to balance the obligation to respect the

right of those with cognitive deficits to be treated as members

of the moral community, with the need to ensure that illinformed or incompetent decisions will not place their welfare

in jeopardy (Ellis, 1992; Grisso, 1986; Lidz, et al., 1984).

Are standards of consent capacity fairly applied? Since the 

decisionmaking styles of those without identified mental disability are rarely evaluated, some have warned that adults with

intellectual impairments may be unfairly held to a higher standard of competency than commonly applied to the general

population (Lidz, Meisel, et al., 1984; Morris, et al., 1993).

Defining consent competency simply, in terms of higher-level

abstract reasoning skills, does not do justice to the complexity

of human judgment as situated in a person’s experiences,

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emotions, needs, and patterns of practical life (Merleau-Ponty,

1945; Widdershoven and Smits). Scientists recognize the role of

affective and practical factors in the decision making of those

without mental impairments, and respect their “non-rational”

preferences to decline research participation.

Consider, for example, persons with diagnosed disorders 

not considered mentally incapacitating who are invited to 

participate in a study to determine the efficacy of a psychopharmacological agent that may potentially reduce symptoms

of their disorder. They have the right to refuse to participate 

if they do not want to subject themselves to the experimental

medication’s side effects (e.g., nausea, dry mouth, headaches),

despite the fact that in objective terms such side effects pose

“minimal” risk with the potential benefits of symptom reduction outweighing the temporary physical discomfort. This is

not the case with individuals with mental deficits who, by 

being presumed incompetent, must demonstrate a capacity 

to make rational decisions, especially when their wishes are

inconsistent with conventional wisdom (Drane, 1985; Grisso,

1986; Lidz, et al., 1984; Roth, et al., 1977).

The moral claims of adults with cognitive deficits. What 

moral claims do adults with mental retardation have on 

science? From a relational perspective, their claims are no different from those with typical intelligence. They have the right

to assume that scientists are obligated to communicate with

them honestly, to develop procedures that do them no harm,

to act to protect their right to autonomy and privacy, and to

treat them fairly. The special cognitive status of adults with

mental deficits does mean that procedures to insure that these

claims are met require special efforts. Such special efforts may

include the use of proxy consent if: (a) standards of consent

capacity are applied equally to those with and without mental

retardation; (b) guardian consent is used to protect the personal rights and welfare of the prospective participant rather than

the interests of science; and (c) the adult with mental impairment sees proxy oversight as a legitimate and/or desirable

means of protecting her or his interests.

Relational ethics recognizes that in some research contexts

denying cognitively impaired individuals, especially those in

institutional settings, the protection of guardian consent may

result in unfair outcomes. Their limited abstract reasoning

skills, restricted knowledge base, and lack of experience and

opportunity to make autonomous decisions, may in some 

contexts make the cognitively impaired particularly vulnerable

to coercion and exploitation. Despite these vulnerabilities, it 

is difficult to justify current ethical procedures that do not

require a person’s assent along with guardian permission or

that allow proxy consent to override an individual’s objections

to research participation.

For example, the principle of justice calls for a re-evaluation

of scientists willingness to rely on proxy consent for research

with only a minor increase over minimal risk that holds out 

no potential benefit to a cognitively impaired individual, but

which might provide general information about her or his 

condition (Bonnie, 1997). Individuals without mental disorders have the right to consent or dissent to requests to 

participate in research that may generate information pertinent to their future welfare or the welfare of others. It is 

inherently unfair to require those with mental disabilities to

participate in research that may benefit members of their 

social group, when that same requirement is not made of those

with typical intelligence.

For experimentation on mental disability, the science establishment has also condoned proxy consent over participant

objections for research holding out direct benefit to the individual, especially when no other treatments are available (Bonnie, 1997). However, accepting this violation of participant

autonomy rests on a false distinction between non-therapeutic

and therapeutic research. First, all knowledge generated by 

science, including basic research, can potentially lead to application. Second, by definition, therapeutic research does not

guarantee benefits and, in fact, can pose greater risk to the 

participant because of the side effects of the experimental

manipulation or the deprivation of treatment if one is assigned

to a non-treatment control group. Consequently, to give investigators and guardians greater power in overriding the objections of vulnerable individuals in treatment research does not

have a convincing moral basis and is unjust if the dissent of

those without cognitive disabilities is considered inviolate.

Informed consent as a process of justice and care. Relational

ethics emphasizes attention to both the person and the context in which research will be conducted. Accordingly, when

working with adults with identified cognitive impairment, it is

incumbent upon the investigator to justify the standard of

consent that will be required for each experimental procedure

and the specific role that proxy consent should play in the

informed consent process. This justification should be based

upon an understanding of the characteristics, life experience,

knowledge base, and attitudes toward proxy consent of the

individuals who will be recruited for participation. Such understanding should be achieved through ongoing dialogue with

prospective participants, their families, and advocates. Engaging prospective participants and their legal guardians in discussion regarding consent decisions can also help determine

how proxy consent, when necessary, can reflect both the participant’s wishes and her or his best interests? 

From a relational perspective, the responsibility to meet a

selected standard of consent should not rest solely on the 

intellectual capacity or prior experience of a person with a 

cognitive impairment. Rather, investigators should seek to

reduce the participant’s vulnerability to research risks by providing information essential for a knowledgeable decision to 

be made in a format that is conducive to the prospective participant’s learning abilities. Many people with longstanding

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RELATIONAL ETHICS AND RESEARCH WITH VULNERABLE POPULATIONS
cognitive impairments are used to other people making decisions and may not understand or have experience applying 

the concept of autonomy. For these individuals, the concept of

voluntary choice may be an important element of the

informed-consent dialogue. In addition, investigators should

be required to develop consent procedures sensitive to the ways

in which those with cognitive impairments may express their

desire not to participate in a study (e.g., physical or verbal 

signs of anxiety or fatigue, body movements indicating a desire

to leave the situation, verbal expressions of distress).

Relational ethics and advance directives for research. As

advance directives for health care have become increasingly

accepted in society, some have suggested that similar directives

by those with advancing cognitive impairment can enhance

substitute decision making for research participation once an

individual’s mental capacity has been compromised. Several

scholars have provided excellent overviews of the ethical issues

associated with using advance directives for research (Moorhouse and Weisstub, 1996; Sachs, 1994). Among the problems

inherent in issuing and following advance directives is that 

neither the individual, in the early stages of increasing mental

disability, nor those who will serve as her or his legal guardians

can know with certainty how the prospective participant will

think and feel in a deficient state (Moorhouse and Weisstub,

1996). In the face of such uncertainty, protectionist policies

precluding research with the cognitively disabled and paternalistic approaches taking consent authority away from the

participant, are equally undesirable. Rather, from a relational

perspective, despite limitations in foreseeing future reactions,

the prospective participant is still the most expert in envisioning how she or he would respond to experimental procedures 

in an eventual state of cognitive impairment.

Persons with advancing cognitive impairments can not 

make decisions regarding future research participation in 

isolation. The process of obtaining ethically acceptable advance

directives requires a series of ongoing co-learning experiences among scientists, the prospective participant, and substitute decision maker. This process, like that of obtaining

informed consent, must insure that participant decisions are

free of coercion and exploitation. This means that statements

precluding participation in research are presented as equally

acceptable directives.

During the co-learning process:

n Investigators provide the prospective participant

with information about the nature and rationale

for different types of experimentation, the 

associated risks and benefits typically associated

with various types of studies, as well as what is

known about her or his future state of cognitive

impairment. Information about experimentation must be specific enough to allow an individual to assent or dissent to different types of

research (e.g., descriptive or intervention

research, greater than minimal risk, physically

invasive versus behavioral).

n Prospective participants provide the investigator and future substitute decision makers with

information that helps them understand: (a) the

participant’s value system; (b) the way she or he

evaluates pain, discomfort, and embarrassment;

(c ) her or his views on altruism; and (d) other

aspects of the person’s character and perspective

that will allow legal guardians to approach consent decisions from the participant’s perspective.

n Future guardians must also be encouraged to

share with prospective participants their moral

philosophies on consent-relevant dimensions so

that both can decide whether or not the advance

directives can be carried out in a manner that

honors both the participant’s and the substitute

decision maker’s value orientations.

As in research with persons already identified as cognitively

impaired, there is no ethical justification for overriding an

advance directive that indicates dissent to participate in research.

However, from a justice-care perspective, advance directives

which do not rule out participation in specific types of studies

do not replace the moral decisionmaking responsibility of the

legal guardian. The fiduciary nature of legal guardianship

obliges substitute decision makers to take ultimate responsibility for deciding the extent to which research participation

protects the rights and welfare of those who have placed their

trust in them. Thus, a substitute decision maker’s dissent

should override advance directives that appear to grant consent

to research participation. The advance directive process should

provide a sufficient understanding of the participant’s character and values to assist the guardian in making consent decisions that most closely represent the prospective participant’s

past wishes and protect the participant’s current best interests.

Consent Policies and Participation Rates 

for Research with Minors

Informed consent has been seen by many as the primary 

mechanism for respecting the rights and protecting the welfare

of research participants. Children and most adolescents do 

not, however, have the legal capacity to consent, may lack the

cognitive capacity to comprehend the nature of experimental

procedures, or perceive they lack power to refuse participation

(Fisher and Rosendahl, 1990; Keith-Spiegel, 1983; Koocher 

and Keith-Spiegel, 1990; Levine, 1986; Melton, et al., 1993;

Thompson, 1990). To insure that more vulnerable persons with

diminished autonomy have their rights as autonomous agents

protected, federal regulations (DHHS, 1991) and professional

codes (e.g., American Psychological Association, 1992; Society

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for Research in Child Development, 1993) require both

guardian permission and assent from the adolescent before a

teenager can participate in research.

Statements regarding confidentiality policies for research on

adolescent risk. Informed consent procedures need to provide

individuals and their guardians with all information that might

affect their willingness to participate in research, including 

the potential risks of participation. In consent practices for

adolescent risk research, one risk often overlooked—or intentionally not included because investigators worry that it may 

be a disincentive to participation—is the possibility that the

researcher will disclose confidential information because of

state laws (e.g., in the case of suspected child abuse), institutional policies (e.g., harm to self or others), or ethical standards

set by IRBs or the investigator’s own moral compass (e.g., illegal substance use or abuse, sexually transmitted diseases).

Applying a co-learning procedure, Colleen O’Sullivan and 

I examined whether disclosure policies stated in informed 

consent forms would deter parental and adolescent agreement

to participate in research on different adolescent risk behaviors

(O’Sullivan and Fisher, 1997). Contrary to assumptions held 

by many investigators, the attitudes expressed by this sample of

predominantly white suburban parents and their teenagers 

suggested that for some risk contexts confidentiality policies

may actually be a deterrent to research participation.

In our examination of prospective participant opinions, a

majority of parents indicated they would refuse to grant permission for their teenager to participate in investigations of

peer harassment, child maltreatment, suicide, sexually transmitted diseases, and violent behavior if they were informed 

that investigators would neither discuss the problem with the

teenager nor report the problem to a concerned adult (O’Sullivan and Fisher, 1997). Moreover, both parents and high school

students indicated they would agree to participate in research

on physical and sexual abuse, suicide, and sexual harassment 

if the investigator had a policy of informing parents if any of

these risk factors were a problem for the adolescent. Parents 

and adolescents also indicated they would consent to participation in studies on other risk factors (e.g., substance use,

shyness, truancy, stealing, and vandalism) if they knew that 

the investigator would discuss the problem with the teenager

and assist him or her in getting help.

Information gained from this study underscores the value 

of obtaining the views of prospective participants and their

guardians about different confidentiality and disclosure policies. This information challenges traditional investigator 

biases which assume that consent forms which include notice

that an investigator will refer adolescents found to be in 

jeopardy for services or report their problem to a concerned

adult participants will reduce participation rates. The views

expressed by parents and teenagers suggest that alternatives 

to confidentiality policies may actually increase participation 

in some types of studies and points to the importance of

telling individuals and their guardians about disclosure policies

during informed consent procedures.

Questioning the use of passive consent as a means of increasing participation in research with children and adolescents. The

cost-benefit calculus has often been applied unjustly to decisions to waive the requirement for parental permission and

guardian consent when research involves ethnic minority 

participants. To insure the rights of those who do not have the

legal capacity to consent, federal regulations (DHHS, 1991,

46.408a; OPRR, 1993) require the permission of legal

guardians, as well as the assent of the minor, before a child can

participate in research. In some situations, however, federal 

regulations (DHHS, 1991, 46.408[c]) allows parental permission to be waived when data are collected anonymously and

questions are assumed to be noninvasive and non-harmful or

when such consent may jeopardize the minor’s welfare. When

guardian consent is waived or when minors are wards of the

state, federal regulations (46.408[c] and 46.409 [2.b]) require

that an advocate for the minor verify the minor’s understanding of assent procedures, support her or his preferences,

ensure that participation is voluntary and that the minor can

terminate participation, assess reactions to planned procedures,

and ensure that debriefing is appropriate (Fisher, 1993; Fisher,

Hoagwood, and Jensen, 1996; OPRR, 1993).

Federal guidelines 46.408[c] also allow for waiver of guardian consent in an unfortunately gray area defined in federal 

regulations 46.116[c.2] and 46.116 [b.3] as “research that 

cannot be practically carried out without the waiver or alteration.” These regulations can lead to an abuse of participant

rights in situations where the investigator successfully argues

that obtaining parental permission is a legitimate “practical”

reason for waiving the consent requirement. Ethnic minority

children, especially those living in economically disadvantaged

or non-English speaking communities, are particularly 

vulnerable to scientific exploitation supported by conventional

justifications for consent waivers. Investigators often find

recruitment in these neighborhoods difficult. In such instances,

some have condoned the use of “passive consent” procedures

(sending home a letter to parents asking for a response only 

if the guardian does not wish their child to participate) as an

acceptable means of protecting child welfare. Middle class

majority populations are not immune from the use of passive

consent procedures, especially when school principals or

administrators in children’s psychiatric centers, out of paternalism or convenience, support or encourage its use.

It has been argued that passive consent is not an ethical 

alternative to active guardian consent because its use creates 

an unjust situation in which certain populations are disproportionately deprived of the protections afforded by parental

and guardian consent (Fisher, 1993; Fisher, et al., 1997; Nolan,

1992). I would also argue that the science establishment’s

44 NATIONAL BIOETHICS ADVISORY COMMISSION

RELATIONAL ETHICS AND RESEARCH WITH VULNERABLE POPULATIONS
acceptance of passive consent as a tool of convenience to

enhance participation rates reflects the scientistic assumptions that knowledge gathering is a fundamental and unconditional good and that scientists are entitled to use humans as

material for their pursuits. As a consequence, underlying 

ethical justifications for the use of passive consent is the implicit assumption that a caring and knowledgeable guardian 

would perceive the research as important and desirable for her

or his child. This assumption leads to the damaging inference

that parents who do not return consent forms either lack the

knowledge to appreciate the importance of the research or are

unconcerned about their child’s welfare (Fisher, 1993).

No empirical data exist to support these assumptions. Such

views fail to consider that parents may decide not to return 

consent forms because they do not approve of the goals or

methods of the research, are generally suspicious of scientific

research, or are concerned that the signing of any form may

trigger inquiries from immigration, welfare, or other government agencies. In the absence of knowledge derived from 

scientist-community dialogues on the potential threats of

passive consent to participant autonomy and adolescent welfare, unwarranted assumptions regarding community attitudes

toward informed consent procedures risk substituting investigator paternalism for parental permission.

Conclusion: Power and Partnership 

Relational ethics draws our attention to the interpersonal

nature and obligations inherent in the scientist-participant

relationship. It expands the traditional universalistic, principle

orientation of ethics-in-science decision making to include the

importance of intersubjectivity, particularity, and context, and

moves scientists toward a reinterpretation of their own moral

agency (see Smith, 1985; Walker, 1992). A relational perspective

also recognizes power-asymmetry as an inherent feature of

human subjects research.

The scientist-participant relationship is not purely contractual because the scientist has directive power that the participant does not have and because the hypothesis may not be

known to the participant. Most prerogatives lie with the

researcher. A scientist has the prerogative to select who will 

be recruited for research and the question under investigation.

The participant has the prerogative to decline research participation or withdraw once consent has been granted. An

investigator can come back and ask a person to participate in 

an extension of the research or a second study, but the participant does not usually have the prerogative to ask for additional

scientific assessments of treatment efficacy or knowledge 

generation once a study is completed. The command performance for the participant is to apply her or his best efforts 

to follow the experimental protocol during the study at the

direction of the scientist. The command performance of the

scientist is to protect the scientific and ethical integrity of

the study before, during, and after experimentation—however,

the investigator’s responsibilities are not commanded by the

participant, but by the scientific establishment and the investigator’s IRB.

When working with individuals identified as vulnerable, the

responsible scientist needs to insure power differentials are 

not a product of the participant’s special circumstance. Context-derived power asymmetries can occur when guardian 

consent is given higher priority than participant assent simply

because of an individuals physical, psychological, or social 

status. Power asymmetries are also magnified when the experimental arrangement itself increases participant dependency.

This can occur, for example, when an individual with cognitive

disabilities or inexperience in challenging authority freely

assents to participation, but is not aware of her or his right to

withdraw participation, does not know the actions she or he

would take to withdraw, or believes that she or he would do 

so at great cost. Potentially destructive power asymmetries 

also emerge when science is used as a tool of subordination to

legitimize oppressive policies (Prilleltensky, 1997).

Those who seek greater symmetry in power relationships

emphasize that each party must derive something out of the

relationship and be able to exercise discretionary control over

the resources prized by the other (Goodin, 1985). However,

these resources must be used to enhance, not compromise, the

ethical and scientific integrity of experimentation. Relational

ethics recognizes both scientists and participants can misuse

their influence to compromise the autonomy of the other:

Scientists can use their status and control of resources to coerce

participant compliance in treatment research that the participant may view as harmful, unjust, or unworthy. Participants

or their community representatives can exploit the science

establishment’s dependency upon their cooperation to coerce

investigator compliance in research practices that compromise

scientific validity. In relational ethics, the development of

ethical procedures must derive from mutual accommodation

rather than coercion.

Although power relationships between scientist and participant may not be truly symmetrical, they can be complementary. Such complementarity must be based upon trust that

each party will work to understand and respect the value 

orientations of the other. Relational ethics views an action as

unethical if it violates the moral values of either the scientist 

or participant. If co-learning discourse reveals that mutual

accommodation can not take place, the investigator must be

willing to abandon a particular research plan. The argument is

that to truly accept a relational model, one must value the

moral claims of both investigators and research participants.

Scientific procedures gain moral legitimacy only if they are 

the product of autonomous solutions which do not require

compromises that would coerce, exploit, or deprecate the values

NATIONAL BIOETHICS ADVISORY COMMISSION 4 5

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of either party. In a justice-care based approach, ethics-inscience decision making is based upon respect and mutual

accommodation between scientist and participant, rather than

compromise and coercion.

Relational ethics encourages scientists to engage research 

participants as partners in creating experimental procedures

reflecting both scientific and interpersonal integrity. It does 

not seek to encourage federal regulations that shackle science 

or that promote protectionist policies that create research

orphans out of vulnerable populations. Rather, a relational perspective should serve as a guide for moral discourse that moves

science toward an orientation of the good life lived with others

in social conditions that are just (Widdershoven and Smits,

1996). Scientific ethics is a process which draws upon investigators’ human responsiveness to those who participate in

research and their awareness of their own boundaries, competencies, and obligations. If becoming a moral subject is the 

critical moral task for all individuals (Smith, 1985), then 

recognizing that morality is embedded in the investigatorparticipant connection is the essential moral activity of science.

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PAPER FOUR CRITICAL ISSUES 

CONCERNING RESEARCH

INVOLVING DECISIONALLY

IMPAIRED PERSONS

Introduction

This is a working paper prepared by staff to the Human 

Subjects Subcommittee of the National Bioethics Advisory

Commission (NBAC). At the request of the subcommittee, the

paper attempts to set out the critical issues facing the commissioners concerning the recruitment and participation in clinical research of those who are decisionally impaired. The critical

issues considered in this working paper are as follows.

n Should the individual’s informed consent always

be required for research participation?

n Should individuals be able to execute substantive

advance research directives?

n Should the patient’s legally authorized representative be empowered to make research participation decisions, and on what basis should he or

she decide?

n Should legally authorized surrogates be empowered to make research participation decisions,

and on what basis should they decide?

n Should those who are decisionally impaired, and

at high risk for decisional incapacity, be excluded from research?

n Should the patient who decides to participate in

research be required to have appointed a legally

authorized representative to make subsequent

medical care decisions?

n Should those who are decisionally incapacitated

be excluded from research?

n Should research involving the decisionally

impaired or incapacitated be limited to that

which is relevant to a medical problem from

which the patient is suffering?

n Should investigators be required to notify individuals that they have been found to be decisionally inacapacitated and that they are to be

entered into a research project without their

consent?

Jonathan D. Moreno, Ph.D.
n Should consent auditors ever be required?

n Should “reconsent” procedures ever be required?

n Should “wraparound” studies ever be required?

n Should placebo arms ever be prohibited?

n Should the NBAC promulgate new regulations

concerning the participation in research of those

who are decisionally impaired, or should it rather

offer guidance for potential subjects, their physicians, clinical investigators, institutional review

boards, and other policymaking bodies?

Should the individual’s informed consent always

be required for research participation?

The Nuremberg Code is perhaps the most important touchstone of research ethics. The first sentence of the Code states

that “[t]he voluntary consent of the human subject is absolutely essential.”1 As the field of medical ethics has grown, some 

distinguished commentators have continued to defend the 

view that no research is permissible without the subject’s

informed consent. They point out that scientific progress is

morally optional, while respect for human beings and their 

self-determination is not.

Yet research with children and other populations has continued and flourished in the half century since Nuremberg.

These practices have been justified by seeking what many

regard as the moral equivalent of subject consent, including

parental permission and subject assent where feasible. A further

justification is that significant benefits to many individuals

would have to be foregone if the consent requirement were

strictly interpreted, but few have found strict interpretation 

of the consent requirement to be morally obligatory. Various

standards and procedures have been established to protect the

well-being of subjects. It is also often noted that, since treatment of individuals for disease must continue, far more harm

would be done through the widespread clinical use of modalities that had not been subjected to controlled study.2

Instead, conditions have been placed on research with those

who cannot give their own consent. If research with children

and others who lack decisionmaking capacity can be ethically

acceptable, then presumably research with the decisionally

impaired, who may have various levels of decisionmaking

capacity, can also be done in a way that is ethically acceptable.3

Foremost among the conditions that may be imposed on

research with those who are decisionally impaired or incapacitated is the gradually higher level of scrutiny that is accorded

research proposals as the risk-benefit ratio becomes less favorable. Conditions may be imposed concerning not only acceptable levels of risk, but also through recruitment and selection 

of subjects, study design, consent processes, and independent monitoring.

Should individuals be able to execute substantive

advance research directives?

Some persons whose decisionmaking capacity is currently

intact may be able to anticipate a period of incapacity, perhaps

extending for the rest of their lives. Various neurodegenerative

diseases have this kind of course, including Alzheimer’s. By 

the time an individual’s disease has progressed to a stage that is

of research interest, he or she may no longer be capable of

granting an informed consent. In theory, the individual may

make both substantive and procedural arrangements, while

capable, to enable study participation after a loss of decisionmaking capacity. An outstanding issue is whether such arrangements are acceptable approximations of the gold standard of

ethical research enrollment, the subject’s contemporaneous

informed consent.4

A substantive advance research directive would specify a

research project or projects that an individual would be prepared to enter, should he or she lose capacity. These advance

directives would be roughly equivalent to living wills for 

standard treatment. States would presumably need to pass legislation recognizing such devices. One question is whether 

federal regulations should recognize research advance directives

and take them into account in rules concerning subjects who

may lose their decisionmaking capacity before they can enter or

complete a study.

The idea of an “advance directive for research” appears to 

be consistent with our society’s dominant philosophical 

beliefs about control over one’s body and with other practices.

Some argue that, just as individuals may donate their remains

to medical schools and laboratories, so they should be permitted to commit themselves to a research project as living 

subjects while they still have the ability to do so. This argument seems to gain strength when the anticipated research 

participation holds some prospect of benefit to the incapacitated subject.5

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1 Rebecca Dresser, “Research Involving Persons with Mental Disabilities: A Review of Policy Issues and Proposals,” contract paper for National Bioethics Advisory Commission, 1997, p.

5. Relevant portions of this paper will hereafter be cited in footnotes as Dresser, followed by the manuscript page number.

2 Dresser, p. 6.

3 Dresser, p. 8.

4 Dresser, pp. 41–51.

5 Dresser, pp. 51, passim.
But potentially beneficial research for those who are incapacitated is the exceptional case; few studies offer even a remote

chance of benefit. Many contend that it is exploitive to permit

people, hoping desperately for a return to lucidity and health,

to make such a commitment, often well in advance of the 

actual research intervention. They note that one’s views about

continued medical procedures may change as one’s illness 

progresses, perhaps without the opportunity to review a

research living will once it has been executed. Further, how 

can it be decided when the experimental involvement should

cease, especially in studies that did not offer benefit to the 

subject in the first place?

If the idea of an advance directive for research is nevertheless attractive because of its consistency with our other values,

such as the protection and promotion of patient autonomy 

and the advancement of medical knowledge, some conditions

could be placed on its use. For instance, research advance directives might only be valid when the research presents some

prospect of patient benefit, and strict time limits could be

imposed that require active renewal of the living will. Another

option is to require the appointment of a legally authorized

representative to make a decision about stopping participation in the study, as a condition of validity of the advance 

directive for research.

There is another objection to research advance directives 

that is rather different from those mentioned above and that

many find decisive. The incapacitated patient may be aware 

of being subjected to various experimental procedures, but be

unable to understand their significance or appreciate that they

had been consented to in advance. A person with waxing and

waning awareness, often highly medicated and perhaps physically restrained, could experience study procedures as quite 

disturbing, and even as a kind of torture. To minimize this 

possibility, careful protections would need to be constructed,

including perhaps the advance appointment of an alternative

decision maker who could stop study participation at the least

sign of subject distress.

Should the patient’s legally authorized 

representative be empowered to make research

participation decisions, and on what basis 

should he or she decide?

In anticipation of a period of incapacity, many individuals 

have appointed others to make treatment decisions on their

behalf. The authority to appoint such representatives, who are

often called health care agents, has been recognized in the laws

of many states, technically known as the “durable power of

attorney” (DPA). In general, the health care agent is obligated 

to make medical decisions that are in accord with the patient’s

previously expressed wishes, or, if those wishes are unknown 

to the agent, consistent with the patient’s expressed values.

Failing that, the health care agent should make decisions that

advance the patient’s medical best interests.6

Many have advocated extending this legal authority to enable

the representative to make research participation decisions.

There are several situations in which such an arrangement has

practical appeal. Often individuals “fail” standard therapy but

are incapable of deciding about trying to take advantage of a

medication or device still under study. Or a person may not

have anticipated becoming ill and, suddenly incapacitated,

may have had no time to consider whether some experimental

treatment might be preferable to a standard therapy. Or an

individual may become decisionally incapacitated in the course

of medical care without having considered the next step in his

or her treatment. Finally, some may find donating their body 

to a research project to be a highly desirable and satisfying way

to exit, but, rather than leave this to chance, wish a representative to identify a worthwhile scientific effort taking place at 

the time of death.

In one important sense, the power to appoint a “research

agent” is an expression of the patient’s self-determination,

for which all sorts of provisions are currently made in the delivery of health care. If individuals are empowered to identify

those whom they wish to speak for them in making decisions

about recognized medical interventions, then why not extend

this authority to emerging medical alternatives? 

One important difference between reliance on health care

agents in the standard treatment setting and in the research 

setting is that recognizing the authority to decide about someone else’s care seems to be more easily justifiable when there is

good reason to believe that the intervention will be in that 

person’s interest. Experimental procedures or maneuvers are

not undertaken with the primary goal of subject benefit, but

rather are intended to help advance knowledge about the 

problem motivating the study. Allowing other persons to decide

about making someone an experimental subject, even when 

the individual in question has authorized them to do so, is a

qualitative departure from ordinary DPA arrangements. Such

decisions may entail considerable risks with little likelihood 

of substantial benefit.

Though great deference is given to individual self-determination in our political system, there does seem to be a legitimate

societal interest when a private arrangement may present 

significant harm to the individual initiating it, in the absence 

of a reasonable prospect of offsetting advantages. Weighing

against this societal interest is the possibility that greater 

medical knowledge may accrue to society in permitting these

arrangements to go forward in spite of their risks. In some

cases, the rejection of those who would make themselves 

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6 Dresser, pp. 29–36.
available for research through an agent could significantly 

hamper studies of the condition that led to the person’s current incapacity.

A balance might be struck by limiting the conditions under

which the health care agent’s authority would be valid. For

instance, studies that present no prospect of direct benefit to

the subject, but entail significant risk, could be ineligible for

enrollment via a DPA. Studies that entail minimal risk could be

regarded as consistent with a patient’s best medical interests

and therefore permissible, even though they do not advance

those interests.

Alternatively, a representative’s decision could be subject to

review to establish that it is consistent with what is known

about the patient’s wishes. But (short of intervention by a court

of law), it is not at all clear how such a challenge could be 

warranted, especially if the patient leaves no written statement

about his or her attitudes toward research. How should other

responsible parties, like researchers and IRBs, assess whether

the patient’s representative, in enrolling the patient in research,

is truly acting in accordance with the patient’s wishes and 

values? Unlike treatment DPAs, one test that would have very

limited applicability is the best interests of the patient. Since

studies are not designed to satisfy individual subjects’ medical

interests (though that may be a happy by-product of a study),

to say that a study is in a person’s best interests, especially 

when that person no longer has capacity, is often going to be

far-fetched. For many, this limitation on objective review of

a representative’s decisions is important enough to reject procedural arrangements.

In partial amelioration of this problem, at least from the

standpoint of potential harms to subjects, a warning to representatives might be appropriate in some cases. For example,

legally authorized representatives could be informed of the 

possibility that the research would add to the patient’s risk of

harm or discomfort. Were such information made part of the

process, the difference between the expected course with and

without research should be clearer to the lay person representing the decisionally incapacitated person.

Procedural advance directives, like DPAs, offer at least two

advantages over substantive research advance directives. The

first is that they are far more flexible than statements about 

preferred or permissible interventions. The second advantage,

and one especially pertinent to patients who suffer from some

degree of decisional impairment, is that it may be much easier

to designate a representative whom one trusts than to assess 

the relative risks and benefits of a research study. Thus, it may

be argued, if one wishes to grant patients the right to research

participation when they no longer have decisionmaking capacity, then the approach that is most reliable concerning their

expressed choice is probably the procedural one. However, it

must be granted that there is little evidence for this argument,

however intuitively plausible it may seem.

One objection to research DPAs is also an objection to

research advance directives and, indeed, to any study participation by the decisionally impaired: that the disoriented patientsubject may feel imprisoned and forced to undergo procedures

without understanding, even though they have been authorized by the legally authorized representative. This could be a

terrifying, nightmarish experience for a decisionally impaired

person. Although a procedural advance directive may reduce

this risk, it remains a serious concern and may require more

than one protective mechanism for the impaired subject.

Should legally authorized surrogates be 

empowered to make research participation 

decisions, and on what basis should they decide?

Usually people who lose decisionmaking capacity have not 

created an advance directive. Sometimes members of their 

family or other caretakers are identified as suitable surrogates 

in granting permission to enter them into research. But these

arrangements have, at best, an uncertain legal standing. Regulations could recognize state legislation that established in 

the law what is now a matter of common practice by granting

“natural” surrogates (such as family members or close friends)

a specific role in the research recruitment process for decisionally impaired persons.

An obvious objection to such arrangements is that, unlike a

representative appointed by the patient in advance, the surrogate’s standing as a substitute decision maker may arise only

from the law. To many the moral basis for the surrogate’s

authority appears inadequate, especially in the research context, because he or she has not been selected by the potential

subject. According to many bioethicists, surrogates are supposed to act on the patient’s behalf in accordance with their

“substituted judgement.” But there is no guarantee that even a

close relative is aware of the patient’s preferences or values 

with respect to standard medical treatments, let alone research

participation, or even that the surrogate will act on those 

preferences or values if they are known. A surrogate may only

be able to decide based on the patient’s medical best interests.

A “medical best interests” standard will not apply to studies 

that offer no prospect of direct benefit to the subject.

However questionable the legal basis of this process, a large

number of research subjects have been recruited through identification of a surrogate and restrictions on these measures

would constitute a severe blow to a great deal of research on

diseases that involve cognitive disabilities. And many studies do

hold out the prospect of direct benefit, including the use of new

drugs and medical monitoring. One option would be to recognize in regulation the role of surrogates in research that involves

only procedures that are potentially beneficial to the subject,

or that entail no more than minimum risk.

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Should those who are decisionally impaired and 

at high risk for decisional incapacity be excluded

from research?

In the final analysis, both substantive and procedural advance

directives for research are at best problematic. The underlying difficulty is that, unlike the usual medical circumstances

for which these legal devices have been designed, in a research

context the individual is giving himself or herself over, in

advance, to an enterprise that is likely to be of benefit only 

to the society at large, through the advancement of medical knowledge.

Considering the inherent limitations of measures intended 

to enable the incapacitated research subject to continue to 

have a voice in his or her treatment, it may be argued that those

who are at greatest risk of decisional incapacity should simply

be excluded from research. Were the assessment of risk for loss

of decisional capacity required prior to enrollment in a study,

the remaining subjects would be those who are less likely to

require the application of substantive or procedural advance

directives, though these devices might still be a condition of

study participation.

There are several objections to a rule-out procedure based 

on the prospect of a potential subject’s losing decisionmaking capacity. First, although the prospect of decisional

incapacity is often clear, especially in progressive diseases or

when a patient is going to be heavily medicated, in many cases

the loss of capacity is not so predictable. Second, however one

weighs the importance of advancing medical knowledge,

prohibiting research on those most likely to lose capacity 

would create a significant obstacle to the study of some 

diseases in their most debilitating stages. Third, some research

may be concerned with determining at what dosage a drug

impairs cognitive function, an issue that could be of great

importance to preventing future patients from losing their

decisionmaking ability. Fourth, the proposed exclusion 

would not avoid instances of uncertainty about the meaning 

of a substantive advance directive or the propriety of a decision made by representative empowered through a procedural

advance directive.

Nonetheless, the idea that ethical problems raised by incapacity should be avoided if possible has intuitive force. One

approach could be to require that a research project begin 

by enrolling those least likely to lose their decisionmaking 

ability during the study period, and that the selection of

at-risk subjects be justified by the particular goals of the 

study. A different approach would look again to the riskbenefit ratio, excluding prospective subjects from certain 

studies depending on their likely ability to make future decisions, as well as the anticipated level of risk.

Should the patient who decides to participate in

research be required to have appointed a legally

authorized representative to make subsequent

medical care decisions?

Apart from decisions having to do specifically with continuing

study participation, medical decisions must often be made

while a patient is enrolled in research. To avoid confusion about

who is authorized to make medical care decisions if the subject

loses capacity, investigators might be required to ensure that 

all subjects have a legally authorized representative. In some

jurisdictions this may require that the subject appoint a health

care agent prior to enrollment in a study.

From the researcher’s standpoint, it also seems prudent to

ensure that a patient with a decisional impairment not be left

without a representative to make health care decisions; such 

a representative could help the study team avoid problems if

treatment issues arise. However, there may be confusion about

the limits of the representative’s authority, since it may not

extend to issues having to do with the research itself. For 

example, conceivably the patient’s medical care representative could decide that continued participation in a current

research project is incompatible with the patient’s medical 

well-being and could have the power to remove the patient

from the study, but lack the power to enroll the patient in a 

different research project.

Should those who are decisionally incapacitated

be excluded from research?

One way to avoid the practical and philosophical problems 

with justifying research with those who are no longer able to

consent would be to exclude such individuals from being part

of research. A wholesale exclusion from research of those 

who lack decisionmaking ability would square with the letter of

the Nuremberg Code, but would not be consistent with

research practices even in the decades since the code was 

written. In general, it is thought that ethical research with

human subjects who cannot give informed consent can be and

has been conducted, especially if some form of advance directive or surrogate decision making arrangement is in place.

Several subsequent ethics guidelines (including those of the

Helsinki declarations of the World Medical Association and 

the Council for International Organizations of Medical Science) have endorsed research with those unable to consent

under certain conditions. Recent scholarship indicates that

even the Nuremberg Code itself was not intended to refer to

clinical research with those who are ill, but to research with

normal subjects.

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Furthermore, though it is controversial, the recently 

authorized exception to informed consent requirements for

certain emergency research is a greater departure from the

Code’s voluntary consent requirement than any contemplated

herein concerning research with those who are decisionally

incapacitated. A primary consideration in the creation of

the narrow exception to the federal rules was the need for

improvements in the care of emergent, life-threatening conditions. A similar argument can be mounted on behalf of the

improved treatment of those who are or are at risk for a loss 

of decisionmaking ability.

Should research involving the decisionally

impaired or incapacitated be limited to that 

which is relevant to a medical problem from 

which the patient is suffering?

Some “vulnerable” or “special” populations are currently

accorded a particular protection in the regulations to ensure

that they are not unfairly burdened with involvement in

research simply because they are easily available. Thus, prison

research is to be limited to conditions that especially affect 

that population. Considering that the decisionally impaired 

are often not only institutionalized but may also be unable to

speak for themselves, their position bears earmarks of special

vulnerability. One important justification for involving those

with decisional impairments in research is the need for progress in the treatment of certain diseases. In order to thwart 

the temptation to engage them in research simply because they

are more available than others, it may be appropriate to restrict

research involving decisionally impaired persons to that which

is relevant to conditions responsible for the impairment 

itself. A less restrictive rule would limit research to that which 

is relevant to conditions that tend to afflict those who are 

decisionally impaired.

Should investigators be required to notify 

individuals that they have been found to be 

decisionally inacapacitated and that they are 

to be entered into a research project without 

their consent?

To be found decisionally incapable and then enrolled in

research according to alternative decisionmaking arrangements

is to have certain of one’s rights curtailed, however justifiable

the curtailment research may be. Some argue that whenever an

individual is found to be decisionally incapable, the individual

should be put on notice of this finding, especially when it could

have important consequences for the individual’s medical

treatment, as in the case of enrollment as a subject.7

Such an notification process will often be an empty ritual.

Worse, a requirement that implies a duty to so inform those

who are in an advanced stage of dementia prior to research

involvement could well contribute to undermining health 

professionals’ respect for the regulatory system. Nevertheless,

to be unaware that one has been found decisionally incapable 

is to be deprived of the opportunity to seek review and perhaps of the right to judicial intervention. The implications of

such a determination, including the loss of control over one’s

own person, are among the most serious one can imagine for 

a liberal, democratic society.

Rather than require that all individuals who have been found

to be decisionally incapacitated be informed of that finding

prior to their enrollment in a study, such a rule may be limited

to those potential subjects who show any signs of consciousness. The notification would also enable the patient to assent 

to his or her research role, by no means a trivial recognition 

of individual dignity.

Should consent auditors ever be required?

The consent auditor is one device that has frequently been 

suggested as an additional procedural protection in the recruitment of research subjects who may be decisionally impaired.

The consent auditor, who is not a member of the study team

but perhaps a member of the IRB or an institutional ethicist,

witnesses the consent process and then either certifies the 

consent as valid, or informs the principal investigator that an

individual is not able to give valid consent.8

The consent auditor may be adopted as an alternative or as 

a complement to the blanket notification requirement discussed above. Rather than requiring researchers to engage in

what will often be an empty ritual, consent auditors could be

required for potential subjects who have conditions associated with a decisional impairment. A system of audited consent

will require a substantial investment by research institutions.

The requirement may be limited to studies that have certain

characteristics, such as those that involve greater than minimal

risk and/or those that do not hold out the prospect of direct

benefit to the subject.

Should “reconsent” procedures ever be required?

Studies with those who are decisionally impaired may take

place over extended periods. One of the essential conditions of

ethical research is continued voluntary participation, but those

who are deeply involved with and dependent upon the health

care system may not feel able to disenroll from a study. A

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7 Another way to express this issue is whether the assent of incapable subjects should be required. Dresser, pp. 36–40.

8 Dresser, pp. 22–25.
requirement for periodic “reconsenting” would help ensure 

that a patient’s continued involvement is truly voluntary by 

giving “permission” to leave the study. Such a requirement

would also provide the occasion to reassess decisionmaking

capacity, and it could trigger an advance directive or surrogate

arrangement. Reconsent mechanisms conform with the spirit

of informed consent as a process rather than a single event,

and with the view of human research participants as collaborators rather than as passive subjects.9

Reconsenting is, however, another labor-intensive measure

that would add to the cost and complexity of the human

research system. Yet a number of long-term studies already

include such a procedure. A reconsent requirement could be

attached to certain studies depending on their length and the

condition of the individuals to be included, such as those 

with progressive neurological disorders.

Should “wraparound” studies ever be required?

With or without a decisional impairment, many who are ill 

and candidates for a research study can suffer from the “therapeutic misconception,” the notion that the research maneuvers

or procedures might be of personal benefit even though that

possibility has clearly been ruled out in the consent process.

One way to deal with the therapeutic misconception is to 

incorporate a non-research or “wraparound” phase into the

project, one that provides the subject with some beneficial

intervention independent of the study itself.

A serious problem with a wraparound phase is that it may

shift the balance in the opposite and equally problematic 

direction of the therapeutic misconception, by providing 

an inappropriate incentive to study participation in order to

derive the benefits of a recognized therapeutic strategy without

payment. On the other hand, wraparounds could be suitable

follow-ups to certain kinds of research that involve the provocation of symptoms.

Should placebo arms ever be prohibited?

Many decisional impairments are associated with psychiatric

disorders that can be managed symptomatically with neuroleptic medication. When a known risk of placebo is the return of

symptoms, it may be argued that it is unethical to include a

placebo arm. Thus, some contend that new drug investigations

should be controlled by measures against standard therapy,

in spite of the methodological shortcomings of such designs.

A basis for excluding placebo arms in particular studies could

be an individualized assessment that concludes that certain

patients would be at high risk for relapse if their current therapeutic regimen was discontinued, that a “drug holiday” is not

contemplated for this patient apart from enrollment in a study,

and that standard therapy is generally considered effective if

not ideal. However, any change in human subjects regulations

concerning permissible research design should presumably

accommodate other federal requirements for drug approval.

When drug-free research is conducted (whether as part of a

“blinded” placebo-controlled study or otherwise), it is important to follow patient-subjects who are at risk for relapse. Presumably, under current regulations for “vulnerable” subjects,

IRBs should take such arrangements into account when evaluating research proposals. One regulatory option is to require

investigators to explain how they propose to monitor subjects

for symptom relapse in studies with a drug-free component

that enroll decisionally impaired individuals with a history of

psychiatric disorders.

Should the National Bioethics Advisory 

Commission promulgate new regulations 

concerning the participation in research of 

those who are decisionally impaired, or 

should it rather offer guidance for potential 

subjects, their physicians, clinical investigators,

institutional review boards, and other 

policymaking bodies?

The desirability of governmental regulation depends not only

on the importance of the policy enunciated or the practices

addressed, but also on the rules’ ultimate efficacy. Presumably,

the least formal measures taken by governmental entities are

the preferred ones, so long as those measures are consistent

with achieving the important societal goals that have been

identified. Many who are familiar with the current federal regulations concerning human subjects research complain that

they are already unjustifiably complex and bureaucratic. Some

of those engaged in research on conditions related to decisional impairment are fearful that further regulation affecting these

populations will unnecessarily retard scientific progress and

stigmatize individuals who may be suitable subjects.

But many others note that, in spite of the imperfections of the

current regulations, the period since their enactment has been

largely free of the sorts of large-scale controversies that helped

give rise to them. It may also urged that the issues discussed in

this working paper illustrate some of the shortcomings of the

common rule. The commission will need to determine whether

issues concerning the decisionally impaired in research are of

such a magnitude that new regulations are required, or whether

some or all of the reforms it may determine are indicated could

be advanced through another mechanism, such as a statement

of recommendations for relevant parties.

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9 There are related suggestions. See Dresser, pp. 26–27.

PAPER FIVE COMPETENCY TO DECIDE ON

TREATMENT AND RESEARCH

The MacArthur Capacity 

Instruments

Introduction

The issue of competency to decide on treatment and research

has come center stage in the arena of bioethics. With the advent

of the doctrine of informed consent came attention to both the

quality of the doctor’s informing and the quality of the

patient’s understanding. Since World War II, moreover, concern about the ethics of doing medical research on human 

subjects, particularly vulnerable subjects, has led commentators to focus on competency to consent. Finally, since the

1970s, many courts, first on federal and now on state law

grounds, have granted competent psychiatric patients the right

to refuse treatment absent an emergency. Indeed, probably 

the vast majority of treatment competency hearings today 

arise out of efforts to medicate psychiatric patients.1

Courts and commentators have struggled with the test for

competency in this setting. Unfortunately, courts typically cite

language that often obscures more than it helps, seldom 

engaging in illuminating analysis. Commentators have done

better. The premier work on competency to make treatment

and research decisions has come out of the MacArthur network on law and mental health.2 The MacArthur researchers,

in particular, Paul Appelbaum and Thomas Grisso, have 

operationalized three research instruments to measure four

capacities involved in treatment competency and have studied

Elyn R. Saks

1 The Supreme Court’s decision in Zinermon v. Burch, 494 U.S. 113 (1990), made this issue important in the context of consent to treatment as well as refusal, in particular, consent to

voluntary psychiatric hospitalization. 2 The literature contains studies of only a few other treatment capacity/competency instruments—my research has uncovered four. See, e.g., C. Dennis Barton, Jr., Harminder S. Mallik,

William B. Orr, and Jeffrey S. Janofsky, “Clinicians’ Judgment of Capacity of Nursing Home Patients to Give Informed Consent,” Psychiatric Services 47 (1996): 956 (Hopkins Competency Assessment Test [HCAT]); Jeffrey S. Janofsky, Richard J. McCarthy, and Marshal F. Folstein, “The Hopkins Competency Assessment Test: A Brief Method for Evaluating Patients’

Capacity to Give Informed Consent,” Hospital and Community Psychiatry 45 (1992): 132 (HCAT); Gary N. Sales, “Assessing Competency” (letter), Hospital and Community Psychiatry

43 (1992): 646 (discussing article on HCAT); Michael Lavin, “Assessing Competency” (letter), Hospital and Community Psychiatry 43 (1992): 646–47 (same); Jay Englehard, “Assessing

Competency,” Hospital and Community Psychiatry 43 (1992): 647 (same); Graham Bean, Shizuhiko Nishisato, Neil Rector, and Graham Clancy, “The Assessment of Competence to

Make a Treatment Decision: An Empirical Approach,” Canadian Journal of Psychiatry 41 (1996): 85 (Competency Interview Schedule [CIS]); Graham Bean, Shizuhiki Nishisato, Neil

Rector, and Graham Clancy, “The Psychometric Properties of the Competency Interview Schedule,” Canadian Journal of Psychiatry 39 (1994): 368 (CIS); Daniel C. Marson, Lawrence

Hawkins, Bronwyn McInturff, and Lindy E. Harrell, “Cognitive Models that Predict Physician Judgments of Capacity to Consent in Mild Alzheimer’s Disease,” Journal of American

Geriatrics Society 45 (1997): 458 (testing of Alzheimer’s patients based on vignette procedure intended to identify incompetency based on Roth, Meisel, and Lidz’ discussion of different

standards in “Tests of Incompetency to Consent to Treatment,” American Journal of Psychiatry 134 (1977): 279; Daniel C. Marson, Heather A. Cody, Kellie K. Ingram, and Lindy E.

Harrell, “Neuropsychologic Predictors of Competency in Alzheimer’s Disease Using a Rational Reasons Legal Standard: A Prototype Instrument,” Archives of Neurology 52 (1995): 955

(same instrument); Daniel C. Marson, Anjan Chatterjee, Kellie K. Ingram, and Lindy E. Harrel, “Toward a Neurological Model of Competency: Cognitive Predictors of Capacity to

Consent In Alzheimer’s Disease Using Three Different Legal Standards,” Neurology 46 (1996): 666 (same instrument); Daniel C. Marson, Lauren Hawkins, Bronwyn McInturff, and

Lindy E. Harrell, “Cognitive Models that Predict Physician Judgments of Capacity to Consent in Mild Alzheimer’s Disease,” Journal of American Geriatrics Society 45 (1997): 458 

(same instrument); Daniel C. Marson, “Determining the Competency of Alzheimer Patients to Consent to Treatment and Research,” Alzheimer Disease and Associated Disorders 8 

(1994 Supp.): 5 (same instrument); and Atsuko Tomada, Takahio Sumiyama, Kazumi Tsukada, Tatsuro Hayakawam, Kimimori Matsubara, Fusako Kitamura, and Roshinori Kitamura,

“Validity and Reliability of Structured Interview for Competency Incompetency Assessment Testing and Ranking Inventory,” Journal of Clinical Psychology 53 (1997): 443 (Structured

Interview for Competency and Incompetency Assessment Testing and Ranking Inventory [SICIATRI]). I focus here on the MacArthur instruments because they appear to be the 

most carefully constructed, best studied, and most discussed in the literature.
the instruments in their application to patients and control

groups. They have also produced a treatment capacity measure that can be administered in the clinic.3 Their work has

been impressive indeed; they have given us a set of generally

well-designed instruments that have achieved high reliability,

can be administered with relative ease, and have been studied 

in interesting and informative ways.

The three research instruments are: (1) the Understanding

Treatment Disclosures (UTD) instrument, which measures

understanding;4 (2) the Perceptions of Disorder (POD) instrument, which measures one’s appreciation of disclosures about

illness and treatment as they apply to one’s own situation;5

and (3) the Thinking Rationally About Treatment (TRAT)

instrument, which measures one’s reasoning skills as one

decides about a hypothetical treatment dilemma based on one’s

own condition.6 A subset of the latter test is a question which

measures one’s ability to express a choice.

Appelbaum and Grisso argue that the three instruments 

measure capacities relevant to different standards of legal competency found in the case law and statutes.7 They distinguish

between capacity and competency—”capacity” refers to abilities relevant to performing a task, while “competency” is a legal

judgment that one has sufficient abilities to perform the task—

and say that their instruments measure only capacities.8 The

term “impaired” means that the subject scored two standard

deviations below the mean of those studied.9

The researchers have recently designed a treatment capacity instrument, to be used for actual evaluations rather than

research purposes (the MacArthur Competence Assessment

Tool-Treatment, or MacCAT-T).10 The MacCAT-T incorporates many of the questions found in the research instruments,

while being more economical to administer and tailoring 

the questions to the person’s particular situation. The investigators do not suggest that MacCAT-T scores translate directly

into competency or incompetency findings (although those

who score average or better on all the tests are said to be likely

to be competent).11 Clinical judgment is required to make 

these findings.

This paper seeks to evaluate the MacArthur instruments 

with a view to understanding their implications for assessing

the competency to participate in research of vulnerable psychiatric patients. This assessment takes place against the background of some of the important normative issues that arise

whenever one selects a competency instrument. The paper

begins by describing the three MacArthur instruments in

greater detail. It then sketches a framework for thinking about

the normative questions raised by any competency instrument, discussing the implicit judgments the MacArthur investigators smuggle in, despite protestations that they have not

addressed these issues and absent an effort to justify the 

choices. The paper then evaluates the MacArthur instruments

in light of the normative framework, focusing on both the 

classification schema itself and specific features of each instrument. The evaluation leads into a discussion of the issues

involved in importing these treatment instruments into the

research context—as well as additional normative issues 

raised in this context. The paper concludes by addressing the

dilemma of what IRBs should require of their investigators in

this regard: first, should researchers be required to evaluate

competency when recruiting subjects for research? And 

second, should they be required to use particular instruments

to do so? A call for further research will end this section.

My conclusions? First, adopting any standard or instrument

to assess capacity/competency will involve normative considerations. The MacArthur investigators have arguably omitted an essential step in developing their instruments. Second,

the implicit judgments that the MacArthur investigators do

make may strike the wrong balance between autonomy and

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3 The MacArthur researchers have written a number of articles describing their development of the three MacArthur research instruments and the treatment of the competence instrument (MacCAT-T), as well as their application to patient populations and matched controls. See, e.g., Paul S. Appelbaum and Thomas Grisso, “The MacArthur Treatment Competence

Study I: Mental Illness and Competence to Consent to Treatment,” Law and Human Behavior 19 (1995): 105; Thomas Grisso, et al., “The MacArthur Treatment Competence Study II:

Measures of Abilities Related to Competence to Consent to Treatment,” Law and Human Behavior 19 (1995): 127; Thomas Grisso and Paul S. Appelbaum, “The MacArthur Treatment

Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment,” Law and Human Behavior 19 (1995): 149; Thomas Grisso and Paul S. Appelbaum, “A

Comparison of Standards for Assessing Patients’ Capacities to Make Treatment Decisions,” American Journal of Psychiatry 152 (1995): 1033; Jessica Wilen Berg, Paul S. Appelbaum, and

Thomas Grisso, “Constructing Competence: Formulating Standards of Legal Competence to Make Medical Decisions,” Rutgers Law Review 48 (1996): 345; and Paul S. Appelbaum and

Thomas Grisso, “Capacities of Hospitalized, Medically Ill Patients to Consent to Treatment,” Psychosomatics 38 (1997): 119. They have also recently published a book on the MacCATT: Thomas Grisso and Paul S. Appelbaum, Assessing Competence to Consent to Treatment (Oxford University Press, 1998). And they have an article in press on the application of their

instruments to the research context. See Jessica Wilen Berg and Paul S. Appelbaum, “Subjects’ Capacity to Consent to Neurobiological Research,” in Ethical Issues In Psychiatric Research:

A Resource Manual on Human Subjects Protection (Harold Alan Pincus, Jeffrey Lieberman, and Sandy Ferris, eds.) (forthcoming in American Psychiatric Association). Finally, they have

copies of their manuals for the different instruments, see note 4–6 and 10 below, which are essential reading for anyone interested in their instruments. Finally, there has been considerable literature discussing the MacArthur instruments, most prominently, the articles in Psychology, Public Policy, and Law 1, vol. 2. 4 The best way to understand the MacArthur instruments is to look at the manuals for the different instruments. For the UTD, see Thomas Grisso and Paul S. Appelbaum, Manual for

Understanding Treatment Disclosures (1992) (available on request from authors). 5 See Paul S. Appelbaum and Thomas Grisso, Manual for Perceptions of Disorder (POD) (1992) (available on request from authors). 6 See Thomas Grisso and Paul S. Appelbaum, Manual for Thinking Rationally About Treatment (1993) (available on request from authors). 7 See, e.g., Berg, Appelbaum, and Grisso, supra note 3, 363; Appelbaum and Grisso, Hospitalized and Medically Ill Patients, supra note 3, 121; and MacArthur I, supra note 3. 8 See, e.g., Grisso and Appelbaum, Assessing Competence, supra note 3, 11. 9 See, e.g., Berg, Appelbaum, and Grisso, Constructing Competence, supra note 3, 373. In this chapter I use the terms “competency,” “capacity,” and “impaired” in the same way. 10 See Thomas Grisso and Paul S. Appelbaum, MacArthur Competence Assessment Tool-Treatment (McCAT-T) (1995) (available on request from authors). 11 See, e.g., Grisso and Appelbaum, MacCAT-T, supra note x, 17.
paternalism. Both of these conclusions are equally applicable 

to the treatment and research contexts, and are important for

the National Bioethics Advisory Commission to consider in

assessing what to require of IRBs in regard to competency 

evaluations in the research context.

The Nature of the MacArthur 

Treatment Instruments

Before evaluating the MacArthur instruments, let us consider

in more detail what they do, and what studies of their application have revealed about different groups of people. The

UTD measures the subject’s understanding of treatment disclosures about the illness he suffers from and its treatment.12

Form disclosures were devised for schizophrenia, depression, and ischemic heart disease (angina). Each disclosure,

using language understandable at the junior high level, consists of five simple paragraphs briefly describing the illness 

and its treatment.

The first paragraph speaks of the illness itself, as well as 

of two common symptoms of the illness (“schizophrenia is 

a mental disorder. People with schizophrenia often have

unpleasant experiences, called symptoms. For example,

they . . . may hear voices talking about what they are doing,

even when there are no other people around”).13 The second 

paragraph talks about treatment, how it is administered, and

what is required of the patient for it to be effective (“fortunately, schizophrenia can be treated with medicine. . . . But if

patients stop taking this medicine, their symptoms may 

come back”14). The third speaks of the potential benefits of

the treatment (“the medicines used to treat schizophrenia help

many patients to think more clearly. They often stop the 

frightening voices that some patients with schizophrenia

hear”15). The fourth paragraph speaks of the potential side

effects of the treatment (“the medicine might make patients

restless or cause their muscles to tighten up”16). The fifth 

paragraph speaks of alternatives, benefits of the alternatives,

and potential problems with the alternatives (“there is also psychotherapy [to help treat schizophrenia]....This talking 

therapy may help patients better understand themselves and

their feelings. But psychotherapy alone does not usually help

with schizophrenia by itself.... [it] is most helpful when the

patient is also taking medicine”17).

The UTD is administered in three forms. First, the patient 

is read the entire disclosure and asked to paraphrase what 

has been said (with questions prompting him if need be).

Second, the patient is read each element of the disclosure in

turn, and after each element is read, is asked to paraphrase 

what has been said. Third, the same element disclosure format

is followed, except the patient is asked, after each element,

whether a statement read is “the same as or different from”

what has been said.

Patients receive points depending on how much they have

remembered and (presumably) understood. For example, if

two symptoms of schizophrenia have been disclosed, a patient

will receive a full score on that issue if he repeats or paraphrases those two symptoms. He will also receive a maximum score

if he includes those two but adds others that were not disclosed

to him. He will receive no credit if he remembers none of the

symptoms or, interestingly, if he brings up other symptoms—

even if they are bona fide symptoms of schizophrenia—that 

he did not hear in the disclosure (and he does not additionally

mention disclosed items).

The POD measures people’s appreciation of their illness and

its treatment: it requires them to apply general information to

their own situation.18 There are two subtests, the NonAcknowledgment of Disorder (NOD) subtest and the NonAcknowledgment of Treatment Potential (NOT) subtest. The

first measures the patient’s failure to acknowledge his diagnosis,

the severity of his condition, or the symptoms he has been

demonstrating. “Objective” measures of these three are provided by the diagnosis given in the patient’s medical chart, the

severity of his symptoms as measured by the Brief Psychiatric

Rating Scale, and the symptoms recently reported in his medical chart.

The NOT measures patients’ failure to acknowledge the

potential value of treatment for their illnesses even when 

successful treatment is likely. It focuses on the extent to which

patients believe (1) any treatment might be of benefit to them,

(2) medication specifically might benefit them, and (3) the

course of improvement is likely to be lessened absent treatment. If they fail to acknowledge the potential benefits of

treatment, they are provided a hypothetical premise that logically nullifies their reasoning (e.g. “imagine that a doctor tells

you that there is a medication that has been shown in research

to help 90 percent of people with your problem, even people

who had not gotten better with any other medication19). Nonacknowledgment is scored only if the patient fails to acknowledge the potential benefits of treatment under the hypothetical

condition. The NOT does not assess whether patients would

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12 The source for these claims about the UTD is the UTD Manual. See supra note 4. 13 Manual for UTD, supra note 5, 24. 14 Id. 15 Id. 16 Id. 17 Id. 18 The source for these claims about the POD is the POD Manual: See supra note 5. 19 POD Manual, supra note 5, 54.
agree to the medication—just whether they believe it might be

of possible benefit.

There are three additional elements of the POD that contribute to no subscale; they have been included for exploratory

reasons only. These items assess patients’ acknowledgment of

potential side effects of medication generally, their perceptions

of the beneficence of the hospital staff, and their perceptions 

of their own need for hospitalization.

The third instrument, the TRAT, measures patients’ ability 

to think rationally about treatment.20 The instrument gives a

vignette including information about a disorder, various treatment alternatives, and their probable risks and benefits. It 

then asks the subject to recommend one of the treatments to 

a friend with the relevant illness, and to describe the reasons 

for the selection. The patient’s reasoning is then scored for 

various cognitive activities that are considered important to

making a decision. A second set of procedures examines more

formal cognitive functions with relevance for decision making.

The cognitive functions identified are “seeking information”

(tendency to seek information beyond what is provided);

“consequential thinking” (consideration of consequences of

treatment alternative when deciding whether to accept or reject

it); “comparative thinking” (simultaneous processing of information about two treatment alternatives, such that they are

considered in relation to each other); “complex thinking”

(attention to the full range of treatment alternatives); and 

“generating consequences” (generation of potential real-life

consequences of the liabilities described in the informed consent disclosure, such as effects of a side effect of medication on

ability to perform job functions).

In the second part of the TRAT, three additional cognitive

functions are measured independent of the vignette: “weighting

consequences” (tendency for consistent application of preferences); “transitive thinking” (assessment of relative quantitative

relationships between several alternatives based on paired comparisons); and “probabilistic thinking” (ability to distinguish

correctly the relative values of percentage probabilities).

All of the abilities measured on the two parts of the TRAT

were derived from discussions in the literature of essential reasoning abilities. Presumably they are measured in a different

way given the constraints of the vignette procedure.

The way the vignette abilities are scored is by presenting the

vignette to the patient, asking her if she needs further information, and asking her to choose one of the alternatives and to

give her reasons for doing so. She is then asked for further reasons, as well as for her least preferred choice and her reasons for

that. Scoring occurs by seeing how many of the kinds of cognitive operations identified earlier occur. For instance, did the patient

compare risks and benefits of the alternatives with each other?

The way the three further abilities are scored is by presenting

the patient with a series of questions that tap into those abilities. For instance, to test probabilistic thinking the patient is

told that some event has a 90 percent probability of occurring

and is then asked if he thinks it likely to occur.

Finally, the TRAT has a question that measures the patient’s

ability to “express a choice.” A full score is received if the patient

unambiguously chooses an option, and partial credit is received

if the patient chooses two or no alternatives, but chooses one

alternative during a “repeat” inquiry.

Early indications are that two of the cognitive operations—

weighting consequences and seeking information—are frequent outliers, and when factor analyses are performed with

these subscales removed, they produce two very consistent factors: consequential, comparative, and complex thinking on the

one hand, transitive and probabilistic thinking together with

generating consequences on the other.

Formulating these instruments to measure capacities relevant to competency has been an impressive achievement.

The instrument designers have also done a large-scale, multicenter study evaluating the reliability and validity of the 

instruments.21 The instruments have done well on such indicators. In addition, the study has enabled the researchers to

draw certain important conclusions about different populations of patients. The research design was to study populations

of patients diagnosed with schizophrenia, depression, and

ischemic heart disease, and to match the patients on various

measures (e.g., age, race, gender, socioeconomic status) to a

sample of community nonpatients.

The results are intriguing. The most important is that a 

significant proportion of patients and nonpatients, in all 

categories, scored in the nonimpaired range, although the

schizophrenic patients did the least well. “Impaired,” as noted,

was defined as two standard deviations below the mean for the

aggregate of everyone studied, patients and nonpatients alike.

Given this definition, approximately 25 percent of the schizophrenic patients scored in the impaired range on each of the

three principal instruments, and approximately 50 percent

scored in that range if the scores on the different instruments

were aggregated. But this means, of course, that approximately

50 percent scored reasonably well.

The researchers noted that their study probably understated the impairment in the group of patients studied, because

probably the most disturbed patients were not deemed suitable for participation by their treaters. One could, however,

look at the matter another way. The study looked only at

recently hospitalized patients who were likely to be in the 

throes of the most acute phase of their illness. One would 

want a study of these patients much later in their hospital stay

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20 The source for the claims below is the TRAT Manual, supra note 6. 21 See Grisso and Appelbaum, MacArthur III, supra note 3, for the findings described below.
as well—the study did look at them a little later—in order to

judge the capacities of hospitalized schizophrenics. And a 

study evaluating schizophrenics in different settings, such as

day hospitals, community mental health centers, and group

homes, would probably have found a much higher percentage of patients scoring in the nonimpaired range. These

patients, of course, also have to make treatment decisions.

Moreover, insofar as schizophrenia is a chronic illness, studying schizophrenics’ decisionmaking abilities should include

them; they may be displaying some symptoms even when 

not hospitalized. In short, many if not most patients—even

those with the most severe psychiatric disorder—are quite

capable of making their own decisions. Beliefs otherwise may

reflect bald prejudice.

The second important finding of the study was that the 

three different instruments seemed to be picking out different

patients. While the UTD and the TRAT somewhat tracked 

each other, the POD was not correlated with either of the 

former two at all.

The final instrument that these researchers have designed 

is the MacCAT-T.22 The MacCAT-T incorporates many of the

questions found in the research instruments, while being 

more economical to administer and tailoring the questions to

the patient’s particular situation. On the normative matters,

the researchers have pointed out that the research instruments

pick out different groups of people as impaired, and therefore

ought all to be used in the MacCAT-T. This is a policy choice

which we will consider below.

Quantitatively, the researchers consider two alternatives:

using a fixed level of performance as a basis for a finding of

competency—say understanding, appreciating, and reasoning

about 75 percent of the information provided; or varying the

level based on the net balance of expected benefits and risks 

of the patient’s choice compared to the alternatives (i.e., requiring more capacity for more problematic decisions). The

researchers seem to prefer the latter, although they do not 

clearly take a position in this work. I consider the issue of

varying the level of competency required depending on the

decision below.

Finally, qualitatively, the researchers note that some items 

of information to be understood, appreciated, and reasoned

about may be much more important than others. Decisions

about the weight to be given to each item are of great importance in formulating a competency standard.

The MacCAT, then, is an instrument, unlike the three

research instruments, which can be used to aid clinical evaluators in a determination of legal competency. It does not 

definitively answer what level of impairment should equal

incompetence. And its authors recommend that the instrument

be used in conjunction with a clinical evaluation that takes 

into account such things as contextual variables. Nevertheless,

it, like the research instruments, is an important contribution

to the literature on competency.

Normative Judgments Required When Designing

Competency and Capacity Instruments

While the MacArthur investigators claim that they have left

open the normative questions in designing their instruments23—a claim I question below—the adoption of any 

standard or instrument for capacity and/or competency

requires careful normative analysis.24 The most critical normative issue facing any designer of a capacity and/or competency instrument is how to strike the balance between 

autonomy and paternalism. It may be true that bioethicists 

have moved beyond this simple dichotomy in many areas.

But in the arena of assessing competency, this conflict remains

the most critical. Competency standards are the mechanism 

by which we draw the line between those who will be permitted to exercise their autonomy and those who will be 

treated paternalistically.

Of course, it is at best incomplete to say that we strike the 

balance in our society between autonomy and paternalism 

by holding that competent patients, and competent patients

alone, are given the right to exercise their autonomy. For this

simply pushes back the question: how we define competency 

is itself the pivotal determiner of how that balance is struck

—requiring much in the way of competency favors paternalistic interests and vice versa.

Perhaps more important, the definitional question replicates

within itself autonomy/paternalism concerns. The MacArthur

researchers recognize that the issue of when to decide for a

patient and when to allow him to decide himself raises an

important autonomy dilemma. We are concerned about 

allowing people choice—say of treatment or participation in

research—when it is appropriate to do so. But the researchers

do not seem to recognize that the very definition of competency requires us to decide how much latitude we will give

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22 The source for the claims below is the MacCAT-T Manual, supra note 10. 23 See, e.g., Thomas Grisso and Paul S. Appelbaum, “Values and Limits of the MacArthur Treatment Competence Study,” Psychology, Public Policy, and Law 2 (1996): 167–70. 24 Since my writing of this chapter, the MacArthur researchers, Thomas Grisso and Paul Appelbaum, have published a book, Assessing Competence to Consent to Treatment (Oxford 

University Press, 1998), supra note 3, which bears on this critique. In this book, the researchers lay out the kind of normative analysis that the competency evaluator, using the MacCAT-T, must go through. In a sense, however, their treatment is not all that helpful. The main thing they say is that a competency judgment must balance autonomy and paternalism,

a value about which there is much more to say than this in describing an instrument. They also say that the balance may change when a decision is more or less consequential. They 

do not fully explain either why we should have such a sliding-scale competency standard (see below) or why they study the abilities they study or decide to draw the line where they 

do. Moreover, they neglect some of the additional normative dimensions involved in adopting a competency standard (see below).
the decision maker to exercise in selecting a method of

decision making. Are intuitive methods adequate? Must decision makers compare all alternatives? A most important 

subset of this issue is how much scope we will give decision

makers to select the version of the truth they will embrace.

What does this all mean? In adopting a competency standard, we must be mindful of several important problems.

First, we want to protect the vulnerable who are unable to

decide for themselves (our “paternalism interest”); this translates into a careful inquiry into what abilities are essential 

for making decisions. Second, an important purpose of our

doctrines regarding competency—which must therefore be

reflected in the standard we adopt—is to protect the unconventional (our “autonomy interest”). Third, we must be 

mindful of the discovery of psychoanalysts, psychiatrists,

and psychologists that irrationality in decision making is 

really quite pervasive: people misunderstand statistics,

overvalue vivid memories, form somewhat distorted beliefs

about their doctors as a result of transference, and so forth.25

This requires us to question whether we want to find many

more people incompetent than our current practices do—

to encompass all of these people who are mildly irrational.

If we do not make this normative choice, it requires us to be

very careful not to find incompetent those who are mentally ill26 but really suffering from no more irrationality in 

the relevant regard than many people. To do otherwise is to

mistake the floridness of many of the patient’s symptoms 

for sufficient decisional impairment and therefore to stigmatize the mentally ill unnecessarily (our “nondiscrimination interest”).

These, it seems to me, are some of the normative parameters

in terms of which we must measure a competency standard 

and its implementing instrument. Concretely, what this means

is that we must justify which abilities we require for competency, as well as the level of these abilities which we require.

Are these abilities, with this level of performance, really necessary, and if so why? Or are they nice, but inessential, much as

speaking a foreign language with a good accent is inessential 

to basic communication? Even if we think them arguably

important, do we trench too much on patient autonomy by

requiring them? And if their absence or impairment is widespread, do we risk discrimination by applying them only to 

the mentally ill? In short, deciding on the abilities and levels 

are thoroughly normative endeavors.27 The choices will be

manifest in the kinds of abilities chosen; the skill level in 

the tests of those abilities chosen (e.g., the reading level in 

the UTD); and the level of performance required in order to 

be deemed competent.28

Can the MacArthur researchers avoid criticism of their

instruments by claiming that they have not made normative

choices—an argument they have made in the Law, Psychology, and Public Policy issue devoted to their research?29

In my view, they cannot. It is true that they avowedly leave 

some choices open: how deficient must one be to be incompetent (vs. “impaired”)? But they have also made certain 

other choices—and these choices must be justified. For

instance, they do set a level at which “impairment” is found.

In addition, in their discussion of the MacCAT-T (admittedly at a time after they invoked the shield of supposed 

normative-lessness), they suggest that a particular score 

should, whatever else we decide, definitely lead to a competency finding. Further, they suggest that we should 

probably adopt a variable competency standard depending 

on a cost-benefit judgment about the patient’s choice.30

These are not pure, value-free statistical questions, but rather

normative choices.

Perhaps most important, the MacArthur researchers point

out that the three main research instruments seem to be picking out different populations of patients, so that a treatment

capacity instrument (their MacCAT-T) should aggregate the

three measures. This judgment presupposes that all the skills

measured by the three instruments are important to competency—something which is not at all obvious and needs to 

be justified.31

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25 See, e.g., Sigmund Freud, The Psychopathology of Everyday Life (1901) (standard ed., vol. VI, 1986); Jay Katz, The Silent World of Doctor and Patient (The Free Press, 1984); Daniel 

Kahneman, “New Challenges to the Rationality Assumption,” Journal of Institutional and Theoretical Economics 150 (1994): 18; Donald A. Redelmeier, Paul Rozin, and Daniel 

Kahneman, “Understanding Patients’ Decisions: Cognitive and Emotional Perspectives,” Journal of the American Medical Association 270 (1993): 72; and Amos Tversky and 

Daniel Kahneman, “Rational Choice and the Framing of Decisions,” Journal of Business 59 (1986): S251. 26 Although “mental illness” is a contested term, I use the term here in roughly the same sense as it is used in The Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition

(American Psychiatric Association, 1994). I do not, in this work, address the many difficult issues that surround the notion of mental illness. 27 In saying this I do not mean to suggest that choosing a competency standard is completely normative, just that it is in large part normative. Choosing such a standard also depends on

empirical findings, such as what impairments lead to substandard decisions, what abilities people actually use when they are deciding, and how psychiatric impairments can impact

decisional ability. 28 There are other normative issues also raised by competency standards, for instance, in the research context, where other values (e.g., the progress of science) are involved. In addition,

the question of whether we should adopt a sliding-scale competency approach cries out for further analysis. I discuss some of these issues below when we turn to the research context. 29 See supra note 3. They have also discussed this issue in other publications, e.g., Berg, Appelbaum, and Grisso, Constructing Competence, supra note 3, 375–90. Here the authors discuss

the kinds of normative issues that must be addressed to adopt a competence standard, conceding that their instruments do not address these issues. 30 See, e.g., Berg, Appelbaum, and Grisso, Constructing Competence, supra note 3, 385–87; Grisso and Appelbaum, Assessing Competence, supra note 3, chapter 7. 31 See, e.g., Berg, Appelbaum, and Grisso, supra note 3, 380–81. Indeed, the authors suggest that there are empirical grounds to aggregate the standards because they pick out different

groups. Actually, however, it is a normative issue whether we should aggregate the standards given that they pick out different groups, depending on whether we think the capacities

judged are important to competency.
Indeed, even by proposing the research instruments the

MacArthur researchers make normative choices.32 True, the

instruments measure only “capacities,” and not “competency.”

But why would one measure these particular capacities unless

one thought them relevant (critical?) to competency? One

could also measure foreign language skills, but no one would

bother to measure these skills in a capacity instrument administered in one’s own language that was designed to be significant for measuring treatment competency. Simply by selecting

the abilities measured, and measuring them down from and 

up to certain levels, the MacArthur researchers are making 

normative choices. Once again, these choices must be justified.

(In addition, as a practical matter many future competency

administerers may mistake the nature of certain of the instruments—thinking that “impairment” simply translates into

“incompetency” or imagining that the standard given for

“clearly competent” on the MacCAT-T should divide the competent from the incompetent. It would be interesting to try to

judge how often these instruments are being used in current

practice, and whether such mistakes are being made.)

The absence of normative justification is the most important

flaw in the MacArthur instruments. (It is difficult to imagine

leaving a harder task to the evaluator on the streets, so to

speak.) Below, I evaluate the instruments by suggesting that

they may strike the balance in the wrong place—without myself

undertaking the sustained normative evaluation that would

fully establish the point. I intend to do so in future work. Until

that time, one might see my critique and proposals as the kind

of critique and proposals one would make if one very much 

valued autonomy. Still, undertaking the appropriate normative justification is the biggest challenge facing future scholars.

Evaluating the MacArthur Instruments

Problems with the MacArthur Scheme

Although it is not clear until one reads through the questions in

the instruments themselves, the UTD is what I have elsewhere

called a “pure understanding” standard, while the POD is what

I have elsewhere called a “naive understanding and belief

standard.”33 By a pure understanding standard, I mean that

what is assessed is whether the patient comprehends what the

caregiver tells him without necessarily believing it,34 while by

an understanding and belief standard I mean that what is

assessed is the adequacy of the beliefs the patient forms (such 

as standard is “naive” to the extent it rests on the notion that

truth is easy to discern). The UTD looks, in particular, at pure 

understanding of general information about an illness and its

treatment, while the POD looks at naive understanding and

belief concerning the illness and the treatment that the patient

applies to himself.

Why do I argue that the UTD measures pure understanding? First, the questions in the UTD ask the patient not to 

tell the evaluator what is the case, what she believes, or even

what the evaluator believes; they ask, instead, only what the

evaluator says. This suggests that the UTD is not measuring

beliefs, even only fairly obvious beliefs such as what someone else purports to believe. Rather, it is measuring simply 

the ability to say back what has been said.

Second, the questions in the third part of the UTD ask

whether a statement is the “same as or different from what has

just been said.” Once again, not belief but comprehension is

being measured. Indeed, if the patient says that a proposed

statement is “true,” rather than “the same,” he is corrected,

because that is not what is being tested.

Third, the researchers distinguish between the UTD and 

the POD on the basis that the former identifies what the patient

knows while the latter identifies what he believes. In at least 

one common philosophical tradition, knowing implies believing, and so is not something less than believing as suggested 

by the researchers here. Still, what the researchers seem to want

to get at is clear—the difference between grasping some information and truly believing it. This is precisely the difference

between abilities measured by the pure understanding and

those measured by the understanding and belief standards 

If I am correct in my assessment of what these MacArthur

instruments are measuring, the next question becomes 

whether the precise distinction they draw makes sense, and the

answer is that the distinction is problematic. The problem 

with the MacArthur schema is that it incorporates two distinctions—pure understanding vs. understanding and belief

on the one hand, and general information vs. specific information on the other—in a way that does not cover the entire

field. While it does cover pure understanding of general 

information and understanding and belief of specific information, it omits pure understanding of specific information

and understanding and belief of general information. Put 

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32 The researchers say that they have based their instruments on standards found in the courts. But the language the courts have used is most ambiguous and does not clearly lead to the

investigator’s selection of measures. For instance, some courts speak about the rationality of the patient’s choice. See, e.g., Osgood v. District of Columbia, 567 F. Supp. 1026, 1031 (D.C.

Cir. 1983); In re Mental Commitment of M.P., 500 N.E. 2d 216 (Ind. Ct. App. 1986); and United States v. Charters, 829 F. 2d 479, 496 (4th Cir, 1987). But is this meant to imply a judgment about the reasonableness of the outcome (the so-called “reasonable result standard”)?; about the intactness of the patient’s reasoning processes (e.g., what is measured by

MacArthur’s TRAT)?; or about the soundness of the beliefs underlying the patient’s choice (e.g., what is measured by MacArthur’s POD)? The language of the courts is simply very

unclear in many instances. For a discussion of the lack of clarity of the courts’ statements on this matter, see Elyn R. Saks, “Competency to Refuse Treatment,” North Carolina Law

Review 69 (1991): 945, 977–84. In addition to this problem, relying on the courts is no substitute for one’s own normative analysis—and is itself a normative choice. 33 For this distinction, see Elyn R. Saks, Competency to Refuse Treatment, supra note 32, 952–53, 955–56. 34 Compare the difference between the sentence, “he understands the theory that the fittest survive”—which does not require that he believe it—with the sentence, “he understands that

the fittest survive”—which does require that he believe it.
differently, only two of the four cells generated by these two 

distinctions is covered.

The problem is that pure understanding is relevant as to 

both general information and information as applied to the

patient’s situation; and adequate beliefs are important both as

to the general information and the information as applied to

the patient’s particular situation. If this is so, the critical 

division should be between a standard requiring only comprehension and one requiring belief, and not between a standard involving understanding of general information and belief

about information as applied to one’s own case.

In my view, the best solution, then, is to preserve the distinction between pure understanding and understanding and 

belief standards, but discard the distinction between general

information and information as applied to oneself; the latter

distinction is a red herring. Otherwise, the instruments do not

cover the entire field.

Evaluating Whether the General Capacities Picked 

Out by the MacArthur Instruments are Necessary 

to Competent Decision making

In my view, the capacities the MacArthur instruments treat as

essential are necessary, but perhaps not sufficient, to adequate

decision making; I discuss below whether the level of abilities

the MacArthur instruments pick out is plausible.35 I understand the essential abilities to be: pure comprehension of relevant information; the ability to assess evidence and form

appropriate beliefs about that information; the ability to reason

with that information; and the ability to evidence a choice. All

of these abilities can be normatively justified as necessary for

competent decision making.

Why is pure understanding required? Comprehension of relevant information is a sine qua non for a person’s assessing that

information as it bears on how the patient should decide. To 

see that a competency standard should require pure understanding, consider the following thought experiment. John is a

captive faced with two contraptions between which he understands that he must decide, on pain of death. One of the contraptions will torture him and the other will grant his every

wish. John cannot tell from looking at the contraptions what

they will do, and he cannot understand his captors’ explanation of them because it is in a foreign language.

It seems plausible to say that John is incompetent to decide

between the two contraptions—with one reservation. We may

want to reserve the term “incompetent” for people who are 

not simply ignorant. Although well-known philosophers have

justified paternalism in the face of ignorance (recall, e.g., John

Stuart Mill’s broken bridge example), the law may prefer to

reserve the term incompetent for those who lack abilities, perhaps as a function of their mental illness, and not simply

knowledge. There may be practical reasons for doing this—

e.g., we often do not know the truth, so we want assurances 

that the person is under some disability and so likelier to be

self-deceived. These practical concerns may not speak to what

we would do if we could always know the truth; perhaps in an

ideal universe, all ignorance would amount to incompetency.

Whatever we decide in the real world, surely most people would

want, in our example above, to be disabled from deciding for

themselves, and to have benign and knowledgeable others

decide for them.36

Indeed, we do not need fanciful thought experiments to 

recognize the importance of pure understanding: imagine

being asked to make any important decision the implications 

of which are described in a foreign language. One is simply 

not in a position to decide in that case. Pure understanding,

then, is a prerequisite for competency.

Yet Pure Understanding, while necessary, is not sufficient.

The ability to assess evidence and form appropriate beliefs is

also necessary; MacArthur’s inclusion of this ability in one of

its capacity instruments makes eminent sense. Consider our

example again. If the captive comprehends his captor’s information, but does not credit it at all—say because he believes 

the captor is delusional—he is not even going to advert to the

information in making his decision. Because making a decision

in one’s best interests requires assessing how those interests are

likely to be affected, the patient must be able to form adequate

beliefs in order to be a competent decision maker.

We can think of the matter yet another way. Decisions are

based on desires37 and beliefs; one desires x, and believes that y

is the way to get x, and thus one decides to y. Believing y is the way

to get x, in turn, requires other subsidiary beliefs. A deficiency

in one’s beliefs may therefore severely affect one’s decisionmaking capacity. (How deficient is too deficient is, of course, another question—one which I shall address below.) One forms

beliefs as a result of assessments of the evidence, so that the skill

tapped here is the ability to assess evidence; and this skill is

clearly needed in some degree or another for competency.

But pure understanding and the ability to assess evidence 

are also arguably not enough; one needs also to be able to reason with some degree of intactness. Reasoning allows one to

put together the information one has purely understood and,

having assessed, has formed beliefs about. Consider, at its simplest, the practical syllogism recited above. If one knows that

one desires x and one believes that y is the way to get x (and say

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35 Thus, while the MacArthur instruments measure capacities, and not competency, they are clearly intended to aid in yielding judgments, after appropriate normative choices are made,

about competency. As a result, it is perfectly appropriate, as I do here and in the next sections, to assess them in terms of whether they are useful or problematic as tools for measuring

competency. 36 The typical consequence of a finding of incompetence is that others are permitted to decide for one—either one’s family, a guardian, the court, or one’s doctors. 37 One could also speak of “wants” or “preferences” here. Nothing of importance, in this context, turns on which term we use.
that not doing y will guarantee not getting x), and if one then

concludes to not y on the basis of deficient reasoning,38 one has

clearly not made a competent choice to not y. Some level of

reasoning ability is required. Thus the MacArthur instruments’

inclusion of a measure of this makes sense.

Should evidencing a choice also be considered a necessary

skill for making a competent choice? There are two possibilities

here. If making a competent choice means (in part) expressing

a choice, then the answer is obviously yes; so much is a tautology. If, on the other hand, making a competent choice can

include going through intact decisionmaking processes without necessarily telling anyone what one has chosen, then the

answer is obviously no. Take a person who is paralyzed and

unable to communicate. He may very well decide, after careful

consideration, that he would like some procedure done. Suppose that by any (other) measure we could formulate he would

be deemed competent. Does his inability to say what he wants

make him incompetent? If not, making a choice and showing

one’s choice are two different things.

Two views are possible, then—evidencing a choice is prima

facie evidence of one’s competency that triggers an inquiry or 

is actually itself necessary for one’s competency-—and it is not

important which view we choose, since in either case the 

ability must be assessed. Thus, the subtest in the MacArthur

instruments measuring evidencing a choice seems justified.

While all the abilities the MacArthur instruments target 

are arguably necessary for competency, are there others they

have omitted? For instance, practical syllogisms also refer to the

person’s desires; so perhaps one must be able to identify one’s

desires. Indeed, perhaps one must make a choice that is true

to one’s desires. More robustly (and relatedly), perhaps one

must be oneself so that one can be true to oneself and one’s 

values. Other noncognitive abilities should also arguably be

required—for instance, that one not be under the sway of

internal compulsion.39

The MacArthur instruments omit any mention of these 

abilities and, to the extent we think them important, the instruments are lacking. I myself have doubts at least about our 

ability to identify such deficits reliably—but it is clearly an 

open question whether we should want to try to test for them.

If the MacArthur instruments plausibly pick out abilities that

any competent decision maker must have, at least formulated 

at a high level of abstraction, do they set the level of abilities

required paying sufficient regard for the various other values

involved in designing competency instruments? We now 

turn to that question, as well as to other questions about the

specific instruments.

Assessing the Individual Instruments and the 

Balance Struck Among the Values Implicated 

by Competency Instruments

Assessment of the UTD

The UTD is a well-crafted instrument, with two qualifications.

First, it seems that the UTD may handle, in the wrong way,

information relevant to the patient’s decision which he

acquired apart from the disclosure. The patient receives no

points if she mentions even real symptoms that were not part

of the current disclosure. Second, the UTD may both overmeasure and undermeasure pure understanding.

The UTD’s treatment of extra-disclosure information makes

sense up to a point. We arguably want the patient to listen to

and understand what he has been told. If he cannot do this, he

cannot assimilate (and eventually assess) information which we

believe to be relevant to his decision.

On the other hand, proper respect for unconventionality

might counsel us to allow the patient completely to diverge

from what he has just been told, provided he recites true information. Patients may get just as good information—or better

information for their situation—from other sources. They

should arguably be entitled to choose what information is

important to them, and they clearly purely understand that

information.

Indeed, the patient may have better information relevant to

his decision than that which the researcher has given him. What

may be most salient about schizophrenia to him, for instance,

may not be the voices mentioned in the disclosure, but the disorganization of his thinking process. So that is what he recites

as a symptom of schizophrenia.

On this view, then, patients do seem to have the requisite 

ability stated at a high enough level of generality. Indeed,

requiring them to understand the particular information 

disclosed may not be necessary for them to be able to make

decisions; it may not disserve our interest in protecting the 

vulnerable to fail to so require. It takes choice away from

patients to require them to purely understand just certain

information, thus disserving our autonomy interest.

In fact, it may be the case that the UTD requires a specificity

of information that is not necessary if a patient is to be capable

of decision making.40 It is arguable that all a patient needs to

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38 I mean to indicate by “deficient reasoning” the faulty syllogism itself—“if I y, I can get x, I want x, therefore I will not y.” 39 A number of commentators have addressed the need for such abilities. See, e.g., President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral

Research, Making Health Care Decisions (1982); Ruth Macklin, “Treatment Refusals: Autonomy, Paternalism, and the ‘Best Interests’ of the Patient,” in D. Pfaff (ed.). Ethical Questions in

Brain and Behavior (1983); Paulo, Bursztajn, and Gutheil, “Christian Science and Competence to Make Treatment Choices: Clinical Challenges in Assessing Values,” International Journal of Law and Psychiatry 10 (1987): 395. I myself am skeptical about incorporating them in an incompetency standard. See Elyn R. Saks, “Competency to Refuse Psychotropic Medication: Three Alternatives to the Law’s Cognitive Standard,” University of Miami Law Review 47 (1993): 689. 40 I am now suggesting not just that it requires patients to understand this specific information as opposed to that, but specific information as opposed to general.
understand to make a treatment decision is that, as a result 

of mental illnesses, people feel distress and suffer certain disabilities; that there are treatments such as medication for the 

illness; and that the medication can help people with the 

distress and/or disability but might have some unpleasant consequences of its own.41 Patients must have a “ballpark” sense of

the seriousness of the condition described, as well as the risks

and benefits of the treatment; but perhaps ballpark generalities

are enough.

Even if we wish for patients to understand only what they

have just heard, patients may not understand well enough that

they are to repeat just that. They may have heard “there are

symptoms of schizophrenia, including x, y, and z,” and appended in their mind some others they know only too well. They

may think that what is important to understand is that there are

unpleasant happenings associated with schizophrenia, and not

the particular ones the researcher has mentioned.

So, at the very least, subjects should be instructed that it is

necessary to mention all of the items on the list and only those

items. Those who nevertheless give “extra-disclosure” information should be warned that this is not the information wanted.

Subjects may still recite extra-disclosure information—they

may have source amnesia, as it were—while understanding

both in-disclosure and extra-disclosure information perfectly

well; but we may want to be sure patients understand the disclosed information, and so we should arguably not be overly

concerned with false positives.

There remains another more serious problem with the UTD:

it may overmeasure and undermeasure pure understanding.42

To do well on the UTD, one must be able to attend, process,

record, retain, and recite back the information provided. Being

able to attend and process information are clearly important for

(pure) understanding. But being able to record, retain, and

recite back are not necessarily so. Thus the UTD may measure

abilities not essential to pure understanding.

Conversely, a person who is able to recite back—which is all

the UTD arguably asks a person to do—may not have (purely)

understood anything he has heard. A parrot can recite phrases

back with no understanding at all. One suggested modification

of the UTD?—in the section asking whether a statement is the

same as one made in the disclosure, use sufficient numbers of

statements that are equivalent in meaning but use completely

different words.43 (Of course there may be people who understood the original information but not the equivalent statements; but no measure can be perfect.)

The UTD, then, is an impressive instrument: it does a good

job spelling out the items of information, for the three relevant

diagnoses, that patients ought to understand; it explains this

information with a simple enough vocabulary that most people

should be able to understand it; and it tests understanding of

these items of information in several different ways, thus allowing patients full scope to demonstrate what they have learned in

the best way they can. On the other hand, the UTD has some

problems. It may set the level required for being unimpaired

too high by requiring disclosed rather than extra-disclosure

information or information at a higher level of generality. In

addition, it may not require enough in the way of understanding inasmuch as it tests essentially recall and repeating ability

rather than understanding. Finally, difficulties remembering

may not disable someone from making an adequate decision,

provided he remembers enough at the moment of decision to

process all the relevant information. Despite these difficulties,

the UTD has many virtues.

Assessment of the TRAT

Requiring highly developed reasoning ability—e.g., knowledge

of all the rules of logic, absence of any strong emotions influencing a decision, etc.—is problematic for a number of reasons,

and we shall have to assess whether the TRAT does so.

First, it is unclear that pure or pristine reasoning plays an

essential role in all effective decision making; intuitive, idiosyncratic processes actually may improve decision making in some

cases. (Consider cases in which people dream of solutions to

difficult mathematical problems.) Thus, fully intact reasoning

may not be necessary for adequate decision making (recall our

example of the good accent). Concerns about protecting the

vulnerable, then, may not be implicated. Moreover, what qualities of reasoning are “good” may be open to dispute, so that to

require some particular form of reasoning may be to discriminate against unconventionality.

Perhaps most important, even generally effective decision

makers who clearly have the ability to form accurate beliefs

misuse statistics, misunderstand probabilities, and accord

undue weight to vivid examples. They also may be affected profoundly by irrational and unconscious factors. Thus, unless we

are to declare most people incompetent, to so declare only the

mentally ill who exhibit these deficiencies amounts to prejudicial discrimination.

Requiring some reasoning ability, on the other hand, seems to

make sense, as I argued above: if one does not know how to put

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41 I am not suggesting, of course, that doctors be required to make disclosures about the patient’s illness and its treatment at such a high level of generality in an actual informed consent

process—just that patients need to take in no more. 42 Indeed, it bears noting that all of the MacArthur measures may be overrating incompetence to the extent that low scores may reflect things other than incapacity—e.g.,

motivational/compliance problems, cultural issues around openness to one’s doctor, and articulateness, to mention a few. 43 As written now, the sentences that are not “the same as” those given are in different language, but the sentences that are “the same” are in very closely similar language. Someone who

didn’t understand the meaning of the sentences could get a high score simply by saying “different” when none of the same language was used. For some examples of these sentences 

in the case of schizophrenia, e.g., UTD Manual, supra note 4, 30–33.
together the information one has understood, so to speak, one

will not be able to reach the right conclusion. The question 

is how much reasoning ability should be required. Does the 

TRAT set the right level? 

In one way, the TRAT does seem to require the presence of

fairly basic abilities. For instance, in testing the understanding

of probabilities, it requires only the understanding of a grossly

obvious inference. One problem with the TRAT, on the other

hand, may be that it does not justify requiring all of these 

abilities it tests for—or rather, giving better scores the more

abilities there are in evidence. A particular decision, for

instance, may involve only two alternatives; what, then, is the

relevance of (say) transitive thinking, or of complex versus

comparative thinking in that case? More important, a patient

might not engage in many of these cognitive functions 

because, for her, one consideration is decisive; she may (say) 

so disvalue a risk of one of the alternatives that thinking 

consequentially is all she needs to do to choose between two

alternatives—particularly since she may trust her doctor not to

propose otherwise horrendous alternatives.

On the other hand, it may be that evidencing all the TRAT

abilities puts one in a better position to decide by giving one

more options. If one asks for further information, for 

example, of if one considers unstated consequences of the

choices, one may be in a better position to decide. The question

is whether this added strength of one’s decisionmaking process

is really necessary to competent decision making.

Another problem with the TRAT may be its requirement 

that one evidence all of these other functions; they may be

occurring at an implicit level. For instance, a patient who says 

I want x and not y because I am terribly frightened of the 

significant seizure risk carried by y—my dad died in a car 

accident when I was three as a result of a seizure—will often

have gauged that x does not carry such a seizure risk (or anything equally abhorrent to the patient). If she has not done 

so, her decision making is arguably deficient. But she may 

well have done so and may simply not say the words “and I 

have compared x to y and x does not have any such abhorrent

consequences to me.”

If this is right, there is at least a problem with the TRAT, i.e.,

that it is difficult to test for the different functions. Perhaps

instead of simply asking for reasons, the patient, once having

given a reason, should be asked directly if he compared y to x

and, if so, what in the comparison led to his choice? On the

other hand, this approach may be too leading. I leave to psychometricians the task of arriving at effective, nonleading 

ways of eliciting this information.44

In short, the TRAT does an impressive job in identifying 

reasoning abilities, arguably necessary for competency, and

testing for them in a reasonable way. It nevertheless suffers 

from two problems. First, it may sometimes require abilities

that do not really add, in a given case, to the patient’s decisionmaking process. Second, it may underestimate how often

those cognitive processes are actually occurring, while the

patient is simply not saying the magic words. Nevertheless,

the TRAT remains an impressive instrument for the reasons

given above.45

Assessment of the POD

The POD, as will be recalled, measures a patient’s appreciation of her or his illness as well as of the potential benefits of

treatment. The ability it taps is the ability to assess evidence;

and so the quality of the patient’s beliefs is at issue. While an

ability to assess evidence is important, the POD requires too

high a level of that ability—and too high a level in a context

when we sometimes cannot even decide what a high level is.

In my view, the POD is seriously flawed and needs to be radically revised.

Deciding what beliefs a patient must have to be deemed 

competent is fraught with danger. Since decisions take effect 

in the world, we want the patient to come to accurate beliefs

about the world. The problem is that it is—more often than 

we like to think—an open question what is true; very few 

beliefs are completely indisputable. This means that requiring

particular beliefs may not further our interest in protecting the

vulnerable; if the beliefs we require are wrong, we are not

putting the patient in a better position to decide. We should 

not say the patient is incompetent—indeed, if most of us are

wrong, the patient may in fact be super competent.

Perhaps, more important, freedom includes freedom to

decide what is true no less than what is good. If we require particular beliefs, we prevent the patient from pursuing the truth

according to her or his own lights. There may be some limits on

what patients can believe. But too stringent limits severely 

curtail patients’ freedom to be unconventional in their pursuit

of truth. And once again, patients may turn out to be right.

In addition, we must be mindful of the fact that many people

have distorted beliefs and make decisions on the basis of those

beliefs. Unless we want to call many, if not most, people incompetent, we are discriminating against the mentally ill if we 

disable them on the basis of many of their distortions.

There is a range in the kinds of beliefs we can require or 

proscribe. The POD is at the far end of the range: patients must,

essentially, believe what their doctors believe about their illness

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44 The issue raises the same kinds of value questions we have seen earlier: not asking may underestimate competence while asking, inasmuch as it is leading, may overestimate it. Which

kind of error we fear most—abrogating autonomy unnecessarily or failing to protect—will determine our choice of test. 45 A submeasure on the TRAT looks at whether the patient meets an “evidencing a choice” standard. I quarrel with this measure’s marking the patient down for only unequivocally 

making a choice on a second inquiry. Cannot people take time to make up their minds?
and treatment. This cannot be a correct standard. Given the

many contested things in our society, an individual doctor 

cannot be held out as the final authority on truth. What would

become of second opinions if doctors were?

Let us look at the submeasures of the POD in a little more

detail. The NOD (Non-Acknowledgment of Disorder) measures appreciation of one’s illness. One receives a full score 

if one accepts the diagnosis one’s doctor has given one;

judges one’s illness as severe as a particular measure of

symptom severity does; and accepts the symptoms reported 

in one’s chart.

The first two are problematic. One’s doctor may be wrong

about one’s diagnosis. To put this in a more technical way, the

NOD is limited by the reliability and validity of psychiatric

diagnosis. In fact, doctors disagree quite often about a particular patient’s diagnosis. They often disagree about the category

of illness (e.g., psychotic disorder vs. mood disorder vs. personality disorder). They sometimes disagree about whether a

patient even has a significant illness.

A single individual cannot be made the final authority on

truth.46 Indeed, the patient may be quite willing to believe 

an earlier doctor’s diagnosis or even that he is seriously ill;

but if he disagrees with this particular diagnosis, he is counted

impaired on this measure of the NOD.47

The second measure of the NOD asks whether the patient

rates his symptoms as severe as the Brief Psychiatric Rating

Scale does. This measure also makes little sense. First, the

patient may be the most important judge of how severely ill 

he feels. Second, even if the question is how severe his illness 

is on some common metric, how shall we expect patients to 

know that metric? This is a comparative judgment which

patients are not in a good position to make. A result that

diverges from the scale is not a profound distortion of reality.

Finally, as with the first measure of the NOD, this measure is

limited to the extent that the severity ratings of the Brief

Psychiatric Rating Scale are not highly reliable and valid.

The third measure of the NOD is more acceptable. It asks

whether patients acknowledge the presence of symptoms 

mentioned in their chart. Many of these symptoms will be

grossly demonstrable. If a patient denies that he has just been

frenetically pacing, or hasn’t slept in days, he is severely distorting reality. Some symptoms, of course, involve more interpretation. Is the patient agitated? Maybe not for him. Other

symptoms essentially duplicate the illness question; patients

cannot deny they are ill and admit to hallucinations and 

delusions, so-called, although they can admit they are seeing,

hearing, and believing things that others do not. Framing the

question in terms of whether patients are experiencing “delusions” or “hallucinations” should therefore be off limits.48

The NOT (Non-Acknowledgment of Treatment Potential),

which measures acknowledgment of treatment potential, is 

also problematic. The NOT requires one to accept a good prognosis with treatment if it exists; a good prognosis in particular

with medication if it exists; and a worse prognosis without

treatment. As will be recalled, if the patient has reasonable

grounds to disagree with the doctor’s judgment, a hypothesis

nullifying his premise is presented and he is asked again his

beliefs. (“Imagine that a doctor tells you there is a medication

that has been shown in research to help 90 percent of people

with your problem, even people who had not gotten better with

any other medication.”49)

The NOT is problematic once again because the doctors 

may simply be wrong about one’s particular likelihood of

benefiting from treatment and declining without it. For

instance, some patients may become demoralized and

depressed at the need to take medication and essentially stop

trying, just as some may regress in hospitals and never want 

to leave. It may be indisputable how patients on average do 

with and without a particular treatment. But averages don’t

speak to this particular patient, and he may be right that he 

will be in the 10 percent that do not respond to a particular

treatment.50

Because no one can predict the future with complete confidence, it is problematic to require patients to form beliefs

about a particular outcome they will experience in the future.

Asking patients to understand what happens generally may

make sense; asking them to believe that the general rule will

apply to them does not have.

To look at this in another way, in essence the NOT measures optimism and pessimism. Many people are unduly 

optimistic or pessimistic about many things. Thus, in addition

to requiring patients to believe things that may be false, and

taking away their right to decide about truth as they will, the

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46 I do not deny that doctors recognize that a differential diagnosis is based on uncertainty. But this recognition is not reflected in the POD, which simply assumes that the doctor’s diagnosis is the measure of truth against which the patient’s beliefs are to be assessed. If the patient disagrees with his doctor, then he is deemed “impaired” on the POD. The doctor’s diagnosis is the “gold standard,” and the patient’s beliefs are only adequate for purposes of this measure of capacity if they agree with the doctor’s beliefs. 47 Unlike the research instruments, the MacCAT-T asks evaluators to assess the patient’s reason for his denial; and the kind of reason given in the text would result in a full score. It

remains the case that the research instruments are counting some people impaired who are arguably not in the least impaired. In addition, as we will discuss below, many of the reasons for denial, which I think should result in a nonimpaired finding, are counted as substantially diminishing capacity on the MacCAT-T. 48 I also argue elsewhere that belief in a serious delusion distorts reality in a way that belief that it is not a delusion—is not a product of mental illness—does not. See Elyn R. Saks, Competency to Refuse Treatment, supra note 32, 991. 49 POD Manual, supra note 5, 54. 50 In the MacCAT-T, supra note 10, the MacArthur researchers allow a patient to get a full score if he says he expects to be in the bottom 10 percent because previous treatments have

failed for him. But the patient may also have his own reasons—maybe even superstitious ones—for thinking that treatment will fail now and he will be in the bottom ten percent.

Once again, he may be right—and many people are pessimistic about treatment (see below).
fest a trait—optimism or pessimism as the case may be—

that many people do not.51

I have noted that there is a range in the kinds of beliefs we can

require. At the far end is the naive view incorporated in the

POD that we can require the patient to believe essentially what

the doctor believes. This view is problematic, it seems to me,

for all the reasons given above. At perhaps the other end of

the range is the view that patients can believe anything but

beliefs impossible in the nature of things. But quite apart from

the fact that some philosophers will tell you that virtually 

anything, technically, is possible,52 this view probably allows

beliefs that are such a serious distortion of reality that we

should not allow them. They are most probably wrong and are

not widespread, so that ruling them out does not unduly

infringe the right to be unconventional.

Within these extremes other standards are possible. Perhaps

patients must believe what most doctors would believe about

them. Or, so as to accommodate people who do not buy into

the medical model,53 perhaps they must believe what most 

people would believe. Or should it be “most rational or most

reasonable people”? On the other hand, is this not just requiring patients to conform to norms? Perhaps we should try—

if this is even possible—to characterize the standard in a way

that does not refer essentially to majorities.

To my own way of thinking, we want a standard somewhere

above a standard that proscribes only impossible beliefs and

below a standard that makes doctors the final authorities on

truth—somewhere, in other words, in the middle: patients cannot hold beliefs that obviously distort reality/are based on little

evidence/are indisputably false/are patently delusional—we 

can choose the precise locution we wish. Perhaps referring to

what most people would believe is the way to get at this; there

may be others. The reader will recognize that I have evaluated

the POD according to a kind of “patent distortion of reality”

standard; I undertake to justify such a standard elsewhere.54

I want to conclude, however, by suggesting an idea that may

be somewhat radical: that, according to such a standard, denial

of mental illness often does not disqualify one from competency.55 I hasten to add that I have no doubts whatsoever

myself about the reality of mental illness and the severe suffering it causes. I subscribe completely to the medical model.56

On the other hand, denying that one is mentally ill may have

characteristics that should lead us to say that it should generally not go toward a finding of incompetency.

Let us consider why. First, a person denying he is mentally ill

may simply not be willing to admit to something that is stigmatizing and carries negative consequences in our society.

He may be frankly lying about what he thinks, or may be conflicted about what to think for these completely understandable reasons. In either case, a person trying to avoid the negative consequences of a mental illness diagnosis may be 

thought to be acting quite rationally in our society—and far

from incompetently.

Second, even if the person cannot admit, even to himself, that

he is mentally ill, he may be acting on the basis of a common,

understandable, and often quite adaptive defense. Denial of

difficult things is quite common. And so one might through

denial be attempting to avoid the narcissistic injury of having a

mental illness. People identify with—and accept ownership

of—the contents of their mind; it is hard to believe that such 

an intimate part of oneself is diseased.

Denial is also understandable in a way that other primitive

defenses may not be. People can perhaps understand another

person’s saying that she just can’t fully believe that her daughter has died or that she herself has cancer; they do not in the

same way understand a person’s saying he just can’t help believing that someone put a transistor in his brain.

In addition, denial can be very adaptive. There is evidence

that seriously physically ill people live longer if they deny the

seriousness of their illness.57 And there are other less striking

examples of the same kind of beneficial effects from denial. A

person denying he is mentally ill might draw on resources he

would be too discouraged to use if he admitted his illness.

Third, mental illness diagnoses are simply less certain than

many, if not most, physical illness diagnoses. Unlike physical illnesses, where there can often be definitive physical findings that

unequivocally establish the diagnosis, there are no physical tests

for any nonorganic mental illness.58

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51 There are three additional measures on the POD that are equally problematic (although they do not contribute to the patient’s score at present): the patient must acknowledge the side

effects of the medication (maybe they don’t and won’t affect her); the patient must think her treaters have the benign motive of helping them (does it patently distort reality to believe

that some do it for the money or prestige?); and the patient must acknowledge the need for hospital treatment (her doctor may be wrong—the patient may be one of the ones who

regress in the hospital and one of the ones who rise to the demands of treatment in the community). 52 Consider that skeptical philosophers doubt even the existence of the physical world as we know it. In my claim in the text I exclude, of course, logical truths. 53 By the “medical model” I mean the views subscribed to by the medical profession on matters of health, illness, and treatment. 54 This is the standard I propose in Competency to Refuse Treatment, supra note 32. I intend to explore this standard further in future work. 55 I discuss this also in Competency to Refuse Treatment, supra note 32, 98–92, although my view since then has been tempered somewhat, see below. 56 In this context, I mean by the “medical model” the model according to which mental illnesses are genuine illnesses, as much so as any physical illnesses, and therefore respond to treatments of various kinds. Mental illnesses are not simply “problems in living” or anything else that an anti-psychiatry person might say they are. 57 See Saks, Competency to Refuse Treatment, supra note 32, 990, for some sources supporting this claim. 58 To the extent that organic mental illnesses can be established by physical tests, patients should arguably have to accept them. This is one context, then, in which the analysis for, say,

demented patients may be very different than the analysis for, say, schizophrenia.

It is interesting to speculate about what would become of this argument if a gene were discovered that was responsible for, or correlated with, mental illness. If this were the sort 

of gene that always resulted in the illness, and if the gene could be identified in a person by genetic tests, then that would offer an incontrovertible test for the presence of the mental

illness, and what used to be called “functional illnesses,” in this case, would be on the same footing as many organic mental illnesses are today.
Thus, even when there is considerable consensus among

physicians about a particular person’s diagnosis, it is possible,

though perhaps not likely, that the consensus is mistaken. Consider seizures prior to the advent of EEGs; or lumps in the

breast prior to the advent of biopsies. Physicians could have

reasonable bases for diagnosing epilepsy or cancer; but they

could always be wrong. In the case of the seizures, an EEG could

establish, with some reliability, that there were no electrical

charges firing and that hysterical seizures were the more likely

diagnosis. Prior to EEGs, that judgment was much less certain.

In the same way, a person presenting with the symptoms of a

psychotic disorder might not actually have a psychotic disorder;

she might instead have what used to be called a “hysterical psychosis” or what might be called today a “factitious disorder with

psychological symptoms.” Alternatively, she could have a less

serious diagnosis, such as obsessive-compulsive disorder with

bizarre obsessional thoughts that she does not quite credit and

that therefore should not be called delusions. Or perhaps she is

frankly malingering for some reason we have not discerned.

Even such serious disorders as schizophrenia are thought by

many to be a collection of different conditions; and sometimes

what looks like schizophrenia may not be an illness at all—or at

least the illness doctors thought it was.

Thus, while psychiatrists may have reasons for preferring to

say a person has a psychotic disorder, they can always be wrong.

In the same way, physical illnesses, without clear physical findings, cannot be as certainly diagnosed as those with clear physical findings. A diagnosis of Gulf War syndrome, chronic

fatigue syndrome, Epstein Barr virus, soft tissue damage, irritable bowel syndrome, even Crohn’s disease, cannot be made as

certainly as, say, a diagnosis of cancer.59

The point I am making is epistemological, not ontological.

Again, I have no doubts about the reality of mental illness. In

the same way, to say that we cannot definitively prove someone

has soft tissue damage is not to deny that there is such an illness

as soft tissue damage or that it can cause considerable pain and

disability. The two issues are different.

Now the reader may object that I have established only that

someone’s belief that she is not mentally ill is not impossible,

not that it does not patently distort reality. Some diagnoses of

mental illness are simply pretty obviously true—the person has

recurrent episodes, responds well to treatment, etc. But denial

of mental illness may still often not patently distort reality

because, coupled with the fact that the belief is not impossible,

why the patient believes as she does given her evidence may be

completely understandable. People often have a hard time

accepting a mental illness diagnosis because they have felt the

way they are feeling for a long time—the illness has come on so

gradually or feels so appropriate to their current surroundings,

that it feels a part of them. Why are they suddenly mentally ill?

In addition, people often accept far more responsibility for

their thoughts, feelings, and actions than they arguably should,

so a patient may feel she has chosen to be the way she is. Her

thoughts, feelings, and behaviors are not an illness, but a choice.

(Compare the reasons people give for their behaviors that are

clearly a response to posthypnotic suggestion.) In short, when a

belief is possible, and when the belief does not wildly depart

from the evidence the patient has, we should not deem the

patient patently delusional.

Fourth, many members of society are skeptical about mental

illness—or at least about whether particular behavior patterns

or symptom constellations amount to an illness.60 They may

think that mental illness is a failure of will or consists of problems in living or is motivated by a desire to be cared for. They

may attribute symptoms to stress and believe that the best

response is coping with or avoiding the stress.

Many of these beliefs are not what we would call “enlightened.” Some amount to frank prejudice, or are at least based on

ignorance. But my point is that if these beliefs are not all that

uncommon, then a particular patient’s believing them does not

represent a gross departure from ordinary ways of thinking.

Once again, we don’t want to single out only the mentally ill

who hold certain beliefs when these beliefs are relatively widespread in society at large. In addition, that many people think

this way is further reason to hold that the patient’s belief in this

nonimpossible belief is reasonable given his evidence and

understandings of the world.

Fifth, I have suggested that it does represent a patent distortion of reality to deny that one is suffering from grossly demonstrable symptoms. But the patient who can admit that she or he

is agitated, pacing, scared, or whatever, has every reason to

accept treatment doctors say will help those symptoms abate. It

is not clear that we need to make the patient admit to the illness; it is almost forcing a humiliation on the patient to do so.

In the same way, a patient who admits to abdominal pain and

all the symptoms of Crohn’s disease, and understands that her

or his doctor can recommend treatments that will help, need

not admit to the disease to be in an adequate position to decide.

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59 It is worth mentioning that with any physical illness there are issues that may adversely affect our certainty about the diagnosis. How reliable is the test for the illness? Could anything

have gone awry between the test and its interpretation (the “wrong blood” problem, if you will)? Even if the test is reliable, how valid is it in identifying symptoms? And how certain is

it that these physical findings mean there is an illness? Cannot the patient admit that she has these physical signs, but deny that they amount to an illness—just deviant physical findings? Nevertheless, there are at least some tests for some illnesses that are extremely reliable and valid. In addition, it may be the right response here, too, that so long as one admits the

symptoms, one doesn’t have to take the next step and admit the illness. See below. 60 The same is true of all physical illnesses; Christian Scientists don’t subscribe to a medical model for any of them. Yet we would not say that denial of a frank cancer is not a serious

problem. But I suggest that beliefs like these about mental illness are much more common than beliefs about physical illness. There just are not that many Christian Scientists.

Another point to bear in mind is that even certain doctors and psychologists have similar views about mental illness; Szasz, for instance, denies that any nonorganic mental 

illness is real. It would be surprising to discover an oncologist similarly denying the existence of cancer.
Perhaps, however, we should require more; patients need to

accept not only that they are pacing, say, but that they have some

condition, even if it is not the condition their doctors say they

have. Or should we require patients to admit they have some

condition that looks like schizophrenia and that most doctors

would so diagnose and that is thought antecedently to be as

likely to benefit from treatment as any other similar presentation. These claims are fairly indisputable in many cases—we

don’t need a physiological test to establish them. Thus, while a

patient may not trust the individual doctor telling him about

his diagnosis, he can and should trust the DSM-IV. In addition,

these claims may be a necessary added ingredient before some

will consent to treatment. I think it is a close call whether 

we require these additional beliefs or whether simply admitting to one’s symptoms and one’s doctor’s belief in potential

benefit of treatment is enough. An intermediate position 

would be to require patients to admit, simply, that “something’s wrong.”

All of this said, there are at least two tacks one could take:

first, one could simply exclude most denial as a basis for an

incompetency finding.61 Alternatively, one could probe the

denial further to see if the patient’s reasoning is such that one

can understand—see as somewhat reasonable—his denial.

Perhaps he is not speaking honestly. Perhaps he is narcissistically wounded but, in his heart of hearts, knows the truth.

Perhaps he thinks of his behaviors as his choice. Perhaps he

holds widely held views about mental illness that lead him to

think he is not really ill. In short, one would probe to see

whether a given case of denial should be thought to amount to

a patent distortion of reality. The implicit assumption is that 

if a belief is not impossible, then one must consider how plausible it is—and whether it is an understandable or common

belief—to see whether the belief patently distorts reality.

One final point about denial: allowing denial to be a basis for

an incompetency finding—and thus forced treatment—is in

fact fraught with danger. Not only would it permit us to force

treatment on an obsessive-compulsive person who denies that

he is ill—and who among us is free of maladaptive personality

traits?—but it would also allow us to characterize political 

dissidents as ill, and then to use their understandable denial

that they are ill as a basis for their involuntary treatment,

despite the fact that their denial is to be expected.

In addition to this central problem of treating denial in the

wrong way, the POD may also, at times, understate the presence of incompetency by focusing too exclusively on disavowal of what one’s doctor believes and not enough on the degree

of distortion which the belief represents. Take the patient who

admits he has the diagnosis his doctor says he has and agrees

with his prognosis with and without treatment. This person

would receive a full score on the POD. But suppose he also

believes that he has the diagnosis his doctor says he has because

aliens are manipulating his neurotransmitters from afar; and

that taking the medication will enrage the aliens and cause

them to destroy the earth—even though he thinks it will cure

his illness. Again, this person would receive a full score on the

POD. But is he really competent to refuse treatment? Do we not

want to look for patently false beliefs and not just disagreement

with what one’s doctor says?

The POD, then, is a fundamentally flawed instrument. It

naively requires patients to believe what their doctors believe,

even though doctors-—certainly individually but maybe even

collectively—can be wrong. It may also, at times, not only overstate but also understate the presence of incompetency by overlooking patently false beliefs that affect the patient’s decision

but do not involve denial. The POD should therefore be

changed in one of two ways.

One way—pending normative argument for the appropriate

level of impairment in assessing evidence—would be to design

an instrument with different levels of the adequacy of one’s

belief. For instance, one could look at whether the patient

denies what his doctor says; what most doctors would say; what

most reasonable people would say; what is patently true; and

what must be true. Future scholars would then establish which

level of each belief to require. Another way is to tentatively

adopt a particular level that one thinks is plausible. I myself

think a level somewhere in the middle—a patently false belief

standard, however characterized, looks likely to be correct. I

intend to try to justify this level normatively in future work. In

addition to either of these recommendations, one would want

a method to probe the patient’s reasons for her beliefs, so as to

ferret out misconceptions at whatever level they may occur.

Assessment of the MacCAT-T

The MacCAT-T, as discussed earlier, is a streamlined version of

the three research instruments described above. Therefore,

many of the observations regarding the instruments described

above also apply to the MacCAT-T. The MacCAT-T’s “appreciation” component does try to acknowledge the difference

between nonagreement that is nondelusional and has some reasonable explanation and nonagreement that is “based on a

delusional premise or some other belief that seriously distorts

reality and does not have a reasonable basis in the patient’s cultural or religious background.” But this effort is not entirely

successful, inasmuch as the range of “reasonable explanations”

given is quite narrow and, once again, only culturally or religiously sanctioned beliefs—conventional beliefs in that sense—

are permitted to ground “reasonable” disagreements. Indeed,

the MacCAT-T scores as “0” a patient’s belief that his symptoms

are related to circumstances other than a psychiatric disorder,

such as stress or overwork. But the patient may be right or—

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61 The exception would be denial based on patently distorted beliefs, e.g., “little men in the sky are causing me to suffer to save the world.”
given widespread beliefs in our society about psychological 

distress—is at least holding a nonpatently false belief.

The MacArthur Instruments Authors’ Response 

to Similar Critiques of Their View 

A 1996 symposium issue of Psychology, Public Policy, and Law,

devoted to the MacArthur Treatment Capacity research instruments, contains a number of articles critiquing the POD on the

basis of my work; Christopher Slobogin62 does so in the most

sustained way, but Susan Stefan63 and Trudi Kirk and Donald

Bersoff64 critique the instrument on similar grounds as well.

The authors’ response to the basic critique is severalfold.65

First, they note that the critics all seem to want some measure of

appreciation of illness and treatment to be included in a competency instrument, even if they object to the precise measure

used. Second, they suggest that they may well not be all that far

apart from the critics in the measure they want: they acknowledge that mere nonacknowledgment of one’s disorder or of the

realistic consequences of treatment is not enough to constitute

incapacity, but the acknowledgment must be related to delusional thinking or other medical or psychological conditions

that are responsible for a serious distortion of reality. They add

that they accept the concept of a “patently false belief,” provided it is not restricted to delusions but may also include nondelusional reasons for denying the existence of one’s disorder,

such as parietal lobe damage and intolerable anxiety related 

to recognition of the disorder. Third, they acknowledge that

their instrument does not formulate a criterion for patently

false beliefs, and suggest that it was difficult for them to operationalize this concept; they invite others to try. Finally, they 

note that the MacCAT-T requires clinicians to make a judgment about patients’ reasons for denial of their symptoms in

order to rate their appreciation. The requirement represents 

an effort to include the patently false belief component in 

the capacity standard; the authors thought it possible to do so

only by relying on clinical judgment, at the cost of sacrificing

some psychometric reliability.

The authors’ response is helpful—and points to some recognition of the concerns that animate my argument—but is not

completely satisfactory. Their first point is well taken: everyone

weighing in on this issue does, and everyone should, care about

beliefs the decision maker forms; they are simply extremely

important to competency.

But I take issue with their second point—that their view is at

all close to mine. They say they want to pick out only beliefs

that seriously distort reality—which is important. But while 

I agree that there may be a variety of reasons for serious 

distortions of reality, such as anxiety or dissociation (although

if the distortions are serious, don’t they necessarily amount

to delusions?), part of my point in discussing denial of

illness has been that denial, at least of mental illness, is often 

not a sufficient distortion of reality to help justify a finding 

of incompetency.

The third point the authors make is that, although they

approve of some notion like a “patently false belief” to help

measure competency, they found it very difficult to operationalize such a notion, and therefore did not include it in 

their research instruments. They invite others to try to formulate a workable concept. It would be tempting to say that this

notion would be fairly easy to apply; but given the authors’

misunderstanding of what the terms mean in the case of denial

of illness and treatment efficacy, that claim is rather hard 

to make. In any case, in future work I intend to undertake to

operationalize this concept in collaboration with others 

skilled in test design.

Finally, the authors note that the MacCAT-T attempts to

introduce the notion of a patently false belief by requiring

examiners to assess the reasons for patients’ denial. This is a

step in the right direction, and I am pleased that the authors 

see a need to introduce such a concept. Given this approach,

the most obviously well-reasoned bases for disagreement 

with one’s doctor would not result in a finding of incapacity,

as they currently do according to the POD. On the other hand,

the reasons that the researchers would allow to justify disavowals are much more limited than makes sense; their exclusion for cultural and religious bases of distorted beliefs is 

also too narrow and they count beliefs that I would find acceptable as the most serious disavowals.

In short, the MacArthur researchers have not adequately

answered some of the same types of criticisms leveled elsewhere, although they make a good faith effort to do so.

Concluding Evaluative Comments About the 

MacArthur Instruments

The MacArthur instruments identify the abilities necessary 

for competency, thus enabling us to protect the vulnerable;

but they set the level of those abilities too high. The central 

failing of the instruments is insufficient attention to the need 

to protect unconventional behavior and to the pervasiveness 

of minor decisional impairment throughout the population 

as a whole.

The instrument designers recognize that competency issues

involve normative judgments that balance freedom of choice

and protection of the vulnerable. But they fail to recognize that

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62 See Christopher Slobogin, “Appreciation” as a Measure of Competency: Some Thoughts About the MacArthur Group’s Approach,” Psychology, Public Policy, and Law 2 (1996): 18. 63 See Susan Stefan, “Race, Competence Testing, and Disability Law: A Review of the MacArthur Competence Research,” Psychology, Public Policy, and Law 2 (1996): 31. 64 See Trudi Kirk and Donald N. Bersoff, “How Many Procedural Safeguards Does It Take to Get a Psychiatrist to Leave the Lightbulb Unchanged? A Due Process Analysis of the

MacArthur Treatment Competence Study,” Psychology, Public Policy, and Law 2 (1996): 45. 65 For the authors’ response, see Thomas Grisso and Paul S. Appelbaum, The Values and Limits of the MacArthur Treatment Competence Study, supra note 23.
freedom of choice includes not only freedom to choose treatment (or no treatment) but also freedom to choose what skills

to use in deciding about treatment. Most important, patients,

within broad limits, should be given their choice of what to

believe, no less than what to decide.66 The patient’s decisionmaking process, as measured by capacity and/or competency

instruments, implicates the same normative issues as the

patient’s choice.

Importing the MacArthur Instruments into 

the Research Context

The MacArthur instruments were designed for measuring

treatment capacity, but may well be of use in the context of consent to participate in research. To think about this issue we must

ask, first, whether any abilities in addition to those the instruments assess are needed in the research context. Second, even

over the range of abilities the instruments cover, certain adaptations may be necessary to tailor the instruments to the research

context. Third, we must face additional normative issues.67

The answer to the first question is, arguably, yes. The patient

asked to participate in research is serving the interests not only

of himself but also of the researcher.68 This means that the

researcher may have something of a conflict of interest, and so

perhaps cannot be counted on to be entirely benign. (I in no

way think that researchers are selfish or malevolent; but 

unconscious motives for wanting to do their research may

make them less reliable guardians of patients’ interests.) It also

means that, given the enormous transference patients bring to

doctor/patient interactions, the patient may not be in a good

position to protect himself—to make the best judgment for

himself in the absence of a doctor whose job it is to make the

best judgment for him.

Indeed, patients may have all sorts of unconscious reasons to

consent to research when a doctor asks them to do so. I have

mentioned transference—clearly the most powerful. Involved

in this may be a desire to please the doctor, a desire not to be the

object of her or his animus, a belief that the doctor offers protection from all harm, or a belief that the doctor must have 

only the patient’s interests at heart. In addition, patients may

believe that they will not get other therapeutic treatment if

they are unwilling to participate, will get the best treatment

only if they participate, or will be able to survive financially

only if they are treated through a research protocol. Finally, the

doctor may put some pressure on the patient to consent, and

many people have a hard time saying no.

I recognize that patients suffer transference distortions in the

treatment context as well. But again, the doctors’ and patients’

interests are largely the same in that context. Moreover,

patients are likelier, in the research context, to want to decline

participation, but feel they cannot. All of this at least suggests

that we may want some measure of ability to protect oneself

against pressure—to negotiate to protect one’s own interests,

or something of the sort—in a capacity/competency measure

for consent to participation in research.

Second, the MacArthur instruments will need to be adapted

in major ways to accommodate the research context. Under 

the UTD, they will need to include the most important information patients need to be able to (purely) understand. Most

notably, the patients will need to understand that nontherapeutic research will not help them, how likely therapeutic research

is to help them, and that the doctors have something of an

interest in doing the research. Also, patients must understand

their right to not participate in the research without incurring

any penalties. In addition, patients may well want to understand the potential gains of the research in terms of increased

knowledge—of what kinds and how much. Of course, patients

will also need the usual disclosures describing the procedure

itself and its potential risks. The UTD offers a good model 

for level of language comprehension to require and for different ways to test for understanding; but, once again, the actual

content of the information will need to be adapted to the

research context.

In the same way, the POD will have to be reformulated to 

ask about the patient’s appreciation (belief formation) concerning these important things. As in the context of treatment,

we arguably want patients to avoid believing only what is

patently false. In nonobvious cases, a patient (who can resist

pressure) who understands that a certain protocol is not

designed to help him and probably will not help him may 

nevertheless optimistically hope it will; the point is, maybe the

protocol will help him, even if there is little reason to expect so

in advance.

On the other hand, if there is no chance the protocol will

help, the patient must at least recognize that that is what his

doctors think, and should perhaps be required to believe this

himself. It all depends on whether this is one of those things on

which doctors could be wrong.

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66 This is the most important failing of the MacArthur instruments because there may be broader agreement about what skills are necessary, at least at a high level of generality, to make

decisions than about what beliefs one should embrace. In addition, our beliefs about the world are simply more important to us, and more important expressions of our person, than

views about what skills to use in deciding. 67 The MacArthur researchers have a book chapter in press that discusses adapting their instruments to the research context. See Jessica Wilen Berg and Paul S. Appelbaum, Subjects’

Capacity to Consent to Neurobiological Research, supra note 3. They do not suggest that additional abilities may be required; they do acknowledge that the instruments must be adapted

to this context—e.g., the UTD must disclose information appropriate to participation in research; and they point to the added value of increasing scientific knowledge. On the other

hand, they once again do not answer the central normative questions, suggesting that we adopt a sliding-scale competency approach, so that each evaluator is free to draw the line

between autonomy and paternalism as she or he sees best. 68 Even in nontherapeutic research, the patient may have an interest in wanting altruistically to help others.
Of course, I am again proposing a kind of “patently false

belief” standard, and one might reject that view. Another level

of belief, required in this context, must then be proposed. Alternatively, the POD in the research context could include a number of different levels at which ideas must be appreciated.

The POD must not only include additional items for the

patient to appreciate, and at the right level, but it must also

omit items which seem irrelevant to the inquiry. For instance,

denial of mental illness seems irrelevant to the case of a patient

who consents to participate in research.69

Third, there are additional normative issues in the research

context. These include whether the additional important value,

in this context of advancing science, justifies a different balance

in our assessment of competency, and whether it makes normative sense to require more ability here because consent is of

more questionable value to the patient in the research context

than in the treatment context.

I address only the second issue here. The question raises a

broader question of whether we should vary our competency

standard depending on the quality of the decision being made.

Everyone agrees that if a task is more difficult, one must have

additional abilities, or a higher level of the relevant abilities, or

both, to perform it. The proposal here is different: that if a

patient is making a good decision, we should require only a low

level of competency, while if he is making a bad decision, we

should require a high level. Here, the decision to participate in

research is not so beneficial to the patient as the decision to

consent to conventional treatment.70

The reason we might want to vary the level of competency is

clear: if patients are about to choose something that will not

help them and may harm them, we want to be very sure that

they know what they are doing.

To my mind, however, there is a very serious conceptual

problem with varying the level of competency: doing so is only

a distant cousin to declaring people who make good choices

competent and people who make bad choices incompetent—a

practice roundly criticized. In essence, one sets up each individual evaluator as judge of the quality of the patient’s decision,

and allows him to substitute his judgment for the patient’s. If

the evaluator, for example, disvalues limitations on occupational functioning to a high degree, he may disable the patient, by

varying the level of competency, from making a choice that

risks such limitations in his occupational functioning. But what

if the patient himself does not much care about this?

One response to this charge—although not entirely satisfactory—is that whatever level of competency we set we are 

balancing well-being against autonomy, so that striking the 

balance differently makes perfect sense when well-being is likely to be affected more seriously.

But there is a difference between saying that one must have

certain abilities as a general matter in order to take responsibility for one’s own choices, without scrutiny of particular

choices, and saying that one must have more abilities when 

we judge one’s particular choices bad. Arguably, competency

doctrine does and should set the balance once, as it were, so 

as to avoid second guessing patients’ decisions and setting

someone else up as a judge of what is a good choice; isn’t that

up to the patient?

If we reject varying the level of competency based on how

good a decision we think the patient is making, there may 

nevertheless be good reasons for requiring a higher level of

competency in general in the research context. For instance,

we may think that, as a risk-of-error matter, evaluators are 

likelier to have an interest in finding competency so that 

their patients will be able to consent to research that will 

help the researchers. We should err on the side of requiring a

higher level of competency.

In addition, we may be concerned that the researcher cannot

be counted on to be entirely well-motivated in recommending

the particular research protocol; once again, the researcher

doesn’t completely have the patient’s interests at heart. This

matters here, not because we think the patient is making a bad

choice, but because we expect him to play a larger role in evaluating the decision, and he may need more capacity for this

evaluation.

What about the argument that research subjects do not lose

much by not being permitted to participate in research, and

may at times suffer injuries by participating, so we should set a

high bar before we allow a vulnerable subject to participate?

This is a slight variation on the “sliding scale” competency

approach we have just discussed. Consenting to participate in

research is not making an obviously good choice for oneself—

and so we want one to know well what one is doing. In addition, one might argue that denying the person the choice to

participate does not much harm him. Indeed, we might even

think that many research subjects do not feel harmed when

deprived of the right to make such choices, because they are

likelier to be acquiescing in what their doctor wants than independently choosing to participate.

This suggestion has some merit, but does not seem to me to

carry the day. Patients can desperately want to participate in

therapeutic research when nothing else is helping them, and

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69 It is also arguably irrelevant to consent to nonexperimental treatment—though consent to such treatment is rarely questioned.

The MacArthur researchers, in their article on adapting their treatment capacity instruments to the research context, suggest that denial of one’s illness should vitiate one’s consent

to participate in research. But it is unclear why this is so. Arguably, one need only believe that the researcher considers one a good subject, whatever one may believe oneself, in order to

be able to consent to participate. Just as people can consent to participate in wholly nontherapeutic research, so they can consent to participate in what their doctors think is therapeutic research for different reasons than they are suggesting for participation. 70 The reader will readily appreciate situations in which this is not true; but as a broad generality it seems sound.
indeed it may be the best choice for them to do so. They can

derive great utility from the thought of helping others. And

they can feel terribly demeaned when their choice is not

respected.71 Thus, it is not obvious that we should raise the bar

for competency to participate in research.

Given all of these competing concerns, I am not sure how 

I come down on the controversy around sliding scale competency measures, although I am tempted by a single level of

competency. At the very least, I believe that we should 

increase the level that we require of patients only in the most

exigent circumstances: when their choice exposes them to a

serious risk of very substantial, perhaps irreversible harm.

This policy would avoid letting individual evaluators make 

normative judgments about their evaluee’s choices.72 Even

then, I might call the impairment justifying overriding the

choice in exigent circumstances something other than incompetency (perhaps impairment?), so as not to open the door to

more manipulation of the concept. In addition, we may have

reasons for thinking that competency should be understood 

in realist terms as either there or not there, and not variable

according to context.73

In sum, how we eventually come down on this issue will

require careful normative consideration, which I have not

undertaken here. And this question must be answered before

we definitively adopt a competency standard or measure.

What recommendations should the National

Bioethics Advisory Commission make to 

institutional review boards regarding 

competency evaluations?

Two questions arise with respect to NBAC recommendations 

to IRBs: first, should researchers be required to evaluate 

competency when recruiting subjects for research? And 

second, should they be required to use particular instruments

to do so? It seems clear that researchers should inquire 

into competency whenever there is reason to suspect it is not

present. This is particularly so in the research context where

consent is not obviously in the patient’s interests. Perhaps 

there should be a presumption that hospitalized psychotic

patients should be evaluated, although requiring evaluation of

anyone with a chronic psychotic illness may underestimate

competency in this population. However we draw the line, if

there is reason to doubt a potential subject’s competency, it

should clearly be evaluated.

Then the question becomes how to evaluate it. What should

the NBAC recommend, if anything, for IRBs to require of investigators who wish to perform research on vulnerable populations? One possibility is that IRBs might wish to require use of

the MacArthur instruments with suitable adaptations.

MacArthur seems the most promising instrument available, but

if the criticisms presented here and elsewhere are sound, it is

also flawed.

If the MacArthur instruments are required, IRBs must realize

that it is never sound for investigators simply to use them without more. At the least, they must be adapted to the research

context. Perhaps they should also be modified in the light of

criticisms I and others have made.

Perhaps most important, because the MacArthur researchers

have omitted the crucial normative judgments necessary 

before the instruments can be used, some effort must be made

to justify the normative choices the evaluator wishes to apply.

For there is a real danger that an investigator faced with 

a requirement to use the MacArthur instruments may 

simply adopt its definition of “impairment” as the cutoff

point for incompetence, or decide that the line the MacArthur researchers say indicates clear competence should 

also be the line below which incompetence falls. The

MacArthur researchers did not justify these normative 

choices, so that using these cutoff points, without normative

analysis, is improper.

If all of this is so, IRBs could require, at the least, that investigators study the MacArthur instruments, as well as critiques 

of the instruments as given here and by other scholars. Alternatively, they could require some sustained analysis, submitted 

to the IRB, of why the investigators are making the normative

choices they are making—as well as of their responses to other

criticisms of the instruments. To my way of thinking, the 

second provides much better assurance that the required analysis is being performed, and that investigators are not simply

adopting the MacArthur researchers’ suggestions.

On the other hand, it may simply be too costly to require such

analysis, and researchers on the street, so to speak, may not be

very skilled at this kind of analysis. It is, arguably, not within

doctors’ and other scientists’ expertise to engage in this kind of

philosophical inquiry. Thus we should encourage scholars to

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71 I am not suggesting we should never let others decide for the incompetent subject—that is a whole other subject in itself; to the extent that we do, some of these reasons lose force. 72 “This choice is somewhat problematic, so we raise the bar a little; that choice is very problematic, so we raise the bar a lot.” Of course, in both cases the evaluator gets to say that —

why a choice is problematic based on his own values rather than having a standard that speaks to the nature of the necessary harm as in the text. 73 Competency, of course, depends on various capacities, which can be a matter of more or less. It is nevertheless arguably the case—although I am not completely persuaded by the

argument—that what it is to be competent is invariant across contexts: one needs, say, to be able to do x percent of the tasks required to do a good job to be “competent” to do that

job. Compare the case of what it is to be a “proficient interpreter.” Some languages are harder than others to be an interpreter of; and certainly some interpreters do the job in a given

language better than others; but we reserve the term “proficient interpreter” to people who get the translation right, or close to right, most of the time. If I am “competent to interpret

from Spanish to English,” I need have no greater interpreting skills than someone “competent to interpret from English to Italian.” There is one skill level required. Of course, in

extremely sensitive negotiations we may want someone with extremely high levels of “capacity”; but this person might be called “super-proficient,” and not just “proficient,” in being 

an interpreter.
engage in the hard analysis of the normative questions. On the

other hand, investigators can hardly be expected to wait for this

kind of analysis, especially if some consensus is required—

research must go on.

There are ultimately only three possibilities:74 require investigators to use MacArthur with suitable adaptations after at least

considering problems with the instruments and choices that

must be made in order to use them, and perhaps justify those

choices in some sustained way; require investigators to use

some other instrument—say an instrument of their own devising; or allow, instead of the use of instruments, clinical investigations of competency.

Which option IRBs should use depends on how problematic

one finds the MacArthur instruments to be; how confident one

is of the ability of investigators to moderate the problems; and

whether one thinks more open-ended evaluation involves the

same kinds of problematic normative judgments, but simply

sweeps them under the table, possibly achieving less accuracy in

the end. How to answer the question of what IRBs should

require is difficult given the state of the art of capacity/competency instruments today. Further research is needed both on the

substantive question of what one’s instrument should look like

and on the procedural question of what to do in the face of the

problems identified in existing instruments.

Conclusion

The MacArthur instruments are an extremely important contribution to the literature on treatment capacity. I have suggested two essential problems. First, the instruments omit necessary

normative evaluation and smuggle in certain judgments without justifying them. Second, in some cases, they arguably strike

the balance between autonomy and paternalism in the wrong

place. Future research must focus on remedying these problems. In particular, to the extent that the normative inquiry

leads us to select a “patently false belief” standard to measure

appreciation, effort must be made to operationalize such a standard. Notwithstanding the need for future research, the

MacArthur instruments are an impressive achievement and will

no doubt be a focal point for the debate on capacity/competency for many years to come.

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74 This is somewhat overstated: IRBs can not only require one of these three, but perhaps others as well. And there are variations on these choices: IRBs, instead of requiring investigators

to do something, can encourage them to do it, or assure themselves that they are being mindful of it—and many more.
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AN OVERSIGHT OF ISSUES ARISING IN THIS REPORT