ANTICIPATE and

COMMUNICATE

Ethical Management of 

Incidental and Secondary Findings 

in the Clinical, Research, and 

Direct-to-Consumer Contexts

December 2013
On the cover: Image* of a biopsy of an 

adenoma, or benign tumor, in the pituitary 

gland of the brain as seen through a 

microscope. Such a finding can originate 

incidentally via a number of diagnostic 

imaging tools. High resolution imaging 

can reveal an incidental pituitary tumor 

10 percent of the time; these tumors are 

usually small and asymptomatic.

Source: Aron, D.C., and T.A. Howlett. (2000). 

Pituitary incidentalomas. Endocrinology 

and Metabolism Clinics of North America, 

29(1), 205-221. 

*Adaptation of original. 

Credit: Biophoto Associates / Science Source
ANTICIPATE and

COMMUNICATE

Ethical Management of 

Incidental and Secondary Findings 

in the Clinical, Research, and 

Direct-to-Consumer Contexts

Washington, D.C.

December 2013

http://www.bioethics.gov
ii

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

ii

ABOUT THE PRESIDENTIAL COMMISSION FOR 

THE STUDY OF BIOETHICAL ISSUES

The Presidential Commission for the Study of Bioethical Issues (Bioethics 

Commission) is an advisory panel of the nation’s leaders in medicine, science, 

ethics, religion, law, and engineering. The Bioethics Commission advises 

the President on bioethical issues arising from advances in biomedicine and 

related areas of science and technology. The Bioethics Commission seeks to 

identify and promote policies and practices that ensure scientific research, 

health care delivery, and technological innovation are conducted in a socially 

and ethically responsible manner. 

For more information about the Bioethics Commission, please see http://

www.bioethics.gov.

The use of trade names and commercial sources in this report is for identification only and 

does not imply endorsement by the Presidential Commission for the Study of Bioethical Issues.
iii

CONTENTS

Letter of Transmittal to the President.................................................................................vi

Members of the Bioethics Commission............................................................................viii

Bioethics Commission Staff and Consultants...................................................................ix

Acknowledgements.................................................................................................................... x

EXECUTIVE SUMMARY......................................................................................................1

ETHICAL BASIS OF THE MANAGEMENT OF INCIDENTAL AND

SECONDARY FINDINGS ..................................................................................................4

RECOMMENDATIONS .....................................................................................................5

Overarching Recommendations.......................................................................................5

Informing Persons Tested................................................................................................5

Evidence-Based Practice Guidelines.............................................................................6

Additional Empirical Research......................................................................................7

Educating Stakeholders...................................................................................................7

Justice and Fairness and Health Inequities .................................................................8

Context-Specific Recommendations...............................................................................9

Clinical Recommendations.............................................................................................9

Research Recommendations..........................................................................................13

Direct-to-Consumer Recommendations.....................................................................17

Conclusion...........................................................................................................................20

CHAPTER 1: Introduction...................................................................................................21

Past Consideration of the Management of Incidental and Secondary Findings.....23

Taxonomy of Incidental Findings..................................................................................25

Ethical Basis of the Management of Incidental and Secondary Findings..............29

The Bioethics Commission’s Process.............................................................................31

About this Report..............................................................................................................32

CHAPTER 2: Modalities and Probable Incidental and Secondary Findings.............33

Large-Scale Genetic Sequencing ....................................................................................34

Testing of Biological Specimens.....................................................................................37

Imaging ................................................................................................................................39

Conclusion...........................................................................................................................41

CHAPTER 3: Overarching Recommendations for Incidental and 

Secondary Findings.............................................................................................................43

Informing Persons Tested ...............................................................................44

Evidence-Based Practice Guidelines................................................................45
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Additional Empirical Research .......................................................................47

Educating Stakeholders...................................................................................49

Justice and Fairness and Health Inequities...................................................... 51

CHAPTER 4: Ethical Management of Incidental and Secondary Findings 

in the Clinical Context...........................................................................................................53

Practical Considerations of Incidental and Secondary Findings 

in the Clinical Context.....................................................................................................55

Legal Considerations of Incidental and Secondary Findings 

in the Clinical Context.....................................................................................................57

Ethical Considerations of Incidental and Secondary Findings 

in the Clinical Context.....................................................................................................58

Respect for Persons..........................................................................................................59

Beneficence......................................................................................................................59

Justice and Fairness .......................................................................................................61

Analysis and Recommendations ....................................................................................63

Consent in the Clinical Context..................................................................................63

Empirical Data in the Clinical Context ...................................................................67

Clinical Judgment in Managing Incidental and Secondary Findings..................69

Conclusion...........................................................................................................................73

CHAPTER 5: Ethical Management of Incidental and Secondary Findings 

in the Research Context..........................................................................................................75

Practical Considerations of Incidental and Secondary Findings 

in the Research Context...................................................................................................78

Legal Considerations of Incidental and Secondary Findings 

in the Research Context...................................................................................................81

Ethical Considerations of Incidental and Secondary Findings 

in the Research Context...................................................................................................82

Respect for Persons..........................................................................................................82

Beneficence......................................................................................................................83

Justice and Fairness .......................................................................................................85

Intellectual Freedom and Responsibility....................................................................85

Analysis and Recommendations ....................................................................................86

Consent in the Research Context.................................................................................86

Planning for Incidental Findings in Research...........................................................88

No Duty to Look for Secondary Findings in Research.............................................91

Conclusion...........................................................................................................................92
v

CHAPTER 6: Ethical Management of Incidental and Secondary Findings 

in the Direct-to-Consumer Context.....................................................................................95

Practical Considerations of Incidental and Secondary Findings 

in the Direct-to-Consumer Context .............................................................................97

Legal Considerations of Incidental and Secondary Findings 

in the Direct-to-Consumer Context .............................................................................98

Ethical Considerations of Incidental and Secondary Findings 

in the Direct-to-Consumer Context ...........................................................................100

Respect for Persons........................................................................................................101

Beneficence....................................................................................................................101

Justice and Fairness .....................................................................................................102

Intellectual Freedom and Responsibility..................................................................102

Analysis and Recommendations ..................................................................................103

Consent in the Direct-to-Consumer Context ..........................................................103

Government Regulation in the Direct-to-Consumer Context..............................104

Industry-Wide Best Practices in the Direct-to-Consumer Context......................105

Conclusion.........................................................................................................................109

CHAPTER 7: Conclusion................................................................................................... 111

ENDNOTES .......................................................................................................................... 115 

APPENDICES........................................................................................................................133

Appendix I: Past National Recommendations 

Regarding Incidental and Secondary Findings........................................................134

Appendix II: Past International Recommendations 

Regarding Incidental and Secondary Findings........................................................140

Appendix III: Guest Presenters to the Bioethics Commission 

Regarding Incidental and Secondary Findings........................................................145
vi

Presidential Commission for the Study of Bioethical Issues

President Barack Obama

The White House

1600 Pennsylvania Avenue, NW

Washington, DC 20500

Dear Mr. President:

On behalf of the Presidential Commission for the Study of Bioethical 

Issues, we present to you Anticipate and Communicate: Ethical Management 

of Incidental and Secondary Findings in the Clinical, Research, and Directto-Consumer Contexts. In this report the Bioethics Commission focuses on 

the distinct ethical issues concerning the management of incidental and 

secondary findings that arise from clinical, research, and direct-to-consumer 

testing. Incidental findings traditionally are defined as results that arise that 

are outside the original purpose for which a diagnostic test or procedure was 

conducted. Such findings can be lifesaving, but also can lead to uncertainty 

and distress if they are unexpected or identify conditions for which no 

effective treatment is available.

Building on its past work in Privacy and Progress in Whole Genome Sequencing, 

released in October 2012, the Bioethics Commission held four public 

meetings regarding incidental findings and heard from speakers with diverse 

backgrounds and perspectives. The Bioethics Commission also solicited public 

comment and received many thoughtful responses.

As technology advances, the likelihood of discovering incidental and 

secondary findings is expected to increase. The Bioethics Commission believes 

that a number of ethical principles can guide clinicians, researchers, and 

direct-to-consumer companies in developing sound policies for the ethical 

management of such findings. The Bioethics Commission therefore offers 17 

recommendations to guide practitioners across testing modalities and health 

care settings. 

1425 New York Avenue, NW, Suite C-100, Washington, DC 20005

Phone 202-233-3960 Fax 202-233-3990 www.bioethics.gov
vii

1425 New York Avenue, NW, Suite C-100, Washington, DC 20005

Phone 202-233-3960 Fax 202-233-3990 www.bioethics.gov

The Bioethics Commission recommends that all practitioners should anticipate 

and plan for incidental and secondary findings to the best of their ability in 

order to provide as much information as possible to guide recipient decision 

making. Potential recipients should be fully informed about the possibility of 

incidental and secondary findings before any tests are conducted. To aid in this 

process, professional organizations and experts should continue to enumerate all 

anticipatable findings and guidance about their ethical management. 

The Bioethics Commission is honored by the trust you have placed in us and 

we are grateful for the opportunity to serve you and the nation in this way.

Sincerely,

Amy Gutmann, Ph.D. James W. Wagner, Ph.D.

Chair Vice Chair
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

PRESIDENTIAL COMMISSION FOR THE STUDY OF BIOETHICAL ISSUES

AMY GUTMANN, Ph.D., CHAIR

President and Christopher H. Browne

Distinguished Professor of Political Science and Professor of Communication, 

University of Pennsylvania

JAMES W. WAGNER, Ph.D., VICE CHAIR

President, Emory University

ANITA L. ALLEN, J.D., Ph.D.

Vice Provost for Faculty, 

Henry R. Silverman Professor of Law 

and Professor of Philosophy, 

University of Pennsylvania

JOHN D. ARRAS, Ph.D.

Porterfield Professor of Biomedical

Ethics, Professor of Philosophy, 

Professor of Public Health Sciences,

University of Virginia

BARBAR A F. ATKINSON, M.D.

Executive Vice Chancellor Emeritus, 

University of Kansas Medical Center;

Professor Emeritus of Pathology and 

Laboratory Medicine, University of

Kansas School of Medicine

NITA A. FAR AHANY, J.D., Ph.D.

Director of Science and Society, 

Professor of Law and Philosophy, 

Professor of Genome Sciences and Policy,

Duke University

CHRISTINE GR ADY, R.N., Ph.D.

Chief, Department of Bioethics, 

National Institutes of Health 

Clinical Center

STEPHEN L. HAUSER, M.D.

Robert A. Fishman Distinguished

Professor and Chair of the Department

of Neurology, University of California,

San Francisco

R AJU S. KUCHERLAPATI, Ph.D.

Paul C. Cabot Professor, Department

of Genetics, Harvard Medical School;

Professor, Department of Medicine,

Brigham and Women’s Hospital

NELSON L. MICHAEL, M.D., Ph.D.

Colonel, Medical Corps, U.S. Army;

Director, U.S. Military HIV Research 

Program, Walter Reed Army Institute 

of Research

DANIEL P. SULMASY, M.D., Ph.D., FACP

Kilbride-Clinton Professor of Medicine

and Ethics, Department of Medicine

and Divinity School; Associate Director,

The MacLean Center for Clinical Medical

Ethics, University of Chicago 
ix

PRESIDENTIAL COMMISSION FOR THE STUDY OF BIOETHICAL ISSUES 

STAFF* AND CONSULTANTS

Executive Director

Lisa M. Lee, Ph.D., M.S.

Associate Directors

Michelle Groman, J.D.

Kayte Spector-Bagdady, J.D., M. Bioethics

Communications Director

Hillary Wicai Viers, M.S.J.

Senior Advisors

Paul A. Lombardo, Ph.D., J.D.

Jonathan D. Moreno, Ph.D.

Research Staff

Misti Ault Anderson, M.S., M.A.

Rachel S. Bressler, J.D.

Kata Chillag, Ph.D.

Elizabeth M. Fenton, Ph.D., M.P.H.

Karen M. Meagher, Ph.D.

Olivia Nevitt, M.P.H.

Cristina Nigro, M.S.

Anne Pierson Allen, J.D.

Elizabeth R. Pike, J.D., LL.M.

Maneesha Sakhuja, M.H.S.

Michelle Spektor, B.S.

Nicolle K. Strand, J.D., M. Bioethics

Victoria Wilbur, B.A.

Tenny R. Zhang, B.A.

Consultants

Burness Communications

Kathi E. Hanna, M.S., Ph.D.

Communications Staff

Elizabeth Schaub, M.A.

Administrative Staff

Svetlana Cicale, M.A., M.P.H.

Tynetta Dreher

Esther E. Yoo

Interns

Ruqayyah Abdul-Karim, B.A.

Eleanor Gilmore-Szott, B.A.

Rahul Nayak, B.S.

Abbas Rattani, M. Bioethics

Kevin Tobia, B.A.

Sean Valle, B.A.

*Includes former research staff
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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ACKNOWLEDGEMENTS

The Bioethics Commission is indebted to those who contributed their 

wisdom, time, and energy to this report. It offers special thanks to the diverse 

group of outstanding speakers who shared their expertise and personal 

experiences, and engaged in productive and thought-provoking discussions 

at its public meetings. 

The Bioethics Commission is also grateful to its talented and capable staff 

for their unflagging support, careful research, and considerable insights on 

the ethics of managing incidental and secondary findings in the clinical, 

research, and direct-to-consumer settings. The Bioethics Commission 

extends particular thanks to Executive Director Lisa M. Lee for her steadfast 

leadership and unwavering commitment to the Bioethics Commission’s work 

and to Senior Advisor Paul Lombardo for his expert review. The Bioethics 

Commission also appreciates the work of Associate Director Kayte SpectorBagdady and staff lead Elizabeth Pike, whose diligence and constant efforts 

ensured a nuanced review of this critical topic.
1

EXECUTIVE SUMMARY
2

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

A healthy young medical student participated in research using functional magnetic resonance imaging to look at brain activity while doing a 

memory test. During this brain scan, the researcher noticed a concerning 

mass. The student rushed to the hospital for further examination, which was 

followed by successful treatment of the incidental finding that she credits with 

saving her life.1

Two years later, a different woman collapsed from over-hydration while 

running a marathon. During an evaluation, her emergency care team discovered a small brain tumor. She opted, in consultation with her physicians, for 

a watch-and-wait approach, monitoring the tumor for changes before making 

any treatment decisions. She has been watching anxiously for almost 10 years, 

even though the tumor might never affect her health.2

Incidental findings—traditionally defined as results that arise that are outside 

the original purpose for which the test or procedure was conducted3—can 

create a range of practical, legal, and ethical challenges for recipients and 

practitioners. Discovering an incidental finding can be lifesaving, but it also 

can lead to uncertainty and distress without any corresponding improvement 

in health or wellbeing. For incidental findings of unknown significance, 

conducting additional follow-up tests or procedures can be risky and costly.4 

Moreover, there is tremendous variation among potential recipients about 

whether, when, and how they would choose to have incidental findings 

disclosed. Information that one recipient regards as an unnecessary cause of 

anxiety could lead another recipient to feel empowered in making healthrelated decisions. 

The increasing technological capability of the modalities discussed in this 

chapter leads to an increased likelihood of discovering incidental and 

secondary findings. The movement from discrete tests toward large-scale 

genetic sequencing increases the likelihood that clinicians, researchers, and 

direct-to-consumer (DTC) providers will confront the issue of incidental and 

secondary findings. And as payment structures evolve so that bundled tests 

are presumed to be more cost effective than discrete tests, the number of 

unintended findings is expected to increase.

In this report, Anticipate and Communicate: Ethical Management of Incidental 

and Secondary Findings in the Clinical, Research, and Direct-to-Consumer 
Executive Summary

3

Contexts, the Presidential Commission for the Study of Bioethical Issues 

(Bioethics Commission) focuses on the distinct ethical issues concerning 

incidental and secondary findings that arise from various modalities—including 

large-scale genetic sequencing, testing of biological specimens, and imaging—in 

contexts that include the clinic, research, and DTC testing. Because the term 

“incidental findings” as traditionally used can limit consideration of critical 

ethical issues, the Bioethics Commission considers several types of ethically 

challenging findings, including incidental, secondary, and discovery findings.

For purposes of this report, the Bioethics Commission divides the term 

“incidental finding” into two categories: incidental findings that are 

“anticipatable” and those that are “unanticipatable.” An anticipatable incidental 

finding is a finding that is known to be associated with a test or procedure. 

An unanticipatable incidental finding includes a finding that could not have 

been anticipated given the current state of scientific knowledge. A secondary 

finding refers to a finding that is actively sought by a practitioner that is 

not the primary target. A discovery finding refers to the results of a broad or 

wide-ranging test that was intended to reveal anything of interest. This report 

focuses primarily on anticipatable and unanticipatable incidental findings as 

well as secondary findings. For simplicity, the generic term “incidental finding” 

is used in reference to both anticipatable and unanticipatable incidental 

findings; distinctions are made as necessary and relevant.

In its previous report, Privacy and Progress in Whole Genome Sequencing, 

the Bioethics Commission addressed incidental findings with regard to 

large-scale genetic sequencing.5 A more thorough deliberation about the 

ethical obligations of clinicians, researchers, and DTC providers, as well as 

consideration of the incidental findings that arise from various diagnostic 

modalities, is the goal of this report, which makes 17 recommendations to 

guide practitioners across modalities and settings. 

The current challenge for public policy and professional ethics is to identify 

through thoughtful deliberation specific criteria that practitioners can use 

to determine when it is ethically permissible or obligatory for clinicians, 

researchers, or DTC companies to disclose and not disclose incidental findings 

to patients, participants, or consumers. The technical aspects of managing the 

response to incidental findings—including the circumstances under which 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

practitioners should return particular findings—is best carried out by those 

with the relevant expertise to make those nuanced determinations. In contrast 

to developing detailed prescriptions for practice, the Bioethics Commission 

aims through this report to provide a broad ethical analysis of the principles, 

virtues, and duties relevant to managing incidental and secondary findings to 

ground these determinations. 

ETHICAL BASIS OF THE MANAGEMENT OF INCIDENTAL AND 

SECONDARY FINDINGS

Longstanding ethical principles ground the Bioethics Commission’s 

consideration of incidental and secondary findings. In seeking to create 

mutually acceptable and justifiable public policy, a process of democratic 

deliberation can lead citizens, policy makers, and experts to identify common 

ground and compromise.6 Because professionals in a variety of contexts can 

encounter incidental and secondary findings, guidance must appeal to principles 

that bridge these contexts. The interpretation, application, scope, strength, and 

stringency of each principle, however, can vary among and within each context. 

The Bioethics Commission found four ethical principles to be particularly 

applicable to the ethical assessment of incidental and secondary findings: 

respect for persons, beneficence, justice and fairness, and intellectual 

freedom and responsibility. The principle of respect for persons recognizes 

the fundamental human capacity for rational self-determination—the 

autonomous ability to identify personal preferences, act on these desires, 

and direct the course of one’s life. The principle of beneficence calls on 

professionals to take actions to ensure the wellbeing of others, while its 

corollary non-maleficence requires not imposing harms on others. The 

principle of justice and fairness requires fair and equitable treatment of all. 

Finally, the principle of intellectual freedom and responsibility protects 

sustained and dedicated creative intellectual exploration that furthers 

scientific progress, while requiring that practitioners take responsibility for 

their actions. A context-specific interpretation of each principle is necessary to 

translate the principles into actionable guidance,7 and is undertaken in each 

of the context-specific chapters that follow.
Executive Summary

5

RECOMMENDATIONS

In this report, the Bioethics Commission makes two types of recommendations: 

those applicable to the ethical management of incidental and secondary findings 

across contexts, and those most relevant in specific settings or situations. The 

following section provides an overview of these recommendations.

Overarching Recommendations

Although many ethical considerations 

concerning the management of incidental 

and secondary findings are specific to the 

setting in which they occur—and the type 

of relationship between the practitioner and 

the potential recipient—there are several 

important considerations applicable to 

these findings in all contexts. The Bioethics 

Commission thus offers five overarching 

recommendations.

Informing Persons Tested

In all contexts, potential recipients of incidental and secondary findings—

patients, research participants, and consumers—should be informed about 

the likelihood of such findings arising from a particular test or procedure. 

Providing this information enables a potential recipient to make an autonomous decision about whether and how to proceed. This disclosure also allows 

practitioners to anticipate and think through the consequences of conducting 

various tests and procedures. Open communication between practitioners 

and individuals, accessible and understandable documents and resources, 

and transparent processes in all three contexts help ensure that individuals 

understand risks and benefits before they consent.

Recommendation 1

Clinicians, researchers, and direct-to-consumer providers should describe to 

potential recipients incidental and secondary findings that are likely to arise 

or be sought from the tests and procedures conducted. Practitioners should 

inform potential recipients about their plan for disclosing and managing 

incidental and secondary findings, including what findings will and will not 

be returned. 

Overarching Recommendations

Informing Persons Tested 

Evidence-Based Practice Guidelines

Additional Empirical Research

Educating Stakeholders

Justice and Fairness and 

Health Inequities
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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Practitioners should facilitate and work to improve the process of informed 

consent in all contexts. Adequately informing individuals about the potential 

for discovering incidental findings should include an explanation of the nature 

of anticipatable incidental findings, as well as the possibility of discovering 

unanticipatable incidental findings, and a thorough description of any 

secondary findings that will be sought.

Evidence-Based Practice Guidelines

Practice guidelines can inform practitioners about the anticipatable incidental 

findings likely to arise during common tests and procedures, and the ways in 

which practitioners can best manage these findings—including the possibility 

of actively seeking particular findings as secondary findings. Guidelines 

tailored to each modality, procedure, or test that address the findings likely to 

arise in each context can help practitioners develop their own ethically sound 

policies for managing such findings. 

Recommendation 2

Professional representative groups should develop guidelines that categorize 

the findings likely to arise from each diagnostic modality; develop best 

practices for managing incidental and secondary findings; and share these 

guidelines among practitioners in the clinical, research, and direct-toconsumer contexts.

Professional and institutional guidelines are crucial to ensuring consistent 

and systematic categorization, disclosure, and management of incidental 

and secondary findings. In developing guidelines, professional organizations 

should employ a variety of criteria, including clinical significance and actionability, and should also take into account the economic costs associated with 

conducting additional diagnostic tests in relation to ascertainable benefits. 

As professional organizations increasingly recognize certain anticipatable 

findings likely to arise from particular tests and procedures, and determine 

that certain findings are sufficiently significant and actionable to merit 

disclosure, a number of findings—previously considered anticipatable 

incidental findings—are likely to become actively sought secondary findings. 

The transition from unanticipated incidental findings to anticipated or 
Executive Summary

7

secondary findings allows for more information to be provided to potential 

recipients and therefore facilitates more meaningful consent across contexts. 

Additional Empirical Research

Additional empirical research and scholarship is needed concerning the 

discovery, disclosure, and management of incidental and secondary findings. 

In its report, Privacy and Progress in Whole Genome Sequencing, the Bioethics 

Commission recommended that funders of whole genome sequencing research 

conduct further studies to evaluate proposed frameworks for offering to return 

incidental findings and other research results.8 The Bioethics Commission 

continues to believe that additional empirical data are critical to informing 

the ethical management of incidental and secondary findings, and therefore 

suggests expanding the scope of such recommended empirical research.

Recommendation 3 

Federal agencies and other interested parties should continue to fund 

research regarding incidental and secondary findings. This research 

should consider the types and frequency of findings that can arise from 

various modalities; the potential costs, benefits, and harms of identifying, 

disclosing, and managing these findings; and recipient and practitioner 

preferences about the discovery, disclosure, and management of incidental 

and secondary findings. 

Data about incidental and secondary findings can come from a variety of 

sources. One potential source is practitioners gathering information about 

incidental and secondary findings through their work, monitoring findings 

that arise, and developing databases about the disclosure and management of 

such findings.9 Professional societies also can address specific questions about 

findings likely to arise from various modalities and in various contexts, and the 

professional skills or training necessary to interpret and manage these findings.10

Educating Stakeholders

Educating the public about incidental and secondary findings enables those 

undergoing tests or procedures to make better informed decisions and 

develop informed preferences about receiving potential findings. Educating 

practitioners about their ethical obligations enables them to make more 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

thoughtful decisions about how to anticipate, disclose, and manage incidental 

and secondary findings. 

Recommendation 4

Public and private entities should prepare educational materials to inform 

all stakeholders—including practitioners, institutional review boards, and 

potential recipients—about the ethical, practical, and legal considerations 

raised by incidental and secondary findings. 

In addition to the educational efforts of the Bioethics Commission, a wide 

variety of groups, governmental bodies, and professional organizations can 

assist in educating stakeholders about incidental and secondary findings. For 

example, public and private entities tasked with providing education about 

and regulation of medical research can bolster existing materials to better 

address the ethical issues raised by incidental and secondary findings. 

Justice and Fairness and Health Inequities

Justice and fairness in health care requires that all individuals have access 

to adequate affordable services to meet basic health care needs. Our society 

should continue to seek cost-effective ways to provide affordable access to 

health care to as many individuals as possible. The right test at the right time 

can be lifesaving, while over-testing comes with its own risks that can be 

detrimental to both mental and physical health. Adequate, affordable care 

provides the backdrop against which competent health care professionals can 

offer expert advice, personalized counseling, and follow-up care to harness 

the benefits of these developing diagnostic technologies. Coupling counseling 

and guidance with new technologies can help patients and their practitioners 

make meaningful decisions about turning medical information into actionable clinical knowledge in accordance with personal health care preferences 

and values.11 Currently, however, many persons lack access to such services. 

The principle of justice and fairness suggests finding affordable, cost-effective 

ways to give all people in need access to informed counseling and related 

medical care.  
Executive Summary

9

Recommendation 5

The principle of justice and fairness requires that all individuals have access 

to adequate information, guidance, and support in making informed choices 

about what medical tests to undergo, what kind of information to seek, and 

what to do with information once received. The principle of justice and 

fairness also requires affordable access to quality information about incidental 

and secondary findings, before and after testing, which when coupled with 

access to care can be potentially lifesaving or life enhancing.

For incidental findings to be managed in an appropriate and ethical way, there 

must be a health care system available to all that is capable of dealing with 

medically significant findings, whether discovered incidentally or as primary 

or secondary findings. This includes support for time afforded to practitioners 

to discuss with potential recipients how incidental and secondary findings will 

be handled. 

Context-Specific Recommendations

The overarching recommendations listed 

above provide guidance for the ethical 

management of incidental and secondary 

findings across contexts. However, given the 

differences among the clinical, research, and 

DTC settings, the Bioethics Commission 

also sought to provide specific guidance 

for practitioners in each context regarding 

the ethical management of incidental and 

secondary findings. 

Clinical Recommendations

W hen clinicians discover incidental 

findings, or contemplate seeking secondary 

findings, their professional judgment must 

include skilled and insightful deliberation 

guided by ethical principles including 

respect for persons, beneficence, and justice 

and fairness. Application of these principles 

Context-Specific

Recommendations

Clinical Recommendations

Consent in the Clinical Context

Empirical Data in the 

Clinical Context

Clinical Judgement in 

Managing Incidental Findings

Research Recommendations

Consent in the Research Context

Planning for Incidental 

Findings in Research

No Duty to Look for 

Secondary Findings in Research

Direct-to-Consumer 

Recommendations

Consent in the 

Direct-to-Consumer Context

Government Regulation in the 

Direct-to-Consumer Context

Industry-Wide Best Practices in 

the Direct-to-Consumer Context
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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to incidental and secondary findings in the clinical context leads to the 

following recommendations. 

Consent in the Clinical Context

A primary point of communication between clinicians and patients occurs 

during the clinical informed consent process, ideally led by the clinician most 

intimately familiar with the intervention and its possible consequences.12 As 

part of the consent process, clinicians should alert patients that a particular test 

or procedure could or will give rise to anticipatable incidental and secondary 

findings. Clinicians should also notify patients about the possibility that 

unanticipatable findings could arise that could lead to additional diagnostic 

testing or clinical care. The patient should be encouraged to ask questions, 

state reservations, and express preferences about the return and management of 

incidental and secondary findings. 

Recommendation 6

Clinicians should make patients aware that incidental and secondary findings 

are a possible, or likely, result of the tests or procedures being conducted. 

Clinicians should engage in shared decision making with patients about 

the scope of findings that will be communicated and the steps to be taken 

upon discovery of incidental findings. Clinicians should respect a patient’s 

preference not to know about incidental or secondary findings to the extent 

consistent with the clinician’s fiduciary duty.

There are multiple points at which a clinician’s ability to communicate 

clearly and effectively about incidental and secondary findings is important. 

Clinicians should alert patients to the possibility of discovering incidental 

findings, and any secondary findings that will be actively sought, before

testing occurs so that patients have the opportunity to express preferences 

regarding their disclosure and subsequent management. 

With the increasing emphasis on patient autonomy and shared decision 

making, it is important to employ effective methods of conveying information 

about risk.13 Clinicians can facilitate patient understanding by effectively 

presenting pertinent facts and data. In approaching shared decision making 

in the clinical setting, clinicians must be aware of factors that shape patients’ 

perceptions of risk in order to communicate effectively. Clinicians should 

give patients enough information so that they comprehend their options, 
Executive Summary

11

and should also protect patients from unnecessary anxiety produced by 

misunderstood communication of risk. 

Recommendation 7 

In communicating difficult to understand information about incidental 

and secondary findings, clinicians should consider providing patients with 

decision aids and graphical representations, using population-based evidence, 

and describing a patient’s absolute risk (the chance of any person getting a 

disease) rather than or in addition to relative risk (whether a person’s chance 

is higher or lower than another’s).

Accurate graphical displays of numerical and probabilistic health information 

can assist patients in accessing, processing, interpreting, and acting on 

numerical health information.14 It is also critical that clinicians use relevant 

and understandable numerical evidence to support shared decision making. 

When appropriate, numeric assessments of risk should be provided as absolute 

risk instead of or in addition to relative risk, as relative risk can be easily 

misinterpreted. Similarly, population-based evidence can help patients 

understand their overall risk compared with the population as a whole. 

Empirical Data in the Clinical Context 

Little is known about the cost effectiveness of tests and procedures that 

generate incidental findings, including using bundled tests or a battery of 

tests.15 Seeking cost effectiveness—an outcome that takes into account both 

the costs and health outcomes of alternative intervention strategies16—in 

laboratory tests or diagnostic procedures is laudable, and in many cases also 

might help address the issue of ever-rising health care costs. While there have 

been some cost-effectiveness studies regarding incidental findings, they have 

generally been limited in scope. 

Recommendation 8

Federal agencies and other interested parties should study the comparative 

benefits to patients and the cost effectiveness of using bundled tests or a 

battery of tests versus conducting sequential, discrete diagnostic tests. 

To inform individual clinicians, as well as support strong clinical practice guidelines, researchers should conduct reliable comparative- and cost-effectiveness 

analyses. Evidence regarding comparative benefits to patients of tests that yield 
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incidental and secondary findings and the cost effectiveness of performing such 

tests can inform laboratory and payer practices and policies regarding efficient 

bundling of tests, and can aid clinicians in deciding whether to order a battery 

of tests rather than sequential, discrete tests.17

Clinical Judgment in Managing Incidental Findings

While empirical analysis is critical to informing cost-effective care choices, 

it is the art of medical decision making that translates data, education, 

professional guidance, and personal experience into good clinical care. 

Prudent judgment, understood through Aristotle’s concept of phronesis

(or practical wisdom), constitutes a “capstone” virtue, linking intellectual 

virtues—such as those that make for good scientists—with the moral 

character traits such as compassion, trustworthiness, and a sense of justice 

that make one a particularly good caregiver.18 Exercising professional 

judgment is a deliberative process combining formal or “book” knowledge 

of a professional domain with contextual understanding gained through 

experience.19 Although professional judgment is required for every decision 

that involves considering competing values, principles, or virtues, there is no 

specific formula by which clinicians identify the right action.20 Many of the 

attributes that constitute respected clinical judgment can be cultivated and 

enabled through classroom and clinical education. 

Recommendation 9

Medical educators, both in the classroom and clinic, should continue to 

cultivate “diagnostic elegance” and “therapeutic parsimony” amongst 

practitioners—ordering and conducting only tests and interventions 

necessary for addressing health concerns related to their patient. 

Clinicians can minimize the likelihood of incidental findings by engaging 

in selective diagnostic testing. They can do this by emphasizing thorough 

communication with patients to better understand symptoms and help 

narrow the list of potential diagnoses before ordering diagnostic tests. In 

this way, clinicians can use diagnostic tests to confirm or eliminate specific 

possible causes of symptoms. 

Another important tool that clinicians have to enhance their exercise of 

professional judgment is the ability to rely on evidence-based standards, 
Executive Summary

13

including recommendations from professional organizations. One critical 

area in which professional organizations make recommendations is preventive 

screening programs—programs in otherwise healthy populations that aim 

to identify undiagnosed diseases and conditions before symptoms develop.21

This type of evidence-based deliberation is critical to ensuring that patients 

have access to preventive screening programs that offer health care benefits 

appropriately calibrated to any foreseeable risks—including those that can 

arise from incidental findings. 

Recommendation 10

Professional and public health organizations should produce evidencebased standards for proposed screening programs that take into account the 

likelihood that incidental findings will arise. Professional organizations should 

provide guidance to clinicians on how to manage these incidental findings.

The implementation of evidence-based standards in screening programs would 

assist physicians in exercising clinical judgment about any findings that might 

arise. Proposed screening programs that take into account the possibility of 

incidental findings enable clinicians to exercise their professional judgment in 

deciding whether to conduct a screening test or procedure for a particular patient. 

Research Recommendations

Existing scholarship regarding incidental and secondary findings in research 

reflects both the research community’s deep concern for research participants’ 

wellbeing, and an emerging consensus regarding what is ethically required, 

permissible, and impermissible. The Bioethics Commission therefore makes the 

following recommendations to guide the ethical management of incidental and 

secondary findings in the research context.

Consent in the Research Context

In response to the trust imparted to them, researchers owe society and 

research participants obligations to design and implement research in a 

responsible manner.22 During the informed consent process, researchers 

should describe the types of incidental and secondary findings that might 

arise to ensure that participants are as informed as possible. This includes, 

but is not limited to, disclosing anticipatable incidental findings, any 
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deliberately sought secondary findings, and the possibility of unanticipatable 

incidental findings. 

Researchers should also clearly communicate to participants the plan for 

disclosing and managing anticipatable incidental findings as well as any 

possible secondary findings, and the distinction between research and clinical 

care. This communication is essential to ensure that participants understand 

what to expect as a result of their decision to participate in research. Clarity 

with respect to whether and how researchers will disclose anticipatable and 

unanticipatable incidental findings, and any secondary findings that are 

deliberately sought, can help sustain public and participant trust in the 

research enterprise. 

Recommendation 11

During the informed consent process, researchers should convey to 

participants the scope of potential incidental or secondary findings, whether 

such findings will be disclosed, the process for disclosing these findings, and 

whether and how participants might opt out of receiving certain types of 

findings. 

If researchers plan to inform participants of certain types of incidental 

findings, they should decide in advance how to respect the wishes of those 

who choose to opt out of receiving incidental findings. If researchers have 

ethical objections to allowing participants to opt out of receiving clinically 

significant, actionable, and lifesaving findings, they need not enroll such individuals in their research study. Delineating such exclusion criteria for study 

enrollment will minimize this type of ethically challenging situation once the 

research protocol is underway. 

Alternatively, given that participants have the right to opt out of research at 

any time,23 if researchers do not object to allowing participants to opt out of 

receiving incidental findings—and participants are well informed regarding 

what opting out could mean for their health and wellbeing—researchers may 

enroll such participants in the research. In the event a researcher discovers a 

potentially lifesaving unanticipatable incidental finding for a participant who 

has opted out of receiving incidental findings, the investigator should seek 

advice from an institutional review board (IRB) about whether and how to 

disclose it.
Executive Summary

15

Planning for Incidental Findings in Research

Given that certain findings are predictably associated with a particular 

modality or type of research, researchers have a duty to anticipate such 

incidental findings—whether common or rare—to the extent possible. 

Researchers should develop a plan to manage anticipatable incidental findings 

based on a careful balancing of the risks and benefits of disclosure, along 

with evidence about the analytic and clinical validity of the findings and 

their clinical or reproductive significance, in addition to considering actively 

seeking them as secondary findings. Researchers should submit their proposed 

plan for the ethical management of incidental findings to an IRB for review 

and approval. IRBs then would be responsible for assessing the ethical 

adequacy of the plan. 

Recommendation 12

Researchers should develop a plan to manage anticipatable incidental 

findings, including but not limited to those findings known to be 

significant and clinically actionable (and, when relevant, analytically valid 

and clinically valid). The plan should be reviewed and approved by an 

institutional review board.

Even with an IRB-approved plan for managing anticipatable incidental 

findings, researchers nevertheless might discover unanticipatable incidental 

findings. The unexpected nature of these findings makes it difficult to 

ascertain at the outset what responses might be required. Despite, and indeed 

because of, this uncertainty, researchers should have a process in place ahead 

of time to manage these unanticipatable incidental findings as well. 

When researchers are uncertain whether an unanticipatable incidental finding 

might have clinical or reproductive significance, researchers should seek out 

qualified clinical or diagnostic experts for consultation. Consultation with 

subject matter experts can help researchers resolve uncertainty, determine 

the significance of the finding, and develop and implement an informed and 

appropriate response.

Recommendation 13

Researchers should develop a process for evaluating and managing 

unanticipatable findings. The plan should be reviewed and approved 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

by an institutional review board. During the informed consent 

process, researchers should notify participants about the possibility 

of unanticipatable incidental findings, including lifesaving incidental 

findings, and the plan for their management. Researchers who discover an 

unanticipatable incidental finding of concern should assess its significance, 

consulting with experts as appropriate. 

An incidental findings management plan should include specific information regarding the method of disclosure. Nonclinical researchers also might 

involve clinicians in discussions with participants about incidental findings. 

The plan for managing incidental findings should also include a description of 

the research team’s responsibilities following disclosure of such a finding. In 

some cases, researchers might provide basic educational information about the 

nature of the finding, advice regarding how to seek care from a clinician or 

specialist, or guidance about obtaining health insurance to secure treatment. 

If a clinical specialist is required, researchers should provide the participant 

with a referral when possible. Disclosure of an incidental finding, however, 

does not transform a research relationship into a clinical one. 

No Duty to Look for Secondary Findings in Research

Researchers’ obligations of beneficence raise questions about whether and to 

what extent they might have a duty to look for secondary findings. While 

some researchers have research funding to look for secondary findings, this 

will not be true for many of those conducting valuable research endeavors. 

Prioritizing a duty to look for secondary findings over the creation of generalizable knowledge has the potential to undermine the research enterprise. 

Recommendation 14

Researchers should consider carefully the decision to actively look for 

secondary findings. In certain circumstances, with approval from an 

institutional review board, researchers can justifiably adopt a plan that 

includes looking for selected clinically significant and actionable secondary 

findings. Approved plans should be disclosed to prospective participants 

during the informed consent process.
Executive Summary

17

Even without an ethical duty to actively look for secondary findings, 

researchers could, in some circumstances, justifiably adopt a plan to look for 

secondary findings. For example, a research team investigating the genetics of 

a particular community could decide—but would not be obligated—to implement the advice of a community advisory board that recommends looking for 

a particular variant if requested by a participant, even if the variant is outside 

the aims of the research. By acknowledging the community’s interest and 

simultaneously completing their research, researchers could advance both the 

public and individual components of beneficence. Also, while researchers do 

not have an affirmative duty to look for secondary findings, this does not 

dilute the importance of developing a plan for managing those that they find 

and of educating participants about the details of this plan. 

Direct-to-Consumer Recommendations

Members of the general public have increasingly gained access to medical tests 

and procedures outside of traditional clinical or research settings. Situated at 

the intersection of medicine and business, DTC companies offer the public 

additional mechanisms for obtaining health-related information. Thus far, the 

full breadth of DTC activities and their associated ethical considerations have 

been relatively underexplored in the literature. 

Consent in the Direct-to-Consumer Context

DTC testing can offer individuals a means through which they can exercise 

self determination, including by providing increased access, reduced cost, or 

greater confidentiality of health information. But the benefits of DTC services 

are contingent upon the quality of the testing and analyses, and the informed 

and voluntary nature of the transaction. To enable consumers to make 

responsible and informed choices regarding DTC testing, consumers must be 

told what these procedures entail, including the possibility of incidental and 

secondary findings. Information provided before selecting a DTC procedure 

can assist consumers in deciding what services are worth pursuing. 

Recommendation 15

Direct-to-consumer companies should provide consumers with sufficient 

information about their services to enable consumers to make informed 

decisions regarding purchasing their product. Companies should clearly 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

communicate the scope of procedures and the types of findings that the 

companies could or will discover and disclose, as well as any findings that 

they know in advance will not be disclosed.

DTC companies must inform consumers considering their services about the 

procedures and results included in the commercial arrangement. Among the 

information needed by consumers is an understanding of the anticipatable 

incidental findings commonly associated with particular modalities and any 

secondary findings that will be deliberately sought. If certain results are not 

returned according to company policy or contractual agreement, this must be 

disclosed to consumers as well.

Government Regulation in the Direct-to-Consumer Context

From air bags and seatbelts to the proper construction of cribs, the 

government has responsibility for ensuring the safety of certain products and 

services offered to consumers.24 As a matter of policy, society has chosen to 

impose oversight to place legitimate limits on the principle of caveat emptor or 

“buyer beware.”25 The primary goal of this oversight is to establish consumer 

protections—to ensure that companies make good on both explicit and 

implicit guarantees that the goods and services proffered are suitable for the 

purposes for which companies sell them.26 Federal and state governments can 

also provide citizens with assurance that DTC companies are conducting 

business in a transparent and responsible manner.

Recommendation 16

Federal agencies should continue to evaluate regulatory oversight of direct-toconsumer health services to ensure safety and reliability. State governments 

should also adopt regulations that ensure a consistent floor of protections for 

consumers who purchase direct-to-consumer testing. 

Policy makers at the state and federal level should examine existing regulations 

governing DTC services to identify gaps in and barriers to ensuring the 

safety and reliability of DTC testing. Policy makers should consider adopting 

regulations governing disclosure of incidental and secondary findings. Policy 

makers at the state and federal level should remain mindful of the principle of 

regulatory parsimony, limiting restrictions on the ability to freely engage in 

commercial transactions only to the extent necessary to prevent serious harm.
Executive Summary

19

Industry-Wide Best Practices in the Direct-to-Consumer Context 

The DTC market is relatively new and growing, and the technologies used 

are often still evolving. Given the diversity in the DTC industry, and the 

evolving practices employed by DTC companies, DTC companies are 

uniquely positioned to understand the nature of their own industry. This 

knowledge could enable DTC companies to develop best practices that are 

consistent with relevant ethical principles.27 For example, DTC providers who 

discover clinically actionable incidental or secondary findings that have health 

implications could provide consumers with educational information about the 

nature of the finding, advice about how best to seek care from a clinician or 

specialist, or even a referral to a clinician who could assist in the management 

of the finding. If companies adopt voluntary best practices, such best practices 

could become standard expectations for consumers who choose to undergo 

DTC testing, giving other companies incentive to adopt and implement these 

practices, thereby leveling the playing field.

Recommendation 17

Direct-to-consumer companies should aid in the creation of industry-wide 

best practices concerning the management of incidental and secondary 

findings. These best practices should include when and how such findings will 

be disclosed and standards for referral to necessary clinical services. Directto-consumer companies should make these “best practices” publicly available 

to encourage broader adoption. 

Voluntary industry-wide best practices can be developed by collaboration 

among companies and through professional organizations whose members 

work in the DTC industry. DTC companies should develop best practices 

regarding disclosure of incidental findings and when secondary findings 

should be deliberately sought, including the types of findings that ought to 

be disclosed and the methods for communicating these findings. 
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CONCLUSION

Although the issue of incidental and secondary findings has been considered 

by several groups focused on concerns that are context- and modalityspecific, the ethical obligations associated with the discovery, disclosure, and 

management of such findings have not been comprehensively considered 

across contexts and modalities. This report seeks to fill this void. In 

Anticipate and Communicate, the Bioethics Commission concludes that 

in any setting, potential recipients should be properly informed about the 

possibility of incidental or secondary findings before the start of a test or 

procedure. Practitioners should also recognize the potentially life-changing 

nature of certain incidental or secondary findings, and should take care to 

minimize harm when disclosing these findings. Practitioners and potential 

recipients benefit from empirical evidence about the likelihood of incidental 

and secondary findings arising from a particular test or procedure. And 

everyone—practitioners and recipients alike—can benefit from broader, more 

inclusive discussions about the ethical concerns, and associated practical and 

legal considerations, raised by incidental and secondary findings.
21

CHAPTER 1

Introduction
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in the Clinical, Research, and Direct-to-Consumer Contexts

A healthy young medical student participated in research using functional 

magnetic resonance imaging to look at brain activity while doing a memory 

test. During this brain scan the researcher noticed a concerning mass. The 

student rushed to the hospital for further examination, which was followed 

by successful treatment of the incidental finding that she credits with saving 

her life.28

Two years later, a different woman collapsed from over-hydration while 

running a marathon. During an evaluation, her emergency care team 

discovered a small brain tumor. She opted, in consultation with her 

physicians, for a watch-and-wait approach, monitoring the tumor for changes 

before making any treatment decisions. She has been watching anxiously for 

almost 10 years, even though the tumor might never affect her health.29

I

ncidental findings—traditionally defined as results that arise that are 

outside the original purpose for which the test or procedure was 

conducted30—can create a range of practical, legal, and ethical challenges 

for recipients and practitioners. Discovering an incidental finding can 

be lifesaving, but it also can lead to uncertainty and distress without any 

corresponding improvement in health or wellbeing. For incidental findings of 

unknown significance, conducting additional follow-up tests or procedures 

can be risky and costly.31 Moreover, there is tremendous variation among 

potential recipients about whether, when, and how they would choose to have 

incidental findings disclosed. Information that one recipient regards as an 

unnecessary cause of anxiety could lead another recipient to feel empowered 

in making health-related decisions.

In this report, Anticipate and Communicate: Ethical Management of Incidental 

and Secondary Findings in the Clinical, Research, and Direct-to-Consumer 

Contexts, the Presidential Commission for the Study of Bioethical Issues 

(Bioethics Commission) focuses on the distinct ethical issues concerning 

incidental and secondary findings that arise from various modalities—including 

large-scale genetic sequencing, testing of biological specimens, and imaging—

in contexts that include the clinic, research, and direct-to-consumer (DTC) 

testing. Because the term “incidental findings” as traditionally used can limit 

consideration of critical ethical issues, the Bioethics Commission considers 
Introduction

23

I

several types of ethically challenging findings, including incidental, secondary, 

and discovery findings, as described below. 

Past Consideration of the Management of Incidental and Secondary 

Findings

Now is an opportune time for a national-level review of the ethics of incidental 

and secondary findings. The issue of returning incidental findings to research 

participants was last considered by a national bioethics commission in 1999, 

when the National Bioethics Advisory Commission (NBAC) issued its 

report Research Involving Human Biological Materials: Ethical Issues and Policy 

Guidance.

32 The NBAC report considered the return of an individual research 

participant’s results rather than incidental findings specifically, and focused 

only on the research context. In its report, NBAC noted its “presumption 

that the disclosure of research results to subjects represents an exceptional 

circumstance” and recommended that researchers return findings only if 

certain threshold criteria were met: (1) that the findings are scientifically valid 

and confirmed, (2) that they have significant implications for the participant’s 

health, and (3) that there is a course of action available to ameliorate or treat 

the associated illness.33

In the 14 years since NBAC’s report, professional organizations, advisory 

commissions, and scholars have drafted a number of guidance documents that 

address the return of incidental findings to patients and research participants. 

Recommendations outlined in these documents detail and defend various 

criteria regarding the disclosure of incidental findings (see Appendix I: Past 

National Recommendations Regarding Incidental and Secondary Findings and 

Appendix II: Past International Recommendations Regarding Incidental and 

Secondary Findings). In contrast to NBAC’s recommendations, which assumed 

as a default position that results should not be returned unless specific 

conditions could be met, several of these guidance documents explicitly 

presume routine return of incidental findings. In fact, there seems to be an 

emerging consensus in some contexts that practitioners have a duty to return 

some incidental findings—even if there is little consensus as to precisely 

which ones.34

One approach to managing findings in the clinical context was set forth by 

the American College of Medical Genetics and Genomics (ACMG) in 2013. 

ACMG advised that laboratories actively look for and return specified findings 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

that arise from large-scale genetic sequencing regardless of individual patient 

preferences.35 Other approaches similarly advocate the return of incidental 

findings, although they employ different threshold criteria. One approach, 

following in the footsteps of NBAC, suggests seeking recipient consent to 

return findings that meet three criteria: analytic validity (the findings are 

accurate and precise), clinical validity (the findings are causally associated 

with pathology), and clinical actionability (individuals or practitioners can 

make use of or act upon the findings for health, personal, reproductive, or 

clinical decision making).36

The current challenge for public policy and professional ethics is to identify 

through thoughtful deliberation specific criteria that practitioners can use 

to determine when it is ethically permissible or obligatory for clinicians, 

researchers, or DTC companies to disclose and not disclose incidental findings 

to patients, participants, or consumers. The technical aspects of managing the 

response to incidental findings—including the circumstances under which 

practitioners should return particular findings—is best carried out by those 

with the relevant expertise to make those nuanced determinations. Indeed, 

many professional organizations, advisory committees, and scholars are already 

hard at work doing just that.37 In contrast to developing detailed prescriptions 

for practice, the Bioethics Commission aims through this report to provide a 

broad ethical analysis of the principles, virtues, and duties relevant to managing 

incidental and secondary findings to ground these determinations. 

In its previous report, Privacy and Progress in Whole Genome Sequencing, the 

Bioethics Commission addressed incidental findings with regard to largescale genetic sequencing.38 Privacy and Progress made two recommendations 

concerning incidental findings that arise from whole genome sequencing. 

The first was a recommendation that practitioners anticipate and disclose the 

possibility of incidental findings:39

Privacy and Progress Recommendation 3.3

Researchers, clinicians, and commercial whole genome sequencing entities must 

make individuals aware that incidental findings are likely to be discovered 

in the course of whole genome sequencing. The consent process should convey 

whether these findings will be communicated, the scope of communicated 

findings, and to whom the findings will be communicated.40
Introduction

25

I

The Bioethics Commission also recognized in Privacy and Progress that more 

data were needed to adequately inform this important issue: 

Privacy and Progress Recommendation 3.4

Funders of whole genome sequencing research should support studies to 

evaluate proposed frameworks for offering return of incidental findings 

and other research results derived from whole genome sequencing. Funders 

should also support research to investigate the related preferences and 

expectations of the individuals contributing samples and data to genomic 

research and undergoing whole genome sequencing in clinical care, research, 

or commercial contexts.41

Because the Bioethics Commission specifically focused on protecting 

individual privacy while advancing the public good through whole genome 

sequencing, full consideration of the ethical issues associated with incidental 

findings was beyond the scope of the Privacy and Progress report. A more 

thorough deliberation about the ethical obligations of clinicians, researchers, 

and DTC providers, as well as consideration of the incidental findings that 

arise from various diagnostic modalities, is the goal of this report. 

Taxonomy of Incidental Findings 

The Bioethics Commission notes the challenges associated with deciding on a 

precise definition of “incidental findings.” Several groups have adopted contextor modality-specific definitions (see Table 1.1, Past Definitions of Incidental 

Findings). For example, a working group funded by the National Human 

Genome Research Institute of the National Institutes of Health offered a 

research-specific definition of incidental findings as “a finding concerning 

an individual research participant that has potential health or reproductive 

importance and is discovered in the course of conducting research but is beyond 

the aims of the study.”42 The Bioethics Commission used a modality-specific 

definition of incidental findings in Privacy and Progress to cover “information 

gleaned from whole genome sequencing research or clinical practice that was 

not its intended or expected object.”43 This report focuses on the ethical 

considerations of incidental findings more broadly. 
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Table 1.1: Past Definitions of Incidental Findings

GROUP DEFINITION CONTEXT/MODALITY

Wolf, et al.44 “[A] finding concerning an individual research participant 

that has potential health or reproductive importance and is 

discovered in the course of conducting research but is beyond 

the aims of the study.”

Research/Genetics 

Public Population 

Project in Genomics45

“[U]nforeseen findings concerning a research participant that 

have potential health or reproductive importance. They are 

discovered during the course of research but are outside its 

objectives.” 

Research/Genetics

American College of 

Medical Genetics and 

Genomics (ACMG)46

“[T]he results of a deliberate search for pathogenic or likely 

pathogenic alterations in genes that are not apparently 

relevant to a diagnostic indication for which the sequencing 

test was ordered.”

Clinical/Genetics

Munk, et al.47 “[F]indings on CT [computed tomography] that are unrelated to 

the original purpose of the scan....”

Clinical/Imaging

Yanagi, et al.48 “[I]ncidentally discovered asymptomatic tumors at the time of 

examinations of other disorders or screening....” (In reference 

to the term “incidentaloma”)

Clinical/Imaging

Illes, et al.49 “[O]bservations of potential clinical significance unexpectedly 

discovered in healthy subjects or in patients recruited to brain 

imaging studies and unrelated to the purpose or variables of 

the study.”

Research/Imaging

To date, the term “incidental findings” has generally implied that findings 

were unanticipated or unintended; this usage is too narrow for the ethical 

issues considered in this report. Some findings are so likely to arise that they 

cannot genuinely be considered unanticipated.50 For example, misattributed 

paternity is a relatively common finding resulting from blood typing or 

genetic testing;51 it would be disingenuous to call this finding unanticipated, 

even though it might be outside the scope of what was being sought, and falls 

squarely within the category of findings ordinarily considered incidental. 

The Bioethics Commission has adopted a definitional framework, based 

in part on the presentation of Erik Parens at the Bioethics Commission’s 

Meeting 14, that it hopes will help bring conceptual clarity to the variety of 

findings that can arise (see Table 1.2, Bioethics Commission’s Classification of 

Individualized Results of Medical Tests).52
Introduction

27

I

Table 1.2: Bioethics Commission’s Classification of Individualized Results of Medical Tests

TYPE OF RESULT 

DISCOVERED

DESCRIPTION EXAMPLE

Primary Finding Practitioner aims to discover A, and result 

is relevant to A

In a child with unknown vaccine history, a 

test done to determine a child’s immunity 

status before the chickenpox vaccine is 

administered

Incidental Finding: 

Anticipatable

Practitioner aims to discover A, but learns 

B, a result known to be associated with the 

test or procedure at the time it takes place

Discovering misattributed paternity when 

assessing a living kidney donor and 

potential recipient who believe they are 

biologically related53

Incidental Finding:

Unanticipatable

Practitioner aims to discover A, but learns 

C, a result not known to be associated 

with the test or procedure at the time it 

takes place

When a DTC genetic testing company 

identifies a health risk based on a newly 

discovered genetic association not knowable at the time a previous sample was 

submitted54

Secondary Finding Practitioner aims to discover A, and 

also actively seeks D per expert 

recommendation 

ACMG recommends that laboratories 

conducting large-scale genetic sequencing 

for any clinical purpose should look for 

variants underlying 24 phenotypic traits55

Discovery Finding Practitioner aims to discover A through Z by 

employing a test or procedure designed to 

detect a broad array of results

A “wellness scan,” a whole body computed 

tomography (CT) scan, is intended to 

discover any abnormal finding throughout 

the body56

Under this paradigm, a primary finding refers to a result that is actively 

sought using a test or procedure designed to find that result. Primary findings 

derive from tests with a single result, such as a blood sugar concentration 

test related to diagnosing or monitoring diabetes, or the discrete genetic 

tests for the BRCA mutations associated with an increased risk of breast and 

ovarian cancer (a primary result of a test that recently gained increased public 

attention when actress Angelina Jolie wrote about her personal experience in 

the New York Times).57

For purposes of this report, the Bioethics Commission also divides the 

term “incidental finding” into two categories: incidental findings that 

are “anticipatable” and those that are “unanticipatable.” An anticipatable 

incidental finding is a finding that is known to be associated with a test or 

procedure. Anticipatable incidental findings need not be common or even 

likely to occur—their defining characteristic is that the possibility of finding 

them is known. For example, anticipatable incidental findings often arise 
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when using imaging technologies, such as computed tomography (CT) 

scans, because a certain organ is the intended focus of the scan but other 

structures also appear in the field. A CT scan of the colon might show a mass 

on an adjacent kidney, for example. Because practitioners can anticipate these 

types of findings at the outset of a test or procedure, anticipatable incidental 

findings should be planned for to the extent possible. Plans for managing 

anticipatable incidental findings do not, however, necessarily require that 

the findings be disclosed; for example, many argue that the anticipatable 

incidental finding of misattributed paternity often should not be disclosed.58

The second category of incidental findings is an unanticipatable incidental 

finding. This category includes a finding that could not have been anticipated 

given the current state of scientific knowledge. For example, a DTC genetic 

testing company could inform its customers that not all genetic variants are 

currently associated with particular medical information but that, over time, 

variants that are not currently associated with disease might later become 

associated with medical information that had not been foreseen.59 Although 

practitioners are not expected to have a plan in place to manage specific 

findings that they could not anticipate, they nevertheless must respond 

appropriately to unanticipatable incidental findings that arise. 

A secondary finding refers to a finding that is actively sought by a practitioner 

that is not the primary target. Practitioners might actively seek secondary 

findings when doing so is recommended by an expert body, or by a consensus 

of practitioners, as ethically and medically appropriate. For example, a 

clinician who conducts large-scale genetic sequencing for the purpose 

of diagnosing a patient’s disease might nevertheless deliberately seek the 

additional phenotypic variants (associated with physical characteristics) 

recommended by ACMG. However, few lists of secondary findings 

recommended by experts currently exist. As more expert panels determine the 

findings that practitioners ought to look for when using certain modalities, 

some findings that were anticipatable incidental findings will likely become 

secondary findings that practitioners should specifically seek. 

A discovery finding refers to the results of a broad or wide-ranging test that 

was intended to reveal anything of interest. For example, “wellness scans” are 

whole body scans marketed by hospitals and DTC companies to detect disease 

in all parts of the body before symptoms exist.60 The “tell me everything” 
Introduction

29

I

aspect of these tests means that practitioners target all findings and none of 

the results are technically “incidental.” Nevertheless, discovery findings often 

can be sensitive or surprising to the patient, participant, or consumer.

This report focuses on anticipatable and unanticipatable incidental findings as 

well as secondary findings. For simplicity, the generic term “incidental finding” 

is used in reference to both anticipatable and unanticipatable incidental findings; 

distinctions are made as necessary and relevant.

Ethical Basis of the Management of Incidental and Secondary Findings

Longstanding ethical principles ground the Bioethics Commission’s 

consideration of incidental and secondary findings. In seeking to create 

mutually acceptable and justifiable public policy, a process of democratic 

deliberation can lead citizens, policy makers, and experts to identify 

common ground and compromise.61 Because professionals in a variety of 

contexts—including clinical, research, and DTC—can encounter incidental 

and secondary findings, guidance must appeal to principles that bridge these 

contexts. The interpretation, application, scope, strength, and stringency of 

each principle, however, can vary among and within each context. 

Ethical action is not only a matter of principles, but also involves fulfilling 

duties owed to others. Such duties can result from promises and commitments 

made by professionals, from the relationships between practitioners and 

recipients, and from the contexts in which professionals operate. The 

interpretation of each principle in the clinical, research, and DTC contexts 

helps clarify the duties of practitioners with respect to incidental and secondary 

findings, and how practitioners can fulfill these obligations responsibly. 

The ethics of incidental and secondary findings also involve notions of 

character, or virtue. Virtues are those character traits associated with moral and 

professional excellence, such as honesty, courage, and humility.62 The question 

of what to do about an incidental finding that arises involves striving for 

excellence in making professional judgments. In its deliberations, the Bioethics 

Commission found that context-specific interpretation and application of 

ethical principles calls for attributes such as prudent professional judgment.
30

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

The Bioethics Commission found four ethical principles to be particularly 

applicable to the ethical assessment of incidental and secondary findings: 

respect for persons, beneficence, justice and fairness, and intellectual freedom 

and responsibility. A context-specific interpretation of each principle is necessary to translate the principles into actionable guidance, and is undertaken in 

each of the context-specific chapters.63

The principle of respect for persons, as articulated by the National Commission 

for the Protection of Human Subjects of Biomedical and Behavioral Research 

in The Belmont Report, recognizes the fundamental human capacity for 

rational self-determination—the autonomous ability to identify personal 

preferences, act on these desires, and direct the course of one’s life.64 For the 

purposes of this report, the principle of respect for persons is interpreted as 

freedom from limitations that prevent meaningful choice and encompasses 

dignity and the right to available information even if it does not affect a 

person’s choice.65

The principle of beneficence calls on professionals to take actions to ensure the 

wellbeing of others, while its corollary non-maleficence requires not imposing 

harms on others.66 In all contexts, the driving concern captured by this 

principle is to take actions that offer a prospect of benefit sufficient to justify 

any related risks of harm.67 One specification of the principle of beneficence is 

the duty to rescue, an obligation to come to the aid of others facing dire peril 

when such assistance is easy to provide.68 The related duty to warn is a special 

case of the duty to rescue, when rescue itself is either impossible or imposes 

significant costs.69 These basic ethical obligations exist among all members 

of society, but special professional obligations of clinicians, researchers, and 

DTC providers are more stringent than the low-level duties to rescue or warn 

imposed upon mere strangers. Disclosure of serious incidental and secondary 

findings in the three contexts examined here can be seen as arising from more 

complex, and often more robust, professional relationships. 

Specifying the principle of beneficence, the Bioethics Commission, in its first 

report, New Directions: The Ethics of Synthetic Biology and Emerging Technologies, 

further articulated the principle of public beneficence, which supports society 

in the pursuit of public benefit while minimizing personal and public harm.70

Public beneficence involves a commitment to improving health care as a whole. 
Introduction

31

I

As applied to incidental and secondary findings, public beneficence demands 

consideration of the needs of key stakeholders—including clinicians and 

patients, researchers and participants, and DTC providers and consumers—

along with the costs and benefits to society more broadly. 

The principle of justice and fairness requires fair and equitable treatment of 

all. There are three interpretations of this principle pertinent to managing 

incidental and secondary findings. First, the principle of justice and fairness 

calls upon individuals and institutions to make reasonable efforts to ensure 

that the benefits and burdens of an enterprise are distributed equitably among 

those who might be affected.71 Second, a society committed to justice and 

fairness must assess claims regarding what individuals or groups are entitled 

to receive—that is, what they can reasonably and legitimately expect of 

others.72 Third, justice requires that ethically similar cases be treated alike.

Finally, the principle of intellectual freedom protects sustained and dedicated 

creative intellectual exploration that furthers scientific progress.73 Along with 

the freedom of intellectual pursuits, clinicians, researchers, and providers 

of DTC testing must take responsibility for their actions, acknowledging 

the profound societal trust placed in them, and the trust afforded them by 

patients, participants, and consumers.74 The principle of intellectual freedom 

and responsibility can be interpreted as a rejection of the technological 

imperative: the mere fact that something new can be done does not mean 

it ought to be done.75 With regard to incidental and secondary findings, 

although technology increasingly enables us to discover more, the information 

gained does not always further individual or collective wellbeing. Incidental 

and secondary finding policies should be designed, in accordance with the 

corollary principle of regulatory parsimony, to limit oversight to that which is 

necessary to further the public good.

The Bioethics Commission’s Process

In concert with the principle of democratic deliberation, the Bioethics 

Commission invited experts from the public and private sectors; individuals 

affiliated with the clinical, research, and DTC contexts; and those with 

specialties in several modalities to inform and engage with the Bioethics 

Commission in its discussions. Over the course of four public meetings, 

speakers addressed the ethical, legal, scientific, and practical issues associated 
32

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

with incidental and secondary findings (see Appendix III: Guest Presenters 

to the Bioethics Commission Regarding Incidental and Secondary Findings). 

The Bioethics Commission also published a Request for Information in the 

Federal Register that elicited many thoughtful comments from individuals and 

professional societies in the United States and from around the world.76 The 

contributions were incorporated into the Bioethics Commission’s deliberations and this report.

About this Report

Using the above guiding principles, Anticipate and Communicate explores 

the ethical obligations of practitioners to manage incidental and secondary 

findings. While it focuses on specific modalities and settings as examples, the 

Bioethics Commission intends the ethical principles, analyses, and recommendations articulated here to guide the ethical management of incidental 

and secondary findings regardless of how or where the finding arises.

Chapter 2 provides an overview of the incidental and secondary findings that 

arise from particular modalities, specifically large-scale genetic sequencing, 

testing of biological specimens, and imaging. Chapter 3 sets forth overarching 

recommendations that apply across contexts. Chapters 4, 5, and 6 explore 

context-specific concerns that arise when managing incidental and secondary 

findings in the clinic, research, and DTC settings. Recognizing that practical 

and legal realities can limit the scope and stringency of a practitioner’s 

obligations with regard to incidental and secondary findings, each of these 

chapters begins with an overview of the practical issues unique to each 

context, addresses some of the pertinent legal concerns, and then applies the 

governing ethical principles. Each chapter concludes with an analysis of these 

considerations and provides recommendations for the ethical management 

of incidental and secondary findings. Although the framework developed 

with a particular focus on three specific contexts, the Bioethics Commission 

intended the ethical analysis to be relevant and applicable in other settings. 

Chapter 7 summarizes the Bioethics Commission’s approach.
33

CHAPTER 2

Modalities and Probable 

Incidental and Secondary Findings
34

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Many tests and procedures can give rise to incidental and secondary findings. At one end of the spectrum are discrete tests that produce 

only the particular result sought and are therefore unlikely to give rise to 

incidental and secondary findings—for example, pregnancy and HIV tests. 

At the other end of the spectrum are broad diagnostic tests, such as direct-toconsumer (DTC) full body scans, for which the intended purpose is to find 

any existing abnormality. These tests have such a broad and all-encompassing 

aim that few of the findings can be considered “incidental.” 

Between discrete and broad diagnostic 

tests are tests and procedures most likely 

to give rise to incidental and secondary 

findings. These tests are designed to give 

practitioners the results sought, but also 

have the potential to reveal other findings. 

In some cases, the potential for incidental 

and secondary findings is inherent in the 

test. For example, imaging technologies 

often capture surrounding organs, or 

areas outside the purpose for which the test was originally conducted. In other 

cases, because of insurance reimbursement schemes or cost guidelines, practitioners order bundled tests that reveal both the targeted result along with other 

results outside the scope of the intended purpose. 

This chapter describes three categories of analytical techniques likely to give 

rise to incidental and secondary findings—large-scale genetic sequencing, 

testing of biological specimens, and imaging—to help elucidate the ethical 

analyses that follow. 

Large-Scale Genetic Sequencing 

Genetic sequencing is the analysis and ordering of the billions of base pairs—

the As, Ts, Cs, and Gs—that make up our genetic code. Interpretation of this 

sequence can predict propensities to develop some diseases.77 Information that 

could be discovered includes a propensity toward contracting heritable genetic 

diseases like breast cancer or Huntington’s disease (a fatal neurodegenerative 

disorder for which there is currently no treatment available).78 Large-scale 

genetic sequencing—encompassing whole genome sequencing, whole exome 

sequencing, and other next-generation genomic analyses—is increasingly used 

“All technological changes and all 

scientific discoveries that lead 

to technological changes have 

unexpected outcomes.” 

Cowan, R.S., Janice and Julian Bers Professor 

Emerita, History and Sociology of Science, 

University of Pennsylvania. (2013). Ethical 

Challenges of Emerging Technologies. 

Presentation to the Presidential Commission 

for the Study of Bioethical Issues (Bioethics 

Commission), April 30. Retrieved from http://

bioethics.gov/node/1616.
Modalities and Probable Incidental and Secondary Findings II

35

to investigate the genome. As the price of 

whole genome sequencing continues to 

fall—from about $95 million in 2001 to 

$5000 in 201379—clinicians, researchers, 

and DTC companies increasingly 

are conducting large-scale genetic 

sequencing. Despite the falling costs of 

sequencing, translating and interpreting 

the genetic sequence is challenging and 

time-consuming and generally requires 

the skills of qualified experts.80

Because of the large number of base pairs 

analyzed, large-scale genetic sequencing 

has the potential to yield large numbers of incidental and secondary findings. 

While some variants discovered during large-scale genetic sequencing reveal 

clinically relevant information, much is of unknown or uncertain medical 

value.81 As the science evolves, variants that are of unknown significance today 

could later be discovered to be associated with important diseases or conditions.

Incidental and secondary findings that arise in genetic sequencing raise an 

additional concern: genetic information has implications not just for the 

individual tested, but for biologically-linked family members as well. Genetic 

information is heritable, and biologic family members share many genetic 

traits. Individuals should therefore consider the implications of seeking information that could affect third parties.82 One implication is uncertainty about 

a practitioner’s obligation to alert at-risk family members of particular genetic 

predispositions, or to recommend that persons tested disclose any predisposition to their at-risk family members.83 Practitioners could also face barriers to 

disclosing confidential medical information to family members not otherwise 

authorized to access this information.84

In the clinical context, clinicians increasingly employ large-scale genetic 

sequencing for “the molecular characterization of rare diseases, the individualization of treatment (particularly in cancer), pharmacogenomics, preconception/

prenatal screening and population screening for disease risk.”85 Recent recommendations developed and advanced by the American College of Medical Genetics 

and Genomics (ACMG) recommended that laboratories seek and report findings 

“[T]his idea of data sort of popping out 

at you and being unexpected doesn’t 

really reflect...the way that genomic 

data have to be analyzed, because 

[they have] to be interpreted in a way, 

and you have to decide what things 

you are going to look for, especially 

when you have a massive amount of 

information.”

Cho, M., Associate Director and Professor 

of Pediatrics, Stanford University Center for 

Biomedical Ethics. (2013). Incidental Findings 

in Genomics: Ethical Frameworks and Practical 

Challenges. Presentation to the Bioethics 

Commission, April 30. Retrieved from http://

bioethics.gov/node/1616. 
36

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

that arise from clinical large-scale genetic sequencing related to 24 phenotypes 

associated with disease that “have been previously reported and are a recognized 

cause of the disorder or variants that are previously unreported and are of the type 

which is expected to cause the disorder.”86

In the research context, researchers often use large-scale genetic sequencing to 

ascertain underlying genetic causes of disease. Any findings that arise outside 

the primary area of inquiry—for example, findings that are not the target of 

research, but that might nevertheless have reproductive significance for the 

participant—are incidental or secondary. 

GENETIC RESEARCH

A woman of childbearing age contributes her genetic material to a research study. Although 

the researchers’ primary interest is in gathering data about genetic factors related to 

fertility, they employ whole genome sequencing given their interest in a wide array of 

variants. In the course of analyzing the data, the researchers discover that this individual 

is a carrier for Tay-Sachs disease, a genetic condition resulting from mutations in the 

HEXA gene on chromosome 15. When an individual inherits two copies of the mutation, 

Tay-Sachs disease manifests as nerve damage and early death. If this individual were to 

conceive with another carrier, there is a 25 percent chance in each pregnancy that the child 

would develop the disease.

Sources: National Library of Medicine. (2012). Tay-Sachs disease [Webpage]. Retrieved from http://www.ncbi.nlm.

nih.gov/pubmedhealth/PMH0002390; National Institutes of Health (NIH). (2008). Genetics Home Reference: HEXA. 

Retrieved from http://ghr.nlm.nih.gov/gene/HEXA.

Carrier 

father

Carrier 

mother

Unaffected

child

Carrier

child

Carrier

child

Affected

child

UNAFFECTED 

GENE

AFFECTED 

GENE

CASE STUDY
Modalities and Probable Incidental and Secondary Findings II

37

Several DTC companies provide large-scale genetic sequencing directly to 

consumers to determine genetic susceptibility or carrier status for a wide 

range of diseases and traits.87 23andMe currently returns findings for over 

240 diseases and traits.88 These findings, though perhaps surprising to the 

customers receiving them, are “discovery findings” rather than incidental 

because they are within the scope of findings sought. Still, despite the broad 

nature of the testing, some findings can be incidental. For example, genetic 

sequencing can reveal an unknown or unrecognized discrepancy between 

chromosomal sex and reported sex, a mismatch between an individual’s 

chromosomal and biological sex—an anticipatable incidental finding that is not listed 

as one of the conditions to be returned or 

disclosed in the company’s terms of service.89

DTC genetic testing also might give rise to 

unanticipatable incidental findings if genetic 

associations to specific diseases are discovered after the initial testing of a consumer’s 

sample. 23andMe, for example, continually 

reexamines consumers’ genetic sequences 

as new tests become available, and sends 

consumers an email notifying them that 

additional results are available.90

Testing of Biological Specimens 

Biological specimens such as blood, urine, or other tissues can also be the 

source of incidental or secondary findings. Incidental and secondary findings 

arising from blood and tissue testing could definitively indicate a health issue 

of concern, or could require a series of additional diagnostic tests to determine 

the health implications, if any, of the result. 

Diagnostic tests on biological specimens can give rise to incidental 

and secondary findings in the clinical context. Although clinicians are 

generally trained to order tests targeted to inform clinical management, 

clinicians nevertheless might order a battery of tests—multiple tests ordered 

simultaneously to ascertain the cause of a problem—to increase efficiency 

or might order bundled tests if dictated by laboratory practice or insurance 

reimbursement.91 For example, a practitioner might order a comprehensive 

“Basically, anything we can tell you 

on the basis of your DNA is part 

of the package, but things might 

at some point get beyond what 

we might have expected. And 

there’s a difference between what 

is spelled out as a broad set of 

information you might receive and 

what you might have expected.”

Mountain, J., Senior Director of Research, 

23andMe. (2013). Incidental Findings: A 

23andMe Perspective. Presentation to the 

Bioethics Commission, April 30. Retrieved 

from http://bioethics.gov/node/1620.
38

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

metabolic panel (a panel of 14 blood tests providing a general assessment of 

kidney and liver function and electrolyte and fluid balance) to assess kidney 

function, but the laboratory results might reveal an incidental finding of liver 

dysfunction.92 Ordering a larger number of tests increases the likelihood of 

obtaining an abnormal test result, which could lead to additional tests or 

follow-up procedures that can expose patients to additional risk.93

In the research setting, incidental and secondary findings might arise when 

testing biological specimens for study purposes or while ascertaining a 

prospective participant’s eligibility to enroll in a study. A researcher could 

discover that a participant has elevated blood sugar, possibly indicating 

diabetes, or notice irregularly shaped red blood cells that could indicate sickle 

cell carrier status. 

INCIDENTAL FINDING OF SICKLE CELL TRAIT 

One example of an incidental finding in research with biological specimens is the 

discovery of cells exhibiting a sickle shape in a blood sample being examined for other 

purposes (depicted in the picture above). Unlike individuals with two copies of the gene, 

carriers of one copy of the sickle gene can have blood cells that exhibit the sickle shape 

without having symptoms of disease. But due to the unique shape of the blood cells, the 

individual’s carrier status is ascertainable by laboratory technicians. The finding could 

have personal utility (e.g., an individual could choose to hydrate well before climbing to 

high altitudes or exercising vigorously) and reproductive significance (e.g., offspring could 

inherit the variant) for the participant. 

Source: U.S. Centers for Disease Control and Prevention (CDC). (n.d.). What You Should Know About Sickle Cell Trait. 

Retrieved from http://www.cdc.gov/ncbddd/sicklecell/documents/SCD%20factsheet_Sickle%20Cell%20Trait.pdf. 

Blood sample of a carrier 

of one copy of sickle cell gene

(asymptomatic)

Unaffected

blood sample

CASE STUDY
Modalities and Probable Incidental and Secondary Findings II

39

A number of companies offer DTC testing of biological specimens including 

testing of blood, fecal matter, and urine.94 Generally, consumers order 

targeted, discrete tests or comprehensive panels that list included tests. 

Incidental or secondary findings might arise if, despite the consumer’s 

primary interest in a particular result, the consumer orders a comprehensive 

panel rather than an individual test because it is more cost effective.95

Imaging

Medical imaging—a modality that includes magnetic resonance imaging 

(MRI), computed tomography (CT) scans, X-rays, neuroimaging, and 

ultrasounds, along with techniques such as electroencephalography and 

electrocardiography that give rise to data capable of being represented as 

images—can lead to incidental and secondary findings. Imaging products 

report results of the entire field of view, even if outside of the area of diagnostic 

interest. For example, MRI and CT scans of the abdomen and pelvis can 

include images of the kidneys, liver, adrenal glands, and pancreas—with the 

associated possibility of discovering incidental and secondary findings in any 

of those organs. The likelihood of encountering incidental findings using 

imaging techniques is high, even among asymptomatic individuals, but few 

of these findings have serious or any health consequences. 

Imaging methods are used, and incidental 

and secondary findings arise, in the 

clinical, research, and DTC contexts. In 

the clinic, imaging technologies often 

reveal findings that are outside the scope 

of the diagnostic purpose of the test. One 

of the more widely used clinical imaging 

techniques is CT, which processes X-ray 

images from multiple angles to create 

tomographic images of the body.96 Of 

particular concern are abdominal CT 

scans in which incidental findings are 

identified in an estimated 30 to 35 

percent of scans.97 In a study of CT scans 

of patients at a trauma center, 43 percent 

of patients had at least one incidental 

“Further compounding the lack 

of awareness of the likelihood of 

incidental findings on imaging is the 

lack of standardized reporting of such 

findings in the radiology report...the 

same type of incidental finding may 

be reported five different ways by 

five different radiologists influenced 

by years in practice, comfort with 

the modality in interpretation, fear 

of malpractice, and even knowledge 

of the referring physician’s practice 

patterns or known patient risk 

factors.” 

Berland, L.L., Chair, American College of 

Radiology. (2013, July 5). Comments submitted 

to the Bioethics Commission.
40

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

finding.98 Incidental findings are so common in abdominal CT scans that, 

even among patients who present with trauma, physicians are more likely to 

discover incidental findings than any evidence of traumatic injury.99 Factors 

such as the field of view captured by the image, the diagnostic purpose for 

which the test was ordered, and the expertise or specialty of the practitioner 

tasked with interpreting the image, can influence the frequency of incidental 

and secondary findings that arise in the clinical context.

Scan-related incidental and secondary 

findings also arise in research. Researchgrade scans are often of lower clinical 

utility than clinical-grade scans. They 

are often less expensive and designed to 

hone in on a particular finding. Because 

they are performed to answer a research 

question rather than address a participant’s medical need, they are generally 

less useful than traditional clinical 

scans for diagnosing or characterizing 

an unknown mass.100 This difference in 

clinical utility has implications for both 

the detection and interpretation of incidental and secondary findings in the 

research context. For example, to assuage concerns that research scans do not 

provide clinical resolution, the intramural research program of the National 

Institutes of Health requires annual clinical-grade scans of all brain imaging 

research participants.101

In DTC settings, full body, partial body, and targeted organ CT and MRI scans 

are available without a medical practitioner’s order.102 These tests are generally 

marketed as preventive—offering early disease detection.103 DTC companies 

generally market full-body CT scans or whole body MRI for the purpose of 

identifying all abnormalities. Certain types of DTC imaging could, however, 

give rise to incidental findings. For example, CT scans of the colon for polyps 

often identify problems with organs other than the colon.104 A number of DTC 

companies also offer non-medical fetal ultrasounds, marketed as providing 2-, 

3-, and 4-dimensional ultrasound pictures and videos of the fetus (see Figure 

“[T]he harder you look, the more you 

will find. It’s a continuum.... With our 

research grade scans, we won’t really 

find much.... If you do clinical grade 

scans, you will more likely find...

more. Where do you draw that line in 

terms of how much effort you put into 

the quality of your research scans?”

Bandettini, P., Chief, Section on Functional 

Imaging Methods, Laboratory of Brain and 

Cognition, National Institute of Mental Health. 

(2013). Issues Regarding the Management of 

Incidental Findings in Neuroimaging. Presentation 

to the Bioethics Commission, April 30. Retrieved 

from http://bioethics.gov/node/1617. 
Modalities and Probable Incidental and Secondary Findings II

41

2.1, An Example of a 3-D Fetal Ultrasound 

Taken by a Direct-to-Consumer Company).105

Although companies generally state that they 

do not intend their ultrasounds to provide 

medical information,106 an “entertainment-only” 

ultrasound can reveal fetal anomalies.107 Some 

companies explain how they will communicate 

any abnormal findings, but typically there are 

no physicians on site to initiate counseling and 

the level of expertise among the technicians 

performing DTC fetal ultrasounds varies.108

Moreover, the clinical significance of variations 

might be ambiguous, particularly with newer, 

higher powered ultrasound technology that can 

display images of previously unidentifiable structures.109

Conclusion

The increasing technological capability of the modalities discussed in this 

chapter leads to an increased likelihood of discovering incidental and 

secondary findings. The movement from discrete genetic tests toward largescale genetic sequencing increases the likelihood that clinicians, researchers, 

and DTC providers will confront the issue of incidental and secondary 

findings. Likewise, imaging technologies are increasingly able to detect 

anomalies that were previously undetectable, making incidental findings more 

likely to be discovered. And as payment structures evolve so that bundled 

tests are presumed to be more cost effective than discrete tests, the number 

of unintended findings is expected to increase. The Bioethics Commission 

recognizes that a variety of tests and procedures, including but not limited 

to those discussed above, give rise to incidental and secondary findings and 

therefore intends the ethical analysis and recommendations in this report to 

apply widely to the management of all incidental and secondary findings. 

Figure 2.1: An Example of a 3-D 

Fetal Ultrasound Taken by a 

Direct-to-Consumer Company
42

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts
43

CHAPTER 3

Overarching Recommendations 

for Incidental and Secondary Findings
44

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Although many ethical considerations concerning the management of incidental and secondary findings are specific to the setting in which 

they occur—and the type of relationship between the practitioner and the 

potential recipient—there are several important considerations applicable 

to such findings in all contexts. This chapter articulates these unifying 

recommendations that span all contexts. These recommendations include the 

importance of informing individuals about incidental and secondary findings; 

the need for evidence-based practice guidelines, additional empirical research, 

and stakeholder education; and the requirements of justice and fairness in 

access to counseling and health care.

Informing Persons Tested

In all contexts, potential recipients of incidental and secondary findings—

patients, research participants, and consumers—should be informed about 

the likelihood of such findings arising from a particular test or procedure. 

Providing this information enables a potential recipient to make an autonomous decision about whether and how to proceed. This disclosure also allows 

practitioners to anticipate and think through the consequences of conducting 

various tests and procedures. Open communication between practitioners 

and individuals, accessible and understandable documents and resources, 

and transparent processes in all three contexts help ensure that individuals 

understand risks and benefits before they consent.

In each context, the informed consent process should be facilitated, rather 

than discouraged or disincentivized. Better informed consent in the clinic 

decreases the likelihood of confusion or miscommunication about follow-up 

and treatment decisions. More transparent and understandable informed 

consent in the research setting facilitates trust in the research enterprise. And 

more accessible and understandable information provided to direct-to-consumer 

(DTC) consumers can help decrease anxiety and confusion about results. 

Recommendation 1

Clinicians, researchers, and direct-to-consumer providers should describe to 

potential recipients incidental and secondary findings that are likely to arise 

or be sought from the tests and procedures conducted. Practitioners should 

inform potential recipients about their plan for disclosing and managing 
Overarching Recommendations for Incidental and Secondary Findings III

45

incidental and secondary findings, including what findings will and will not 

be returned. 

Practitioners should facilitate and work to improve the process of informed 

consent in all contexts. Adequately informing individuals about the potential 

for discovering incidental findings should include an explanation of the nature 

of anticipatable incidental findings, as well as the possibility of discovering 

unanticipatable incidental findings, and a thorough description of any 

secondary findings that will be sought.

Informing individuals about the nature of incidental and secondary findings 

likely to arise, and the practitioner’s plan for their management and disclosure, 

is critical in all contexts, but should be implemented differently in each. For 

further context-specific analysis and application, see Recommendation 6 in 

Chapter 4 for implementation in the clinical context, Recommendation 11 in 

Chapter 5 for implementation in the research context, and Recommendation 

15 in Chapter 6 for implementation in the DTC context.

Evidence-Based Practice Guidelines

Practice guidelines can inform practitioners about the anticipatable incidental 

findings likely to arise during common tests and procedures, and the ways 

in which practitioners can best manage these findings—including the possibility of actively seeking particular findings as secondary findings. Guidelines 

tailored to each modality, procedure, or test that address the findings that 

arise in each context can help practitioners develop their own ethically sound 

policies for managing such findings. 

A number of professional societies and institutions—including the American 

College of Medical Genetics and Genomics, the American Medical 

Association, the American Cancer Society, the American College of Preventive 

Medicine, and the U.S. Preventive Services Task Force—have promulgated 

recommendations and guidelines that seek to provide best practices for 

various medical tests and procedures.110 One such example is the American 

College of Radiology Incidental Findings Committee’s guidelines on the 

management of incidental findings in abdominal computed tomography 

(CT) scans. These guidelines establish and recommend management systems 

based on the characteristics of the incidental finding in question.111 In the 

clinical context, the Endocrine Society developed guidelines that delineate 
46

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

what clinical action should be taken for incidental findings discovered on the 

pituitary gland, including whether and when to conduct follow-up testing, 

and what further diagnostic steps to take.112

Groups have also proposed approaches 

for categorizing incidental findings that 

arise in research into those that should, 

might, or should not be disclosed. 

For example, a working group of the 

National Heart Lung and Blood Institute 

provided examples of genetic variants 

discovered during research that they 

believe should not be withheld absent an 

expressed participant preference for nondisclosure; these determinations were 

made on the basis of clinical actionability and gene penetrance (the degree to 

which the disease risk is elevated by a genetic mutation).113

Across contexts, evidence-based practice guidelines can bolster a practitioner’s 

ability to make decisions about how best to manage incidental and secondary 

findings. Guidelines developed within medical specialties should elucidate the 

types of incidental findings that might arise in common tests and procedures, 

findings that should be actively sought as secondary, salient features that 

might indicate a serious problem warranting immediate follow up, factors 

that indicate cause for potential concern that should be observed, and relevant 

features that might denote a lack of medical significance. Based upon these 

parameters, specialty-specific guidelines can recommend reasonable courses 

of action in each scenario.

Recommendation 2

Professional representative groups should develop guidelines that categorize 

the findings likely to arise from each diagnostic modality; develop best 

practices for managing incidental and secondary findings; and share these 

guidelines among practitioners in the clinical, research, and direct-toconsumer contexts.

Professional and institutional guidelines are crucial to ensuring consistent 

and systematic categorization, disclosure, and management of incidental and 

“I think we need...to recognize a 

population-focused and evidencebased reasoning for using diagnostic 

tests—for pursuing odd findings and 

so forth.”

Morreim, H., Professor, Department of Internal 

Medicine, College of Medicine, University 

of Tennessee Health Science Center. (2013). 

Incidental Findings in the Clinic. Presentation 

to the Presidential Commission for the Study 

of Bioethical Issues (Bioethics Commission), 

April 30. Retrieved from http://bioethics.gov/

node/1619. 
Overarching Recommendations for Incidental and Secondary Findings III

47

secondary findings. Professional societies and institutions should continue 

to identify anticipatable incidental findings and develop evidence-based best 

practices for managing them. 

In developing guidelines, professional organizations should employ a variety 

of criteria, including clinical significance and actionability. Personal utility 

might be another factor included in any assessment as it allows a recipient to 

make different life choices (such as improving nutritional habits or keeping 

apprised of new medical developments), change life priorities, plan for the 

end of life, or simply develop a better understanding of themselves.114 Practice 

guidelines also should take into account the economic costs associated with 

conducting additional diagnostic tests in relation to ascertainable benefits. 

Different findings could have vastly different economic impacts depending on 

the nature and amount of follow-up required. 

As professional organizations increasingly recognize certain anticipatable 

findings likely to arise from particular tests and procedures, and determine 

that certain findings are sufficiently significant and actionable to merit disclosure, a number of findings—previously considered anticipatable incidental 

findings—are likely to become actively sought secondary findings. The 

transition from unanticipated incidental findings to anticipated or secondary 

findings allows more information to be provided to potential recipients and 

therefore facilitates more meaningful consent across contexts. 

Additional Empirical Research

Additional empirical research and scholarship is needed concerning the 

discovery, disclosure, and management of incidental and secondary findings. 

In its report, Privacy and Progress in Whole Genome Sequencing, the Bioethics 

Commission recommended that funders of whole genome sequencing research 

conduct further studies to evaluate proposed frameworks for offering to return 

incidental findings and other research results.115 The Bioethics Commission 

continues to believe that additional empirical data are critical to informing 

the ethical management of incidental and secondary findings, and therefore 

suggests expanding the scope of such recommended empirical research.

Research regarding the incidental and secondary findings that arise from a 

variety of modalities can help establish rigorous, evidence-based best practices 
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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that can guide practitioners across contexts. To date, the limited empirical 

research regarding incidental and secondary findings has primarily focused 

on findings that arise in the clinical and research contexts.116 Scholarship 

focusing on incidental findings in the DTC context is even more limited. 

There are also limited empirical data on the preferences of potential recipients 

concerning disclosure and management of incidental findings.117

Recommendation 3 

Federal agencies and other interested parties should continue to fund 

research regarding incidental and secondary findings. This research 

should consider the types and frequency of findings that can arise from 

various modalities; the potential costs, benefits, and harms of identifying, 

disclosing, and managing these findings; and recipient and practitioner 

preferences about the discovery, disclosure, and management of incidental 

and secondary findings. 

Data about incidental and secondary findings can come from a variety of 

sources. One potential source is practitioners gathering information about 

incidental and secondary findings through their work, monitoring findings 

that arise, and developing databases about the disclosure and management 

of such findings.118 Professional societies also can address specific questions 

about findings likely to arise from various modalities and in various contexts 

and the professional skills or training necessary to interpret and manage 

these findings.119

Research groups funded by the National Institutes of Health—including 

those led by Susan Wolf, Judy Illes, and Robert Green—have focused on 

the management of incidental findings that arise in the research and clinical 

contexts.120 The National Institutes of Health, the U.S. Centers for Disease 

Control and Prevention, and other public and private entities should continue 

to conduct research to inform the development of evidence-based and ethical 

policies for the management of incidental and secondary findings. Moreover, 

given that the technologies that give rise to incidental and secondary findings 

are fast-moving and ever evolving, the research questions that accompany 

these technologies will continue to evolve. Research questions should therefore seek to keep pace with advances in technology.
Overarching Recommendations for Incidental and Secondary Findings III

49

Educating Stakeholders

Educating the public about incidental and secondary findings enables those 

undergoing tests or procedures to make better informed decisions and 

develop informed preferences about receiving potential findings. Educating 

practitioners about their ethical obligations enables them to make more 

thoughtful decisions about how to anticipate, disclose, and manage incidental 

and secondary findings. 

For example, the National Cancer Institute’s “Pink Book” offers practical 

tools to better understand target audiences, develop materials with appropriate 

attention to health literacy, and identify and implement strategies through 

various communication channels including mass, digital, and social media.121

Federal, state, and local public health institutions and patient and health 

professional organizations should also play a role in educating the public.122

Employing proven, evidence-based methods of health communication is critical 

to help individuals make informed choices about the possible benefits and 

harms of testing in light of the possibility of incidental and secondary findings. 

Effective communication also might increase the likelihood that specific 

findings—for example, the presence of a genetic marker (or a lack thereof) for 

cardiovascular disease—will contribute to positive health behaviors.123

THE NATIONAL CANCER INSTITUTE’S PINK BOOK

The National Cancer Institute has published a “Pink Book,” a guide for health care providers 

designed to facilitate and improve health care communication. The detailed document is 

geared toward public health officials in a diverse array of settings. It outlines techniques 

for communicating with the public to improve health that are supported by research, case 

studies, and complex behavioral psychology. The Pink Book details specific methods for 

communication and guides public health officials in making choices regarding messaging, 

cultural sensitivity, media choice, program testing, implementation, and assessment. Some 

of the programs described include efforts to increase the number of women in a community 

who get annual mammogram screenings, public education about high blood pressure, and 

prescription drug abuse prevention.

Source: National Cancer Institute. (n.d.). Pink Book - Making Health Communications Work. Retrieved from http://

www.cancer.gov/cancertopics/cancerlibrary/pinkbook/page1.

EXAMPLE IN ACTION
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Recommendation 4

Public and private entities should prepare educational materials to inform 

all stakeholders—including practitioners, institutional review boards, and 

potential recipients—about the ethical, practical, and legal considerations 

raised by incidental and secondary findings. 

In addition to the educational efforts of the Bioethics Commission, a wide 

variety of groups, governmental bodies, and professional organizations can 

assist in educating stakeholders about incidental and secondary findings. 

For example, private institutions such as the American Association of 

Medical Colleges and the Accreditation Council for Graduate Medical 

Education can provide guidance to clinicians about managing incidental 

and secondary findings. 

Public and private entities tasked with providing education about and 

regulation of medical research can bolster existing materials to better 

address the ethical issues raised by incidental and secondary findings. For 

example, Public Responsibility in Medicine and Research (PRIM&R) has 

an IRB education and IRB professional certification program that could 

provide training to IRB members on these ethically challenging topics.124

Governmental bodies, like the U.S. Federal Trade Commission and the Food 

and Drug Administration, can provide guidance on their websites to educate 

the public about the types of findings that DTC technologies can discover. 

Although such education is not the traditional role of these government 

agencies, when agencies make decisions that affect the public and other 

stakeholders, they should issue statements explaining their policies to foster 

public trust and understanding. 

Policies for educating stakeholders about the complex ethical considerations 

and practical realities of incidental and secondary findings should draw 

from multidisciplinary research about health communication and decision 

making.125 Because incidental findings are often characterized by uncertainty 

and can require conveying complex information, certain guiding principles 

should be employed. These include enhancing trust through transparency 

and stakeholder engagement, and incorporating emotional, social, cultural, 

and other experiential factors into communication methods.126 Educating 
Overarching Recommendations for Incidental and Secondary Findings III

51

clinicians, researchers, and providers of DTC testing about the ethical, 

practical, and legal concerns associated with incidental and secondary 

findings is critical to fostering a culture of professional responsibility. 

Justice and Fairness and Health Inequities

Justice and fairness in health care requires that all individuals have access 

to adequate affordable services to meet basic health care needs. Our society 

should continue to seek cost-effective ways to provide affordable access to 

health care to as many individuals as possible. The right test at the right time 

can be lifesaving, while over-testing comes with its own risks that can be 

detrimental to both mental and physical health. Adequate, affordable care 

provides the backdrop against which competent health care professionals 

can offer expert advice, personalized counseling, and follow-up care to 

harness the benefits of these developing diagnostic technologies. Coupling 

counseling and guidance with new technologies can help patients and their 

practitioners make meaningful decisions about turning medical information 

into actionable clinical knowledge in accordance with personal health care 

preferences and values.127 Currently, however, many persons lack access to 

such services. The principle of justice and fairness suggests finding affordable, 

cost-effective ways to give all people in need access to informed counseling 

and related medical care. 

Recommendation 5

The principle of justice and fairness requires that all individuals have access 

to adequate information, guidance, and support in making informed choices 

about what medical tests to undergo, what kind of information to seek, and 

what to do with information once received. The principle of justice and 

fairness also requires affordable access to quality information about incidental 

and secondary findings, before and after testing, which when coupled with 

access to care can be potentially lifesaving or life enhancing.

Clinical counseling can be of utmost importance to attaining the best and 

most equitable health outcomes prior to participating in tests or procedures.128

Counseling can help assess whether a particular test is necessary given 

the likely quality and reliability of results, and can highlight any limits 

professionals face in interpreting these results. 
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Clinicians, researchers, and DTC companies all operate in a world where 

some people lack adequate access to quality counseling and health care. 

More equitable access to quality counseling and care is critically important 

whenever someone is confronted with health information such as incidental 

and secondary findings that can carry significant, negative health consequences. 

For incidental findings to be managed in an appropriate and ethical way, there 

must be a health care system available to all that is capable of dealing with 

medically significant findings, whether discovered incidentally or as primary 

or secondary findings. This includes support for time afforded to practitioners 

to discuss with potential recipients how incidental and secondary findings will 

be handled.

* * *

These overarching recommendations—calling for a robust informed consent 

process, evidence-based practice guidelines and additional empirical research, 

additional stakeholder education, and justice in access to health care—provide 

guidance for the ethical management of incidental and secondary findings 

across contexts. The following chapters provide context-specific analyses and 

recommendations that provide additional guidance to clinicians (Chapter 4), 

researchers (Chapter 5), and DTC providers (Chapter 6). 

“How do we convey to [patients] what all this means in a way that doesn’t lead them to make 

a mistake in either potentially dangerous direction? One mistake I am terrified about is a 

woman is told she doesn’t have a high risk of breast cancer so she decides she doesn’t need 

mammograms. That could be a fatal error.” 

Greely, H., Deane F. and Kate Edelman Johnson Professor of Law, Stanford Law School; Professor (by courtesy) of 

Genetics, Stanford Medical School; Director, Center for Law and the Biosciences; Director, Stanford Interdisciplinary 

Group on Neuroscience and Society and its Program in Neuroethics, Stanford Law School; Chair, Steering 

Committee of the Center for Biomedical Ethics. (2011). Ethics of Emerging Diagnostic and Predictive Tools. 

Presentation to the Bioethics Commission, February 28. Retrieved from http://bioethics.gov/node/195. 
53

CHAPTER 4

Ethical Management of 

Incidental and Secondary Findings 

in the Clinical Context
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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In 2004, Carol Krucoff sat for her annual physical. She remembers her 

primary care doctor performing the routine checks while looking through her 

medical records. “Let’s get your cholesterol checked,” advised the doctor, “and 

you’ll need to get a repeat MRI [magnetic resonance imaging test] to monitor 

that little brain tumor.” Carol was stunned. “What brain tumor?” she 

stammered. The doctor explained to Carol that a previous MRI, conducted 

when Carol had been in a coma, revealed an abnormality. 

About six months earlier, Carol had participated in a marathon in Jamaica 

and had over-hydrated, inadvertently consuming too much water. In the last 

mile, she began to feel dizzy as her sodium level fell dangerously low. Just 

after crossing the finish line, Carol had a hyponatremia-induced seizure and 

was air lifted for medical treatment. She awoke from a coma four days later 

in an intensive care unit. 

Carol had only a vague recollection of the doctors telling her that they 

had performed an MRI and had incidentally discovered a small acoustic 

neuroma. At the time, Carol had not thought of this incidental finding 

as potentially dangerous; her trauma clinicians had never used the phrase 

“brain tumor.”

After Carol’s 2004 annual checkup, she went online to learn more about her 

acoustic neuroma. Carol researched her options: she could have a surgical 

removal, undergo radiation therapy, or simply submit to routine observation. 

After much deliberation, Carol chose to watch and wait. Carol has been 

watching for nine years—and watching has required commitment and nine 

MRIs. 

Now, says Carol, “I try to completely forget that I even have this little brain 

tumor. Had I not learned about it as an incidental finding, I would have 

been blissfully ignorant.” But Carol is not certain that blissful ignorance 

would have been her preference. “If the question [is], do I wish they hadn’t 

told me, my answer is definitely no. If they know, I want to know.”

Source: Krucoff, C., Recipient of a finding incidental to clinical care. (2013). Incidental Findings in the Clinic. 

Presentation to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), April 30. 

Retrieved from http://bioethics.gov/node/1619.
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

55

When patients enter their health care provider’s office, they often seek preventive care, diagnoses, or relief of specific symptoms. Clinical 

means of achieving these goals can, however, reveal previously unidentified, 

potentially asymptomatic, incidental and secondary findings. This chapter 

considers the practical, legal, and ethical implications of such findings that 

arise in the clinic, and makes context-specific recommendations. 

Practical Considerations of Incidental and Secondary Findings in the 

Clinical Context

For clinicians and patients, one of the most challenging aspects of an incidental 

finding is determining what should be done in response.129 In some cases, clinical 

investigation of such a finding can lead to a diagnosis and beneficial, perhaps 

HYPOTHETICAL INCIDENTAL FINDINGS IN THE CLINIC

An incidental finding with devastating consequences 

A 68-year-old man with no vascular risk factors (and no history of smoking) experienced 

transient weakness on one side of his body lasting 10 minutes. As part of a standard 

workup for a transient ischemic attack—a warning sign for a stroke—he received a 

computed tomography (CT) angiogram of the head and neck. The exam was negative for 

any clinically significant atherosclerosis of the carotid arteries or great vessels leading from 

the heart, but the study also revealed an unrelated one-centimeter nodule in the left upper 

lobe of the lung that was then biopsied for concern of malignancy. During the CT-guided 

biopsy, he suffered a pneumothorax (collapsed lung) followed by a cardiac arrest due to 

hypoxia, and was left with permanent anoxic brain injury. The pathology report on the lung 

nodule revealed a benign area of inflammation.

A most useful incidental finding 

A 16-year-old high school junior suffered a concussion sustained in a school soccer match. 

Although he only lost consciousness momentarily—his main recollection was “seeing 

stars”—over the next week he experienced post-concussive complaints of dizziness, 

fatigue, and cognitive clouding. An MRI scan of the brain was obtained to search for 

evidence of a brain injury. No trauma was found, but an unexpected mass was identified. 

This resulted in neurosurgical resection of an early brain tumor (glioma); complete removal 

was possible because the tumor was identified at a very early stage. The patient made a 

complete recovery and, after more than 20 years, has had no recurrence. It is extremely 

unlikely that cure would have been achieved had the tumor not been detected at such an 

early, presymptomatic stage.

CASE STUDIES
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ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

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even lifesaving, treatment.130 In many other cases, however, further testing 

reveals that the incidental finding would have had no health consequences if left 

untreated.131 Pursuing an incidental finding might require conducting additional 

diagnostic tests or procedures that expose patients to additional risk, anxiety, or 

other psychological ramifications.132 If the finding turns out to have no medical 

significance, patients undertake these additional risks, including the risk of 

further incidental findings, without corresponding benefit. 

For a variety of reasons, clinicians might be motivated to pursue diagnostic 

workups of incidental findings even when a clinician’s professional judgment 

suggests that such workup is unnecessary.133 This motivation could stem, in 

part, from the prevailing notion that learning more information necessarily 

means providing better care.134 Both clinicians and patients can have 

difficulty accepting this uncertainty, even if certainty is unlikely to be 

obtained through additional testing.135 And ignoring an incidental finding 

or pursuing a “wait and see” course of action, often referred to as “watchful 

waiting,” might be questioned if this decision results in a poor outcome.136

Clinicians might be motivated by patients and their families who prefer 

to be “better safe than sorry,” without fully understanding that pursuing 

incidental findings often entails additional risks.137 Clinicians also might be 

motivated to err on the side of investigating incidental findings for fear of 

legal action,138 even though data on the motivations and rates of litigation do 

not substantiate these fears.139 In addition, clinicians might choose to seek 

secondary findings when suggested by professional guidance, such as the 

recent recommendations by the American College of Genetics and Genomics 

(ACMG) that laboratories seek and report a list of actionable genetic variants 

whenever clinical genomic sequencing is conducted.

“We have a bias toward doing something as opposed to doing nothing. It feels right even 

if it’s wrong, which in many cases it surely is. And our patients almost uniformly want 

us to do something. Both doctor and patient are enthralled in this overwhelming medical 

imperative to act. Remaining still—old-fashioned watchful waiting—requires a fortitude 

that few doctors are able to muster.”

Ofri, D., Associate Professor, New York University School of Medicine, Editor-In-Chief, Bellevue Literary Review. 

(2013). Incidental Findings in the Clinic. Presentation to the Bioethics Commission, April 30. Retrieved from http://

bioethics.gov/node/1619. 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

57

Pursuing incidental and secondary findings also can have financial costs. For 

example, the Centers for Medicare and Medicaid Services recently decided 

not to cover CT colonographies for colorectal cancer in part because of the 

follow-up costs associated with incidental findings.140 And recently published 

cost-effectiveness studies determined that low dose X-ray CT screening 

for lung cancer in high-risk patients was cost effective even though the 

studies did not take into account the full costs of incidental findings.141 The 

American College of Radiology is incorporating the results of this study into 

the ongoing development of new clinical practice guidelines.142 There are, 

however, few data on the cost effectiveness of following up on many other 

incidental or secondary findings or the level of benefit conferred to average 

patients.143

Finally, members of the clinical care team must engage in careful communication with regard to incidental and secondary findings. Inadequate 

communication about a test result or a patient’s record can impede decision 

making concerning such findings. For example, primary care physicians 

who order imaging scans often rely on radiologists to interpret the scan. 

Radiological consent might not include information about potential incidental or secondary findings, and radiologists might have little or no contact 

with individual patients.144 If clinicians do not specifically request information about incidental findings at the outset, or do not transmit particular 

patient preferences, radiologists might return an interpretation to the primary 

clinician without contextualizing the findings in light of a patient’s medical or 

family history or preferences about receiving incidental findings.145 Moreover, 

although not unique to the management of incidental or secondary findings, 

without proper communication among clinicians, patients might be subjected 

to testing that is broader than necessary, with the attendant possibility of 

discovering additional findings.146 Communication among members of the 

clinical care team and between the clinician and patient is discussed in more 

detail below in the text surrounding Recommendation 6.

Legal Considerations of Incidental and Secondary Findings in the 

Clinical Context

There are currently no federal or state statutes that directly address a clinician’s 

duty to return incidental or secondary findings to patients. Medical malpractice 
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law, however, offers insight into how courts have interpreted a clinician’s duty 

to report incidental or secondary findings, and the potential legal liability a 

clinician might face for failing to identify and disclose such findings. 

Medical malpractice is a legal claim alleging an act or omission by a physician 

or other health care provider during a patient’s treatment that deviates from 

the standard of care (defined in the legal system as the accepted practice 

among other clinicians practicing in the same specialty) and that causes injury 

to a patient.147 Professional guidelines regarding the management of incidental 

and secondary findings have the potential to affect the legal standard of care 

if practitioners adopt them into their practice of medicine.

To date, few reported U.S. medical malpractice cases (as opposed to those 

settled out of court) have addressed clinician liability for failure to identify 

or disclose incidental findings.148 A recent study evaluating this limited body 

of case law concluded that it is possible that clinicians could face liability 

for failure to identify or appreciate the significance of an incidental finding, 

or failure to disclose an incidental finding to the patient or other clinicians, 

if recognition and disclosure would have prevented or altered the course of 

future disease.149 In the 2006 case of Riley v. Stone, however, a Rhode Island 

court found that the defendant neurologist did not breach the standard of 

care when he failed to further assess an incidental finding that he deemed not 

to pose a danger to the patient.150

Ethical Considerations of Incidental and Secondary Findings in the 

Clinical Context 

The physician-patient relationship encompasses trust, dependency, and the 

moral aspects of medical decision making.151 The ethical principles that 

help guide clinical practice—including respect for persons, beneficence, 

and justice and fairness—also can be used to ground clinicians’ obligations 

to patients regarding the ethical management of incidental and secondary 

findings.152 This analysis also highlights prudent clinical judgment as a central 

professional virtue that facilitates interpretation and application of these 

principles in medical decision making.
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

59

Respect for Persons

Respect for persons, as implemented in the clinical context, helps ensure 

that patients are sufficiently informed about tests and procedures to make 

health care decisions that are consistent with their values and beliefs.153 The 

standards by which clinicians have fulfilled their ethical duties have evolved 

over time, transitioning from the paternalistic model of clinician-centric 

decision making to a model of shared decision making, which recognizes 

a patient’s ability to make autonomous decisions concerning their medical 

care.154 The consent process and the process of shared decision making 

support patient autonomy by ensuring that patients are informed and enabled 

to make choices regarding their health care and evaluate health information 

consistent with their values and beliefs.155

Some have argued that respect for persons requires that clinicians disclose all 

incidental and secondary findings, no matter how clinically insignificant.156 This 

approach is consistent with data showing that patients prefer increased access 

to information, regardless of any anxiety or uncertainty that could result.157

Others contend that respect for persons does not establish an unbounded duty 

to provide patients with all possible clinical information; nondisclosure can be 

justified “by the need to avoid harm to patients, to promote patient welfare, and 

the practical necessities of everyday medical practice.”158

The autonomous patient also has a right not to know selected information and 

should be able to exercise this right (to the extent possible). For example, an 

elderly and frail patient who has undergone several rounds of treatment for 

cancer thought to be in remission might not want her practitioner to tell her 

about a mass spotted on a scan conducted for another purpose. Or a patient 

might not want to know of all findings from large-scale genetic sequencing. 

Respecting persons means that clinicians, acting in accordance with a patient’s 

best interest and expressed wishes, must use professional judgment to provide 

information that supports an individual’s ability to make medical care decisions—which sometimes includes respecting a patient’s desire not to know. 

Beneficence

The principle of beneficence, demonstrated in part by appropriate care and 

concern for a patient’s wellbeing, is central to the ethos of physicians and other 
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health professionals.159 Beneficence begins with a basic duty to rescue that is 

applicable to everyone. The duty to rescue is an obligation to come to the aid of 

those facing dire peril when assistance is easily given.160 In the clinic, however, 

the obligation to provide rescue is more robust and applies even when providing 

rescue is burdensome. Clinicians’ expertise makes them more capable of offering 

help and therefore more responsible for providing it. Their professional commitment requires clinicians to shoulder burdens for their patients far greater than 

we would expect of those without a preexisting relationship. 

Patients entrust clinicians with many aspects of their health, engendering the 

strong fiduciary obligations that characterize clinical care.161 A clinician’s fiduciary duty entails “[a] duty of utmost good faith, trust, confidence...; a duty 

to act with the highest degree of honesty and loyalty toward another person 

and in the best interests of the other person.”162 Non-physician clinicians have 

the same fiduciary duties. For example, 

the American Nurses Association’s Code 

of Ethics for Nurses states that a nurse’s 

primary professional commitment is to 

the patient.163

Non-maleficence, beneficence’s corollary 

ethical obligation to “do no harm,” 

requires that clinicians consider any 

benefit sought in light of the risks 

incurred. The ethical obligation to 

do no harm also supports the use of 

“therapeutic parsimony”—a virtue 

that calls for selectivity in the choice 

of interventions.164 With respect to 

incidental findings, clinicians must 

consider whether the risk of harm of 

pursuing an incidental finding is greater 

than the risk that the finding presents in the first place. The development of 

clinical best practices and institutional-level policies allows clinicians to act 

on their inclination that “doing more does not always mean better care.”165

“Clinicians have strong fiduciary 

duties to patients, meaning they 

have the duty to place the interest 

of the patient above almost all other 

competing concerns. Moreover, they 

have these duties because they 

possess distinctive knowledge and 

expertise that patients lack, which 

patients must rely on in order to 

preserve or advance momentous 

individual interests related to 

the avoidance of suffering [and] 

preserving and promoting their health 

and longevity.”

London, A.J., Professor of Philosophy, Carnegie 

Mellon University, Director, Center for Ethics 

and Policy, Carnegie Mellon University. (2013). 

Incidental Findings in Research. Presentation to 

the Bioethics Commission, April 30. Retrieved 

from http://bioethics.gov/node/1617. 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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Although clinicians have a fiduciary duty to act in a patient’s best interest, 

there are instances in which the beneficent action is unclear or when not

acting might be best. For example, the question of whether a clinician should 

disclose a patient’s genetic predisposition to Alzheimer’s disease—a disease 

for which there is currently no effective cure and no ability to prevent onset—

raises nuanced and difficult questions. Beneficence demands that a physician 

use professional judgment to determine whether disclosure would do more 

harm than good for the particular patient, and respect for persons requires 

that a patient’s preferences be ascertained, preferably before testing. 

The focus of the principle of beneficence is on the individual patient. The 

corollary principle of public beneficence supports society in its pursuit to 

secure public benefit and minimize personal and public harm. Public 

beneficence asks clinicians to facilitate the betterment of health care as a 

whole. It requires that clinicians consider not only the benefits and harms 

of disclosing and managing incidental and secondary findings with one 

patient, but also consider how these actions affect other stakeholders in 

medical care. For example, when incidental or secondary findings arise in 

the emergency room setting, clinicians must consider the time and resources 

needed to manage one patient’s finding in light of other patients who require 

urgent care.166 In deciding whether to pursue follow-up testing of such a 

finding, public beneficence might call on institutions to consider the costs 

of pursuing incidental or secondary findings generally to help ensure the 

responsible use of medical resources.167

Justice and Fairness

The principle of justice and fairness relates to the distribution of benefits and 

burdens across society.168 The United States spends more per capita on health 

care than other countries and also has one of the highest rates of spending 

growth.169 The principle of justice and fairness requires that patients with 

incidental or secondary findings receive resources appropriate to the medical 

priority of their needs and cautions against using health resources in a profligate manner or without considering other health priorities.170 Clinicians 

make decisions every day regarding resource allocation.171 Best practices that 

encourage the responsible use of tests and procedures can help clinicians 

manage health care resources effectively and efficiently.172
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By choosing interventions to diagnose and manage incidental and secondary 

findings on the basis of evidence and cost effectiveness, clinicians exercise 

stewardship in a responsible manner.173 Individual clinicians can help reduce 

the unnecessary use of health resources, such as unnecessary follow up or 

duplicative tests and procedures, by exercising professional judgment and 

using available guidance.174 For example, the Choosing Wisely Campaign 

is an initiative that is co-sponsored by more than 50 professional medical 

societies that seeks to educate physicians and patients about how to choose 

the appropriate medical test for a particular patient’s circumstances, and 

how to recognize when a particular test is unnecessary or might cause more 

harm than good.175 A common repercussion of discovering an incidental or 

secondary finding is that an individual can enter into a “chain” of medical 

interventions.176 When such tests and procedures are unnecessary, they will at 

best fail to help, and worse might harm, patients. 

Clinicians should also consider the proper use of health resources in their 

daily activities, including both material resources and their time. While 

society generally expects clinicians to prioritize their obligations to individual 

patients, each clinician-patient relationship is situated within a larger health 

care infrastructure that must attend to the needs of all patients. 

When considering how best to manage incidental and secondary findings, 

clinicians also should assess the finding’s urgency in light of the patient’s 

INCIDENTAL FINDING ARISING FROM A CT SCAN

A patient arrived in an emergency department with abdominal pains and a CT scan was 

ordered, revealing a small nodule on an adrenal gland. Ninety-eight percent of the time 

these incidentally found nodules are benign. However, medical reference texts state that 

the standard of care for these nodules is to conduct several complicated tests to rule out 

cancer. These tests include a 24-hour urinary collection and refrigeration, a prescription 

that must be taken on an empty stomach at exact times before the follow-up blood 

test, and additional CT scans—immediately and at 6 months, 1 year, and 2 years out. 

Describing these tests to a patient might take away a clinician’s ability to devote time to 

discussing the patient’s other pressing health concerns—such as the abdominal pain for 

which the CT was ordered in the first place.

Source: Ofri, D., Associate Professor, New York University, School of Medicine. (2013). Incidental Findings in the 

Clinic. Presentation to the Bioethics Commission, April 30. Retrieved from http://bioethics.gov/node/1619.

CASE STUDY
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

63

overall health to determine how best to use the time allotted for a particular 

clinical visit, and should communicate the relative priority of a particular 

finding given the patient’s other health needs. Clinicians and patients must 

work together to ensure that an incidental or secondary finding does not 

undermine the best use of a clinical encounter.177

Justice and fairness is also a matter of ensuring that patients have appropriate 

access to care in a way that neither creates nor exacerbates health disparities.178

Policies for managing incidental and secondary findings should acknowledge 

patients’ differing capacities to access and consume health care resources, 

and recognize that existing socioeconomic conditions of inequality can act as 

barriers to patients’ access to medical care.

Analysis and Recommendations

When clinicians discover incidental findings, or contemplate seeking 

secondary findings, their professional judgment must include skilled and 

insightful deliberation guided by the ethical principles described above: 

respect for persons, beneficence, and justice and fairness. Application of these 

principles to incidental and secondary findings in the clinical context leads to 

the following recommendations. 

Consent in the Clinical Context

A primary point of communication between clinicians and patients occurs 

during the clinical informed consent process, ideally led by the clinician most 

intimately familiar with the intervention and its possible consequences (e.g., 

radiologists in the case of imaging).179 As part of the consent process, clinicians 

should alert patients that a particular test or procedure could or will give rise 

to anticipatable incidental and secondary findings. Clinicians should also 

notify patients about the possibility that unanticipatable findings could arise 

that lead to additional diagnostic testing or clinical care. The patient should be 

encouraged to ask questions, state reservations, and express preferences about 

the return and management of incidental and secondary findings. Clinicians 

who adopt a policy of seeking and returning secondary findings should ensure 

that their patients are aware of the kinds of findings that will be sought and 

disclosed. Clinicians should ascertain and respect patient preferences whenever 

possible with regard to disclosure of non-primary findings.
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One of the arts of clinical communication is to distinguish and focus on 

the medical information central to the particular clinical encounter. For 

incidental findings that are of uncertain significance or for which disclosure 

is unlikely to benefit patients, clinicians can exercise professional discretion 

in deciding what level of detail, if any, to disclose while still demonstrating 

respect for patients’ self-determination.180 In fact, often this discretion of 

detail is what enables patients to process and focus on the most relevant 

issues, thereby enhancing shared decision making.

Some have argued that these conversations are too burdensome given the time 

pressures clinicians face.181 When done properly, however, the informed consent 

discussion need not be particularly time-consuming and could prevent future 

testing and patient anxiety—saving clinicians time in the long term.182

Recommendation 6

Clinicians should make patients aware that incidental and secondary findings 

are a possible, or likely, result of the tests or procedures being conducted. 

Clinicians should engage in shared decision making with patients about 

the scope of findings that will be communicated and the steps to be taken 

upon discovery of incidental findings. Clinicians should respect a patient’s 

preference not to know about incidental or secondary findings to the extent 

consistent with the clinician’s fiduciary duty.

There are multiple points at which a clinician’s ability to communicate 

clearly and effectively about incidental and secondary findings is important. 

Clinicians should alert patients to the possibility of discovering incidental 

findings, and any secondary findings that will be actively sought, before testing 

occurs so that patients have the opportunity to express preferences regarding 

their disclosure and subsequent management. While many patients will want 

their practitioner to tell them about any information discovered, others might 

not want to learn about incidental or secondary findings. Patients who do 

not wish to learn about information related to the primary purpose of the test 

should not undergo the test. 

On the other hand, if patients wish to opt out of receiving incidental or

secondary findings that are clinically significant, actionable, and of serious 

importance to their health, then clinicians should exercise discretion.183
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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Clinicians should explain the potential benefits of receiving information 

about clinically actionable findings. Within certain limitations, clinicians 

could, on ethical grounds, decline to perform the test and elect to refer the 

patient elsewhere. Alternatively, clinicians can ethically agree to perform the 

test but not return any incidental or secondary findings. Clinicians should 

also inform patients of their obligation to comply with reportable disease 

statutes in their state.

Once clinicians discover and disclose an incidental or secondary finding, they 

must communicate with their patients about various options for additional 

pursuit of the finding. Clinicians should clearly convey to patients the 

possible outcomes of investigating an incidental finding, the possibility of 

discovering additional incidental findings, and the potential benefits and risks 

of either pursuing or not pursuing the finding. Payment systems should not 

disincentivize clinicians from taking sufficient time to fully communicate this 

necessary information to each patient.

In all circumstances, clinicians can ethically filter incidental findings that 

have no or little clinical significance according to available evidence and 

decide not to seek them as secondary findings. 

* * *

INFECTIOUS INCIDENTAL FINDINGS

Public health considerations underlie state and local laws requiring the reporting of certain 

infectious diseases. Although subject to some variation, all U.S. state and some local 

jurisdictions require that selected communicable conditions be reported because of the 

danger they present to those infected and society at large. U.S. states derive this power 

from “police powers,” which include “the inherent authority of sovereign governments 

to do what is necessary to protect the health and well-being of its citizens.” Incidental 

findings of infectious diseases are therefore managed by public health officials regardless 

of context or method of discovery.

Source: Hoffman, R.E., and F.E. Shaw (2013). Legal basis for infectious disease surveillance and control in the USA. 

In N.M. M’ikanatha, et al. (Eds.). Infectious Disease Surveillance, Second Edition (pp. 583-595). Hoboken, NJ: John 

Wiley and Sons.

EXAMPLE IN ACTION
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With the increasing emphasis on patient autonomy and shared decision 

making, it is important to employ effective methods of conveying information 

about risk.184 Clinicians can facilitate patient understanding by effectively 

presenting pertinent facts and data. Both patients and clinicians tend to 

respond to personal risks emotionally, regardless of the facts, which can 

affect their decision making.185 Relaying relevant information in a clear and 

understandable manner is essential to patient comprehension and effective 

decision making. In approaching shared decision making in the clinical 

setting, clinicians must be aware of factors that shape patients’ perceptions 

of risk in order to communicate effectively. Clinicians should give patients 

enough information so that they comprehend their options, and should 

also protect patients from unnecessary anxiety produced by misunderstood 

communication of risk. 

Recommendation 7 

In communicating difficult to understand information about incidental 

and secondary findings, clinicians should consider providing patients with 

decision aids and graphical representations, using population-based evidence, 

and describing a patient’s absolute risk (the chance of any person getting a 

disease) rather than or in addition to relative risk (whether a person’s chance 

is higher or lower than another’s).

Clinicians should consider incorporating graphs and other visual displays to 

enhance comprehension for risk communication and medical decision making. 

Accurate graphical displays of numerical and probabilistic health information 

can assist patients in accessing, processing, interpreting, and acting on 

numerical health information.186 It is also critical that clinicians use relevant 

and understandable numerical evidence to support shared decision making. 

Accuracy remains an important criterion, as graphs and visual displays can 

be as misleading as wrong thoughts about risk. When appropriate, numeric 

assessments of risk should be provided as absolute risk instead of or in addition 

to relative risk, as relative risk can be easily misinterpreted (e.g., a patient’s 

risk of future disease might be twice as high as that of the general population 

but an individual patient’s risk might still be extremely low). For example, 

telling a patient that an incidental or secondary finding increases relative risk 

of disease 10-fold can sound alarming, but if this is based on a change in 

absolute risk from one in a million to one in 100,000, the patient is likely 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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to be reassured by having this relative risk placed in an absolute perspective. 

Similarly, population-based evidence can help patients understand their overall 

risk compared with the population as a whole. 

Empirical Data in the Clinical Context 

Little is known about the cost effectiveness of tests and procedures that 

generate incidental and secondary findings.187 One study suggested that 

while diagnostic testing constituted only five percent of hospital costs and 

1.6 percent of Medicare costs, the findings from these tests influenced 60 to 

70 percent of downstream decisions.188 If these tests are not likely to result in 

health benefits for the patient, they are not an effective use of funds. 

Seeking cost effectiveness—an outcome that takes into account both the costs 

and health outcomes of alternative intervention strategies189—in laboratory 

tests or diagnostic procedures is laudable, 

and in many cases also might help 

address the issue of ever-rising health 

care costs. While there have been some 

cost-effectiveness studies regarding 

incidental findings, they have generally 

been limited in scope. For example, 

some studies have analyzed the follow-up 

costs from incidental findings in CT 

colonography, but they have almost 

always excluded the cost of subsequent 

s u r g ic a l pr o c e du r e s , i n-p a t ie nt 

hospitalizations, psychological impacts, 

long-term consequences, or estimates of 

net health benefit to patients.190

One decision that clinicians make is whether to use sequential, discrete 

diagnostic tests or instead order a battery of related tests, perhaps based on a 

desire to save time. A clinician might order a battery of tests when a patient 

complains of generalized symptoms, and the physician wishes to investigate 

several diagnostic avenues at once to ascertain the likely cause quickly and 

efficiently. Discrete, targeted testing can take more time when the diagnostic 

process involves eliminating probable causes of symptoms sequentially. 

“[I]t is important to realize that there 

is no clear evidence, to date, that 

obtaining a diagnostic evaluation 

of any specific incidental finding 

improves patient outcomes. What is 

certain is that follow-up of incidental 

findings increases health care costs. 

Research is needed to document 

outcomes associated with specific 

incidental findings to provide an 

evidence base on which these 

decisions can be made.” 

Berland, L.L., Chair, American College of 

Radiology. (2013, July 5). Comments submitted 

to the Bioethics Commission.
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Ordering a battery of tests instead of discrete tests, however, can increase the 

likelihood of discovering incidental and secondary findings. 

Clinicians might also order bundled tests—tests that are grouped together 

by insurers or laboratories for cost or efficiency reasons. Bundled tests are 

thought to be less expensive, and are often encouraged by laboratories or 

health care institutions.191 In the case of bundled tests, physicians often do 

not have the option of choosing discrete tests as an alternative—the decision 

to bundle tests is made at the insurer, laboratory, or institutional level. 

If bundled tests or a battery of tests give rise to incidental or secondary 

findings that would not have been discovered using discrete targeted tests, 

the total costs of these tests, measured both in terms of cost effectiveness and 

in terms of potential harms to patients, actually might be higher. 

Recommendation 8

Federal agencies and other interested parties should study the comparative 

benefits to patients and the cost effectiveness of using bundled tests or a 

battery of tests versus conducting sequential, discrete diagnostic tests. 

Few studies elucidate the difference, both in terms of financial costs and 

medical benefits to patients, between conducting bundled tests or a battery 

of tests versus sequential, discrete diagnostic tests.192 Compounding the 

problem is that payers do not always consider the cost effectiveness or quality 

of laboratory testing in their reimbursement decisions. 

To inform individual clinicians, as well as support strong clinical practice 

guidelines, researchers should conduct reliable comparative- and costeffectiveness analyses. Empirical evidence assessing the comparative 

effectiveness of discrete, sequential diagnostic testing versus batteries of tests 

should be developed. As discussed below in Recommendation 9, clinicians 

should aim to practice “diagnostic elegance” and “therapeutic parsimony,” 

choosing tests selectively to confirm or help narrow potential diagnoses. The 

alternative, testing broadly and ordering a battery of tests to generate possible 

avenues of diagnostic inquiry, can be viewed favorably as a more efficient way 

of obtaining information about a particular patient’s condition. But ordering 

a broad battery of tests can also generate incidental and secondary findings 

that lead to additional diagnostic tests and procedures that expose patients 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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to potentially unnecessary risks. Empirical data about the comparative 

effectiveness of these two approaches can enable clinicians to make informed 

decisions in ways that are most beneficial to patients. These analyses should 

take into account the overall cost to the patient of following up on an 

incidental or secondary finding—including the medical risks of downstream 

diagnostic techniques and procedures, anxiety, pain, inconvenience, and lost 

time—to better characterize the net benefits and harms.

Cost-effectiveness studies should assess 

the long-term costs, along with the risks 

and benefits to patients, from the use 

of a “bundled tests” approach versus a 

“sequential discrete diagnostic tests” 

approach. Although bundled tests are 

presumed to be more cost effective (and 

are generally bundled by laboratories 

or insurers precisely for their presumed 

cost ef fectiveness), bundled tests 

return several results instead of one, 

increasing the possibility of incidental 

and secondary findings, which could 

lead to additional testing to diagnose 

any findings that are discovered. This 

additional testing has financial, medical, and psychological costs as well as 

benefits that should be considered in any comparison of the two approaches. 

Evidence regarding comparative benefits to patients of tests that yield 

incidental and secondary findings and the cost effectiveness of performing 

such tests can inform laboratory and payer practices and policies regarding 

efficient bundling of tests, and can aid clinicians in deciding whether to 

order a battery of tests rather than sequential, discrete tests.193 Such costeffectiveness evidence can help inform health policy, including the practices 

and policies of hospitals and insurance providers.194

Clinical Judgment in Managing Incidental and Secondary Findings

While empirical analysis is critical to informing cost-effective care choices, 

it is the art of medical decision making that translates data, education, 

“More weight will need to be given to 

practice guidelines and comparativeeffectiveness analyses in which 

we consider, among other things, 

costs—not only the actual cost of 

administering the tests, but also 

the harms that may follow from the 

‘follow up,’ particularly for invasive 

interventions.” 

Clayton, E.W., Craig-Weaver Professor of 

Pediatrics; Professor of Law and Director, 

Center for Biomedical Ethics and Society, 

Vanderbilt University. (2011). Challenges 

in Translating Whole Genome in the Clinic. 

Presentation to the Bioethics Commission, 

February 28. Retrieved from http://bioethics.

gov/node/196. 
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professional guidance, and personal experience into good clinical care. 

Prudent judgment, understood through Aristotle’s concept of phronesis

(or practical wisdom), constitutes a “capstone” virtue, linking intellectual 

virtues—such as those that make for good scientists—with the moral 

character traits—such as compassion, trustworthiness, and a sense of justice 

—that make one a particularly good caregiver.195 Exercising professional 

judgment is a deliberative process combining formal or “book” knowledge 

of a professional domain with contextual understanding gained through 

experience.196 Although professional judgment is required for every decision 

that involves considering competing values, principles, or virtues, there is no 

specific formula by which clinicians identify the right action.197

Many of the attributes that constitute respected clinical judgment can be 

cultivated and enabled through classroom and clinical education. Clinical 

educators can enable students to learn how to employ professional judgment 

founded not only on medical textbooks and lectures but also by emulating 

other physicians, apprentice learning, and through their own experiences 

in clinical decision making.198 This judgment reflects a capacity to make 

decisions and advise patients under conditions of uncertainty.

Clinicians can minimize the likelihood of incidental findings by engaging 

in selective diagnostic testing. They can do this by emphasizing thorough 

communication with patients to better understand symptoms and help 

narrow the list of potential diagnoses before ordering diagnostic tests. In 

this way, clinicians can use diagnostic tests to confirm or eliminate specific 

possible causes of symptoms. 

Recommendation 9

Medical educators, both in the classroom and clinic, should continue to 

cultivate “diagnostic elegance” and “therapeutic parsimony” amongst 

practitioners—ordering and conducting only tests and interventions 

necessary for addressing health concerns related to their patient. 

An absence of diagnostic protocols, prognostic uncertainty, and varying patient 

preferences can complicate effective clinical decision making. For example, an 

oncologist providing palliative care for a terminally ill patient might incidentally 

discover an unrelated health condition for which treatment is available. The 

oncologist would rely on clinical judgment, coupled with expressed patient 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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preferences to decide whether to pursue 

the incidental finding considering the 

possible psychological and physical harms 

of additional tests, and the discomforts 

of the anticipated course of treatment, 

in light of the patient’s current medical 

condition and prognosis. 

Clinical practice guidelines can be 

helpful in establishing standards 

regarding how clinicians ought to 

ha nd le incidenta l a nd seconda r y 

findings, but guidelines do not mandate 

standard of care or substitute for a 

medical professional’s independent 

judgment. Rather, adherence to current 

professional guidelines is voluntary, and 

many guidelines emphasize that their purpose is to assist clinicians’ exercise 

of professional judgment with regard to particular clinical situations.199 For 

example, although recent ACMG recommendations suggest that laboratories 

seek and return certain secondary findings, clinical circumstances will 

influence a clinician’s professional judgment and shared decision making 

about whether to adhere to such guidance.

Clinicians should also be mindful of factors that could lead to increased 

diagnostic testing, including compensation incentives, industry influences, 

and hindsight bias (or the inclination to see events that have already occurred 

as more likely to occur than they were before they took place). For example, 

under a fee-for-service reimbursement system, clinicians might have financial 

incentives to conduct further tests or procedures, whereas clinicians under a 

salary or a capitated reimbursement system might have financial incentives 

to minimize further testing.200 Particular medical specialties might be prone 

to conducting additional testing, especially those that provide in-office 

ancillary services.201 Clinicians should be vigilant against becoming unduly 

biased by industry influences (e.g., diagnostic laboratories and medical device 

companies) or by various forms of remuneration or professional support from 

industry representatives.202

“[E]ven...clinicians...may not all be 

cognizant of [a] particular condition 

[that can be found incidentally]. They 

will be [focused on] what they’re 

looking for, breast cancer for instance, 

but they may not [see] the clinically 

significant incidental findings...that 

are staring them in the face when 

they do next generation sequencing—

including both whole genome and 

whole exome.”

Knoppers, B., Director, Centre of Genomics 

and Policy; Canada Research Chair in Law 

and Medicine, McGill University. (2012). 

International Perspectives on the Return of 

Individual Results and Incidental Findings. 

Presentation to the Bioethics Commission, 

August 1. Retrieved from http://bioethics.gov/

node/740.
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Clinicians’ duties include the obligation to review all of the clinical data 

generated, and not to bracket or ignore potential incidental findings.203

Clinicians’ fiduciary duty suggests that they ought not filter certain results 

exclusively in order to evade moral responsibility. Clinicians should not blind 

or limit themselves from discovering incidental findings to avoid further 

accountability. 

* * *

Another important tool that clinicians have to enhance their exercise of 

professional judgment is the ability to rely on evidence-based standards, 

including recommendations from professional organizations. One critical 

area in which professional organizations make recommendations is preventive 

screening programs—programs in otherwise healthy populations that aim to 

identify undiagnosed diseases and conditions before symptoms develop.204

Examples of preventive screening programs include screening for various 

cancers—including breast, cervical, colorectal, and prostate cancers—

and other diseases such as diabetes mellitus (type 2 diabetes), human 

immunodeficiency virus (HIV), and high blood pressure.205

For example, deliberations about the effectiveness of the use of CT in lung 

cancer screening are ongoing. A 2012 study found that practitioners detected 

the incidental finding of coronary artery calcification in approximately 50 

percent of individuals,206 and recent data from the National Lung Cancer 

Screening Trial indicate that CT lung cancer screening might be cost-effective 

for high-risk patients. Accordingly, the U.S. Preventive Services Task Force 

recommended annual screening of certain patients determining that there 

was sufficient net benefit even in light of potential harms associated with 

incidental findings.207

This type of evidence-based deliberation is critical to ensuring that patients 

have access to preventive screening programs that offer health care benefits 

appropriately calibrated to any foreseeable risks—including those that can 

arise from incidental and secondary findings. 

Recommendation 10

Professional and public health organizations should produce evidencebased standards for proposed screening programs that take into account the 
Ethical Management of Incidental and Secondary Findings in the Clinical Context IV

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likelihood that incidental findings will arise. Professional organizations should 

provide guidance to clinicians on how to manage these incidental findings.

The implementation of evidence-based standards in screening programs 

would assist physicians in exercising clinical judgment about any findings 

that might arise. Proposed screening programs that take into account 

the possibility of incidental findings enable clinicians to exercise their 

professional judgment in deciding whether to conduct a screening test or 

procedure for a particular patient. 

For example, one type of test employed in screening programs is CT 

colonography; a CT examination of the abdomen and pelvis can reveal 

incidental “extracolonic” findings as well as non-cancer colonic disorders.208

Due in part to the unknown benefits and harms of detecting and evaluating 

incidental findings, the Centers for Medicare and Medicaid Services issued a 

non-coverage decision for this technology.209 Better data and evidence-based 

standards would aid payers like the Centers for Medicare and Medicaid 

Services in making coverage decisions, in addition to assisting physicians in 

exercising judgment about which screening procedures to conduct. 

Conclusion

A combination of ethical principles and practitioner virtues and duties—

instilled during clinical education, informed by updated clinical practice 

guidelines, and operationalized through the use of prudent clinical 

judgment—forms the basis for managing incidental and secondary findings in 

the clinical context. Having a plan for managing the incidental and secondary 

findings expected to arise from a test or procedure that is disclosed to and 

discussed with patients in a process of shared decision making will help clinicians navigate the ethical management of incidental findings towards greater 

patient benefit. 
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CHAPTER 5

Ethical Management of 

Incidental and Secondary Findings 

in the Research Context
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in the Clinical, Research, and Direct-to-Consumer Contexts

Sarah Hilgenberg will never forget the summer of 2002. She had finished 

her second year as a clinical researcher in neurology at Massachusetts 

General Hospital and was about to begin her first year at Stanford 

University School of Medicine. Young and healthy, Sarah looked forward 

to her future.

As part of her medical school orientation, Sarah spent four days camping 

in the Sierra Nevada Mountains with her new classmates. A few weeks 

later, Sarah received an email from one of the camping leaders, a graduate 

student studying functional magnetic resonance imaging (fMRI). Two 

research participants had canceled their sessions for an upcoming research 

study and the camping leader wondered if any group members would be 

interested in having their brain scanned while performing a memory task. 

Sarah volunteered to help.

The next day, Sarah went to the campus imaging center and participated 

in the fMRI study. Later that day, her phone rang. The fMRI researchers 

had found an anomaly on her scans. Sarah rushed to the emergency room 

for further evaluation. Ultimately, the doctors concluded that Sarah had an 

arteriovenous malformation, an abnormal connection between arteries and 

veins in her brain. They recommended that she undergo removal of the mass.

Sarah chose to stay in medical school during this time. Pursuing treatment of 

the incidental finding on her fMRI scan gave Sarah a new perspective: that 

of a patient. She remembers, “I was learning firsthand the material taught in 

class, the vulnerability of the body and, in particular, of my brain.” 

Fortunately, Sarah’s surgery was successful and she has recovered well. She 

notes: “I believe I’ve had the best outcome I probably could have had.... In 

2011, my husband and I had a daughter...who is the most special person in 

our lives. I was so unbelievably thankful that I no longer had [this malformation] in my brain during childbirth as I learned this is a common time for 

one to bleed.” 

Sarah is now a pediatric hospitalist, dealing occasionally with incidental findings 

as a practitioner rather than as a patient. But she will undoubtedly remember 

her time as a patient and the incidental finding that might have saved her life.
Ethical Management of Incidental and Secondary Findings in the Research Context V

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As indicated in the image above, researchers incidentally discovered an arteriovenous 

malformation in Sarah Hilgenberg’s brain on a scan during a memory research study.

Source: Hilgenberg, S., Recipient of a finding incidental to research. (2013). Incidental Findings in Research. 

Presentation to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), April 30. 

Retrieved from http://bioethics.gov/node/1617.

The diversity of the research enterprise presents a challenge when establishing best practices for managing incidental and secondary 

findings. Researchers conduct studies in a variety of settings, use an array 

of methods and procedures, possess a wide range of qualifications, set 

recruitment goals of various sizes, draw from a variety of funding sources, 

and form researcher-participant relationships that vary in depth and duration. 

Despite this diversity, researchers and institutions need clear, consistent, and 

practical guidance about the ethical duties owed to research participants with 

respect to incidental and secondary findings. 

A defining feature of research, as distinct from clinical care, is that participants 

contribute to the creation of generalizable knowledge; they take on potential 

risks of harm for the benefit of others. Unlike clinical care, in which potential 

harms are weighed against direct benefits to the individual patient, research 

participants might not receive individual direct benefit commensurate with 

risks assumed. The ethical management of incidental and secondary findings 

in research therefore differs from the clinical context because participants 

cannot routinely expect the same degree of personal benefit that patients 

customarily receive. This chapter details the practical, legal, and ethical 

considerations of the management of incidental and secondary findings that 

arise in the research context and makes context-specific recommendations. 
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Practical Considerations of 

Incidental and Secondary Findings 

in the Research Context

A thorough analysis of the ethical 

management of incidental and secondary 

findings in the research context must 

take into account the complex practical 

realities of researchers’ activities. Some 

features unique to the research context 

are both practically and ethically 

relevant to any guidance developed, and 

help delineate the scope and stringency 

of researchers’ obligations.210

For instance, researchers are involved in 

a broad range of researcher-participant 

relationships that vary in depth and 

duration. 211 Researchers who have 

long-standing relationships with their 

participants might be better able to 

ascertain participants’ preferences with respect to incidental and secondary 

findings and to more appropriately return results; some clear and dire 

findings that potentially could save lives might, however, be less influenced 

by interpersonal relationships. 

Researchers also have a wide range of expertise. While some researchers are 

clinicians with relevant subject matter expertise, other investigators lack the 

expertise needed to detect and interpret various anomalies. For example, 

a psychologist engaged in research using brain scans might know how to 

detect the neural correlate of a behavior central to the research, but lack the 

diagnostic skill set necessary to detect many incidental findings. 

Participant preferences can influence a researcher’s ethical obligation to return 

incidental and secondary findings. One study found that up to 90 percent of 

research participants wanted all research results returned to them, regardless 

of whether the results were clinically actionable.212 When considering whether 

and how to return findings, researchers should be aware of the possibility and 

potential consequences of exacerbating the therapeutic misconception—a 

“Research is the social enterprise 

of generating new knowledge. It 

serves the legitimate social purpose 

of supplying the information base 

necessary to understand human 

conduct; human health; to create, 

assess, and improve interventions; 

and ultimately, in the context of 

medical research, to improve 

the ability of health systems to 

understand and to meet the needs 

of the populations that they serve. 

In contrast, clinical care is the 

social enterprise of bringing to bear 

current knowledge, expertise, and 

interventions to address the health 

needs of individual patients.”

London, A.J., Professor of Philosophy, Carnegie 

Mellon University, Director, Center for Ethics 

and Policy, Carnegie Mellon University. (2013). 

Incidental Findings in Research. Presentation to 

the Bioethics Commission, April 30. Retrieved 

from http://bioethics.gov/node/1617. 
Ethical Management of Incidental and Secondary Findings in the Research Context V

79

participant’s mistaken conflation of the goals of research with the goals of 

clinical care, and the consequences that might flow therefrom.213 Participants in 

imaging research, for example, commonly believe that a qualified professional 

will review all research scans.214 Elsewhere, a majority of research participants 

involved in brain imaging research who did not expect a clinician to be involved 

nevertheless expected researchers to detect any existing brain abnormality.215

Some have suggested that researchers’ ethical obligations to return incidental 

or secondary findings depends on features of the finding itself.216 These 

features can include: 

•	 analytic validity (the accuracy and precision of the finding);217

•	 clinical validity (the causal association of the finding with pathology); 

•	 clinical actionability (the extent to which a finding can be acted upon in 

clinical decision making); 

•	 clinical or reproductive significance (the extent to which a finding has 

medical implications for one’s self or offspring);218 and 

•	 the magnitude, or seriousness, of potential harm.219

Congruent with the ethical principle of beneficence, findings that indicate 

the possibility of serious harm to a participant support a policy of returning 

incidental and secondary findings, as disclosure might help forestall or prevent 

harm. By contrast, disclosing a finding that lacks clinical or reproductive 

significance might cause more harm than benefit if disclosing the finding 

causes anxiety for the participant with no ability to reduce foreseeable harm. 

To the extent that researchers do have ethical duties to disclose and manage 

incidental and secondary findings, researchers should discharge these duties 

in a timely manner, particularly if findings require urgent action and if 

doing so can minimize anxiety to participants.220 If a great deal of time has 

passed since the participant’s active role in research, researchers must consider 

whether disclosing incidental or secondary findings is still advisable given 

the potentially dated nature of the information (e.g., an anomaly seen on an 

imaging test might have already been discovered and treated).221

Researchers also must remain mindful of the costs associated with returning 

incidental and secondary findings. Confirming findings, obtaining 
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appropriate interpretation, returning findings in a responsible manner, 

providing referrals, and conducting follow up all impose costs.222 If patientspecific results from tests on biological specimens are going to be returned to 

participants, most agree that they should be analyzed in or confirmed by a 

laboratory certified under the Clinical Laboratory Improvement Amendments 

(CLIA, which establishes standards for clinical laboratory testing).223 The 

costs of discovering, interpreting, and disclosing incidental or secondary 

findings might interfere with the ability to complete research projects and 

thereby jeopardize the production of generalizable knowledge. 

BIOBANK RESEARCH

Biobank research raises practical considerations distinct from other research settings. 

A recent study reviewing biobank policies found that half of the surveyed biobanks 

address the return of incidental findings, but few suggest that they should be returned. 

Often, the data stored in biobanks are de-identified such that researchers cannot readily 

link the data to particular individuals. De-identification makes the return of incidental 

findings much more difficult. Biobank researchers often lack access to the code that 

facilitates re-identification, and in many cases agreed that they would not attempt 

re-identification. A recent study of incidental findings in biobank research estimated the 

cost to be $1,322 per disclosure, including the cost of retesting archived DNA samples, 

providing genetic counseling, contacting participants, and conducting follow up. 

“Because one biorepository may supply tissue specimens to hundreds of investigators, the 

return of incidental findings to participants from the secondary research that follows is 

impracticable. Hence the biorepository community views any such requirement with great 

concern. Biorepositories serve as an intermediary between patients from whom specimens are 

collected and processed, and investigators to whom specimens are provided and who generate 

research results. Most biorepositories do not have access to secondary research results, and 

have no infrastructure for the return of incidental findings to participants. Developing such 

an infrastructure, including informatics necessary to support the return of incidental findings 

would be extremely costly for biorepositories, most of which have marginal funding.”* 

Sources: Wolf, S.M., et al. (2012). Managing incidental findings and research results in genomic research involving 

biobanks and archived data sets. Genetics in Medicine, 14(4), 361-384; Johnson, G., Lawrenz, F., and M. Thao. (2012). 

An empirical examination of the management of return of individual research results and incidental findings in genomic 

biobanks. Genetics in Medicine, 14(4), 448; Christensen, K.D., et al. (2011). Disclosing individual CDKN2A research 

results to melanoma survivors: Interest, impact, and demands on researchers. Cancer Epidemiology, Markers and 

Prevention, 20, 522-529; Bledsoe, M.J., et al. (2013). Return of research results from genomic biobanks: Cost matters. 

Genetics in Medicine, 15(2), 103-105. 

* Zaayenga, A., President Elect, International Society for Biological and Environmental Repositories (ISBER). (2013, 

July 8). Comments submitted to the Bioethics Commission. 

CASE STUDY
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Legal Considerations of Incidental and Secondary Findings in the 

Research Context

No federal law, federal regulation, or state law directly addresses the return 

of research results or incidental or secondary findings.224 The Common Rule, 

formally titled the “Federal Policy for the Protection of Human Subjects,” is a 

set of regulations governing research with humans that establishes protections 

central to the ethical treatment of research participants. Among other things, 

the Common Rule generally requires that the 18 federal departments and 

agencies that sponsor research with humans have an informed consent process 

that adequately notifies participants of the potential benefits and risks of 

the study. If discovering incidental or secondary findings is viewed as either 

a benefit or a risk, the Common Rule could require disclosure about the 

possibility of such findings and any policy for their return.225 The Common 

Rule could also require disclosure of particular incidental or secondary findings 

as “significant new findings developed during the course of the research which 

may relate to the subject’s willingness to continue participation.”226

The Health Insurance Portability and Accountability Act’s (HIPAA’s) Privacy 

Rule grants individuals a right to access certain aspects of their medical 

information upon request.227 This right to access, however, only relates to 

information from “covered entities” that store personal health information in a 

designated record set. Covered entities include health insurance plans; health 

care providers, such as hospitals; doctors, nurses and other practitioners; and 

health care clearinghouses—third parties that are contracted by hospitals to 

process billing claims and perform other functions.228 Participants enrolled in 

research studies conducted at covered entities could therefore have access under 

HIPAA to medical information ascertained through the research process.229

CLIA provides a set of federally mandated standards for all laboratory 

testing involving human biological specimens. Because CLIA does not apply 

to research laboratories that “do not report patient specific results for the 

diagnosis, prevention or treatment of any disease,” research laboratories often 

choose not to obtain CLIA certification.230 There is currently disagreement 

about whether research findings discovered in non-CLIA-certified laboratories 

can be returned to participants. A National Institutes of Health National 

Heart, Lung, and Blood Institute working group suggested that if results 
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are disclosed as research findings as opposed to clinical findings, institutions 

should be able report results and avoid the need for CLIA certification.231

Other groups, such as the National Research Council and the Institute of 

Medicine, have interpreted the regulations to mean that any reporting of individual results subjects a laboratory to the CLIA requirements.232 This debate 

leaves researchers uncertain about their obligations under CLIA. 

It is possible that researchers could face potential liability for failing to return 

incidental or secondary findings, although no court has specifically addressed 

the issue of a researcher’s legal obligation to return such findings.233

Ethical Considerations of Incidental and Secondary Findings in the 

Research Context

The discovery of incidental or secondary findings gives rise to ethical 

obligations owed by researchers to participants. Approaches to managing 

such findings are generally grounded in the traditional research ethics 

principles of respect for persons, beneficence, and justice and fairness.234

Approaches can similarly be grounded in the principle of intellectual freedom 

and responsibility, which recognizes the social value of scientific research 

and the attendant requirement that researchers take responsibility for their 

contributions.235

Respect for Persons

Respect for persons recognizes an individual’s fundamental capacity for 

self-determination and protects individuals from being used merely as means 

to an end. Participants’ decisions to take part in research involves a choice 

to open up aspects of their private lives to researchers—to grant researchers 

permission to intervene with their bodies or lives in ways that would be 

illegitimate without consent. Henry Richardson expands upon this concept 

in his recent book Moral Entanglements: The Ancillary-Care Obligations of 

Medical Researchers.

236 To demonstrate respect for persons, researchers must 

communicate the fundamental aspects of their research to participants so 

that participants can make autonomous decisions about whether to enroll in 

research. Researchers also demonstrate respect for participants by informing 

them about the possibility of discovering incidental or secondary findings and 

the plan for their disclosure or management.237
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Informed consent is one mechanism 

for respecting persons, but it is not the 

exclusive means by which researchers 

display due consideration for participants 

and their interests. Researchers should 

ascertain at the outset what participants 

prefer to know—or not to know—about 

incidental or secondary findings. Acting 

in accordance with participants’ expressed 

preferences, to the extent possible, 

recognizes that participants are capable 

of autonomously determining whether 

this information should be considered a 

benefit or a burden.

Communicating to participants in 

advance the scope of the incidental or 

secondary findings that researchers 

plan to disclose—including letting participants know that, in some 

circumstances, certain findings might not be disclosed at all—can display 

respect for individual autonomy by permitting participants to assess the 

ramifications of participation.238

Beneficence

Beneficence requires that researchers demonstrate concern for the wellbeing 

of others,239 and could stem, at least in part, from the trust implicit in 

participants allowing privileged access into their private lives.240 Researchers 

therefore might have obligations to act in ways that benefit participants 

stemming from this privileged access.241 The ethical counterpart of 

beneficence is non-maleficence, or the ethical imperative to “do no harm.” 

Non-maleficence does not, however, require that no harm ever befall 

participants. Rather, this ethical principle warns against avoidable harm 

and requires an evaluation of whether the prospective benefits of an action 

outweigh the risks. Beneficence and its corollary non-maleficence therefore 

require that researchers and IRBs evaluate and justify the risks and benefits of 

particular approaches to managing incidental and secondary findings. 

“Respect for persons or autonomy 

is ensured when we engage in 

an honest and fulsome informed 

consent process with the intent of 

promoting knowledgeable decision 

making by the subjects. Respect for 

persons or autonomy, however, does 

not promote a subject’s ‘right’ to 

specific research results. Rather, the 

autonomy principle should ensure 

that potential subjects know what 

to expect about return of research 

results prior to deciding whether to 

participate in the research.” 

Gasson, J., Senior Associate Dean for Research, 

and Dubinett, S., Associate Vice Chancellor for 

Research, University of California, Los Angeles. 

(2013, July 5). Comments submitted to the 

Bioethics Commission.
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With respect to incidental and secondary findings, beneficence calls upon 

researchers and institutional review boards (IRBs) to consider whether 

the benefits of disclosing a finding outweigh the risks of disclosure. For 

example, disclosing an incidentally discovered brain malformation that has 

the potential to cause long-lasting damage but that is otherwise treatable 

could allow a participant to avoid future harm, thereby providing benefit. 

By contrast, disclosing an incidental finding for which no preventive or 

positive action can be taken has the potential to cause anxiety and distress 

with no corresponding medical benefit. One example of such a finding is the 

disclosure of misattributed paternity. 

The avoidance of harm also provides a strong basis for exercising restraint 

when considering whether to disclose incidental or secondary findings that 

have the potential to lead participants into a chain of potentially risky followup tests and procedures.242 Whether researchers ethically should disclose 

a finding that is not clinically actionable is a nuanced question, requiring 

consideration of practical matters, patient preferences, and a weighing of the 

benefits and harms. Researchers must be mindful of differentiating between 

the harms of returning an incidental or secondary finding and any harm 

posed by the underlying condition itself.243

Some have suggested that incidental findings be categorized based on the 

benefits and risks of disclosing the particular finding.244 Under this model, 

there would be three tiers of findings to be disclosed: findings that generally 

should be disclosed, findings for which disclosure is ethically permissible, 

and findings that should not be disclosed. When the benefits of disclosure 

outweigh the risks, the finding should be disclosed; one such example is a 

BRCA mutation, a clinically actionable indication of an increased risk for 

breast or cervical cancer. When the benefit of disclosure might outweigh the 

anxiety and other associated risks, depending on participant preferences and 

other factors, disclosure is ethically permissible, as in the case of Huntington’s 

disease, which is not clinically actionable but might have reproductive significance. In these cases, researchers should use discretion regarding whether 

to disclose these findings in consultation with IRBs or other consultative 

bodies. And when the finding would lead to distress and anxiety without 

corresponding benefit, the finding should not be disclosed.245 One such 

example would be a very small lung nodule in a non-smoker, a finding that is 
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exceedingly likely to be benign, and for which follow-up investigation would 

cause anxiety and potential health risk.246

Researchers also have duties of public beneficence, or duties to society more 

broadly.247 Public beneficence involves supporting and promoting research 

activities and practices that offer the potential to improve the public’s wellbeing 

by advancing the state of generalizable knowledge.248 In deciding whether to 

return incidental or secondary findings, researchers should consider the costs 

of returning such findings in light of their duties to individual research participants and to the production of generalizable knowledge. 

Justice and Fairness

The principle of justice and fairness requires the equitable distribution of 

benefits and burdens of research.249 Decisions about whether to return 

incidental or secondary findings—including whether to allocate time 

and resources to interpreting, assessing, and disclosing findings—involve 

determinations about the allocation of the benefits and burdens of research. 

Researchers who disclose incidental and secondary findings might benefit 

some participants (who are able to effectively address health concerns) while 

burdening others (who are not able to address such concerns). The principle 

of justice and fairness calls upon researchers and society at large to take 

into account how incidental and secondary findings policies shed light on 

the allocation of scarce research resources. Allocating research resources to 

returning large numbers of incidental or secondary findings could burden the 

research enterprise and the ability to create generalizable knowledge. 

Incidental and secondary findings implicate the principle of justice and fairness 

in another way—by making visible the dire and unmet needs of others. 

For example, those who lack adequate access to health care might be more 

likely to have undetected health conditions, and might therefore have readily 

discoverable incidental or secondary findings.250 As a result, incidental or 

secondary findings in research can make existing health disparities more visible. 

Intellectual Freedom and Responsibility 

Intellectual freedom is the liberty to engage in sustained and dedicated 

creative intellectual exploration—an activity necessary to further scientific 

and technological progress.251 The principle of intellectual freedom and 
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responsibility is particularly pertinent to the research context, where the 

advancement of individual and collective capacities for investigation coincides 

with the responsibilities that attend novel developments in knowledge, 

science, and technology. Intellectual freedom gives researchers the latitude 

necessary to engage and persevere in dedicated intellectual exploration for the 

good of society.252

The principle of intellectual freedom and responsibility consists of two 

parts: the liberty to use creative capacities in scientific investigation, 

and the corresponding responsibility that researchers have to conduct 

themselves professionally.253 Researchers must take responsibility for their 

actions—acknowledging the profound trust placed in them both by research 

participants and by society. Researcher responsibilities include complying 

with all policies governing research, and adhering to the ideals of responsible 

conduct of research.254 A corollary principle of regulatory parsimony calls 

for “only as much oversight as is truly necessary to ensure justice, fairness, 

security, and safety while pursing the public good.”255 In this spirit, policies 

concerning the return of incidental or secondary findings should avoid 

excessively restrictive rules that might jeopardize and hinder progress in 

science, medicine, and health care.

Analysis and Recommendations

Existing scholarship regarding incidental and secondary findings in research 

reflects both the research community’s deep concern for participants’ 

wellbeing, and an emerging consensus regarding what is ethically required, 

permissible, and impermissible. The Bioethics Commission therefore makes 

the following recommendations to guide the ethical management of incidental 

and secondary findings in the research context.

Consent in the Research Context

In response to the trust imparted to them, researchers owe society and research 

participants obligations to design and implement research in a responsible 

manner.256 During the informed consent process, researchers should describe 

the types of incidental and secondary findings that might arise to ensure that 

participants are as informed as possible. This includes, but is not limited to, 

disclosing anticipatable incidental findings, any deliberately sought secondary 

findings, and the possibility of unanticipatable incidental findings. 
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Researchers should also clearly communicate to participants the plan for 

disclosing and managing anticipatable incidental findings as well as any 

possible secondary findings, and the distinction between research and clinical 

care. This communication is essential to ensure that participants understand 

what to expect as a result of their decision to participate in research. Clarity 

with respect to whether and how researchers will disclose anticipatable and 

unanticipatable incidental findings, as well as any secondary findings that 

are deliberately sought, can help sustain public and participant trust in the 

research enterprise. 

Recommendation 11

During the informed consent process, researchers should convey to participants 

the scope of potential incidental or secondary findings, whether such findings 

will be disclosed, the process for disclosing these findings, and whether and 

how participants might opt out of receiving certain types of findings. 

If researchers plan to inform participants of certain types of incidental 

findings, they should decide in advance how to respect the wishes of those who 

choose to opt out of receiving incidental findings. If researchers have ethical 

objections to allowing participants to opt out of receiving clinically significant, 

actionable, and lifesaving findings, they need not enroll such individuals in 

their research study. Delineating such exclusion criteria for study enrollment 

will minimize this type of ethically challenging situation once the research 

protocol is underway. For example, disclosing a secondary finding of a genetic 

predisposition to malignant hyperthermia—a condition associated with severe, 

life-threatening reactions to certain kinds of anesthesia—could be lifesaving, 

and a researcher reasonably might believe it is unethical to enroll a potential 

participant who does not want to know this information. 

Alternatively, given that participants have the right to opt out of research at 

any time,257 if researchers do not object to allowing participants to opt out of 

receiving incidental findings—and participants are well informed regarding 

what opting out could mean for their health and wellbeing—researchers may 

enroll such participants in the research. In the event a researcher discovers a 

potentially lifesaving unanticipatable incidental finding for a participant who 

has opted out of receiving incidental findings, the investigator should seek 

advice from an IRB about whether and how to disclose it. 
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In 2010, a National Institutes of Health National Heart, Lung, and Blood 

Institute working group addressed the issue of whether researchers could 

override a participant’s expressed preference not to receive an important 

finding. The working group’s views were split. It recommended that the 

researchers honor participants’ expressed preferences not to know, but 

recognized that “there may be exceptional circumstances in which the 

evidence of potential harm is so great, and the potential for reducing the 

harm associated with the finding is so compelling that the principal 

investigator should confer with the IRB on whether there is an ethical basis 

to override the wishes of the participant.”258 The Bioethics Commission agrees 

with the importance of planning ahead for incidental findings, providing 

clear exclusion criteria should participants disagree with the researchers’ 

plans regarding returning or not returning such findings, and notifying 

participants during informed consent so they are clear about the implications 

of participating.

Planning for Incidental Findings in Research

Given that certain findings are predictably associated with a particular 

modality or type of research, researchers have a duty to anticipate such 

incidental findings—whether common or rare—to the extent possible. 

Researchers should develop a plan to manage anticipatable incidental findings 

based on a careful balancing of the risks and benefits of disclosure, along 

with evidence about the analytic and clinical validity of the findings and 

their clinical or reproductive significance, in addition to considering actively 

seeking them as secondary findings. Researchers should submit their proposed 

plan for the ethical management of incidental findings to an IRB for review 

and approval. IRBs then would be responsible for assessing the ethical 

adequacy of the plan. 

Even for incidental findings that fall outside of researchers’ expertise, 

researchers should nevertheless be familiar enough with the anticipatable 

incidental findings associated with the modalities used in their research 

to formulate and describe a plan for how these findings will be managed. 

Researchers could, for example, propose adding members to the research team 

who have sufficient expertise to manage the range of anticipatable incidental 

findings. Researchers could also propose relying on research ethics consultants 
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or IRBs if there is uncertainty as to the advisability of disclosing a particular 

finding to a participant. 

If practical or logistical constraints prevent a researcher from searching for, 

interpreting, or disclosing incidental findings, the researcher can propose a 

plan for IRB review that states that certain types of anticipatable incidental 

findings will not be returned. Disclosing a plan for managing incidental 

findings, and allowing for nonparticipation if a prospective participant 

disagrees, appropriately respects an individual’s ability to make autonomous 

and informed decisions about whether to participate in research.

Recommendation 12

Researchers should develop a plan to manage anticipatable incidental 

findings, including but not limited to those findings known to be 

significant and clinically actionable (and, when relevant, analytically valid 

and clinically valid). The plan should be reviewed and approved by an 

institutional review board.

Even with an IRB-approved plan for managing anticipatable incidental 

findings, researchers nevertheless might discover unanticipatable incidental 

findings. The unexpected nature of these findings makes it difficult to 

ascertain at the outset what responses might be required. Despite, and indeed 

because of, this uncertainty, researchers should have a process in place ahead 

of time to manage these unanticipatable incidental findings as well. 

When researchers are uncertain whether an unanticipatable incidental finding 

might have clinical or reproductive significance, researchers should seek out 

qualified clinical or diagnostic experts for consultation. Consultation with 

subject matter experts can help researchers resolve uncertainty, determine 

the significance of the finding, and develop and implement an informed and 

appropriate response.259

Recommendation 13

Researchers should develop a process for evaluating and managing 

unanticipatable findings. The plan should be reviewed and approved 

by an institutional review board. During the informed consent 

process, researchers should notify participants about the possibility 
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of unanticipatable incidental findings, including lifesaving incidental 

findings, and the plan for their management. Researchers who discover an 

unanticipatable incidental finding of concern should assess its significance, 

consulting with experts as appropriate. 

An incidental findings management plan should include specific information 

regarding the method of disclosure. For example, researchers might wish 

to disclose the existence of genetic incidental findings in the presence of 

a genetic counselor to assist participants in understanding the finding’s 

significance.260 Nonclinical researchers also might involve clinicians in 

discussions with participants about incidental findings, or researchers using 

materials obtained from biobanks conducting secondary analysis might 

involve the original researcher.

The plan for managing incidental findings should also include a description of 

the research team’s responsibilities following disclosure of such a finding. In 

some cases, researchers might provide basic educational information about the 

nature of the finding, advice regarding how to seek care from a clinician or 

specialist, or guidance about obtaining health insurance to secure treatment. 

If a clinical specialist is required, researchers should provide the participant 

with a referral when possible. Disclosure of an incidental finding, however, 

does not transform a research relationship into a clinical one. 

For certain kinds of research, disclosure of incidental findings is difficult, 

if not impossible. One such example might include biobank research using 

de-identified samples. But even in these instances, researchers should demonstrate thoughtful deliberation in developing and justifying their plan of 

nondisclosure. Researchers should not design their research protocols with 

the explicit purpose of avoiding discovery of incidental findings. Researchers 

should have sound scientific, practical, and ethical reasons to use de-identified 

samples, to employ non-experts (such as graduate students) to read scans 

or interpret research results, to conduct research in resource-poor settings 

where follow-up care is difficult, or to not analyze data that were collected. 

Such choices can and should be informed by the availability of resources, 

the study’s scientific objectives, the accuracy of the data obtained or analysis 

required, and the protection of participants. 
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No Duty to Look for Secondary Findings in Research

Researchers’ obligations of beneficence raise questions about whether and to 

what extent researchers might have a duty to look for secondary findings. 

While some researchers have research funding to look for secondary findings, 

this will not be true for many of those conducting valuable research endeavors. 

Prioritizing a duty to look for secondary findings over the creation of generalizable knowledge has the potential to undermine the research enterprise. 

Recent recommendations issued by the 

American College of Medical Genetics 

and Genomics (ACMG) about largescale genetic sequencing articulate an 

ethical “duty to look” for a given set 

of secondary findings in the clinical

context.261 The ethical obligations of 

clinicians and researchers are, however, 

distinct. W hereas clinicians have 

strong fiduciary duties to act in the 

best interests of patients, researchers 

have obligations to their participants 

and to society. Both society at large and 

participants engaged in research have a vested interest in completed research 

that furthers scientific knowledge. 

Because researchers have obligations both to research participants and the 

creation of generalizable knowledge, their obligations to deliberately seek 

secondary findings that are outside the primary purpose of their research 

are less extensive than obligations of clinicians. Researchers have no general 

duty to actively look for secondary findings. Researchers are not, however, 

precluded from pursuing, disclosing, and managing secondary findings 

should they so choose. Any plan to deliberately seek secondary findings 

should be reviewed and approved by an IRB and should be disclosed to 

prospective research participants. 

“I worry that the ethical drive to 

return incidental findings in research, 

however good some of the outcomes 

may be...turns the research 

enterprise into a proxy clinical 

enterprise.”

Green, R., Associate Director for Research, 

Partners HealthCare Center for Personalized 

Genetic Medicine, Associate Professor of 

Medicine, Division of Genetics, Brigham 

and Women’s Hospital and Harvard Medical 

School. (2013). Ethical Challenges of Emerging 

Technologies. Presentation to the Bioethics 

Commission, April 30. Retrieved from http://

bioethics.gov/node/1618.
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Recommendation 14

Researchers should consider carefully the decision to actively look for 

secondary findings. In certain circumstances, with approval from an 

institutional review board, researchers can justifiably adopt a plan that 

includes looking for selected clinically significant and actionable secondary 

findings. Approved plans should be disclosed to prospective participants 

during the informed consent process.

Even without an ethical duty to actively look for secondary findings, 

researchers could, in some circumstances, justifiably adopt a plan to look for 

secondary findings. For example, a research team investigating the genetics of 

a particular community could decide—but would not be obligated—to implement the advice of a community advisory board that recommends looking for 

a particular variant if requested by a participant, even if the variant is outside 

the aims of the research. By acknowledging the community’s interest and 

simultaneously completing their research, researchers could advance both the 

public and individual components of beneficence. Also, while researchers do 

not have an affirmative duty to look for secondary findings, this does not 

dilute the importance of developing a plan for managing those that they find 

and of educating participants about the details of this plan. 

Conclusion

An established set of ethical principles—informed by the practical realities 

of research—form the basis for the ethical management of incidental and 

secondary findings in the research context. Respect for persons requires that 

researchers be open and transparent about the procedures used in conducting 

research, and that they communicate to participants in advance the possibility 

of discovering incidental and secondary findings. Obligations of beneficence 

require that researchers consider and justify the potential risks and benefits 

involved in disclosing such findings. The principle of justice and fairness 

calls upon researchers to strive to respond appropriately and professionally 

to incidental and secondary findings. Finally, the principle of intellectual 

freedom and responsibility grants researchers the liberty to use their 

creative capacities in scientific investigation, while simultaneously expecting 

researchers to exercise their freedom responsibly. Together, these ethical 
Ethical Management of Incidental and Secondary Findings in the Research Context V

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principles require that researchers have a plan for the ethical management of 

incidental and secondary findings that arise in research—put in place ahead 

of time and clearly communicated to potential participants—that is vetted 

and supported by an IRB or expert review structure.
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CHAPTER 6

Ethical Management of 

Incidental and Secondary Findings 

in the Direct-to-Consumer Context
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DIRECT-TO-CONSUMER GENETIC TESTING

Thirty-four year old Jackie,* an employee of a biomedical research laboratory, was curious about her predisposition to various diseases so signed up for 

a medical risk report from 23andMe, a direct-to-consumer genetic testing 

company. She knew that cancer, alcoholism, and bipolar disorder ran in the 

family. Jackie and her brother Alex* wanted to know more, so the siblings sent 

saliva samples into the company and agreed to go over their results together. 

Jackie and Alex read through their reports online, and were not surprised by 

any of the results. At the end of the report, the system prompted them to opt in 

to an additional service that could link users to close relatives who had also 

submitted genetic information. Jackie and Alex both opted in to the service—

and learned of a result that took them by surprise. The results stated that Alex 

was Jackie’s uncle.

Jackie posted this odd finding on a forum for questions and discussion about 

the company’s results. The community of users told Jackie that the system had 

detected that Jackie and Alex shared one-quarter of their DNA. While full 

siblings share 50 percent of their DNA, more distant relationships, such as 

uncle and niece, grandfather and granddaughter, or half siblings share only 

25 percent of their DNA. This meant that Alex and Jackie could be uncle and 

niece, grandfather and granddaughter, or half siblings. 

Jackie and Alex were confused and distressed by the news. Jackie asked their 

mother about the result, and her mother admitted to an affair that resulted in 

Jackie’s birth. Jackie described the experience as surreal, saying, “I looked in the 

mirror and thought, who is this person?”

23andMe informs its users that its genetic testing service can reveal misattributed paternity and other surprises about biological relationships that could 

“evoke strong emotions” or “alter your worldview.” Despite being warned about 

this risk, Jackie was shocked to discover this anticipatable incidental finding. 

*These names have been changed.

Sources: Engber, D. (2013, May 21). Who’s your Daddy? The perils of personal genomics. Slate. Retrieved from 

http://www.slate.com/articles/health_and_science/science/2013/05/paternity_testing_personal_genomics_

companies_will_reveal_dna_secrets.html; 23andMe. (n.d.). Terms of Service [Webpage]. Retrieved from https://

www.23andme.com/about/tos/. 
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Members of the general public have increasingly gained access to medical tests and procedures outside of traditional clinical or research settings. 

Situated at the intersection of medicine and business, direct-to-consumer 

(DTC) companies offer the public additional mechanisms for obtaining 

health-related information. Thus far, the full breadth of DTC activities, and 

their associated ethical considerations, have been relatively underexplored 

in the literature. This chapter provides an overview of the practical, legal, 

and ethical considerations facing providers of DTC testing with regard to 

incidental and secondary findings. 

Practical Considerations of Incidental and Secondary Findings in the 

Direct-to-Consumer Context

A growing number of tests are available DTC.262 These include genetic testing, 

whole body scans, computed tomography (CT) colonography, non-medical 

fetal ultrasound, and cholesterol tests.263 Some DTC tests, such as at-home 

pregnancy or HIV tests, provide only the information explicitly sought, and 

so generally do not give rise to incidental or secondary findings.264 Some DTC 

tests, including whole body scans intended to find any and all anomalies, 

are unlikely to give rise to incidental or secondary findings because the test 

has the broad purpose of revealing all discovery findings; by design, almost 

nothing is incidental. Still other DTC tests—including fetal ultrasounds and 

DTC genetic tests (both discussed in more detail in Chapter 2: Modalities and 

EXAMPLE IN ACTION

MOBILE MEDICAL APPLICATIONS

One example of an emerging form of DTC testing is mobile medical applications. These 

products offer medical information and diagnosis through applications (or “apps”) on smart 

phones and tablet computers. While some mobile medical applications simply deliver 

general medical information, others function more like medical devices. Some applications, 

for example, act as diagnostic tools using only the built-in capabilities of the smart phone 

or tablet, such as programs that allow users to take images of skin lesions to check 

for melanoma. Unlike many other DTC services, the return of information from mobile 

medical applications is frequently automated and does not permit the exercise of individual 

discretion.

Sources: U.S. Food and Drug Administration (FDA). (2013). Mobile Medical Applications – Guidance for Industry and 

Food and Drug Administration Staff. September 25. Retrieved from http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.
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Probable Incidental and Secondary Findings)—have the potential to generate 

incidental and secondary findings. 

A number of practical considerations affect the ethical management of incidental 

and secondary findings in the DTC context. One critical consideration is a 

consumer’s motivation for undertaking DTC testing. Some choose DTC testing 

services, such as full-body scans, that otherwise might not be available through 

routine clinical care. Others choose DTC testing because, given the rising costs 

of co-payments and insurance deductibles, it can be less expensive than similar 

tests offered in the clinic.265 Individuals also might undergo DTC testing to 

avoid having particular results entered into their medical records.266 And still 

others use DTC services for entertainment or education; they might simply be 

curious about health-related or ancestry information.267

The level of medical expertise available at DTC testing companies varies 

widely, with implications for the quality of information consumers can expect 

to receive. While some companies employ many types of specialists, others 

employ technicians who do not have expertise in identifying, interpreting, 

or returning incidental and secondary findings.268 Even DTC companies 

that have experience identifying incidental and secondary findings might 

be unable to adequately contextualize findings due to a lack of additional 

relevant medical information, such as a family history, that is generally 

available in the clinic.269

Legal Considerations of Incidental and Secondary Findings in the 

Direct-to-Consumer Context

Individual states have adopted laws regulating or prohibiting DTC services 

although, as of yet, no state laws directly regulate the return of incidental or 

secondary findings. According to a 2007 survey, 25 states and the District of 

Columbia permit DTC testing without any restrictions, 13 states prohibit all 

DTC testing, and 12 states permit DTC testing only for targeted categories 

of tests.270 In a few states, DTC testing can occur only with the authorization 

and supervision of a physician, bringing it more in line with clinical care.271

Many states also have consumer protection laws and agencies that regulate the 

marketing of consumer goods and services.272

Several federal agencies regulate specific aspects of DTC testing, though there 

is not yet a coherent framework for regulating these enterprises. The U.S. 
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

99

Food and Drug Administration (FDA) is charged with ensuring the safety 

and effectiveness of medical devices for approved use, but generally does 

not have authority to regulate how medical devices are used in practice. For 

example, FDA regulates the safety and effectiveness of X-ray CT machines273

and, in a statement, FDA noted that the benefits of performing a preventive 

full-body CT on healthy individuals is questionable.274 But because FDA lacks 

the authority to regulate how devices are used, the federal government does 

not have a way of preventing companies from offering these tests. However, 

FDA recently initiated regulatory enforcement of DTC genetic tests.275

As the agency with primary responsibility 

for implementing the Clinical Laboratory 

Improvement Amendments (CLIA), 

the U.S. Centers for Medicare and 

Medicaid Services (CMS) has regulatory 

jurisdiction over DTC laborator y 

testing.276 CLIA establishes quality 

standards for the accuracy and precision 

of all laboratory testing; it does not, 

however, guarantee clinical validity 

or actionability, nor does it impose an 

obligation to explain the findings that 

might result from a particular test. Thus, 

CLIA does not play a direct role in the 

management of incidental or secondary findings (see Chapter 5 for a more in 

depth discussion of CLIA). 

The U.S. Federal Trade Commission (FTC), tasked with preventing unfair or 

deceptive acts or practices in or affecting commerce, also has regulatory authority 

over DTC advertising and promotion.277 “Unfair” acts or practices include 

those that injure consumers, violate established public policy, or are unethical or 

unscrupulous.278 “Deceptive acts or practices” include things such as false oral or 

written representations, or the use of bait and switch techniques.279

Even outside the realm of regulatory agencies, other types of law could influence a DTC provider’s management of incidental and secondary findings. For 

example, contract law could play a role in determining the scope of a DTC 

provider’s legal obligations. When consumers purchase a health-related test 

“With the whole body [scan], that’s 

where you really get into this gray 

zone between practice of medicine, 

where a government entity may 

regulate the machine, but then state 

law to a greater or lesser extent 

regulates the use of that machine.”

Javitt, G., Counsel, Sidney Austin LLP; 

Research Scholar, Berman Institute of 

Bioethics, Johns Hopkins University. (2013). 

Incidental Findings and Direct-to-Consumer 

Genetic Testing. Presentation to the 

Presidential Commission for the Study of 

Bioethical Issues (Bioethics Commission), 

April 30. Retrieved from http://bioethics.gov/

node/1620. 
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through a DTC provider, the parties enter 

into a contract for services.280 In most—if 

not all—cases, there is a written agreement 

between the parties that specifies the 

services that consumers agree to purchase. 

This document also might describe the 

types of information that consumers will 

receive. Even if the terms and conditions 

specify the tests and results consumers 

purchase, courts might look at other representations made in companies’ advertising, 

and could find that consumers are entitled 

to additional results.281

Various tort law claims could also be 

asserted against DTC testing companies but 

there is, as yet, no case law directly related 

to this point. DTC companies potentially 

could be held liable for negligence if they cause harm to consumers by failing 

to use due care in conducting a test or reporting test results.282 Finally, DTC 

companies could face liability for failure to adequately warn or instruct if they 

do not adequately communicate the risks and limitations of a test in a manner 

accessible to consumers.283

Ethical Considerations of Incidental and Secondary Findings in the 

Direct-to-Consumer Context

The ethical principles articulated throughout this report—respect for persons, 

beneficence, justice and fairness, and intellectual freedom and responsibility—must be interpreted in light of private industry’s role in providing 

health information, as well as the economic nature of the relationships 

between providers of DTC testing and consumers. DTC providers interact 

in both the business and medical realms, and could find themselves subject 

to the ethical principles pertinent to business transactions as well as those of 

medical care. Such ethical guidelines are interpreted in the DTC context in 

accordance with the principle of regulatory parsimony, suggesting only as 

much oversight as is truly necessary to ensure responsible business practices.

“There can be incidental findings 

[in the DTC context] too. [These 

findings are] incidental to the 

contractual arrangement—an 

arrangement which allows people 

to opt out [of] finding certain 

kinds of information. So there 

may be very important kinds 

of information [that the DTC 

companies are] holding that [are] 

not part of the contract....”

Donaldson, T., Mark O. Winkelman 

Professor of Legal Studies; Director, Zicklin 

Center for Research in Business Ethics, 

The Wharton School of the University of 

Pennsylvania. (2013). Incidental Findings 

in the Direct-to-Consumer Context. 

Presentation to Bioethics Commission, April, 

30. Retrieved from http://bioethics.gov/

node/1620. 
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

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Respect for Persons

Respect for persons recognizes an individual’s fundamental capacity for 

self-determination—which also is considered a cornerstone of DTC testing. 

DTC testing enables consumers to exercise greater control over what they 

know about themselves. Respect for persons also recognizes that individuals 

have the right to form contracts with others in a free society, so long as 

such exchanges are not actively contrary to the public good.284 Autonomous 

transactions are premised on particular conditions, including that both 

parties are informed about the nature of the exchange and free from coercion 

that would effectively force participation in the transaction. In general, 

the principle of respect for persons is fostered when both parties engage in 

voluntary and informed consent to the exchange285 and, with respect to the 

return of incidental or secondary findings, should include an understanding 

about how DTC companies intend to disclose and manage such findings.

Beneficence

Beneficence requires that individuals consider and act to advance another’s 

wellbeing. Every individual has an ethical duty to act when confronted with 

an individual in dire peril, particularly when doing so imposes minimal 

burden and can prevent or alleviate harm.286 In the DTC context, disclosure 

of clinically actionable and significant incidental and secondary findings 

might fall within this basic duty to warn. Given that DTC providers have a 

relationship with consumers, and that those with clinical expertise who provide 

DTC testing retain some fiduciary duties even for tests conducted outside of 

the clinic, the duties of DTC providers could extend even beyond this minimal 

duty to warn.287 By gaining access to and intervening in consumers’ lives 

on a commercial basis, and by virtue of providers’ superior knowledge and 

skills, DTC professionals have responsibilities to respond appropriately to the 

consequences of their services.288

Non-maleficence, a corollary of beneficence, directs DTC companies 

returning incidental and secondary findings to refrain from doing so in ways 

that could cause undue harm. The principle of non-maleficence does not 

impose a prohibition on any harm resulting from private transactions—as 

a society, we allow people to purchase goods and services that might harm 

them provided that consumers agree to assume these risks knowingly and 
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voluntarily. For example, although driving a car carries a risk of accidental 

injury, people are allowed to purchase and drive cars. Likewise, although 

exposure to radiation has the potential to cause harm, competent adults can 

nevertheless knowingly accept this risk in return for the perceived benefits of 

undergoing a particular DTC imaging test. 

Justice and Fairness

The principle of justice and fairness calls upon all stakeholders to consider the 

reasonableness and legitimacy of the claims of groups or individuals to receipt 

of goods or fair treatment to which they are entitled.289 To that end, justice 

and fairness requires consideration of whether it is reasonable for consumers 

to expect that DTC companies will return incidental and secondary findings 

even if not explicitly delineated in a contract. 

Intellectual Freedom and Responsibility

The principle of intellectual freedom and responsibility enables consumers and 

DTC providers to exercise their individual and collective creative potential 

in morally responsible ways.290 This principle has two parts: intellectual 

freedom, and the related duty to manage this freedom responsibly. The 

exercise of intellectual freedom is expressed through the innovation and 

ingenuity necessary to make advances in the development and provision of 

DTC testing services. DTC providers also have a corresponding responsibility 

to conscientiously manage incidental and secondary findings. 

The corollary principle of regulatory parsimony calls for only as much 

oversight as is truly necessary. 291 This principle suggests adopting 

regulations that are needed to establish business practices consistent with 

a just, fair, secure, and safe society but that are not unduly restrictive or 

counterproductive.292 In the DTC context, this principle calls attention to the 

diverse number of agencies currently responsible for oversight of various DTC 

activities that nevertheless lack policies that specifically address incidental or 

secondary findings. While current regulations might need to be modified 

or specified to ensure that consumers receive safe and reliable information, 

the principle of regulatory parsimony requires policy makers to consider how 

new regulations will affect the industry. In the DTC setting, parsimonious 

regulations could provide both the necessary protections for potential 

consumers and avoid overly burdensome compliance requirements.
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

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Analysis and Recommendations

With this general analysis in mind, the Bioethics Commission makes the 

following recommendations for the ethical management of incidental and 

secondary findings in the DTC context. 

Consent in the Direct-to-Consumer Context

DTC testing can offer individuals a means through which they can exercise 

self determination, including by providing increased access, reduced cost, and 

greater confidentiality of health information. But the benefits of DTC services 

are contingent upon the quality of the testing and analyses, and the informed 

and voluntary nature of the transaction. To enable consumers to make 

responsible and informed choices regarding DTC testing, consumers must be 

told what these procedures entail, including the possibility of incidental and 

secondary findings. Information provided before selecting a DTC procedure 

can assist consumers in deciding what services are worth pursuing. 

To willingly undertake the risks of DTC transactions, individuals must be 

aware of the consequences of any DTC transaction, which include the potential 

discovery of incidental and secondary findings. Consistent with respect for 

persons, DTC providers should provide clear and comprehensible information 

about anticipatable incidental and 

secondary findings. Accurate information 

and decision making support, both before 

and after the transaction, is essential to 

establish consumers’ capacity to exercise 

self determination regarding whether to 

undertake DTC testing.

Although some consumers seek out 

DTC testing as an alternative to clinical 

care, clinicians and DTC providers owe 

different ethical and practical duties to 

patients and consumers. Clinicians owe 

stringent fiduciary duties to patients, 

which entail an obligation to act in furtherance of the patient’s best interests. 

Non-clinician DTC providers have less stringent duties, including duties that 

“[T]here are ways to communicate 

the implications of this information, 

even to lay people, but it takes a 

tremendous amount of effort and 

curation of the scientific literature 

and thoughtfulness around how 

you present the information. It’s 

expensive to return the information in 

a responsible way.”

Mountain, J., Senior Director of Research, 

23andMe. (2013). Roundtable Discussion. 

Presentation to the Bioethics Commission, 

April 30. Retrieved from http://bioethics.gov/

node/1621.
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might be limited or circumscribed by contract. Consumers should be made 

aware of these distinctions prior to consenting to undergo DTC testing.

Recommendation 15

Direct-to-consumer companies should provide consumers with sufficient 

information about their services to enable consumers to make informed 

decisions regarding purchasing their product. Companies should clearly 

communicate the scope of procedures and the types of findings that the 

companies could or will discover and disclose, as well as any findings that 

they know in advance will not be disclosed.

DTC companies must inform consumers considering their services about the 

procedures and results included in the commercial arrangement. Among the 

information needed by consumers is an understanding of the anticipatable 

incidental findings commonly associated with particular modalities and any 

secondary findings that will be deliberately sought. If certain results are not 

returned according to company policy or contractual agreement, this must be 

disclosed to consumers as well. For example, the DTC genetic testing company 

23andMe provides a list on its website of the conditions it will not return.293

A company’s policy not to return certain information should be made clear 

during the consent process. This practice ensures that consumers are fully 

informed about the nature of the results they can expect and the results they 

should not expect. 

Government Regulation in the Direct-to-Consumer Context

From air bags and seatbelts to the proper construction of cribs, the government has responsibility for ensuring the safety of certain products and services 

offered to consumers.294 As a matter of policy, society has chosen to impose 

oversight to place legitimate limits on the principle of caveat emptor or “buyer 

beware.”295 The primary goal of this oversight is to establish consumer protections—to ensure that companies make good on both explicit and implicit 

guarantees that the goods and services proffered are suitable for the purposes 

for which companies sell them.296 Federal and state governments can also 

provide citizens with assurance that DTC companies are conducting business 

in a transparent and responsible manner.

As discussed above, a variety of government agencies have partial oversight 

over DTC activities. This patchwork of oversight indicates the need to assure 
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

105

consumers that DTC providers are engaging in responsible business practices, 

particularly with respect to the disclosure of incidental and secondary 

findings. State governments generally are responsible for regulating the 

practice of medicine. Accordingly, state and federal governments, working 

together, should be vigilant in monitoring and regulating the safety and 

reliability of health-related DTC products and services.

Recommendation 16

Federal agencies should continue to evaluate regulatory oversight of direct-toconsumer health services to ensure safety and reliability. State governments 

also should adopt regulations that ensure a consistent floor of protections for 

consumers who purchase direct-to-consumer testing. 

Policy makers at the state and federal level should examine existing regulations 

governing DTC services to identify gaps in and barriers to ensuring the 

safety and reliability of DTC testing. Policy makers should consider adopting 

regulations governing disclosure of incidental and secondary findings. Policy 

makers at the state and federal level should remain mindful of the principle 

of regulatory parsimony, limiting restrictions on the ability to freely engage in 

commercial transactions only to the extent necessary to prevent serious harm.

Industry-Wide Best Practices in the Direct-to-Consumer Context 

The DTC market is relatively new and growing, and the technologies used 

are often still evolving. Given the diversity in the DTC industry, and the 

evolving practices employed by DTC companies, DTC companies are 

uniquely positioned to understand the nature of their own industry. This 

knowledge could enable DTC companies to develop best practices that are 

consistent with relevant ethical principles.297 For example, DTC providers who 

discover clinically actionable incidental or secondary findings that have health 

implications could provide consumers with educational information about the 

nature of the finding, advice about how best to seek care from a clinician or 

specialist, or even a referral to a clinician who could assist in the management 

of the finding. If companies adopt voluntary best practices, such best practices 

could become standard expectations for consumers who choose to undergo 

DTC testing, giving other companies incentive to adopt and implement these 

practices, thereby leveling the playing field.
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While the creation of voluntary industry-wide best practices is an important 

step toward ensuring accountability in this emerging industry, self-regulation 

raises a number of concerns, including conflicts of interest. Self-regulation, 

therefore, might be insufficient to protect consumer interests. When there 

is not universal adoption of voluntary industry standards, or if voluntary 

best practices are inadequate, federal regulation might be needed to prevent 

companies from avoiding ethical obligations. 

These guidelines could be supplemented or supplanted by binding rules 

crafted by federal or state entities with jurisdictional authority over DTC 

testing. The process could, for example, follow the precedent set by the 

Pharmaceutical Research and Manufacturers of America (PhRMA) voluntary best practices have become mandatory in several jurisdictions through 

incorporation into state law.298

THE PhRMA CODE

In 2002, PhRMA drafted a voluntary code of conduct to govern best practices for 

interactions between pharmaceutical companies and health care professionals. This code 

seeks to ensure that relationships between pharmaceutical representatives and health 

care providers are designed solely to benefit patients and improve the practice of medicine. 

Although PhRMA’s code is voluntary, the principles and best practices that it encourages 

became mandatory in several states through incorporation into state law. California, for 

example, requires all pharmaceutical companies to demonstrate compliance with the code. 

Source: Pharmaceutical Research and Manufacturers of America (PhRMA). (n.d.). Ethical relationships with 

health care professionals are critical to our mission [Webpage]. Retrieved from http://www.phrma.org/code-oninteractions-with-healthcare-professionals; PhRMA. (2009). 105 CMR970.000: Pharmaceutical and Medical Device 

Manufacturer Conduct. Retrieved from http://policymed.typepad.com/files/mass-code-of-conduct----final-3-11-09.

pdf; Cal. Health & Safety §§ 119400-119402 (Deering 2005).

EXAMPLE IN ACTION

Recommendation 17

Direct-to-consumer companies should aid in the creation of industry-wide 

best practices concerning the management of incidental and secondary 

findings. These best practices should include when and how such findings will 

be disclosed and standards for referral to necessary clinical services. Directto-consumer companies should make these “best practices” publicly available 

to encourage broader adoption. 
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

107

Voluntary industry-wide best practices can be developed by collaboration 

among companies and through professional organizations whose members 

work in the DTC industry. Some professional organizations have issued ethical 

guidelines for members who are employed by DTC companies. The American 

Medical Association Council on Ethical and Judicial Affairs, for example, 

issued a report on DTC imaging services that included recommendations about 

the responsibilities of physicians employed by DTC imaging companies.299 The 

American Institute of Ultrasound in Medicine has also issued a statement about 

the ethical obligations of members of its profession who are working in the 

DTC context.300

DTC companies should develop best practices regarding disclosure of 

incidental findings and when secondary findings should be deliberately 

sought, including the types of findings that ought to be disclosed and the 

methods for communicating these findings. For particularly sensitive findings, 

DTC companies could adopt certain procedural safeguards. As an example, 

a DTC company might require that consumers pass through several layers of 

information on its web portal to access highly sensitive results.301 This type 

of procedural safeguard is one way, absent the availability of comprehensive 

genetic counseling that might be standard in a clinical setting, that DTC 

companies could communicate findings that have the potential to cause 

confusion or anxiety. 

DTC companies also should develop best practices for facilitating access to 

clinical care or other counseling for consumers grappling with the consequences of sensitive disclosures. For example, Inherent Health, a DTC genetic 

testing company offers a one-on-one appointment with a licensed, board certified genetic professional—a service that is included in the cost of the test.302

Finally, because DTC providers are involved in widely varied practices, from full 

body scans to highly sensitive laboratory assays, each of these modalities might 

need to develop separate voluntary industry-wide best practices. The overarching 

ethical principles of respect for persons, beneficence, justice and fairness, and 

intellectual freedom and responsibility should remain consistent throughout.
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EXAMPLE IN ACTION

23andMe CONSENT 

23andMe, a leading DTC genetic testing company, informs its customers that they might 

receive unexpected information in their results. In its “Terms of Service,” 23andMe alerts 

its customers, before purchase, that a resulting finding “may evoke strong emotions and 

has the potential to alter your life and worldview. You may discover things about yourself 

that trouble you and that you may not have the ability to control or change (e.g., your father 

is not genetically your father, surprising facts related to your ancestry, or that someone with 

your genotype may have a higher than average chance of developing a specific condition or 

disease). These outcomes could have social, legal, or economic implications.” 

In addition, customers must opt in to view particularly sensitive information in “locked 

reports” that are not initially displayed on their results page. 

Before selecting a “locked report,” customers are provided with additional information 

about the nature of the information without seeing their individual results. 

Source: 23andMe. (2013). Terms of Service: Risks and Considerations Regarding 23andMe Services [Webpage]. 

Retrieved from https://www.23andMe.com/about/tos; Mountain, J. Senior Director of Research, 23andMe. (2013). 

Incidental Findings: A 23andMe Perspective. Presentation to the Bioethics Commission, April 30. Retrieved from 

http://bioethics.gov/node/1620.

Locked Reports

NAME CONFIDENCE YOUR RISK AVG. RISK COMPARED TO AVERAGE

Alzheimer’s Disease 

Parkinson’s Disease

Your results do not affect whether you see the text below. Everyone must view this information 

before choosing whether to view their results for this report.

Parkinson’s Disease is a serious disease with no known cure for which strong genetic factors 

have been established. Consider the following before choosing whether to view your genetic 

data regarding Parkinson’s Disease:

• Genetics can substantially affect your Parkinson’s risk: This report includes information on 

a relatively rare mutation in the LRRK2 gene associated with significantly increased risk in 

European populations, in addition to other variants with relatively smaller effects in both 

European and Asian populations.

• Your family history affects your chances of having the LRRKs mutation: Though rare in the 

general populations, this mutation is much more common in families with European ancestry 

and a history of Parkinson’s.

• These genetic variants cannot predict definitively whether you will develop Parkinson’s: 

Genes and environment both contribute to a person’s chances of developing Parkinson’s. 

Many people who have the risk-associated versions of the genetic variants in this report will 

never get the disease. Conversely, lacking these versions does not substantially reduce one’s 

Parkinson’s risk below average.

• This information may have implications for your relatives: Because you are genetically similar to 

your relatives, anything you learn about your own genes may have implications for them as well.

• The significance of your genetic information could change: The development of new 

treatments or cures could substantially change the implications of this information. New 

discoveries could refine our understanding of the risks associated with certain genotypes or 

link them to additional diseases or conditions.

I understand, please show me my results
Ethical Management of Incidental and Secondary Findings in the Direct-to-Consumer Context VI

109

Conclusion

The challenge of incidental and secondary findings in the DTC context 

highlights a complex professional relationship that is still developing. The 

Bioethics Commission recognizes that a thorough ethical analysis must be 

responsive to the development of new ways for citizens to access information 

with medical implications. Applying the principles of respect for persons, 

beneficence, justice and fairness, and intellectual freedom and responsibility 

in this context indicates that consumers, the government, DTC professionals, 

and society all share responsibility for ensuring that incidental and secondary 

findings are responded to in an ethically appropriate manner. A combination 

of explicit ethical requirements and voluntary development of industry-wide 

best practices offers the most promising prospects for both DTC companies 

and private consumers. 
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in the Clinical, Research, and Direct-to-Consumer Contexts
111

CHAPTER 7

Conclusion
112

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

This report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer 

Contexts, has focused on the ethical management of incidental and secondary 

findings that arise in the clinical, research, and direct-to-consumer (DTC) 

contexts. The Bioethics Commission also recognizes that incidental and secondary 

findings can arise in circumstances that do not fit neatly into one of these three 

contexts and that new situations will evolve that we do not yet imagine. The 

principles, ethical analyses, and recommendations set forth in this report are 

intended to guide practitioners in a variety of contexts, current and future. 

The ethical principles do not themselves provide explicit mandates about what 

must be done. Rather, they provide guidance regarding factors that should 

be taken into account when determining how best to manage incidental and 

secondary findings. Interpretation and application of these principles can 

assist professionals in crafting informed, reflective, and ethical responses to 

incidental and secondary findings in any context.

Incidental findings are challenging because they might, but do not always, 

have important implications for an individual’s health and wellbeing. When 

the health and wellbeing of individuals is at stake, society has a duty to 

protect and promote health and safety. To advance these aims, practitioners 

must be aided by the best available evidence and by clear, yet flexible, 

guidelines concerning the management of incidental and secondary findings. 

Policies pertaining to such findings should ensure that practitioners give 

potential recipients appropriate information about the possibility, likelihood, 

and consequences of incidental and secondary findings sufficient to enable 

informed decision making before the start of a test or procedure. 

There are many obligations concerning the ethical management of incidental 

and secondary findings that are context specific. For example, in the clinical 

context, the fiduciary duty is dominant and requires that clinicians act in the 

best interest of their patients. In the research context, although researchers 

are not fiduciaries of participants, they nevertheless owe ethical obligations 

arising, in part, from moral entanglements based on privileged access to 

private medical information. The DTC context, situated at the intersection of 

the business and medical realms, requires consumer protections that extend 

beyond mere caveat emptor or “buyer beware.”
Conclusion VII

113

Although the issue of incidental and secondary findings has been considered 

by several groups focused on concerns that are context- and modalityspecific, the ethical obligations associated with the discovery, disclosure, and 

management of such findings have not been comprehensively considered 

across contexts and modalities. This report seeks to fill this void. In 

Anticipate and Communicate, the Bioethics Commission concludes that 

in any setting, potential recipients should be properly informed about the 

possibility of incidental or secondary findings before the start of a test or 

procedure. Practitioners should also recognize the potentially life-changing 

nature of certain incidental or secondary findings, and should take care to 

minimize harm when disclosing these findings. Practitioners and potential 

recipients benefit from empirical evidence about the likelihood of incidental 

and secondary findings arising from a particular test or procedure. And 

everyone—practitioners and recipients alike—can benefit from broader, more 

inclusive discussions about the ethical concerns, and associated practical and 

legal considerations, raised by incidental and secondary findings.
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in the Clinical, Research, and Direct-to-Consumer Contexts
115

ENDNOTES
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in the Clinical, Research, and Direct-to-Consumer Contexts

1 Hilgenberg, S., Recipient of a finding incidental to research. (2013). Incidental Findings in Research. 

Presentation to the Presidential Commission for the Study of Bioethical Issues (PCSBI), April 30. Retrieved 

from http://bioethics.gov/node/1617.

2 Krucoff, C., Recipient of a finding incidental to clinical care. (2013). Incidental Findings in the Clinic. 

Presentation to PCSBI, April 30. Retrieved from http://bioethics.gov/node/1619.

3 Wolf, S.M., et al. (2008). Managing incidental findings in human subjects research: Analysis and 

recommendations. Journal of Law, Medicine & Ethics, 36(2), 219-248.

4 Westbrook, J.I., Braithwaite, J., and J.H. McIntosh. (1998). The outcomes for patients with incidental lesions: 

Serendipitous or iatrogenic? American Journal of Roentgenology, 171(5), 1193-1196.

5 Presidential Commission for the Study of Bioethical Issues. (2013, October). Privacy and Progress in Whole 

Genome Sequencing. Washington, DC: PCSBI. 

6 Gutmann, A., and D. Thompson. (2004). Why Deliberative Democracy? Princeton, NJ: Princeton University 

Press.

7 Beauchamp, T.L., and J.F. Childress. (2012). Principles of Biomedical Ethics, Seventh Edition. Oxford: Oxford 

University Press.

8 PCSBI, supra note 5, at 98.

9 See, e.g., Illes, J., et al. (2002). Ethical and practical considerations in managing incidental findings in 

functional magnetic resonance imaging. Brain and Cognition, 50(3), 358-365; Manolio, T.A. (2006). Taking 

our obligations to research participants seriously: Disclosing individual results of genetic research. American 

Journal of Bioethics, 6(6), 32-34.

10 Illes, J., et al., supra note 9. 

11 Almeling, R., and S.K. Gadarian. (2013). Public opinion on policy issues in genetics and genomics. Genetics in 

Medicine, doi:10.1038/gim.2013.175.

12 Kole, J., and A. Fiester. (2013). Incidental findings and the need for a revised informed consent process. 

American Journal of Roentgenology, 201(5), 1064-1068. 

13 Moore, R.A., et al. (2008). What do we know about communicating risk? A brief review and suggestion for 

contextualizing serious, but rare, risk, and the example of cox-2 selective and non-selective NSAIDs. Arthritis 

Research and Therapy, 10(1), 1-16.

14 Nelson, W., et al. (2008). Clinical implications of numeracy: Theory and practice. Annals of Behavioral 

Medicine, 35(3), 261-274. 

15 The decision not to cover computed tomography (CT) colonography by the Centers for Medicare and Medicaid 

Services (CMS) was due, in part, to the lack of empirical data regarding the benefits and harms caused by 

incidental findings. CMS. (2009). Decision Memo for Screening Computed Tomography Colonography (CTC) 

for Colorectal Cancer (CAG-00396N). Retrieved from http://www.cms.gov/medicare-coverage-database/

details/nca-decision-memo.aspx?NCAId=220&TAId=58&NcaName=Screening+Computed+Tomography+Col

onography+(CTC)+for+Colorectal+Cancer.

16 U.S. Centers for Disease Control and Prevention (CDC). (n.d.). Cost Effectiveness Analysis [Webpage]. 

Retrieved from http://www.cdc.gov/owcd/eet/costeffect2/fixed/1.html. 

17 See, e.g., Hernandez, J.S. (2003). Cost effectiveness of laboratory testing. Archives of Pathology & Laboratory 

Medicine, 127(4), 440-445; and Ramsey, S.D., et al. (2006). Toward evidence-based assessment for coverage 

and reimbursement of laboratory-based diagnostic and genetic tests. American Journal of Managed Care, 12(4), 

197-202. 

18 Those who possess the virtue of prudent judgment have the “deliberative capacity to reason well with respect to 

the means to be used to attain the good of the activity in which we have been engaged.” Pellegrino, E.D., and 

D.C. Thomasma. (1993). The Virtues in Medical Practice. New York, NY: Oxford University Press, p. 90.
ENDNOTES VIII

117

19 Aristotle. (2012). Nichomachean Ethics (Robert C. Bartlett and Susan D. Collins, Trans.). Chicago, IL: 

University of Chicago Press, p. 124.

20 Pellegrino, E.D., and D.C. Thomasma, supra note 18, at 87.

21 Agency for Healthcare Research and Quality. (2013). Glossary of Terms: Screening [Webpage]. Retrieved from 

http://effectivehealthcare.ahrq.gov/glossary-of-terms/?pageaction=showterm&termid=62.

22 Richardson, H.S. (2012). Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers. Oxford: 

Oxford University Press; Knoppers, B.M., et al. (2013). Population studies: Return of research results and 

incidental findings policy statement. European Journal of Human Genetics, 21(3), 245-247.

23 Protection of Human Subjects, Department of Health and Human Services (HHS). 45 C.F.R. § 46.116 (a)(8).

24 See, e.g., Consumer Product Safety Commission (CPSC). (n.d.). About CPSC [Webpage]. Retrieved from 

http://www.cpsc.gov/en/About-CPSC/; National Highway Traffic Safety Administration (NHTSA). (n.d.). 

About NHTSA [Webpage]. Retrieved from http://www.nhtsa.gov/About; and Federal Communications 

Commission (FCC). (n.d.). The FCC: What We Do [Webpage]. Retrieved from http://www.fcc.gov/

what-we-do.

25 Carson, T.L. (2002). Ethical Issues in Selling and Advertising. In N.E. Bowie (Ed.). Blackwell Guide to Business 

Ethics (pp.186-205). Malden, MA: Blackwell Publishers.

26 Ibid. 

27 Donaldson, T., Director, Zicklin Center for Business Ethics Research, The Wharton School of the University 

of Pennsylvania. (2013). Incidental Findings in the Direct-to-Consumer Context. Presentation to PCSBI, April 

30. Retrieved from http://bioethics.gov/node/1620.

28 Hilgenberg, S., supra note 1. 

29 Krucoff, C., supra note 2.

30 Wolf, S.M., et al., supra note 3. 

31 Westbrook, J.I., Braithwaite, J., and J.H. McIntosh, supra note 4. 

32 National Bioethics Advisory Commission (NBAC). (1999). Research Involving Human Biological Materials: 

Ethical Issues and Policy Guidance. Rockville, MD: NBAC. Retrieved from http://bioethics.georgetown.edu/

nbac/hbm.pdf.

33 Ibid, pp. vi-vii.

34 See, e.g., Gordon, M.P. (2009). A Legal Duty to Disclose Individual Research Findings To Research Subjects? 

Food and Drug Law Journal, 64, 235 (“Commentators generally support the notion that there is a moral duty 

to disclose medically important information.”); Clayton, E.W., and A. McGuire. (2012). The legal risks of 

return results of genomics research. Genetics in Medicine, 14(4), 1 (“There is substantial consensus that people 

should be offered results that could trigger interventions that are lifesaving or that could avert serious adverse 

health outcomes; there is somewhat less consensus about whether people should be offered results that may have 

reproductive implications or that could be personally meaningful.”); and Gliwa, C., and B.E. Berkman. (2013). 

Do researchers have an obligation to actively look for genetic incidental findings? American Journal of Bioethics, 

13(2), 33 (“[O]pinion seems to be moving toward the idea that there is some obligation to offer to disclose a 

limited set of findings”).

35 Green, R.C., et al. (2013). ACMG recommendations for reporting of incidental findings in clinical exams and 

genome sequencing. Genetics in Medicine, 15(4), 565-574.

36 National Heart, Lung, and Blood Institute (NHLBI). (2004). NHLBI Working Group on Reporting Genetic 

Results in Research Studies, Meeting Summary. Retrieved from http://www.nhlbi.nih.gov/meetings/workshops/

gene-results.htm; U.S. National Library of Medicine. (n.d.). Genetics Home Reference: How can consumers be 

sure a genetic test is valid and useful? Retrieved from http://ghr.nlm.nih.gov/handbook/testing/validtest.

37 See, e.g., Appendix I: Past National Recommendations Regarding Incidental and Secondary Findings and Appendix 

II: Past International Recommendations Regarding Incidental and Secondary Findings.
118

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

38 PCSBI, supra note 5. 

39 Ibid. 

40 Ibid, at 98.

41 Ibid. 

42 Wolf, S.M., et al., supra note 3, at 219. [Emphasis added].

43 PCSBI, supra note 5, at 8. [Emphasis added].

44 Wolf, S.M., et al., supra note 3, at 219.

45 Knoppers, B.M., et al., supra note 22, at 246. 

46 Green, R.C., et al., supra note 35, at 566.

47 Munk, M.D., et al. (2010). Frequency and follow-up of incidental findings on trauma computed tomography 

scans: Experience at a level one trauma center. Journal of Emergency Medicine, 38(3), 346.

48 Yanagi, Y., et al. (2003). Incidentally found and unexpected tumors discovered by magnetic resonance imaging 

(MRI) examination for temporomandibular joint arthrosis. European Journal of Radiology, 47(1), 6. 

49 Illes, J., et al. (2006). Incidental findings in brain imaging research. Science, 311(5762), 783.

50 Parker, L.S. (2008). The future of incidental findings: Should they be viewed as benefits? Journal of Law, 

Medicine & Ethics, 36(2), 341.

51 See, e.g., Neale, M.C., Neale, B.M., and P.F. Sullivan. (2002). Nonpaternity in linkage studies of extremely 

discordant sib pairs. American Journal of Human Genetics, 70(2), 526-529 (“We define “nonpaternity” as the 

situation in which the ostensible father of a child is not the biological father. Estimates of nonpaternity in 

the general population vary, ranging from 1% to as high as 20%”); Macintyre, S., and A. Sooman. (1991). 

Non-paternity and prenatal genetic screening. Lancet, 338(8771), 869-871 (“Unfortunately, reliable estimates 

of the incidence of non-paternity are few and far between, although various rates are quoted in an authoritative 

manner by several sources. Medical students are usually taught that the rate is 10-15%; 10% is a figure widely 

used in DNA studies and quoted in standard genetics textbooks; and commentators on proposed screening 

programmes for cystic fibrosis carriers have recently quoted similar incidence rates.”).

52 Parens, E., Senior Research Scholar, The Hastings Center. (2013). Defining Incidental Findings and a Proposed 

Ethical Framework. Presentation to PCSBI, August 19. Retrieved from http://bioethics.gov/node/2783. 

This presentation, in turn, was based largely on a piece by Parens with co-authors Paul Appelbaum and 

Wendy Chung. Parens, E., Applebaum, P., and W. Chung. (2013). Incidental findings in the era of whole 

genome sequencing? Hastings Center Report, 43(4), 16-19. A similar taxonomy was submitted to the Bioethics 

Commission as a public comment. Cambon-Thomsen, A., Director of Research in CNRS (French national 

centre for scientific research). (2013, July 7). Comments submitted to PCSBI.

53 Young, A., et al. (2009). Discovering misattributed paternity in living kidney donation: Prevalence, preference, 

and practice. Journal of Transplantation, 87(10), 1429-1435.

54 Mountain, J., Senior Director of Research, 23andMe. (2013). Incidental Findings: A 23andMe Perspective. 

Presentation to PCSBI, April 30. Retrieved from http://bioethics.gov/node/1620. 

55 Green, R.C., et al., supra note 35.

56 Virginia Hospital Center. (n.d.). The Wellness Scan [Webpage]. Retrieved from http://www.

virginiahospitalcenter.com/medical/radiology/wellnessscan.aspx; U.S. Food and Drug Administration 

(FDA). (2010). Radiation-Emitting Products: Full-Body CT Scans—What You Need to Know [Webpage]. 

Retrieved from http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/

MedicalImaging/MedicalX-Rays/ucm115340.htm. 

57 Jolie, A. (2013, May 14). My medical choice. New York Times, A25.

58 Wolf, S.M., et al., supra note 3. 
ENDNOTES VIII

119

59 Although the finding was unanticipatable when the sample was collected, 23andMe nevertheless implements a 

plan for how these findings will be handled including, when appropriate, subsequent disclosure. Mountain, J., 

supra note 54. 

60 Virginia Hospital Center, supra note 56. 

61 Gutmann, A., and D. Thompson, supra note 6. 

62 Aristotle, supra note 19; Pellegrino, E.D., and D.C. Thomasma, supra note 18. 

63 Beauchamp, T.L., and J.F. Childress, supra note 7. 

64 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 

(1978). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

(DHEW Publication OS 78-0012). Washington, DC: Department of Health, Education, and Welfare. 

Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

65 Beauchamp, T.L., and J.F. Childress, supra note 7, at Chapter 3.

66 Beauchamp, T.L., and J.F. Childress, supra note 7.

67 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra

note 64. 

68 MacIntyre, A. (1994). Guilty bystanders? On the legitimacy of duty to rescue statues. Philosophy and Public 

Affairs, 23(2), 157-191; Scanlon, T.S. (1998). What We Owe to Each Other. Cambridge, MA: Belknap Press of 

Harvard University Press.

69 Richardson, H.S., supra note 22, at 75-76.

70 Presidential Commission for the Study of Bioethical Issues. (2010, December). New Directions: The Ethics of 

Synthetic Biology and Emerging Technologies. Washington, DC: PCSBI, pp. 24-25, 113.

71 Ibid, at 30-31. 

72 Ibid. 

73 Ibid, at 27-28, 141-150.

74 Ibid, at 28, 141.

75 Ibid. 

76 HHS, Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical, Research, and 

Direct-To-Consumer Contexts, 78 Fed. Reg. 33,843 (June 5, 2013).

77 Ormond, K.E., et al. (2010). Challenges in the clinical application of whole-genome sequencing. Lancet, 

375(9727), 1749-1751.

78 U.S. National Library of Medicine. (2013, July 15). Genetics Home Reference: Huntington disease [Webpage]. 

Retrieved from http://ghr.nlm.nih.gov/condition/huntington-disease.

79 National Human Genome Research Institute. (n.d.). DNA Sequencing Costs: Data from the NHGRO 

Genome Sequencing Program (GSP). Retrieved from http://www.genome.gov/sequencingcosts/.

80 Gliwa, C., and B.E. Berkman, supra note 34, at 36; Ormond, K.E., et al., supra note 77, at 1750; Mardis, E.R. 

(2011). The $1,000 genome, the $100,000 analysis? Genome Medicine, 2(11), 84; Sboner, A., et al. (2011). The 

real cost of sequencing: Higher than you think! Genome Biology, 12(8), 125-135.

81 Gliwa, C., and B.E. Berkman, supra note 34, at 36. (“Genomic science is still in its infancy, and the amount we 

know about the relationship between genomic data and human disease is dwarfed by the amount we do not yet 

know.”).

82 These are the kind of actions J.S. Mill distinguished as “other-regarding behavior.” According to Mill’s harm 

principle, individual freedom is limited by potential consequences for others: “[T]he principle requires liberty 

of tastes and pursuits; of framing the plan of our life to suit our own character; of doing as we like, subject to 
120

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

such consequences as may follow: without impediment from our fellow-creatures, so long as what we do does 

not harm them...” Mill, J.S. (2003). On Liberty. D.B. Bromwich and G. Kateb. (Eds.). New Haven, CT: Yale 

University Press, pp. 89, 139. 

83 See, e.g., the American College of Medical Genetics and Genomics (ACMG) recently recommended that results 

of large-scale genetic sequencing of children be returned by laboratories, as the information might be of clinical 

or reproductive significance to parents as well. Green, R.C., et al., supra note 35. 

84 McGuire, A.L., Caulfield T., and M.K. Cho. (2008). Research ethics and the challenge of whole-genome 

sequencing. Nature Reviews Genetics, 9(2), 152-156; Offit, K., et al. (2004). The ‘duty to warn’ a patient’s 

family members about hereditary disease risks. JAMA, 292(12), 1469-1473; Wilson, B.J., et al. (2004). Family 

communication about genetic risk: The little that is known. Community Genetics, 7, 15-24; American Society of 

Human Genetics. (1998). Professional disclosure of familial genetic information. American Journal of Human 

Genetics, 62(2), 474-483; Sulmasy, D.P. (2000). On warning families about genetic risk: The ghost of Tarasoff. 

American Journal of Medicine, 109(9), 738-739.

85 Green, R.C., et al., supra note 35, at 565. 

86 Ibid, at 569.

87 Genetic Testing Laboratories Inc. (n.d.). Health Testing. Retrieved from http://www.gtldna.com/

HealthTesting/DNA-Predisposition-Testing.htm; Easy DNA. (n.d.). Genetic Predisposition Health Testing: 

Your Future Health is in Your Genes. Retrieved from http://www.easy-dna.com/genetic-predisposition-dnatesting.html. 

88 Mountain, J., supra note 54. 

89 Ibid.

90 “That’s the key thing I want to mention here. We’ve added reports. We started with 13. Now we have over 240. 

So if you got tested in 2007, you would have an increasing number of reports based on that. So that’s part of the 

model.” Ibid.

91 Volk, M.I., and P.A. Ubel. (2011). Less is more: Better off not knowing. Archives of Internal Medicine, 171(6), 

487.

92 Medline Plus. (n.d). Comprehensive Metabolic Panel. [Webpage]. Retrieved from http://www.nlm.nih.gov/

medlineplus/ency/article/003468.htm. 

93 Kohane, I.A., Masys, D.R., and R.B. Altman. (2006). The incidentalome: A threat to genomic medicine. 

JAMA, 296(2), 212-215.

94 See, e.g., Walk-in Lab. (n.d.). Order Tests Online [Webpage]. Retrieved from http://www.walkinlab.com/

category. 

95 The “Comprehensive Wellness Profile” and the “10 Most Important Tests” offered by DirectLabs are bundled 

blood tests. DirectLabs. (n.d.). 10 Most Important Tests [Webpage]. Retrieved from https://www.directlabs.

com/OrderTests/tabid/55/language/en-US/Default.aspx.

96 Medical imaging contributes to approximately 50 percent of the overall radiation dose to the U.S. 

population, up from 15 percent in 1980; the increase in CT scans are the largest contributor to this increase. 

Brenner, D.J., and H. Hricak. (2010). Radiation exposure from medical imaging: Time to regulate? JAMA, 

304(2), 208-209; Brenner, D.J. (2010). Slowing the increase in the population dose resulting from CT scans. 

Radiation Research, 174(6), 809-815; FDA. (2013). Computed Tomography (CT). Retrieved from http://

www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/

MedicalX-Rays/ucm115317.htm. 

97 Ekeh, A.P., et al. (2010). The prevalence of incidental findings on abdominal computed tomography scans of 

trauma patients. Journal of Emergency Medicine, 38(4), 484-489; Munk, M., et al., supra note 47, at 346-350.

98 Munk, M., et al., supra note 47, at 348. 

99 Ibid. 
ENDNOTES VIII

121

100 Nelson, C.A. (2008). Incidental findings in magnetic resonance imaging (MRI) brain research. Journal of Law, 

Medicine & Ethics, 36(2), 315-319; Royal, J.M., and B.S. Peterson. (2008). The risks and benefits of searching for 

incidental findings in MRI research scans. Journal of Law, Medicine & Ethics, 36(2), 305-314.

101 Illes, J., and V.N. Chin. (2008). Bridging philosophical and practical implications of incidental findings in brain 

research. Journal of Law, Medicine & Ethics, 36(2), 302.

102 See, e.g., Be Well Body Scan. (n.d.). FAQ [Webpage]. Retrieved from http://www.bewellbodyscan.com/

faq_home.asp.

103 See, e.g., Virtual Physical. (n.d.). What is a virtual physical? [Webpage]. Retrieved from http://www.

virtualphysical.com/index_virtualphysical.html; and Affordable Medical Imaging. (n.d.). Health Screening. 

[Webpage]. Retrieved from http://affordablemedicalimaging.com/services/.

104 National Cancer Institute, National Institutes of Health (NIH). (2012). Colorectal Cancer Screening. Retrieved 

from http://www.cancer.gov/cancertopics/pdq/screening/colorectal/Patient/page1/AllPages/Print.

105 Greene, N., and L.D. Platt. (2005). Nonmedical use of ultrasounds: Greater harm than good? Journal of 

Ultrasound Medicine, 24(1), 123-125. Obstetric ultrasonography uses high-frequency sound waves to produce 

relatively precise images of structures within the womb. Mayo Clinic. (n.d.). Ultrasound [Webpage]. Retrieved 

from http://www.mayoclinic.com/health/ultrasound/MY00308; Chervenak, F.A., and L.B. McCullough. 

(2005). An ethical critique of boutique fetal imaging: A case for the medicalization of fetal imaging. American 

Journal of Obstetrics and Gynecology, 192(1), 31-33; FDA. (2004). FDA cautions against ultrasound ‘keepsake’ 

images. FDA Consumer Magazine, January-February; Lubell, S. (2004, September 23). The womb as photo 

studio. New York Times. Retrieved from http://www.nytimes.com/2004/09/23/technology/circuits/23ultr.

html?pagewanted=all&position=.

106 For example, one company states on their website that: “We offer elective 2D, 3D & 4D prenatal ultrasounds 

to provide a positive bonding experience for the mother, father and family members with the unborn baby...We 

make no claims that 3-D as used in this examination is performed to better assess the baby for abnormalities. 

A routine ultrasound examination must have already been performed to assess the gestational age of the 

fetus and to evaluate for fetal anomalies as well as the basic components of fetal anatomy recommended for 

screening.” Enlightened 4D Imaging and Photography. (n.d.). FAQ [Webpage]. Retrieved from http://www.

enlightened4dimaging.com/faqs.html.

107 Chervenak, F.A., and L.B. McCullough, supra note 105. 

108 FDA, supra note 105. 

109 American Institute of Ultrasound in Medicine. (n.d.). Entertainment Ultrasound: Why it’s a bad idea. Retrieved 

from http://www.doctorag.com/pdf/news/entertainment.pdf.

110 CDC. (2010). Healthier Worksite Initiative: Selected Preventative Screening Recommendations [Webpage]. 

Retrieved from http://www.cdc.gov/nccdphp/dnpao/hwi/resources/preventative_screening.htm.

111 Berland, L.L., et al. (2010). Managing incidental findings on abdominal CT: White paper of the ACR 

Incidental Findings Committee. Journal of the American College of Radiology, 7(10), 754-773.

112 Freda, P.U., et al. (2011). Pituitary incidentaloma: An Endocrine Society clinical practice guideline. Journal of 

Clinical Endocrinology and Metabolism, 96(4), 894-904.

113 National Heart, Lung, and Blood Institute, supra note 36. 

114 Daack-Hirsc, S., et al. (2013).  ‘Information is information’: A public perspective on incidental findings in 

clinical and research genome-based testing. Clinical Genetics, 84(1), 11-18.

115 PCSBI, supra note 5, at 98. 

116 See, e.g., Ormond, K.E., et al. (2009). Assessing the understanding of biobank participants. American Journal 

of Medical Genetics, 149A(2), 188-198; Schmidt, C.O., et al. (2013). Psychosocial consequence and severity of 

disclosed incidental findings from whole-body MRI in a general population study. European Radiology, 23(5), 

1343-1351; Berland, L.L. (2009). Incidental extracolonic findings on CT colonography: The impending deluge 

and its implications. Journal of the American College of Radiology, 6(1), 14-20; Pickhardt, P.J., et al. (2008). 
122

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Unsuspected extracolonic findings at screening CT colonography: Clinical and economic impact. Radiology, 

249(1), 151-159; Xiong, T., et al. (2005). Incidental lesions found on CT colonography: Their nature and 

frequency. British Journal of Radiology, 78(925), 22-29; MacHaalany, J., et al. (2009). Potential clinical and 

economic consequences of noncardiac incidental findings on cardiac computed tomography. Journal of the 

American College of Cardiology, 54(16), 1533-1541; Ekeh, A.P., et al., supra note 97; Munk, M., et al., supra note 

47, at 346-350; Vernooij, M.W., et al. (2007). Incidental findings on brain MRI in the general population. New 

England Journal of Medicine, 357(18), 1821-1828; Yue, N.C., et al. (1997). Clinically serious abnormalities found 

incidentally at MR imaging of the brain data from the Cardiovascular Health Study. Radiology, 202(1), 41-46; 

and Rogers, A.J., et al. (2013). Incidental findings in children with blunt head trauma evaluated with cranial CT 

scans. Pediatrics, 132(2), e356-e363.

117 Facio, F.M. (2006). One size does not fit all. American Journal of Bioethics, 6(6), 40-42; Manolio, T.A., supra

note 9. 

118 Illes, J., et al., supra note 9; Manolio, T.A., supra note 9.

119 Illes, J., et al., supra note 9.

120 National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI) grant #R01-

HG00178 for a two-year project on “Managing Incidental Findings in Human Subjects Research” (Susan M. 

Wolf, principal investigator; Jeffrey P. Kahn, Frances Lawrenz, Charles A. Nelson, co-investigators). Work 

on this paper was supported by The Greenwall Foundation (Judy Illes, principal investigator), NIH/NINDS 

grant #RO1 NS O45831 (Judy Illes, principal investigator) and NHGRI grant #R01 HG003178 (principal 

investigator, S. M. Wolf; co-investigators, J. P. Kahn, F. Lawrenz, C. A. Nelson); Genomes2People: Research 

in Translational Genomics and Health Outcomes. (n.d.). Projects: The MedSeq Project. Retrieved from http://

www.genomes2people.org/the-medseq-project/; Genomes2People: Research in Translational Genomics 

and Health Outcomes. (n.d.). Projects: The REVEAL Study. Retrieved from http://www.genomes2people.

org/reveal/; Genomes2People: Research in Translational Genomics and Health Outcomes. (n.d.). Projects: 

Incidental Finding Preferences in Whole Genome Sequencing. Retrieved from http://www.genomes2people.

org/incidental-finding-preferences-in-whole-genome-sequencing/.

121 National Cancer Institute. (n.d.). Pink Book - Making Health Communications Work. Retrieved from http://

www.cancer.gov/cancertopics/cancerlibrary/pinkbook/page1.

122 See, e.g., Lachance, C.R., et al. (2010). Informational content, literacy demands, and usability of websites 

offering health-related genetic tests directly to consumers. Genetics in Medicine, 12(5), 304-312.

123 Zolnierek, K.B.H., and M.R. DiMatteo. (2009) Physician communication and patient adherence to treatment: 

A meta-analysis. Medical Care, 47(8), 826-834.

124 Public Responsibility in Medicine and Research (PRIM&R). (n.d.). Certification for Institutional Review 

Board (IRB) Professionals. Retrieved from http://www.primr.org/certification.aspx?id=206.

125 Glick, D.C. (2007). Risk Communication for public health emergencies. Annual Review of Public Health, 28, 

33-54; Wray, R.J. (2008). Communicating with the public about emerging health threats: Lessons from the 

Pre-Event Message Development Project. American Journal of Public Health, 98(12), 2214-2222.

126 Vaughan, E., and T. Tinker. (2009) Effective health risk communication about pandemic influenza for 

vulnerable populations. American Journal of Public Health, 99(S2), S324-S332. 

127 A recent study found that 65 percent of Americans agree that clinicians should always be involved in explaining 

and interpreting genetic tests results, no matter how they were obtained. Almeling, R., and Gadarian, S.K., 

supra note 11. 

128 De Maeseneer, J., et al. (2007). Primary health care as a strategy for achieving equitable care: A 

literature review commissioned by the Health Systems Knowledge Network. WHO Health Systems 

Knowledge Network. Retrieved from http://www.who.int/social_determinants/resources/csdh_media/

primary_health_care_2007_en.pdf.

129 Drazin, D., et al. (2013). Incidental findings of tumor while investigating subarachnoid hemorrhage: Ethical 

considerations and practical strategies. Science and Engineering Ethics, 19(3), 1107-1120.
ENDNOTES VIII

123

130 Mamourian, A. (2004). Incidental findings on research functional MR images: Should we look? American

Journal of Neuroradiology, 25(4), 520-522.

131 Westbrook, J.I., Braithwaite, J., and J.H. McIntosh, supra note 4, at 1195; Katzman, G.L., Dagher, A.P., and 

N.J. Patronas. (1999). Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic 

volunteers. JAMA, 282(1), 36-39.

132 Westbrook, J.I., Braithwaite, J., and J.H. McIntosh, supra note 4, at 1195.

133 Ibid. 

134 Ibid, at 1193-1198.

135 Berland, L.L., et al., supra note 111, at 756.

136 Whitney, S.N., and L.B. McCullough. (2007). Physicians’ silent decisions: Because patient autonomy does not 

always come first. American Journal of Bioethics, 7(7), 34.

137 Berland, L.L., et al., supra note 111, at 756.

138 Carrier, E.R., et al. (2013). High physician concern about malpractice risk predicts more aggressive diagnostic 

testing in office-based practice. Health Affairs, 32(8), 1383-1391. 

139 Lawthers, A.G., at al. (1992). Physicians’ perceptions of the risk of being sued. Journal of Health Politics, Policy, 

and Law, 17(3), 463-482.

140 CMS, supra note 15. 

141 U.S. Preventive Services Task Force. (2013). Screening for Lung Cancer: Draft Recommendation Statement 

(AHRQ Publication No. 13-05196-EF-3). Rockville, MD: U.S. Preventive Services Task Force. Retrieved 

from http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcandraftrec.htm; Humphrey, L., et 

al. (2013, July). Screening for Lung Cancer: Systematic Review to Update the U.S. Preventive Services Task 

Force Recommendation (Contract No. HHSA-290-2007-10057-I-EPC3, Task Order No. 13). Rockville, MD: 

Agency for Healthcare Research and Quality. Retrieved from http://www.uspreventiveservicestaskforce.org/

uspstf13/lungcan/lungcanes103.pdf.

142 The National Lung Screening Trial Research Team. (2013). Results of initial low-dose computed tomographic 

screening for lung cancer. New England Journal of Medicine, 368(21), 1980-1991; The American College of 

Radiology. (2013, June 24). Guidance for ACR members on lung cancer screening with CT [News]. Retrieved 

from http://www.acr.org/News-Publications/News/News-Articles/2013/Quality-Care/20130624-Guidancefor-ACR-Members-on-Lung-Cancer-Screening-with-CT; Kole, J., and A. Fiester, supra note 12. 

143 Westbrook, J.I., Braithewaite, J., and J.H. McIntosh, supra note 4; Berland, L.L., et al., supra note 111, at 756. 

In one review of 966 patients undergoing cardiac CT anigram, the scans of 401 patients revealed non-cardiac 

incidental findings; the total cost of investigating these incidental findings was $83,035. MacHaalany, J., et al., 

supra note 116.

144 Kole, J., and A. Fiester, supra note 12; Royal, H.D., Siegel, B.A., and W.A. Murphy Jr. (1993). An incidental 

finding: A radiologist’s perspective. American Journal of Roentgenology, 160, 237-240; Ginsberg, L.E. (2010). “If 

clinically indicated:” Is it? Radiology, 254(2), 324-325; Solet, D.J., et al. (2005). Lost in translation: Challenges 

and opportunities in physician-to-physician communication during patient handoffs. Academic Medicine, 

80(12), 1094-1099.

145 Royal, H.D., Siegel, B.A., and W.A. Murphy Jr., supra note 144. 

146 Ofri, D., Associate Professor, New York University School of Medicine, and Editor-In-Chief, “Bellevue Literary 

Review.” (2013). Incidental Findings in the Clinic. Presentation to PCSBI, April 30. Retrieved from http://

bioethics.gov/node/1619.

147 Bal, B.S. (2009). An Introduction to medical malpractice in the United States. Clinical Orthopaedics and Related 

Research, 467(2), 340; Peeples, R., et al. (2002). The process of managing medical malpractice cases: The role of 

standard of care. Wake Forest Law Review, 37, 877.
124

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

148 Clayton, E., et al. (2013). Managing incidental genomic findings: Legal obligations of clinicians. Genetics in 

Medicine, 15(8), 624-629. (Searching all federal and state cases using legal databases and identifying eight cases 

involving medical malpractice and incidental findings). 

149 Ibid. 

150 Riley v. Stone, 900 A.2d 1087 (R.I. 2006). 

151 Pellegrino, E.D, and D.C. Thomasma, supra note 18, at 89.

152 Beauchamp, T.L., and J.F. Childress, supra note 7.

153 Quill, T.E., and H. Brody. (1996). Physician recommendations and patient autonomy: Finding a balance 

between physician power and patient choice. Annals of Internal Medicine, 125(9), 763-769; Charles, C., Gafni, 

A., and T. Whelan. (1997). Shared decision-making in the medical encounter: What does it mean? (Or it takes 

at least two to tango). Social Science and Medicine, 44(5), 681-692; Charles, C., Gafni, A., and T. Whelan. 

(1999). Decision-making in the physician-patient encounter: Revisiting the shared treatment decision-making 

model. Social Science and Medicine, 49(5), 651-661.

154 Stiggelbout, A.M., et al. (2012). Shared decision making: Really putting patients at the centre of healthcare. 

BMJ, 344, e256; Elwyn, G., et al. (2012). Shared decision making: A model for clinical practice. Journal 

of General Internal Medicine, 27(10), 1361-1367; Siegler, M. (1985). The progression of medicine: From 

physician paternalism to patient autonomy to bureaucratic parsimony. Archives of Internal Medicine, 145(4), 

713-715; The National Commission for the Protection of Human Subjects of Biomedical and Behavioral 

Research, supra note 64.

155 Quill, T.E., and H. Brody, supra note 153; Charles, C., Gafni, A., and T. Whelan (1997), supra note 153; 

Charles, C., Gafni, A., and T. Whelan (1999), supra note 153. 

156 Townsend, A., et al. (2012). “I want to know what’s in pandora’s box”: Comparing stakeholder perspectives on 

incidental findings in clinical whole genome sequencing. American Journal of Medical Genetics, 158A(10), 2519-

2525; Shalowitz, D.I., and F.G. Miller. (2005). Disclosing individual results of clinical research: implications of 

respect for participants. JAMA, 294(6), 737-740.

157 Townsend, A., et al., supra note 156, at 2519.

158 Whitney, S.N., and L.B. McCullough, supra note 136, at 33.

159 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra

note 64.

160 MacIntyre, A., supra note 68. 

161 Richardson, H.S., and L. Belsky. (2004). The ancillary-care responsibilities of medical researchers: An ethical 

framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report, 

34(1), 25-33; Pellegrino, E.D., and D.C. Thomasma. (1988). For the Patient’s Good: The restoration of beneficence 

in health care. New York, NY: Oxford University Press, Chapter 4; McCullough, L.B. (1997). John Gregory 

(1724-1773) and the Invention of Professional Relationships in Medicine. Journal of Clinical Ethics, 8(1), 11-21.

162 Garner, B.A. (Ed.). (2004). Black’s Law Dictionary. St. Paul, MN: West Publishing Co.

163 See Provision 2: “The nurse’s primary commitment is to the patient, whether individual, family, group, or 

community.” Interpretation 2.1 establishes the primacy of patient’s interests and interpretation 2.2 directs 

nurses to minimize unreasonable conflict between patient care and direct personal gain. See Provision 3: “The 

nurse promotes, advocates for, and strives to protect the health, safety, and rights of the patient.” American 

Nurses Association. (2001). Code of Ethics for Nurses with Interpretive Statements. Retrieved from http://

nursingworld.org/MainMenuCategories/EthicsStandards/CodeofEthicsforNurses/Code-of-Ethics.pdf. 

164 Therapeutic parsimony derives from the virtue of temperance. Pellegrino, E.D., and D.C. Thomasma, supra note 

18, at 122.

165 Jansen, L.A. (2013). Between beneficence and justice: The ethics of stewardship in medicine. Journal of Medicine 

and Philosophy, 38(1), 50-63.
ENDNOTES VIII

125

166 Biegler, N., et al. (2012). Management of incidental findings in the trauma patient: Is the trauma team a 

primary care provider as well? Journal of Trauma Nursing, 19(1), 23-32.

167 Jansen ascribes the responsible use of a society’s medical resources to an ethical duty of stewardship. See Jansen, 

L.A., supra note 165.

168 PCSBI, supra note 70, at 30-31, 161-166.

169 Kaiser Family Foundation. (2011, April 12). Snapshots: Healthcare Spending in the United States 

& Selected OECD Countries [Webpage]. Retrieved from http://kff.org/health-costs/issue-brief/

snapshots-health-care-spending-in-the-united-states-selected-oecd-countries/.

170 Gillon, R. (1985). Justice and allocation of medical resources. British Medical Journal, 27(291), 266-268.

171 Ibid; Jansen, L.A., supra note 165. 

172 Ibid. 

173 McKneally, M.F., et al. (1997). Bioethics for clinicians: Resource allocation. Canadian Medical Association 

Journal, 157(2), 163; PCSBI, supra note 70. 

174 Sonnenberg, A., and C.R. Boardman. (2013). Costs of fear. American Journal of Gastroenterology, 108, 173-175.

175 American Boards of Internal Medicine (ABIM) Foundation. (n.d.). Choosing Wisely: An initiative of the ABIM 

Foundation [Webpage]. Retrieved from http://www.choosingwisely.org/.

176 Berland, L.L., et al., supra note 111. 

177 Ofri, D., supra note 146. 

178 Health disparities are evident in disparate access to medical services and medical technologies. Dubay, L.C., and 

L.A. Lebrun. (2012). Health, behavior, and health care disparities: Disentangling the effects of income and race 

in the United States. International Journal of Health Services, 42(4), 607-625.

179 Kole, J., and A. Fiester, supra note 12.

180 Whitney, S.N., and L.B. McCullough, supra note 136, 33-38.

181 Beach, D., Swischuk, J.L., and H.B. Smouse. (2006). Using midlevel providers in interventional radiology. 

Seminars in Interventional Radiology, 23(4), 332; Kole, J., and A. Fiester, supra note 12. 

182 Kole, J., and A. Fiester, supra note 12.

183 It might be difficult in practice, however, to shield patients from seeing information in their electronic medical 

records. Accessing records online, or even through a mobile application, gives patients immediate access to 

several data components including information regarding medication administration, physical assessment, past 

medical history, lifestyle, diagnoses, and procedures. Freudenheim, M. (2012, October 8). The ups and downs 

of electronic medical records. New York Times. Retrieved from http://www.nytimes.com/2012/10/09/health/

the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=all&_r=0; Hayrinen, 

K., Saranto, K., and P. Nykanen. (2008). Definition, structure, content, use and impacts of electronic health 

records: A review of the research literature. International Journal of Medical Informatics, 77(5), 291-304. To 

the extent possible, while designing such patient access portals, clinics should attempt to protect patients who 

opt out of such information. Patients who do not wish to receive all of the medical information also bear some 

responsibility to avoid such situations where concealing this information might be impossible.

184 Moore, R.A., et al., supra note 13, at 2. 

185 Studies show that people tend to overestimate the risk of rare events by 100-fold and underestimate the risk of 

common events by a factor of 10. Moore, R.A., et al., supra note 13. 

186 Nelson, W., et al., supra note 14. 

187 CMS, supra note 15. 

188 The Lewin Group. (2005, July). The Value of Diagnostics Innovation, Adoption and Diffusion into Health. 

Retrieved from http://www.lewin.com/~/media/Lewin/Site_Sections/Publications/ValueofDiagnostics.pdf. 
126

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

189 CDC, supra note 16. 

190 Pickhardt, P.J., et al., supra note 116, at 158; Scherer, R., Knudsen, A., and S.D. Pearson. (2008). CT 

colonography for colorectal cancer screening. Institute for Clinical and Economic Review, p. 6. Retrieved from 

http://www.icer-review.org/index.php/CT-Colonography/View-category.html?dir=ASC&limit=5&order=date.

191 Volk, M.I., and P.A. Ubel, supra note 91. 

192 Hernandez, J.S., supra note 17. 

193 Ibid; Ramsey, S.D., et al., supra note 17.

194 The ethical use of cost effectiveness assessments is important for health policy makers to consider. From one 

perspective, such information can help inform the most efficient use of limited health resources, thereby 

maximizing health outcomes for the larger population. From another perspective, efficiency is only one value 

among many that can inform the development of ethically sound health policy. For an overview, see Brock, D. 

(2004). Ethical Issues in the Use of Cost Effectiveness Analysis for the Prioritization of Health Resources. In 

G. Khushf, (Ed.). Handbook of Bioethics: Taking Stock of the Field from a Philosophical Perspective (pp. 353-380). 

Dordrecht: Kluwer Academic Publishers. 

195 Those who possess it have the “deliberative capacity to reason well with respect to the means to be used to attain 

the good of the activity in which we have been engaged.” Pellegrino, E.D., and D.C. Thomasma, supra note 18, 

at 90.

196 Aristotle, supra note 19, at 124.

197 Pellegrino, E.D., and D.C. Thomasma, supra note 18, at 87.

198 An application of Polanyi’s theory of “tacit knowledge” to Pellegrino’s clinical prudence suggests that much of 

medical decision making is tacit. Tacit knowledge involves the use of intuition, but this is distinct from purely 

subjective intuition, or in ethical contexts what might be more commonly considered following one’s personal 

moral conscience. Rather, the “personal knowledge” of professional judgment draws from the individual 

experiences that help professionals to inform their ability to detect and solve problems. See Henry, S.G. (2006). 

Recognizing tacit knowledge in medical epistemology. Theoretical Medicine and Bioethics, 27(3), 187-213.

199 See, e.g., American Association of Clinical Endocrinologists (AACE). (n.d.). AACE Guidelines: Disclaimer 

[Webpage]. Retrieved from https://www.aace.com/publications/guidelines; American Thyroid Association. 

(n.d.). American Thyroid Association Professional Guidelines [Webpage]. Retrieved from http://

thyroidguidelines.net/.

200 Chandra, A., and J.S. Skinner. (2012). Technology growth and expenditure growth in health care. Journal of 

Economic Literature, 50(3), 645-680; Hellinger, F.J. (1996). The impact of financial incentives on physician 

behavior in managed care plans: A review of the evidence. Medical Care Research and Review, 53(3), 294-314. 

201 Levin, D.C., et al. (2008). Ownership or leasing of MRI facilities by nonradiologist physicians is a rapidly 

growing trend. Journal of the American College of Radiology, 5(2), 105-109; Iglehart, J.K. (2006). The new era 

of medical imaging—Progress and pitfalls. New England Journal of Medicine, 354(26), 2822-2828; Coyle, 

S.L. (2002). Physician–industry relations. Part 1: Individual physicians. Annals of Internal Medicine, 136(5), 

396-402.

202 Coyle, S.L., supra note 201. 

203 For example, imaging scans might require analyzing the entire field captured by the scan, not selectively 

focusing on the organ of immediate concern and deliberately ignoring the rest. Budoff, M.J., Fischer, H., 

and A. Gopal. (2006). Incidental findings with cardiac CT evaluation: Should we read beyond the heart? 

Catheterization and Cardiovascular Interventions, 68(6), 971. 

204 Agency for Healthcare Research and Quality, supra note 21. 

205 CDC, supra note 110. 

206 Humphrey, L., et al., supra note 141. 
ENDNOTES VIII

127

207 U.S. Preventive Services Task Force, supra note 141; U.S. Preventive Services Task Force. (2013). Screening for 

Lung Cancer: Systematic Review to Update the U.S. Preventive Services Task Force Recommendation Statement, 

Evidence Synthesis Number 105. (AHRQ Publication No. 13-05196-EF-1). Rockville, MD. Retrieved from 

http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanes105.pdf.

208 Berland, L.L., supra note 116.

209 CMS, supra note 15.

210 Miller, F.G., Mello, M.M., and S. Joffe. (2008). Incidental findings in human subjects research: What do 

investigators owe research participants? Journal of Law, Medicine & Ethics, 36(2), 277; Richardson, H.S., and 

M. Cho. (2012). Secondary researchers’ duties to return incidental findings and individual research results: 

A partial entrustment account. Genetics in Medicine, 14(4), 467-472; Richardson, H.S., supra note 22, at 

Chapter 6.

211 For a discussion of depth and duration see Richardson, H.S., and L. Belsky, supra note 161; Richardson, H.S., 

supra note 22, at 161-163; and Wolf, S.M., et al., supra note 3; For a discussion of degrees of separation between 

researchers and subjects see Ravitsky, V., and B.S. Wilfond. (2006). Disclosing individual genetic results to 

research participants. American Journal of Bioethics, 6(6), 8-17.

212 Kirschen, M.P., Jaworska, A., and J. Illes. (2006). Subjects’ expectations in neuroimaging research. Magnetic 

Resonance Imaging, 23(2), 205-209.

213 Miller, F.G., and H. Brody. (2002). What makes placebo-controlled trials unethical? American Journal of 

Bioethics, 2(2), 3-9; Parker, L.S. (2006). Best laid plans for offering results go awry. American Journal of Bioethics, 

6(6), 22-23; Sharp, H.M., and R.D. Orr. (2010). When “minimal risk” research yields clinically-significant 

data, maybe the risks aren’t so minimal. American Journal of Bioethics, 4(2), 33.

214 The Royal College of Radiologists. (2010). Management of Incidental Findings Detected During Research. 

London: The Royal College of Radiologists. Retrieved from https://www.rcr.ac.uk/docs/radiology/pdf/

BFCR(11)8_Ethics.pdf.

215 Kirschen, M.P., Jaworska, A., and J. Illes, supra note 212. 

216 Caulfield, T., et al., (2008). Research ethics recommendations for whole-genome research: Consensus statement. 

PLoS Biology, 6(3), 430-434; Cho, M. (2008). Understanding Incidental Findings in the Context of Genetics 

and Genomics. Journal of Law, Medicine & Ethics, 36(2), 280-285; Fabsitz, R.R., et al. (2010). Ethical and 

practical guidelines for reporting genetic research results to study participants: Updated guidelines from a 

National Heart, Lung and Blood Institute working group. Circulation: Cardiovascular Genetics, 3(6), 574-580; 

Ravitsky, V., and B.S. Wilfond, supra note 211.

217 Kohane, I.S., and P.L. Taylor. (2010). Multidimensional results reporting to participants in genomic studies: 

Getting it right. Science Translational Medicine, 2(37), 1-4.

218 Caulfield, T., et al., supra note 216; Fabsitz, R.R., et al., supra note 216; Kohane, I.S., and P.L. Taylor, supra

note 217. 

219 Fabsitz, R.R., et al., supra note 216.

220 Bombard, Y., Offit, L., and M.E. Robson. (2012). Risks to relatives in genomic research: A duty to warn. 

American Journal of Bioethics, 12(10), 12-14; Keane, M.A. (2008). Incidental findings in human subjects 

research: From imaging to genomics – Institutional review board approaches to the incidental findings problem. 

Journal of Law, Medicine & Ethics, 36(2), 352-355; Schmidt, C.O., et al., supra note 116. 

221 Bombard, Y., Offit, L., and M.E. Robson, supra note 220; Keane, M.A., supra note 220. 

222 Fernandez, C.V., Kodish, E., and C. Weijer. (2003). Informing study participants of research results: An ethical 

imperative. IRB, 25(3), 12-19; Illes, J., and V.N. Chin, supra note 101, at 298-312; Illes, J., et al., supra note 

49, at 783-784; Terry, S.F. (2012).The tension between policy and practice in returning research results and 

incidental findings in genomic biobank research. Minnesota Journal of Law, Science & Technology, 13, 691.
128

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

223 The Clinical Laboratory Improvement Amendments (CLIA) was passed in 1988 as a means of establishing 

standards of accuracy and reliability of all laboratory results intended for clinical use. Laboratory Requirements, 

53 Fed. Reg. 29590 (Aug. 5, 1988). 

224 See, e.g., Wolf, S.M. (2012). The role of law in the debate over return of research results and incidental findings: 

The challenge of developing law for translational science. Minnesota Journal of Law, Science & Technology, 13(2), 

435-448.

225 Wolf, S., Paradise, J.D., and C. Caga-anan. (2008). The law of incidental findings in human subjects 

research: Establishing researchers’ duties. Journal of Law, Medicine & Ethics, 36(2), 361-383; Wolf, S.M. et 

al., supra note 3.

226 Protection of Human Subjects, HHS. 45 C.F.R. § 46.116 (b)(5). 

227 Health Insurance Portability and Accountability Act (HIPAA), 110 Stat. 1936 (1996). 

228 Ibid.

229 Gordon, M.P., supra note 34, at 225-260. In 2011, CMS and the U.S. Department of Health and Human 

Services Office for Civil Rights proposed a rule that would modify HIPAA to require clinical labs to 

directly report laboratory test results to patients upon request. This proposed rule is unlikely to apply to 

research participants as the rule is limited to patients, though it is possible that either in its final form or 

as implemented CMS could enlarge the rule to include individuals who are research participants. The rule 

is also limited to CLIA-certified laboratories and would not apply to research laboratories that are not 

CLIA-certified. CLIA Program and HIPAA Privacy Rule; Patients Access to Test Reports, 76 Fed. Reg. 56, 

712-56, 724. (Sept. 14, 2011). 

230 CLIA, 57 Fed Reg. 7139, 493.3 (b)(2) (Feb. 28, 1992); Fabsitz, R.R., et al., supra note 216.

231 Fabsitz, R.R., et al., supra note 216.

232 National Research Council and Institute of Medicine Committee on Guidelines for Human Embryonic 

Stem Cell Research. (2005). Guidelines for Human Embryonic Stem Cell Research. Washington, DC: National 

Academies Press; Wolf, S.M., et al., supra note 3. 

233 Pike, E.R., Rothenberg, K., and B.E. Berkman. (2013). Finding fault?: Exploring legal duties to return 

incidental findings in genomic research. Georgetown Law Journal [forthcoming]; Zarzeczny, A., and T. 

Caulfield. (2012). Legal liability and research ethics boards: The case of neuroimaging and incidental findings. 

International Journal of Law and Psychiatry, 35(2), 137-145.

234 See, e.g., Knoppers, B.M., and R. Chadwick. (2005). Human genetic research: Emerging trends in ethics. 

Nature Reviews Genetics, 6(1), 75-79; Kristman, V.I., and N. Krieger. (2008). Information disclosure in 

population-based research involving genetics: A framework for the practice of ethics in epidemiology. Annals 

of Epidemiology, 18(4), 335-341; Ravitsky, V., and B.S. Wilfond, supra note 211. For a discussion of traditional 

research ethics principles see The National Commission for the Protection of Human Subjects of Biomedical 

and Behavioral Research, supra note 64; and PCSBI, supra note 70. 

235 PCSBI, supra note 70. 

236 Richardson, H.S., supra note 22. 

237 Ravitsky, V., and B.S. Wilfond, supra note 211. 

238 Rothstein, M.A. (2013). Should researchers disclose results to descendants. American Journal of Bioethics, 13(10), 

64-65.

239 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra

note 64 (“The obligations of beneficence affect both individual investigators and society at large, because they 

extend both to particular research projects and to the entire enterprise of research. In the case of particular 

projects, investigators and members of their institutions are obliged to give forethought to the maximization 

of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific 

research in general, members of the larger society are obliged to recognize the longer term benefits and risks that 

may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, 

and social procedures.”).
ENDNOTES VIII

129

240 Miller, F.G., Mello, M.M., and S. Joffe. (2008). Incidental findings in human subjects research: What do 

investigators owe research participants? Journal of Law, Medicine & Ethics, 36(2), 276; Richardson, H.S., supra

note 22, at Chapter 3.

241 Richardson, H.S., supra note 22, at Chapter 3. 

242 Black, W.C., and H.G. Welch. (1993). Advances in diagnostic imaging and overestimations of disease 

prevalence and the benefits of therapy. New England Journal of Medicine, 328(17), 1237-1243.

243 For a discussion of harm related to return of findings see Miller, F.G., Mello, M.M., and S. Joffe, supra note 210, 

at 271-279; Meacham, M.C., et al. (2010). Researcher perspectives on disclosure of incidental findings in genetic 

research. Journal of Empirical Research, 5(3), 31-41; For a contrasting view see Biesecker, L., Chief and Senior 

Investigator, Genetic Disease Research Branch, National Human Genome Research Institute. (2013, May 14). 

Comments submitted to PCSBI.

244 Berg, J.S., et al. (2013). An informatics approach to analyzing the incidentalome. Genetics in Medicine, 15(1), 

36-44; Rangel, E.K. (2010). Management of incidental findings in neuro-imaging research: Framework and 

recommendations. Journal of Law, Medicine & Ethics, 38(1), 117-126.

245 Rangel, E.K., supra note 244. 

246 Wolf, S.M., et al., supra note 3. 

247 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra

note 64; PCSBI, supra note 70, at 6.

248 PCSBI, supra note 70, at 24-25.

249 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra

note 64.

250 National Cancer Institute. (2003). Area Socioeconomic Variations in U.S. Cancer Incidence, Mortality, Stage, 

Treatment, and Survival, 1975-1999. NCI Cancer Surveillance Monograph Series, Number 4. (NIH Publication 

No. 03-0000). Bethesda, MD: National Cancer Institute. Retrieved from http://open-dev.umms.med.umich.

edu/sites/default/files/1232/reading-resources-1/Singh-fullarticle.pdf.

251 PCSBI, supra note 70, at 141-142.

252 Ibid, at 27-28, 141-145.

253 Ibid.

254 Ibid.

255 Ibid, at 28, 141. 

256 Richardson, H.S., supra note 22; Knoppers, B.M., et al., supra note 22. 

257 Protection of Human Subjects, HHS, supra note 23. 

258 Fabsitz, R.R., et al., supra note 216. 

259 Drazin, D., et al., supra note 129. 

260 Some health insurers now require that genetic counseling accompany testing for genetic predispositions to 

diseases like breast cancer. Genetic counseling helps patients (and research participants) better understand 

and interpret the nature of genetic findings, and can alleviate fears and anxieties about the results. See, e.g., 

Langreth, R. (2013, August 19) Cigna demands counseling for breast test in myriad threats. Bloomberg. 

Retrieved from http://mobile.bloomberg.com/news/2013-08-19/cigna-demands-counseling-for-breast-test-inmyriad-threat.html?source=email_rt_mc_body.

261 Green, R.C., Associate Director for Research, Partners HealthCare Center for Personalized Genetic Medicine, 

Associate Professor of Medicine, Division of Genetics, Brigham and Women’s Hospital and Harvard Medical 

School. (2013). Presentation to PCSBI, April 30. Retrieved from http://bioethics.gov/node/1616.
130

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

262 The availability of DTC biological specimens testing and imaging has grown over the last decade. DTC genetic 

testing has also increased over this period, though there has been a contraction in the DTC genetic services 

market during the last several years. Mathews, A.W. (2011, January 11). Worried about cholesterol? Order your 

own tests. Wall Street Journal. Retrieved from http://online.wsj.com/article/SB1000142405274870445820457

6073913850150324.html (Stating that DTC lab tests are “a small but growing part of the overall lab industry” 

and estimating that people are “spending about $20 million a year for such tests, and the segment [i]s growing 

at 15% to 20% annually.”); Wallace, E.A., Schumann, J.H., and S.E. Weinberger. (2012). Ethics of commercial 

screening tests. Annals of Internal Medicine, 157(10), 747-748 (discussing the growth of DTC imaging services); 

Su, Y., Howard, H.C., and P. Borry. (2011). Users’ motivations to purchase direct-to-consumer genome-wide 

testing: An exploratory study of personal stories. Journal of Community Genetics, 2(3), 135-146 (Stating that the 

DTC genetic testing market has rapidly expanded); Allison, M. (2012). Direct-to-consumer genomics reinvents 

itself. Nature Biotechnology, 30(11), 1027-1029 (explaining that “DTC genomics has changed dramatically over 

the past few years...some companies—those with actual products—have turned from working directly with 

consumers to offering their tests only through physicians, in part because of FDA pressure, but also because 

consumer demand appears to be lackluster.”). 

263 The discovery and return of incidental findings in the DTC context takes place within the larger domain of 

general DTC business practices. For this reason, a thorough consideration of incidental findings in the DTC 

context must take into account the ethically relevant aspects of these general practices. A complete analysis of 

the ethics of such larger phenomena as the commercialization of health care in the United States, skyrocketing 

costs for both consumers and government, and issues of access to clinical care are beyond the scope of this 

report. This analysis addresses these larger factors only to the extent that they clarify what must be done to 

anticipate and respond to consumers’ sensitive information.

264 See, e.g., FDA. (n.d.). First Rapid Home-Use HIV Kit Approved for Self-Testing [Webpage]. Retrieved from 

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm310545.htm; and Office on Women’s Health. (n.d.). 

Pregnancy tests fact sheet [Webpage]. Retrieved from http://womenshealth.gov/publications/our-publications/

fact-sheet/pregnancy-tests.cfm.

265 Mathews, A.W., supra note 262. 

266 DirectLabs explains on its website “[w]e respect your privacy and maintain confidentiality. You are the only one 

who receives the results unless you specify otherwise, with a signed HIPAA release. Not even your insurance 

company will obtain results from DLS [DirectLabs] and/or its associates without written consent from you.” 

DirectLabs. (2013). Frequently Asked Questions [Webpage]. Retrieved from https://www.directlabs.com/

AboutUs/FAQ/tabid/65/language/en-US/Default.aspx.

267 Su, Y., Howard, H.C., and P. Borry, supra note 262. 

268 Mountain, J., supra note 54.

269 Hogarth, S., Javitt, G., and D. Melzer. (2008). The current landscape for direct-to-consumer genetic testing: 

Legal, ethical, and policy issues. Annual Review of Genomics Human Genetics, 9, 161-182.

270 For example, Connecticut has banned DTC fetal ultrasounds. Maine allows for testing without a physician’s 

referral for glucose, colon cancer, pregnancy, and cholesterol tests, but prohibits other tests. Genetics and Public 

Policy Center. (2007). Publication Announcement: Comparison of State Laws for Direct-to-Consumer Testing 

[Press release]. Retrieved from http://www.dnapolicy.org/news.release.php?action=detail&pressrelease_id=81.

271 Genetics and Public Policy Center. (2007). Survey of Direct-to-Consumer Testing Statues and Regulations. 

Retrieved from http://www.dnapolicy.org/resources/DTCStateLawChart.pdf; Schlanger, S. (2011). Filling in 

the cracks: Improving the regulation of direct-to-consumer genetic tests. Journal of Health Care Law and Policy, 

14, Supp. 11, S1-S29.

272 Schlanger, S., supra note 271. 

273 In addition to being regulated for safety by FDA as medical devices, imaging products, including CT, 

MRI, and ultrasonography products, are also regulated for safety by FDA as radiation-emitting electronic 

products. FDA. (2010). Does the Product Emit Radiation? [Webpage]. Retrieved from http://www.fda.gov/

MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051504.htm; FDA. 

(2010). Full-Body CT Scans—What You Need to Know. [Webpage]. Retrieved from http://www.fda.gov/

Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/

ucm115340.htm.
ENDNOTES VIII

131

274 FDA, supra note 273. 

275 See, e.g., Warning letter from Alberto Gutierrez to Ann Wojcicki. (2013, November 22). Retrieved from 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm; Although as DTC 

genetic testing companies move away from providing sequencing interpretation and corresponding health 

care information to providing either sequencing data or medical information, FDA will face new challenges 

to regulation. Spector-Bagdady, K. and E.R. Pike (Forthcoming, 2014). Consuming Genomics: Regulating 

Direct-to-Consumer Genomic Interpretation. Nebraska Law Review. 

276 CMS. (2013). Clinical Laboratory Improvement Amendments (CLIA) [Webpage]. Retrieved from http://www.

cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/.

277 Federal Trade Commission, Promotion of Export Trade and Prevention of Unfair Methods of Competition, 15 U.S.C. 

§§ 41-58. 

278 Letter from Michael Perschuck, et al., Chairman, Federal Trade Commission, to Wendell H. Ford, Chairman, 

Consumer Subcommittee, and John C. Danforth, Ranking Minority Member, Consumer Subcommittee, 

Committee on Commerce, Science, and Transportation. (1980, December 17). FTC Policy Statement on 

Unfairness. Retrieved from http://www.ftc.gov/bcp/policystmt/ad-unfair.htm.

279 Letter from James C. Miller III, Chairman, Federal Trade Commission, to John D. Dingell, Chairman, 

Committee on Energy and Commerce. (1983, October 14). FTC Policy Statement on Deception. Retrieved 

from http://www.ftc.gov/bcp/policystmt/ad-decept.htm.

280 A contract is a promise that the law will enforce, or the performance of which will, in some way, be recognized 

as a legal duty. John Edward Murray, Murray on Contracts Chapter 1 §2 (5th ed. 2011). See also E. Allan 

Farnsworth, Contracts §1.1 4 (4th ed. 2004).

281 Some commentators have questioned courts that narrowly rely on the terms and conditions provided by an 

online company without taking into account other information and representations made elsewhere on the 

website. See Hartzog, W. (2011). Website design as contract. American University Law Review, 60, 1635-1671. 

282 Ossorio, P.N. (2001). Product liability for predictive genetic tests. Jurimetrics Journal, 41, 239-260.

283 Ibid. 

284 Smith, A. (1976). An Inquiry into the Nature and Causes of the Wealth of Nations. R.H. Campbell, A.S. Skinner, 

and W.B. Todd. (Eds). Oxford: Oxford University Press. 

285 Ibid; Stigler, G.J. (1957). Perfect competition, historically contemplated. Journal of Political Economy, 65(1), 1-17.

286 MacIntyre, A., supra note 68; Richardson, H.S., supra note 22, at 75-76; Scanlon, T.S., supra note 68. 

287 American Medical Association. (2005). Report of the Council on Ethical and Judicial Affairs: 

Direct-to-Consumer Diagnostic Imaging Tests. Retrieved from http://www.ama-assn.org/resources/doc/codemedical-ethics/8045a.pdf.

288 This argument for the professional duties of DTC providers is based on Henry Richardson’s analogous 

arguments regarding researchers. Richardson, H.S., supra note 22, at 59-98.

289 PCSBI, supra note 70, at 16-18.

290 Ibid, at 28, 141.

291 Ibid, at 141.

292 Ibid, at 5.

293 23andMe. (2012, September 7). Customer Care: What health conditions are not covered by 

23andMe’s Personal Genome Service? [Webpage]. Retrieved from https://customercare.23andme.com/

entries/21979637-What-health-conditions-are-not-covered-by-23andMe-s-Personal-Genome-Service-.

294 CPSC, supra note 24; NHTSA, supra note 24; FCC, supra note 24. 

295 Carson, T.L., supra note 25. 

296 Ibid. 
132

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

297 Donaldson, T., supra note 27. 

298 Pharmaceutical Research and Manufacturers of America (PhRMA). (n.d.). Ethical relationships with health 

care professionals are critical to our mission [Webpage]. Retrieved from http://www.phrma.org/code-oninteractions-with-healthcare-professionals; PhRMA. (2009). 105 CMR970.000: Pharmaceutical and Medical 

Device Manufacturer Conduct. Retrieved from http://policymed.typepad.com/files/mass-code-of-conduct----

final-3-11-09.pdf; See, e.g., Cal. Health & Safety §§ 119400-119402 (Deering 2005).

299 American Medical Association, supra note 287. 

300 American Institute of Ultrasound in Medicine. (2012). Keepsake Fetal Imaging. Retrieved from http://www.

aium.org/officialStatements/31. 

301 Mountain, J., supra note 54.

302 Inherent Health. (2009). Frequently Asked Questions [Webpage]. Retrieved from http://www.inherenthealth.

com/faq.aspx#S5Q2.
133

APPENDICES
134

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

American College 

of Medical Genetics 

and Genomics 

(ACMG), ACMG 

Recommendations 

for Reporting of 

Incidental Findings 

in Clinical Exome and 

Genome Sequencing 

(2013)*

Clinical; 

Large-Scale 

Genetic 

Sequencing

When large-scale genetic sequencing is conducted in the clinic, “a 

minimum list of conditions, genes and variants should be routinely 

evaluated and reported to the ordering clinician who can place them 

into the context of that patient’s medical and family history, physical 

examination and other laboratory testing.”

Only known variants of tested genes should be reported.

Any findings arising from such evaluation should be reported by 

laboratories “without seeking preferences from the patient and family 

and without limitation due to the patient’s age.” 

A clinician “should be properly trained and prepared in genetics and 

genomics with an understanding of genetic counseling, pedigree 

analysis and risk assessment to provide pre-test and post-test 

patient care associated with clinical sequencing.”

“It is the responsibility of the ordering clinician/team to provide 

comprehensive pre- and post-test counseling for the patient.”

Public Population 

Project in 

Genomics and 

Society, Population 

Studies: Return of 

Research Results and 

Incidental Findings 

Policy Statement 

(2013)†

Research 

(Biobank); 

Large-Scale 

Genetic 

Sequencing

Disclosure of individual research results and incidental findings to 

subjects should be considered when:

•	 “the participant has consented thereto in the initial consent form 

or at a later time;

•	 the findings are analytically valid (i.e., confirmed independently);

•	 they reveal a significant risk of a serious health condition; and 

•	 they are actionable.”

Disclosure of individual research results and incidental findings to 

subjects might be considered when:

•	 “the participant has consented thereto in the initial consent form 

or at a later time;

•	 the findings are analytically valid (i.e., confirmed independently);

•	 they reveal an established risk of likely health importance to the 

participant; and 

•	 they have a likely therapeutic benefit.”

National Human 

Genome Research 

Institute, 

Federal Policy 

Recommendations 

Including [the Health 

Insurance Portability 

and Accountability 

Act (HIPAA)] (2012)‡

Research;

Large-Scale 

Genetic 

Sequencing

Individual research results should be available to participants except when:

•	 “[t]he information includes information obtained under a promise 

of confidentiality, is about another person, and patient inspection 

would cause harm to another individual...”

•	 [a]ccess would break the ‘masking’ of the study or otherwise 

significantly interfere with the conduct or results of the study; or

•	 [t]he research results are of unproven clinical validity, and the IRB 

has judged that there is no benefit to the research subjects.” In 

this latter case, “the informed consent must explicitly state that 

individual research results will not be shared.”

Appendix I: Past National Recommendations Regarding Incidental and 

Secondary Findings

* Green, R.C., et al. (2013). ACMG recommendations for reporting of incidental findings in clinical exams and genome 

sequencing. Genetics in Medicine, 15(4), 565-574; American College of Medical Genetics and Genomics. (2013). 

Incidental Findings in Clinical Genomics: A Clarification—A Policy Statement of the American College of Medical 

Genetics and Genomics, Bethesda, MD. Retrieved from https://www.acmg.net/docs/Incidental_Findings_in_Clinical_

genomics_A_Clarification.pdf.

† Knoppers, B.M., et al. (2013). Population studies: Return of research results and incidental findings Policy Statement. 

European Journal of Human Genetics, 21(3), 245-247 (formatting changed for Appendix presentation).

‡ National Human Genome Research Institute. (2012, February 28). Federal Policy Recommendations Including HIPAA. 

Retrieved from http://www.genome.gov/11510216.
IX

135

Appendix I: Past National Recommendations Regarding Incidental and Secondary Findings

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Wolf, Susan, et al., 

Managing Incidental 

Findings and 

Research Results in 

Genomic Research 

Involving Biobanks 

and Archived 

Datasets (2012)*

Research;

Large-Scale 

Genetic 

Sequencing

Biobanks should strive to:

•	 Fulfill their responsibilities with respect to incidental findings.

•	 Develop explicit policy on whether incidental findings and 

individual research results should be returned by:

» “[c]larifying the criteria for evaluating findings and the roster 

of returnable [incidental findings] and [individual research 

results];”

» “[a]nalyzing a particular finding to decide whether it should be 

offered to the contributor;”

» re-identifying that contributor; and

» re-contacting the contributor to offer the finding.

•	 “[A]nalyze whether a particular finding qualifies as an [incidental 

finding] or [individual research result] that should be offered to a 

consenting contributor or contributors.”

•	 Anticipate how they will handle identification, re-identification, 

and re-contacting of contributors.

Researchers in the biobank research system should offer to return 

incidental findings and individual research results that meet all of 

the following criteria:

•	 “[t]he findings are analytically valid;

•	 [r]eturning them to the contributor comports with applicable law, 

including [the Clinical Laboratory Improvement Amendments] 

(CLIA) (which may require ascertaining or verifying results in a 

CLIA-certified lab);

•	 [t]he contributor has been offered the option of consenting to 

return of individual findings (either in the initial informed consent 

process, or in a subsequent consent process that may be a 

request for an individual’s consent or part of a larger effort to 

elicit many contributors’ consent) and has opted to receive them;

•	 [t]he findings reveal an established and substantial risk of a 

serious health condition; and

•	 the findings are clinically actionable.”

Researchers in the biobank research system might offer to return 

incidental findings and individual research results that fail to meet 

the above criteria, if they instead meet all of the following criteria:

•	 “[t]he findings are analytically valid;

•	 [r]eturning them to the contributor comports with applicable law, 

including CLIA...;

•	 [t]he contributor has been offered the option of consenting to 

return of individual findings (either in the initial informed consent 

process or subsequently...) and has opted to receive them; and

•	 [t]he findings reveal an established and substantial risk of likely 

health or reproductive importance or personal utility to the 

contributor and return is likely to provide net benefit from the 

contributor’s perspective.”

* Wolf, S.M., et al. (2012). Managing incidental findings and research results in genomic research involving biobanks and 

archived datasets. Genetics in Medicine, 14(4), 361-384. 
136

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Freda, Pamela, 

et al., Pituitary 

Incidentaloma: An 

Endocrine Society 

Clinical Practice 

Guideline (2011)*

Clinical; Imaging Patients with an incidentally found pituitary incidentaloma should 

undergo a history and physical examination, laboratory evaluations 

screening for hormone hypersecretion and for hypopituitarism, and a 

visual field examination if the lesion touches the optic nerve or chiasm. 

Patients with pituitary incidentalomas that do not meet the criteria for 

surgical removal should have follow up including clinical assessments, 

neuroimaging, visual field examinations for incidentalomas that touch the 

optic nerve or chiasm, and endocrine testing for macroincidentalomas. 

Patients should be referred to surgery if they have a visual field deficit 

due to the lesion, signs of compression by the tumor, a lesion touching 

the optic nerves or chiasm, pituitary apoplexy with visual disturbance, 

or a hypersecreting tumor that is not a prolactinoma. 

American College 

of Radiology (ACR), 

Managing Incidental 

Findings on Abdominal 

[computed tomography 

(CT)]: White Paper of 

the ACR Incidental 

Findings Committee 

(2010)†

Clinical; Imaging Incidental findings on abdominal CT scans should be evaluated and 

addressed based on certain criteria of the mass and the organ in 

which the mass was found.

In the kidneys, cystic renal masses should be ignored or observed 

if they are less than or equal to 3 cm or if there is no measurable 

enhancement, and should be operated on if they have thickened 

irregular or smooth walls or septa, with measurable enhancement. 

Solid renal masses should be operated on if they are larger than 1 cm 

and should be observed if they are smaller than 1 cm. 

National Heart, 

Lung, and Blood 

Institute (NHLBI), 

NHLBI Working Group 

on Reporting Genetic 

Results in Research 

Studies, Meeting 

Summary (2010)‡

Research; 

Large-Scale 

Genetic 

Sequencing

Disclosure of individual research result to subjects should occur 

if/when the following are satisfied:

•	 “[t]he genetic finding has important health implications for the participant, and the associated risks are established and substantial;

•	 the genetic finding is actionable; that is, there are established 

therapeutic or preventive interventions or other available actions 

that have the potential to change the clinical course of the disease;

•	 the test is analytically valid and the disclosure plan complies with 

all applicable laws; and

•	 during the informed consent process or subsequently, the study 

participant has opted to receive his or her individual genetic results.”

Disclosure of individual research result to subjects may occur if/when 

the following are satisfied:

•	 “[t]he investigator has concluded that the potential benefits of 

disclosure outweigh the risks from the participant’s perspective; 

•	 [t]he investigator’s [institutional review board (IRB)] has approved 

the disclosure plan;

•	 [t]he test is analytically valid and the disclosure plan complies 

with all applicable laws; and

•	 [d]uring the informed consent process or subsequently, the study 

participant has opted to receive his/her individual genetic results.”

* Freda, P.U., et al. (2011). Pituitary incidentaloma: An Endocrine Society clinical practice guideline. Journal of Clinical 

Endocrinology and Metabolism, 96(4), 894-904.

† Berland, L.L., et al. (2010). Managing incidental findings on abdominal CT: White paper of the ACR Incidental Findings 

Committee. Journal of the American College of Radiology, 7(10), 754-773.

‡ Fabsitz, R.R., et al. (2010). Ethical and practical guidelines for reporting genetic research results to study participants: 

Updated guidelines from a National Heart, Lung and Blood Institute working group. Circulation: Cardiovascular 

Genetics, 3(6), 574-580 (formatting changed for Appendix presentation) (updating an earlier set of NHLBI working 

group recommendations: Brookman, E.B., et al. (2006). Reporting genetic results in research studies: Summary and 

recommendations of an NHLBI working group. American Journal of Medical Genetics Part A, 140, 1033-1040.).
IX

137

Appendix I: Past National Recommendations Regarding Incidental and Secondary Findings

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Wolf, Susan, et al.,

Managing Incidental 

Findings in Human 

Subjects Research: 

Analysis and 

Recommendations 

(2008)*

Research;

Large-Scale 

Genetic 

Sequencing

Researchers have an obligation to:

•	 plan for the types of incidental findings potentially produced and 

“consider how quickly members of the research team should bring 

a suspected [incidental finding] to the attention of the principal 

investigator and how quickly the principal investigator should act 

to evaluate the [incidental finding];”

•	 address incidental findings with research participants during the 

informed consent process;

•	 “[p]lan to verify and evaluate a suspected [incidental finding], with 

an expert consultant if needed;”

•	 “[p]lan to determine whether to report [incidental findings] based 

on likely health or reproductive importance;” and

•	 in some cases offer to disclose incidental findings directly to 

research participants.

Disclosure of incidental findings should be based on the net benefit 

of disclosure:

•	 Strong net benefit: incidental finding reveals a “condition likely 

to be life-threatening or a condition likely to be grave that can be 

avoided or ameliorated.” Researchers should offer to disclose.

•	 Possible net benefit: incidental finding might offer more benefit 

than burden to participant; reveals health condition that participant is likely to view as important. Researchers may disclose, but 

are not obligated to do so.

•	 Unlikely net benefit: incidental finding offers more burden than 

benefit. Researcher should not disclose.

Illes, Judy, et al., 

Practical Approaches 

to Incidental Findings 

in Brain Imaging 

Research (2008)†

Research;

Imaging

Researchers should:

•	 “[e]stablish a pathway for managing incidental findings that is 

fully transparent and addressed in the institutional review board 

review and consent process, including explicit language about 

how incidental findings will be handled, subject selection, and 

responsibility for follow up;”

•	 “[a]llow for...the involvement of a medical professional who is 

competent and readily available to interpret neuroimaging scans 

for clinically significant information;”

•	 “[d]isclose incidental findings to a subject or surrogate first” 

(communication is the responsibility of the principal investigator 

or a qualified member of the research team, if the principal investigator is not a physician); and

•	 “[c]ommunicate the news of an incidental finding verbally and in a 

timely manner...and follow up with written communication that 

draws on the informed consent language.”

Caulfield, 

Timothy, et al., 

Research Ethics 

Recommendations 

for Whole-Genome 

Research: Consensus 

Statement (2008)‡

Research; 

Large-Scale 

Genetic 

Sequencing 

Research involving genome sequencing should have a process for 

determining whether findings, including incidental findings, meet the 

requirements for the return to the participant. 

This process should be approved by a research ethics review entity. 

Research participants should be informed of this process during consent. 

The consent process should also acknowledge the participants’ right 

not to know certain results.

* Wolf, S.M., et al. (2008). Managing incidental findings in human subjects research: Analysis and recommendations. 

Journal of Law, Medicine & Ethics, 36(2), 220-248.

† Illes, J., et al. (2008). Practical approaches to incidental findings in brain imaging research. Neurology, 70(5), 384-390.

‡ Caulfield, T., et al. (2008). Research ethics recommendations for whole-genome research: Consensus statement. 

PLoS Biology, 6(3), 430-435.
138

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

National Research 

Council and 

Institute of 

Medicine, Guidelines 

for Human Embryonic 

Stem Cell Research 

(2005)*

Research; 

Biological 

Specimens

Obligations to report individual research results to participants 

during embryonic stem cell research should depend on: 

•	 The reliability of the findings; and

•	 The significance of the findings to the participants’ health and 

wellbeing.

Research results should not be returned if tests were not conducted 

in CLIA-approved lab.

National Institute 

of Neurological 

Disorders and 

Stroke, Detection 

and Disclosure of 

Incidental Findings 

in Neuroimaging 

Research (2005)†

Research; 

Imaging

The potential for incidental findings should be anticipated in 

experimental design.

Researchers, scientists, and clinicians should develop a plan to 

handle the discovery of an incidental finding. 

This process should include review of the neuroimaging scan by a 

competent professional. 

Communication of the incidental finding to the research subject or 

surrogate should be done by the principal investigator or another 

qualified member of the research team.

Communication of the incidental finding should be done verbally, in a 

timely manner, and documented in writing. 

Incidental findings should be included in the informed consent 

process, including information about follow up and cost of managing 

the finding. 

The process for managing an incidental finding must be completely 

transparent, and template disclosure language should be provided 

to the IRB. 

The process for managing incidental findings should not impede 

neuroimaging research, but should “highlight the responsibility of 

the research team.” 

A database of incidental findings “would be a valuable scientific 

resource.” 

Beskow, Laura M., 

et al. (U.S. Centers 

for Disease Control 

and Prevention), 

Informed Consent 

for Population-Based 

Research Involving 

Genetics (2001)‡

Research; 

Large-Scale 

Genetic 

Sequencing

“When the risks identified in the study are both valid and associated 

with a proven intervention for risk reduction, disclosure may be 

appropriate.”

* National Research Council and Institute of Medicine of the National Academies. (2005). Guidelines for Human Embryonic 

Stem Cell Research. Washington, D.C.: The National Academies Press.

† National Institutes of Health. (2005). Detection and Disclosure of Incidental Findings in Neuroimaging Research. 

Retrieved from http://www.ninds.nih.gov/news_and_events/proceedings/ifexecsummary.htm.

‡ Beskow, L.M., et al. (2001). Informed consent for population-based research involving genetics. JAMA, 286(18), 2315-2321.
IX

139

Appendix I: Past National Recommendations Regarding Incidental and Secondary Findings

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Medical Research 

Council, Human 

Tissue and Biological 

Samples for Use 

in Research – 

Operational and 

Ethical guidelines 

(2001)*

Research; 

Biological 

Specimens

When an incidental finding has “immediate clinical relevance, the 

clinician involved has a duty of care to inform the research participant, 

either directly or via the clinician responsible for his or her care. The 

clinician responsible for care should always be notified.” 

Research participants should be informed of these practices during 

consent. 

National Bioethics 

Advisory 

Commission, 

Research Involving 

Human Biological 

Materials: Ethical 

Issues and Policy 

Guidance (1999)†

Research; 

Large-Scale 

Genetic 

Sequencing 

and Biological 

Specimens

Disclosure of individual research result to participants should only 

occur if/when: 

•	 “the findings are scientifically valid and confirmed,

•	 the findings have significant implications for the subject’s health 

concerns, and 

•	 the course of action to ameliorate or treat these concerns is 

readily available.”

The “...research protocol should describe anticipated research 

findings and circumstances that might lead to a decision to disclose 

the findings.” 

“When research results are disclosed to a subject, appropriate 

medical advice or referral should be provided.”

National Human 

Genome Research 

Institute, Final 

Report of the Task 

Force on Genetic 

Testing (1997)‡

Direct-toConsumer; 

Genetic Testing 

Information from genetic tests presented directly to the public must 

be accurate and include information about the risks and limitations in 

addition to the benefits. 

Consumers should discuss testing with a health care provider. 

Advertising or marketing of predictive genetic tests is discouraged. 

* Medical Research Council. (2001, May 4). Human Tissue and Biological Samples for use in Research – Operational and 

Ethical guidelines. Retrieved from http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420.

† National Bioethics Advisory Commission (NBAC). (1999). Research Involving Human Biological Materials: Ethical Issues 

and Policy Guidance. Rockville, MD: NBAC. Retrieved from http://bioethics.georgetown.edu/nbac/hbm.pdf (formatting 

changed for Appendix presentation). 

‡ National Human Genome Research Institute. (1997, September). Promoting Safe and Effective Genetic Testing in the 

United States. Retrieved from http://www.genome.gov/10002403.
140

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Appendix II: Past International Recommendations Regarding Incidental 

and Secondary Findings 

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

European Society 

of Human Genetics, 

Whole-Genome 

Sequencing in 

Health Care: 

Recommendations of 

the European Society 

of Human Genetics 

(2013)* 

Clinical;

Large-Scale 

Genetic 

Sequencing

Targeted approaches are preferable to “avoid unsolicited findings or 

findings that cannot be interpreted.” Filtering should be used to filter 

out known genetic variants with limited or no clinical utility. 

Guidelines for informed consent regarding diagnostic testing should 

be developed. 

“Patients’ claims to a right not to know about findings do not automatically over-ride professional responsibilities...Patient groups 

could provide important input into how this should be handled.”

“[G]uidelines need to be established [regarding testing minors] as to 

what unsolicited information should be disclosed to balance” the 

interests of the child and parental rights.

Danish Council of 

Ethics, Genome 

Testing: Ethical 

Dilemmas in Relation 

to Diagnostics, 

Research and Directto-Consumer Testing 

(2012)†

Clinical, 

Research, 

and DTC; 

Large-Scale 

Genetic 

Sequencing

Large-scale genetic testing should be “accompanied by impartial and 

comprehensive information as well as counseling, both before and after 

testing,” whether conducted in the clinic, research, or DTC setting.

Patients should be given a “degree of involvement in deciding whether, 

and to what extent, they are to receive feedback on any incidental findings.” The conversation should take place prior to testing. 

“Clinical trial subjects should not be offered information about genetic 

risk factors.”

PHG Foundation 

[UK], Next Steps in 

the Sequence: The 

Implications of Whole 

Genome Sequencing 

for Health (2011)‡

Clinical; 

Large-Scale 

Genetic 

Sequencing

The possibility of incidental findings should be minimized whenever 

possible. Targeted tests or analyses that answer specific clinical 

questions are preferred. 

Health care professionals are not obligated to provide incidental 

findings that do not relate to the clinical question, except for cases 

in which they are unavoidably discovered and have high predictive value. There is no obligation to provide patients with their raw 

genomic sequence data.

Informed consent might not be sufficient to deal with incidental findings. 

The operationalization of a right not to know about findings is not 

straightforward. 

The possibility of identifying clinically actionable findings should be 

reflected in pre-test and post-test counseling.

The debate over opportunistic whole genome sequencing screening 

has not yet been undertaken. Any decision must consider the relative 

risks and benefits both to a patient and the wider community.

The requirement to “do no harm” might require not subjecting 

patients to years of invasive screening.

Where variants are of unknown significance, the responsibility to 

investigate might be less clear.

* Van El, C.G., et al. (2013). Whole-genome sequencing in health care: Recommendations of the European Society of 

Human Genetics. European Journal of Human Genetics, 21, 580-584.

† The Danish Council of Ethics. (2012). Executive Summary. Genome testing: Ethical dilemmas in relation to 

diagnostics, research and direct-to-consumer testing. Retrieved from: http://etiskraad.dk/en/Udgivelser/BookPage.

aspx?bookID={0F84411D-1DD3-49CD-B8ED-679D29419E20}.

‡ PHG Foundation. (2011). Next steps in the sequence: The implications of whole genome sequencing for health in the UK. 

Cambridge: PHG Foundation. Retrieved from http://www.phgfoundation.org/file/10363.
IX

141

Appendix II: Past International Recommendations Regarding Incidental and Secondary Findings

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

The Royal College 

of Radiologists

[UK], Management of 

Incidental Findings 

Detected During 

Research Imaging 

(2010)* 

Research; 

Imaging

Imaging research centers should assess the risk of incidental findings 

that they are likely to encounter. 

“Researchers must provide a reasonable standard of care. They should 

aim to give feedback on health information that is likely to result in avoidance or significant harm to participant.” 

Someone “able to judge the potential health implications” of a finding 

should be available to advise a participant. 

“Research participants should be fully informed of the likelihood” of 

incidental findings, the threat that incidental findings might pose, how 

researchers will identify incidental findings, and the problems of false 

positives and false negatives.

Collaborations should be implemented to im increase access to expert 

image interpretations. Guidelines should describe when uncertain cases 

should be escalated to professionals with more expertise.

“Information on incidental findings should be provided to the participant 

and their clinically responsible physician.” Results that are unverified 

should not be returned. 

Nuffield Council 

on Bioethics

[UK], Medical 

Profiling and Online 

Medicine: The Ethics 

of “Personalized 

Healthcare” in a 

Consumer Age 

(2010)†

DTC; 

Large-Scale 

Genetic 

Sequencing 

and Imaging 

Genetic testing

•	 A publically funded website should be created that includes: 

information about DTC genetic services, the potential risks and 

benefits, difficulties of establishing clinical validity, and the 

possibility of finding out about conditions with no treatments.

•	 Prior to purchase, DTC companies should make the following 

information available:

» information about the quality, evidence, and limitations of 

the tests; 

» that test results might require interpretation by a qualified 

medical practitioner or genetic counselor; 

» the possibility of finding serious health problems and family 

genetic relationships;

» the nature of the risk communicated to the consumer 

(e.g., absolute or relative);

» whether third parties have access to the data; 

» how data are protected; and 

» where to find independent information about the service. 

•	 DTC companies should require that “their customers at the point 

of sale click on a statement confirming that they have the consent 

of the person whose DNA they intend to have analyzed.”

•	 Companies should only analyze the DNA of children if a genetic 

test meets the criteria of the UK National Screening Committee, 

and valid parental consent has been obtained. 

Imaging 

•	 Independent research on the impact and effects on individuals 

should be conducted. 

•	 Services should be appropriately regulated.

•	 Clinical practice should adapt to circumstances in which patients 

have had these tests.

* The Royal College of Radiologists. (2010). Management of Incidental Findings Detected During Research. London: The 

Royal College of Radiologists. Retrieved from https://www.rcr.ac.uk/docs/radiology/pdf/BFCR(11)8_Ethics.pdf.

† Nuffield Council on Bioethics. (2010). Medical Profiling and Online Medicine: The ethics of ‘personalized healthcare’ 

in a consumer age. London: Nuffield Press. 
142

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Canadian College of 

Medical Geneticists, 

Direct-to-Consumer 

Genetic Testing 

(2011)*

DTC;

Large-Scale 

Genetic 

Sequencing

DTC testing should comply with the following standards and regulations: 

•	 “[g]enetic testing must be based on valid scientific evidence;

•	 [t]he utility of the test in assessing health should be clearly stated;

•	 [t]esting laboratories and personnel must be accredited/certified by reputable accrediting/certifying bodies for the provision 

of clinical genetic testing and must participate in recognized 

proficiency testing programs;

•	 [g]enetic test results should be accurately labeled as medically 

significant or not;

•	 [p]roviders of genetic testing must practice responsible 

marketing;

•	 [o]rders for tests with medically significant implications should 

only be accepted from a medical professional on behalf of the 

individual to be tested;

•	 [p]rofessional guidelines related to the practice of medical 

genetics should be adhered to, particularly with respect to 

genetic testing of children;

•	 [p]rivacy and confidentiality must be addressed and maintained; and

•	 [s]amples for tests with medically significant implications must 

be collected in a manner that limits the possibility of accidental 

or purposeful misidentification and contamination.”

Canadian Institutes 

of Health Research, 

Natural Sciences 

and Engineering 

Research Council 

of Canada, and 

Social Sciences and 

Humanities Research 

Council of Canada, 

Tri-council Policy 

Statement: Ethical 

Conduct for Research 

Involving Humans 

(2010)†

Research; 

Large-Scale 

Genetic 

Sequencing 

and Biological 

Specimens

“Researchers have an obligation to disclose to the participant any 

material incidental findings discovered in the course of research and 

to direct participants to a qualified professional when necessary.”

“[R]esearchers should develop a plan indicating how they will disclose 

such findings,” if clinically significant incidental findings are likely. 

The plan should be submitted to the review board. 

“Researchers should be exercise caution in disclosing incidental 

findings that might cause needless concern;” researchers who are 

unsure if findings are material should consult with colleagues. 

“To seek consent for use of human biological materials in research,” 

disclosure should be made about the handling of results and findings, 

including clinically relevant information and incidental findings.

Participants should be allowed to make the choice of “whether they 

wish to receive information about themselves.” 

Participants can “express whether information will be shared with 

biological relatives,” family, community or other groups. 

* Canadian College of Medical Geneticists (CCMG). (2011). CCMG Statement on Direct-to-Consumer Genetic Testing. 

Retrieved from http://www.ccmg-ccgm.org/documents/Policies_etc/Pos_Statements/PosStmt_EPP_DTC_

FINAL_20Jan2011.pdf (formatting changed for Appendix presentation).

† Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social 

Sciences and Humanities Research Council of Canada. (2010). Tri-Council Policy Statement: Ethical Conduct for 

Research Involving Humans. Retrieved from http://www.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf.
IX

143

Appendix II: Past International Recommendations Regarding Incidental and Secondary Findings

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

Austrian Bioethics 

Commission, Report 

of the Austrian 

Bioethics Commission 

on Internet-Based 

Genetic and GenomeWide Testing (2010)* 

DTC; 

Large-Scale 

Genetic 

Sequencing

“Tested persons must be granted access to all information pertaining 

to them if they so request.”

“Tested persons must be informed of all incidental findings that are 

of immediate clinical importance, or about which they have explicitly 

enquired. This information must be presented in a way that does not 

upset the tested person, especially in cases where the person has 

not asked for the information.” 

Canadian College of 

Medical Geneticists 

and Canadian 

Association of 

Genetic Counselors, 

Joint Statement 

on the Process of 

Informed Consent 

for Genetic Research 

(2008)†

Research; 

Large-Scale 

Genetic 

Sequencing

“[G]enetic counseling should be a component of the informed consent 

process” in all studies in which results will be disclosed. 

“[C]linically significant laboratory results ascertained through a 

research laboratory and disclosed to the research participant 

[should] be validated in an accredited clinical diagnostic laboratory....”

“If individual results are to be disclosed, research participants 

should be made aware of the possibility” of incidental findings and 

the policy with regard to their disclosure. “Prior consent should be 

obtained” for disclosure.

National Council of 

Ethics for the Life 

Sciences: Portugal, 

Opinion on Direct 

Marketing of Genetic 

Tests to the Public 

(2008)‡

DTC; 

Large-Scale 

Genetic 

sequencing

“Genetic tests related to health should not be offered without medical 

indication and personalized supervision.”

“In case the test provides or may provide predictive health-related 

information, it should not be conducted unless genetic counseling is 

made available, before and after the results.”

“Health-related genetic tests for diagnostic or predictive purposes 

should not be made available for direct marketing to the public.” 

Indian Council of 

Medical Research, 

Ethical Guidelines 

for Biomedical 

Research on Human 

Participants (2006)§

Clinical and 

Research; 

Large-scale 

Genetic 

sequencing

“Genetic counseling should be readily available for those who are being 

screened.” 

Local community representatives should be informed of the research, 

possible outcomes or unexpected events, and the results of the 

research to ensure that participants understand this information. 

* Austrian Bioethics Commission. (2010). Report of the Austrian Bioethics Commission on Internet-Based Genetic and 

Genome-wide Testing. Vienna: Secretariat of the Austrian Bioethics Commission. Retrieved from http://www.bka.gv.at/

DocView.axd?CobId=40383. 

† Canadian College of Medical Geneticists and Canadian Association of Genetic Counselors. (2008). Joint Statement on 

the Process of Informed Consent for Genetic Research. Retrieved from http://www.ccmg-ccgm.org/documents/Policies_

etc/Pos_Statements/PosStmt_EPP_CAGCInformedConsent_16Jul2008.pdf.

‡ National Council of Ethics for the Life Sciences. (2008). Opinion on Direct Marketing of Genetic Tests to the Public. 

Retrieved from http://www.cnecv.pt/admin/files/data/docs/1312230235_Portugal%20CNECV%20P056%20EN.pdf.

§ Indian Council of Medical Research. (2006). Ethical Guidelines for Biomedical Research on Human Participants. 

Retrieved from http://www.icmr.nic.in/ethical_guidelines.pdf. [Emphasis added].
144

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

AUTHOR/

ORGANIZATION, 

REPORT TITLE 

(YEAR)

CONTEXT;

MODALITY

KEY POINTS

The Bioethics 

Advisory 

Committee: 

Singapore, Genetic 

Testing and Genetic 

Research (2005)* 

Clinical and 

Research; 

Large-scale 

Genetic 

Sequencing

Pre-test counseling should include the: 

•	 “[n]ature of the condition to be tested;

•	 [p]otential consequence of not being tested;

•	 [f]oreseeable consequences as a result of testing...;

•	 [t]est reliability and clinical validity...; 

•	 [t]he nature and efficacy of any interventions that might follow 

after genetic testing...;

•	 [t]ype of sample required, test procedure and possible risks;

•	 [t]urnaround time and how the results will be conveyed to the 

patient;

•	 [t]reatment or management options; and

•	 [a]lternatives to [g]enetic [t]esting and their pros and cons.”

German National 

Ethics Council, 

Biobanks for 

Research (2004)†

Research;

Large-scale 

Genetic 

Sequencing

Consent should include “the possibility or otherwise of communication of research results to the donor” and “information about the 

possible consequences of the communication of results of genetic 

analyses for the donor and his relatives.” 

Communication of “findings must be imparted by a person with the 

appropriate counseling skills.” 

Donors should be “informed in advance of the possible results, so 

that they could exercise their right not to know.”

World Health 

Organization, Genetic 

Databases: Assessing 

the Benefits and the 

Impact on Human 

& Patient Rights 

(2003)‡

Research;

Large-scale 

Genetic 

Sequencing

Disclosure of research data to participants is permissible when:

•	 The finding has “clear clinical benefit to identifiable individual;”

•	 “disclosure will avert or minimise significant harm to those 

individuals;” and 

•	 “there is no indication that the individuals in question would prefer 

not to know.”

United Nations 

Educational, Social 

and Cultural 

Organization, 

International 

Declaration on Human 

Genetic Data (2003)§

Clinical and 

Research; 

Large-scale 

Genetic 

Sequencing

Research participants have the right to decide at the time of 

informed consent whether to be informed of the results of the 

research pertaining to their individual data. 

“[W]hen genetic testing that may have significant implications for a 

person’s health is being considered, genetic counseling should be 

made available....”

Japanese Ministry 

of Health, Labour 

and Welfare, Ethics 

Guidelines for Human 

Genome/Gene Analysis 

Research (2001)¶

Research; 

Large-scale 

Genetic 

Sequencing

Participants must be informed of potential disease discovery. 

Principal investigators “must provide an opportunity for genetic 

counseling.”

If participants do not want their genetic information to be disclosed, 

the researcher should not disclose the information. 

* The Bioethics Advisory Committee: Singapore. (2005). Genetic Testing and Genetic Research. Helios, Singapore: The 

Bioethics Advisory Committee. 

† German National Ethics Council. (2004). Biobanks for Research. Berlin: German National Ethics Council. Retrieved from 

http://www.ethikrat.org/files/ner_opinion_biobanks.pdf. 

‡ World Health Organization: European Partnership on Patients’ Rights and Citizens’ Empowerment. (2003). Genetic 

Databases: Assessing the Benefits and the Impact on Human & Patient Rights. Geneva: World Health Organization. 

Retrieved from http://www.codex.vr.se/texts/whofinalreport.rtf. 

§ United Nations Educational, Social and Cultural Organization (UNESCO). (2003). International Declaration on Human Genetic 

Data. Retrieved from http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html. 

¶ Ministry of Health, Labour, and Welfare. (2001). Ethics Guidelines for Human Genome/Gene Analysis Research. 

Retrieved from http://www.lifescience.mext.go.jp/files/pdf/40_213.pdf. 
IX

145

Appendix III: Guest Presenters to the Bioethics Commission Regarding 

Incidental and Secondary Findings

Appendix III: Guest Presenters to the Bioethics Commission Regarding 

Incidental and Secondary Findings

Peter Bandettini, Ph.D.

Chief, Section on Functional Imaging 

Methods, Laboratory of Brain and 

Cognition, National Institute of Mental 

Health, National Institutes of Health

Mildred Cho, Ph.D. 

Associate Director and Professor of 

Pediatrics, Stanford University Center 

for Biomedical Ethics

Ellen Wright Clayton, J.D., M.D.

Craig-Weaver Professor of Pediatrics; 

Professor of Law and Director, 

Center for Biomedical Ethics and Society, 

Vanderbilt University

Ruth Schwartz Cowan, M.A., Ph.D.

Janice and Julian Bers Professor Emerita, 

History and Sociology of Science, 

University of Pennsylvania

Thomas Donaldson, Ph.D. 

Mark O. Winkelman Professor of 

Legal Studies; Director, Zicklin 

Center for Research in Business Ethics, 

The Wharton School of the University 

of Pennsylvania

Hank Greely, J.D. 

Deane F. and Kate Edelman Johnson 

Professor of Law, Stanford Law School; 

Professor (by courtesy) of Genetics, 

Stanford Medical School; Director, 

Center for Law and the Biosciences; 

Director, Stanford Interdisciplinary 

Group on Neuroscience and Society and 

its Program in Neuroethics, Stanford Law 

School; Chair, Steering Committee of the 

Center for Biomedical Ethics

Robert C. Green, M.D., M.P.H. 

Associate Director for Research, 

Partners HealthCare Center for 

Personalized Genetic Medicine; 

Associate Professor of Medicine, Division 

of Genetics, Brigham and Women’s 

Hospital and Harvard Medical School

Sarah Hilgenberg, M.D. 

Recipient of a finding incidental 

to research

Judy Illes, Ph.D.

Professor of Neurology, 

Canada Research Chair in Neuroethics; 

Director, National Core for Neuroethics; 

Faculty, Brain Research Centre, 

University of British Columbia

Gail Javitt, J.D., M.P.H. 

Counsel, Sidley Austin LLP; 

Research Scholar, Berman Institute of 

Bioethics, Johns Hopkins University

Carol Krucoff 

Recipient of a finding incidental 

to clinical care

Alex John London, M.A., Ph.D. 

Professor of Philosophy, Carnegie Mellon 

University; Director, Center for Ethics 

and Policy, Carnegie Mellon University

Bartha Knoppers, Ph.D.

Director, Centre of Genomics and Policy;

Canada Research Chair in Law and 

Medicine, McGill University
146

ANTICIPATE AND COMMUNICATE Ethical Management of Incidental and Secondary Findings

in the Clinical, Research, and Direct-to-Consumer Contexts

Haavi Morreim, J.D., Ph.D.

Professor, Department of Internal 

Medicine, College of Medicine, University 

of Tennessee Health Science Center

Joanna Mountain, Ph.D. 

Senior Director of Research, 23andMe

Danielle Ofri, M.D., Ph.D.

Associate Professor, New York University 

School of Medicine; Editor-In-Chief, 

Bellevue Literary Review

Erik Parens, Ph.D.

Senior Research Scholar, 

The Hastings Center

Henry S. Richardson, J.D., M.P.P., Ph.D.

Professor, Senior Research Scholar, 

Kennedy Institute of Ethics, 

Georgetown University

Susan Wolf, J.D.

McKnight Presidential Professor of Law,

Medicine and Public Policy;

Faegre & Benson Professor of Law;

Professor of Medicine;

Faculty Member, Center for Bioethics,

University of Minnesota

Presidential Commission for the Study of Bioethical Issues

1425 New York Avenue NW, Suite C-100

Washington, D.C. 20005

(202) 233-3960

http://www.bioethics.gov