Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JUNE GIBBS BROWN 

Inspector General 

JUNE 2000 

OEI-01-97-00196 

Recruiting Human Subjects 

Sample Guidelines for Practice 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 

protect the integrity of the Department of Health and Human Services programs as well as the 

health and welfare of beneficiaries served by them. This statutory mission is carried out through a 

nationwide program of audits, investigations, inspections, sanctions, and fraud alerts. The 

Inspector General informs the Secretary of program and management problems and recommends 

legislative, regulatory, and operational approaches to correct them. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 

Inspector General. It conducts short-term management and program evaluations (called 

inspections) that focus on issues of concern to the Department, the Congress, and the public. The 

inspection reports provide findings and recommendations on the efficiency, vulnerability, and 

effectiveness of departmental programs. 

OEI's Boston regional office prepared this report under the direction of Mark R. Yessian, Ph.D., 

Regional Inspector General. Principal OEI staff included: 

REGION HEADQUARTERS 

Nancy L. London, Lead Analyst Elise Stein, Program Specialist 

Laura C. McBride, Lead Analyst 

To obtain copies of this report, please call the Boston Regional Office at (617) 565-1050. 

Reports are also available on the World Wide Web at our home page address: 

http://www.dhhs.gov/progorg/oei 
EXECUTIVE SUMMARY 

PURPOSE 

To identify institutional review board and professional medical association human-subject 

recruitment guidelines that exceed guidelines set forth by the Department of Health and 

Human Services. 

BACKGROUND 

In our companion report, Recruiting Human Subjects: Pressures in Industry-Sponsored 

Clinical Research (OEI-01-97-00195), we indicated that the Department of Health and 

Human Services (HHS) guidelines do not address the recruitment practices that IRBs and 

others involved in clinical research find most troubling. In this report, we present other 

sources of guidance for IRBs and investigators, from such entities as professional medical 

associations and IRBs. We also include Canadian guidelines on recruitment practices to 

illustrate how these practices have been addressed by another nation’s research 

community. 

This report focuses on guidance provided by IRBs, medical associations, and Canada on 

recruitment practices not covered in HHS guidelines. Specifically, we focus on guidance 

given by these entities on how three main issues— recruitment incentives, the dual 

investigator-physician role, and the confidentiality of medical records— should be 

handled. These particular issues, as discussed in our companion report, have raised many 

concerns among those involved in clinical research. 

Recruitment Incentives 

Recruitment incentives include bonuses that sponsors give to investigators to boost 

enrollment and referral fees given to doctors for referring their patients to another 

investigator’s study. Some IRBs prohibit such incentives, claiming that they pose too 

much of a conflict of interest for investigators. Many professional medical associations, 

including the American Medical Association, prohibit referral fees, branding them 

unethical. Other IRBs and medical associations favor investigator disclosure of incentives 

to potential subjects, allowing the subjects to make their own decisions about the 

significance of the incentives. Finally, Canada promotes a “proportionate approach,” in 

which an IRB determines the severity of a conflict and metes out safeguards accordingly; 

minor conflicts may just need to be disclosed to the subject, whereas large ones may 

require investigators to abandon one of their conflicted interests. 

Recruiting Subjects: Guidelines 1 OEI-01-97-00196 
Dual Investigator-Physician Role 

When an investigator is also the physician of the subject-patient, the investigator may be 

faced with a conflict between what is best for the subject and what is best for the research 

protocol. Some IRBs and medical associations assert that this potential conflict must be 

disclosed to subjects. One medical association goes so far as to suggest using an 

“uninterested” party to explain the trial to particularly vulnerable subjects. Other medical 

associations state that if such a conflict should arise, it should always be resolved in the 

best interest of the patient. 

Confidentiality of Medical Records 

Investigators often search patients’ private medical records to identify and contact 

potential subjects for clinical trials. Some IRBs prohibit investigators from directly 

accessing this confidential information unless it pertains to the investigator’s own patients. 

Professional medical associations do not address this issue explicitly, but do explain the 

appropriate uses of medical information, divulged in confidence between doctor and 

patient. 

CONCLUSION 

The guidelines featured in this report have implications for the implementation of the 

recommendations advanced in our companion report. 

Toward improved practice and a level playing field 

One of the key recommendations we set forth in our companion report is for HHS to 

provide IRBs with direction regarding oversight of recruitment practices. Specifically, we 

call for HHS to clarify that IRBs have the authority to review certain recruiting practices 

based on existing Federal regulation and to disseminate guidance on what IRBs can 

address in their review of recruitment practices. Although all of the IRB guidelines and 

policies mentioned in this report exceed guidelines specified by Federal oversight agencies, 

these IRB guidelines are the exception rather than the rule. In order to foster a level 

playing field, in which sponsors and investigators adhere to common standards in 

recruiting human subjects, Federal oversight bodies must clarify IRB authority to review 

recruitment practices and provide them with respective guidance. 

A second major recommendation from our companion report is that HHS should facilitate 

discussion and consensus about appropriate human-subject recruiting practices by 

convening forums and sponsoring studies, among other initiatives. The guidelines 

highlighted in this report represent much reflection and deliberation by IRBs, their parent 

Recruiting Subjects: Guidelines 2 OEI-01-97-00196 
institutions, professional medical associations, and the Canadian government, on 

recruitment issues. Any future debate or research on appropriate recruitment practices 

ought to draw on these and other existing guidelines. 

Comments on the Draft Reports 

We received comments on our two draft reports from the Department of Health and 

Human Services. We also solicited and received comments from the following external 

parties: the Applied Research Ethics National Association, the Consortium of 

Independent Review Boards, Pharmaceutical Research and Manufacturers of America, 

and Public Citizen’s Health Research Group. We include the detailed text of all of these 

comments and our responses to them in our companion report, Recruiting Human 

Subjects: Pressures in Industry-Sponsored Clinical Research. In the executive summary 

of that report, we summarize the thrust of these comments and our responses. 

Recruiting Subjects: Guidelines 3 OEI-01-97-00196 
TABLE OF CONTENTS 

PAGE

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

INTRODUCTION .......................................................... 5

ADDITIONAL GUIDANCE

Recruitment Incentives ............................................. 8 

Dual Physician-Investigator Role .................................... 11

Confidentiality of Medical Records ................................... 13

CONCLUSION ........................................................... 15

APPENDICES 

A: Professional Medical Association Guidelines .............................. 16

B: Professional Medical Association Sources ................................ 18

C: Endnotes ......................................................... 21

Recruiting Subjects: Guidelines 4 OEI-01-97-00196 
INTRODUCTION 

PURPOSE 

To identify institutional review board and professional medical association human-subject 

recruitment guidelines that exceed guidelines set forth by the Department of Health and 

Human Services. 

BACKGROUND 

In our companion report, Recruiting Human Subjects: Pressures in Industry-Sponsored 

Clinical Research (OEI-01-97-00195), we presented concerns that sponsors, 

investigators, and IRBs expressed about current practices used to recruit human subjects.1 

In that report, we found that most of the concerns fit into three broad categories: the 

erosion of informed consent, the compromise of patient confidentiality, and enrolling 

ineligible subjects. We also noted that many of these concerns are not addressed in 

guidelines offered by the Food and Drug Administration (FDA) or the National Institutes 

of Health (NIH), through its Office for the Protection from Research Risks (OPRR). 

In fact, we found that the FDA and OPRR guidelines fail to address many of the 

recruitment practices that IRBs and others involved in clinical research find most 

troubling. Thus, we set out in this report to find other sources of guidance available to 

IRBs and investigators. We found that several other entities, such as IRBs and 

professional medical associations, do provide such guidance. We include examples of 

these guidelines in this report. We also include guidelines from a collaboration among 

three Canadian medical research funding agencies, the Tri-Council Policy Statement on 

Ethical Conduct for Research Involving Humans, to illustrate how these recruitment 

issues have been addressed by another nation’s research community.2 

This report focuses on guidance provided by IRBs and medical associations on 

recruitment practices not covered in HHS guidelines. Specifically, we focus on guidance 

given by these entities on three main issues: recruitment incentives, the dual investigatorphysician role, and the confidentiality of medical records. These three issues parallel the 

main recruitment strategies set forth in our companion report: offering incentives, 

targeting one’s own patients, and seeking additional patient bases. We have chosen not to 

highlight guidelines on the fourth recruitment strategy, advertising. Although many IRBs 

and professional medical associations have their own guidelines on advertisements and 

subject incentives, there are explicit HHS guidelines for those methods. 

Recruiting Subjects: Guidelines 5 OEI-01-97-00196 
Institutional Review Boards 

In our companion report, we explain that many IRBs are uncertain of their authority to 

review certain recruitment practices, particularly those that take place apart from the 

investigator-subject interaction. The IRBs whose guidelines and policies are featured in 

this report have proceeded with the assumption that they have this authority. In fact, 

many are taking strong stances on some recruitment issues. These IRB or institutional 

guidelines serve the dual purpose of assisting IRB members when reviewing protocols and 

guiding investigators as they consider how they will recruit subjects (or how to handle 

sponsor incentives for boosting enrollment). The guidance falls along a continuum, from 

merely raising awareness of potential problems associated with a particular recruitment 

practice to forbidding certain practices. 

Professional Medical Associations 

Professional medical associations are another source of guidance regarding ethical conduct 

of clinical research for both investigators and IRBs,. Guidance from professional 

associations may not be an obvious resource to those involved in research, but this 

guidance is, in fact, quite rich and may be gaining in importance.3 According to a recent 

article on professional medical associations in the Journal of the American Medical 

Association, “the time is propitious for the medical profession to act responsibly to 

reaffirm the ethical commitment that grounds physicians’ authenticity. Only then can 

physicians justify the claim to the moral integrity that patients expect.”4 

Professional medical association guidance contrasts with IRB and Federal guidance in that 

it emanates from physicians, who are often themselves investigators. Therefore, this 

guidance can be seen as a reflection of physicians’ own concerns as well as a form of selfmonitoring. The American College of Physicians states that, “although the responsibility 

for assuring reasonable protection of human research participants resides with the 

investigators and the local institutional review board, the medical profession as a whole 

also has responsibilities. Clinical investigation is fraught with opportunities for conflicts to 

arise.”5 

Many medical associations have set forth ethical guidelines relating to clinical research. 

Others have ethical guidelines that relate to general professional conduct, but which could 

be extrapolated to clinical research. Although many associations have valuable guidance 

on many aspects of clinical research, we have limited this report to examples focused on 

recruitment practices. See appendix A for a chart summarizing subject recruitment 

guidelines mentioned by the 20 professional medical associations covered in this report. 

See appendix B for a full listing of our sources of these guidelines. 

Recruiting Subjects: Guidelines 6 OEI-01-97-00196 
Methodology 

As part of our survey of 200 IRBs, we requested any institutional or IRB guidelines on 

recruitment issues to which IRBs adhere. We obtained other IRB guidelines during site 

visits and conversations with IRB representatives. From these, we culled recruitment 

guidelines that exceeded the scope of Federal guidelines. In addition, we gathered codes 

of ethics, guidelines, and position papers relevant to subject recruitment from 20 

professional medical associations. We selected these medical associations as a sample of 

the major medical associations; it is not a comprehensive selection. We also thoroughly 

reviewed the Canadian Tri-Council Policy Statement on Ethical Conduct for Research 

Involving Humans. 

These guidelines do not necessarily represent the best or most suitable response to 

concerns raised in our other report. Rather, they serve as reference points. These 

guidelines are intended to stimulate discussion and debate among Federal policymakers, 

IRBs, sponsors, and investigators over what constitutes appropriate recruitment practices 

and how to develop guidelines that ensure that appropriate practices are followed. We did 

not independently evaluate any of the guidelines highlighted in this report. A guideline’s 

inclusion does not mean that it receives our approval, or that it is being used only at the 

institution that we highlighted. While we have highlighted many guidelines, we may have 

omitted some useful ones. 

We conducted this inspection in accordance with the Quality Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

Recruiting Subjects: Guidelines 7 OEI-01-97-00196 
Recruitment Incentives 

ISSUE 

Sponsors often offer investigators or their staff incentives to boost subject enrollment. 

Some of these incentives may be financial, often in the form of a bonus payment per 

additional subject enrolled. Other incentives include, but are not limited to: granting the 

investigator authorship on a paper about the study; supplying the research site with office 

or medical equipment; and offering educational gifts, such as books or conference 

attendance to research staff. 

People involved in clinical research have raised concerns that such incentives could 

prompt investigators to distort information that they provide to potential subjects during 

the consent process or pressure potential subjects to enroll in a trial. Some fear that these 

incentives could cause investigators to stretch eligibility criteria to enroll a potential 

subject. Finally, some are concerned about whether potential subjects can truly make 

informed choices about participating in trials without knowing how, and to what extent, 

investigators are being rewarded for their participation. 

GUIDELINES 

On the appropriateness of incentives 

IRBs. The University of Rochester prohibits bonus payments to investigators and 

research administrators that are intended to encourage subject recruitment, saying: 

Bonus payments for subject recruitment may compromise the integrity of that study 

by giving an appearance of affecting the judgment of the investigator/research team 

and in some cases may violate regulations and institutional policies.

6 

However, the institution does permit additional, per-subject payments made to 

investigators if these payments cover additional expenses incurred by the investigator to 

accelerate enrollment (e.g., for additional advertisements). 

Partners Healthcare System, Inc., which is comprised of Massachusetts General Hospital 

and Brigham and Women’s Hospital, prohibits finder’s fees given to a physician for 

referring a potential subject to an investigator. It also prohibits financial incentives given 

to investigators to accelerate enrollment. It claims that both of these practices pose a 

conflict of interest. 

Recruiting Subjects: Guidelines 8 OEI-01-97-00196 
St. Vincent Mercy Medical Center IRB assesses all additional payments given to 

investigators during the course of a trial to determine whether these payments reflect 

“reasonable payment for bona fide services performed.”7 If the Board finds that the 

additional payments fail to meet this criteria, but rather, these payments are merely for 

enrolling subjects, the Board will not allow them. 

Medical Associations. Many medical associations also provide guidance on financial 

incentives to investigators. The American Medical Association asserts that “offering or 

accepting payment for referring patients to research studies (finder’s fees) is unethical.”8 

Similarly, the American College of Physicians asserts that these finder’s fees “generate an 

unethical conflict of interest.”9 In addition, five other medical associations (see Appendix 

A) note that fees paid to doctors for referring patients to another physician are unethical; 

one could interpret this warning to apply to clinical research, in addition to general 

medical practice. 

The American Academy of Orthopaedic Surgeons and the American Academy of 

Pediatrics both warn investigators against accepting unreasonable compensation for 

conducting a trial. The American Academy of Pediatrics states that, “it is important to 

avoid undue rewards to health care providers that may constitute an undue incentive for 

coercing patients to participate in a study.”10 Finally, the American Academy of 

Ophthalmology and the American College of Physicians recommend using the British 

Royal College of Physicians guideline for determining the appropriateness of a financial 

arrangement; that is, “would I be willing to have these arrangements generally known?” 

Disclosure 

IRBs. UCLA, as a result of a recent legal case, requires that a physician “disclose 

personal interest unrelated to the patient’s health, whether research or economic, that may 

affect the physician’s professional judgment,” or risk legal action taken on behalf of the 

subject for “performing medical procedures without consent or breach of 

confidentiality.”11 

Partners Healthcare System, Inc., requires “full disclosure of any financial arrangements 

that may encourage physicians to recruit patients for research participation that may not be 

in their best interests.”12 

Medical Associations. The American College of Emergency Physicians advises that 

investigators disclose to subjects payments from the biomedical industry, while the 

American Psychiatric Association suggests that investigators disclose the funding source 

to subjects. Six other associations have guidelines for physicians’ disclosure to patients of 

financial interests in general commercial ventures, if they seem to pose conflicts of interest. 

One could infer from these guidelines that financial conflicts of interest in clinical research 

should be disclosed to potential subjects as well. 

Recruiting Subjects: Guidelines 9 OEI-01-97-00196 
Canada. An entire section of the Canadian Tri-Council Policy Statement on Ethical 

Conduct for Research Involving Humans is devoted to conflict of interest issues.13 In this 

section, it states that researchers hold trust relationships with research subjects and that 

these trust relationships “can be put at risk by conflicts of interest that may compromise 

independence, objectivity or ethical duties of loyalty.” The policy asserts that, though 

these potential conflicts are not new, “pressures to commercialize research have led to 

increased concerns.” The policy proposes IRB guidelines for “actual, perceived and 

potential” conflicts of interest, which include investigator incentives. It recommends that 

IRBs take a “proportionate approach” to reviewing conflicts of interest. If the IRB 

perceives a potential conflict to be relatively small, then the IRB should merely require the 

investigator to disclose this conflict. However, if the IRB perceives a potential conflict to 

be large, then the IRB should require the investigator to abandon one of the interests in 

conflict, either by withdrawing from the research or authorizing someone else to make 

certain decisions about the research. 

Recruiting Subjects: Guidelines 10 OEI-01-97-00196 
Dual Investigator-Physician Role 

ISSUE 

Many investigators recruit subjects from their own patient populations. In such scenarios, 

the physician-investigator must both consider the best interest of the patient-subject and 

remain objective in order to foster scientific advancement and discovery. One of the main 

concerns raised about this practice is that the distinction between physician and 

investigator will be blurred, as will the distinction between patient and subject. Patientsubjects may become confused as to whether they are involved in therapy or research. 

GUIDELINES 

Acknowledging and separating the dual roles 

IRBs. UCLA recognizes the potential conflict of interest that faces an investigator who is 

also the physician of the subject-patient. Thus, the University requires that investigators in 

this situation disclose their possible conflicts to subjects at the top of the informed consent 

form, using the following wording: 

Your health care provider may be an investigator of this research protocol, and as an 

investigator, is interested both in your clinical welfare and in the conduct of this 

study. Before entering this study or at any time during the research, you may ask for 

a second opinion about your care from another doctor who is in no way associated 

with this project. You are not under any obligation to participate in any research 

project offered by your doctor.

14 

In some cases, the UCLA IRB may discourage investigators from directly approaching 

their patients. Instead, the Board will suggest that the investigator place information 

about a trial in the waiting room and wait to be approached by the patient about 

participating. 

Medical Associations. The American Academy of Neurology clearly acknowledges the 

threat that the doctor-patient relationship may pose on the objectivity of the consent 

process. The Academy suggests precautions that IRBs and researchers may want to take 

to mitigate this threat when trying to recruit particularly vulnerable subjects, such as 

people with severe, progressive or terminal neurological illnesses: 

Recruiting Subjects: Guidelines 11 OEI-01-97-00196 
Experienced physicians and researchers know that some patients will accede, on the 

basis of trust, to just about any medical requests their physicians make. Therefore, 

particular problems may arise when the researcher has a long-standing doctor-patient 

relationship with a person who also enrolls in his or her research protocol. Physicians 

and researchers must be vigilant about their relationships with these patients/subjects 

because the distinction between standard medical care and experimental treatment 

may become blurred. In such cases, researchers and IRBs may want to consider 

additional safeguards. For example, the IRB may request that an ‘uninterested’ 

individual, such as a clinical neurologist not involved in the research, discuss with 

prospective subjects the research study and other clinical or research alternatives.

15 

Both the American College of Physicians and the American Medical Association 

recommend that physician-investigators handle their dual role by always placing the health 

and welfare of their patients first, before their value as study subjects. 

Canada. The Canadian Tri-Council Policy directs physician-investigators to disclose their 

dual roles to potential subjects, stating that: 

[Researchers have] relevant ethical duties that govern potential or actual conflicts of 

interest, as they relate to the free and informed consent of subjects. To preserve and 

not abuse the trust on which many professional relations reside, researchers should 

separate their roles as therapists...If a researcher is acting in dual roles, this fact must 

always be disclosed to the subject. Researchers should disassociate their role as 

researcher from other roles, in the recruitment process and throughout the project.16 

Recruiting Subjects: Guidelines 12 OEI-01-97-00196 
Confidentiality of Medical Records 

ISSUE 

Investigators and their staff may use patient medical records to identify potential subjects 

for clinical trials and then may contact these patients to inquire about their interest in 

participation. Sometimes other researchers who are not the patients’ physician will have 

access to these same patient databases and may use them for the same recruitment 

purposes. 

Concerns relate to how private medical information, divulged in confidence by patients to 

their physician, ought to be used. Specifically, people question whether using this 

information for purposes other than treating or diagnosing, or transmitting this information 

to a third party, constitutes a breach of confidentiality. 

GUIDELINES 

IRBs. Some IRBs have guidelines about accessing confidential medical information 

through a physician’s or hospital’s database. Others have guidelines for investigators’ use 

of information to contact potential subjects. 

The Medical College of Ohio states that: 

Review of departmental log books, medical charts, and databases for potential subjects 

is not an acceptable practice prior to IRB review and approval...Persons with access 

to patient names and diagnoses should not, nor should they be asked to, provide such 

lists for an investigator to use to contact potential participants who could view such 

an unexpected communication to be an invasion of privacy and a breach of doctorpatient confidentiality...If an investigator plans to recruit subjects that are not his own 

patients or not from his department’s clinic(s), s/he should enlist the assistance of 

potential participants’ own physicians to introduce the study. 17 

UCLA emphasizes that investigators must take care to ensure the confidentiality and 

privacy of potential research subjects when identifying eligible subjects for their research: 

In order to avoid a breach of the potential subject’s privacy, investigators should not 

ask institutions, or their employees, such as physicians or case workers to directly 

identify potential subjects for a research study. Instead, an investigator should ask the 

physican, case worker, etc., to first approach potential subjects (or their 

parent/guardian, as appropriate).

18 

Recruiting Subjects: Guidelines 13 OEI-01-97-00196 
Likewise, Partners HealthCare System, Inc. and the University of Rochester also prohibit 

anyone who lacks legitimate access to the potential subjects’ private medical records, 

generally the primary care-giver, from contacting these subjects for recruitment purposes. 

The University of Washington recommends that when investigators lack legitimate access 

to private medical records that they use a neutral “intermediary” whose sole job is to ask 

the potential subject whether the subject’s name and contact information could be released 

to the investigator. The investigator would then be allowed to contact the subject directly. 

If an investigator intends to use private medical records to find potential subjects for a 

study, the Mobile Infirmary Medical Center instructs its IRB to ascertain whether the 

investigator is allowed access to the records by the institution or the physician. Once the 

permissibility of the investigator’s access is determined, the investigator must accept 

responsibility for protecting the potential subjects’ privacy. 

Medical Associations. No medical associations in our sample have guidelines specifically 

relating to the use of medical records for identifying and contacting research subjects. 

However, many have guidelines regarding how private medical information should be 

used, and indicate that all other uses are impermissible unless specifically agreed upon by 

the patient. For example, the American Academy of Family Physicians states that: 

Historically, the privileged nature of communications between physician and patient 

has been a safeguard for the patient’s personal privacy and constitutional rights. 

However, new forces in the medical marketplace, including the proliferation of 

electronically linked data bases and a growing demand for health care data of all types 

by...academic and commercial researchers...are encroaching upon that 

relationship...No physician should disclose in individually identifiable form any 

information about the individual without the individual’s explicit authorization.

19 

Similarly, the American Medical Association maintains that: 

Patients divulge information to their physicians only for purposes of diagnosis and 

treatment. If other uses are to be made of the information, patients must give their 

permission after being fully informed about the purpose of such disclosures. If 

permission is not obtained, physicians violate patient confidentiality by sharing 

specific and intimate information from patients’ records with commercial interests.20 

Recruiting Subjects: Guidelines 14 OEI-01-97-00196 
CONCLUSION 

The additional guidelines featured in this report provide further evidence of the 

pervasiveness of concerns about certain recruitment practices among both IRBs and 

professional medical associations. More importantly, these guidelines have implications 

for implementing the recommendations advanced in our companion report. 

Toward improved practice and a level playing field 

One of the key recommendations we set forth in our companion report is for HHS to 

provide IRBs with direction regarding oversight of recruitment practices. Specifically, we 

call for HHS to clarify that IRBs have the authority to review certain recruiting practices 

based on existing Federal regulation and to disseminate guidance on what IRBs can 

address in their review of recruitment practices. All of the IRB guidelines and policies 

mentioned in this report exceed guidelines specified by Federal oversight agencies. These 

IRB guidelines indicate that some IRBs believe that recruitment practices raise enough 

concern to warrant a more rigorous review than called for by Federal guidelines. Yet, 

these IRBs, according to data from our IRB survey mentioned in the companion report, 

are the exception rather than the rule. In order to foster a level playing field, in which 

sponsors and investigators adhere to a common standard in recruiting human subjects, 

Federal oversight bodies must clarify IRB authority to review recruitment practices and 

provide appropriate guidance. Otherwise, only the exceptional IRB is likely to add this 

extra layer to their standard protocol review, as it may be to their competitive 

disadvantage to do so. 

A second major recommendation that we make in our companion report is that HHS 

should facilitate discussion and consensus about appropriate human-subject recruiting 

practices by convening forums and sponsoring studies, among other initiatives. The 

guidelines highlighted in this report represent much reflection and deliberation by IRBs, 

their parent institutions, professional medical associations, and the Canadian government 

on recruitment issues. Any future debate or research on appropriate recruitment practices 

ought to draw on these and other existing guidelines, including any incidents that led to 

the guidelines’ creation and the discussions that preceded their adoption. These 

guidelines, and the debate that led to them, represent a rich source of material that should 

be tapped by Federal bodies in exploring recruitment issues. 

Recruiting Subjects: Guidelines 15 OEI-01-97-00196 
APPENDIX A 

Professional Medical Association Guidelines

The following chart indicates which medical associations have such guidelines or codes of 

ethics. Guidelines that specifically pertain to clinical trials are denoted by a U. 

Associations that have general medical practice guidelines or codes of ethics that could 

have implications for clinical research are denoted by a k. 

Incentives l 

Dua 

Role 

Confidential 

Records 

Other 

Guidance 

referral fees 

financial arrangements disclosure to subjects of 

Compensation to investigators 

for conducting clinical trial 

dual investigator-physician role 

potential subjects for identifying /contacting Use of medical records 

payment to subjects Advertisement/ 

news briefs 

guidance also defers to other 

American Academy of Allergy, 

Asthma and Immunology 

American Academy of Family 

Physicians 

k k

American Academy of 

Neurology 

U

American Academy of 

Ophthalmology 

k k

American Academy of 

Orthopaedic Surgeons 

k U AMA Code 

of Ethics 

American Academy of 

Pediatrics 

U U

American Academy of 

Physical Medicine and 

Rehabilitation 

k Nuremberg 

laws 

American Association of 

Neurological Surgeons 

k

Recruiting Subjects: Guidelines 16 OEI-01-97-00196 
APPENDIX A 

Incentives l 

Dua 

Role 

Confidential 

Records 

Other 

Guidance 

referral fees 

financial arrangements disclosure to subjects of 

Compensation to investigators 

for conducting clinical trial 

dual investigator-physician role 

potential subjects for identifying /contacting Use of medical records 

payment to subjects Advertisement/ 

news briefs 

guidance also defers to other 

American College of 

Emergency Physicians 

U Declaration 

of Helsinki 

American College of 

Obstetricians and 

Gynecologists 

k

American College of 

Physicians 

U k U k U

American College of 

Radiology 

k

American College of Surgeons k k

American Geriatrics Society 

American Medical Association U k U

American Women’s Medical 

Association 

American Pharmaceutical 

Association 

American Psychiatric 

Association 

k U k AMA Code 

of Ethics 

American Society of 

Anesthesiologists 

k AMA Code 

of Ethics 

American Society of Plastic 

and Reconstructive Surgeons 

k k

National Medical Association 

Recruiting Subjects: Guidelines 17 OEI-01-97-00196 
APPENDIX B 

Professional Medical Association Sources

1. American Academy of Allergy, Asthma, & Immunology

Code of Ethics, adopted March 1998. [http://www.aaaai.org/members/codeofethics.stm, accessed December

1999].

And, Physician Reference Materials: Position Statement 14, “Unproven Procedures for Diagnosis

and Treatment of Allergic and Immunologic Diseases, Reviewed,” 1992.

[http://www.aaaai.org/professional/reference/positionstatements/ps14.stm, accessed December 1999]

2. American Academy of Family Physicians

Compendium of AAFP Positions on Selected Health Issues, “Fees,” “Confidentiality,” and

“Proprietary Practices.” [http://www.aafp.org/policy, accessed December 1999]

3. American Academy of Neurology

Ethics Subcommittee of the American Academy of Neurology, “Position Statement: Ethical

Issues in Clinical Research in Neurology,” Neurology, March 1998; 50:592-595. 

4. American Academy of Ophthalmology

Code of Ethics, Revised 1995, and Advisory Opinion of the Code of Ethics, “Disclosures of

Professionally Related Commercial Interests,” approved June 1990, reaffirmed April 1998.

5. American Academy of Orthopaedic Surgeons

Code of Ethics for Orthopaedic Surgeons, adopted October 1988, amended December 1995.

6. American Academy of Pediatrics

“Policy Statement: Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric

Populations,” 1995; 95(2): 286-294.

7. American Academy of Physical Medicine and Rehabilitation

American Academy of Physical Medicine and Rehabilitation, Code of Conduct, November 1995.

8. American Association of Neurological Surgeons,

American Association of Neurological Surgeons, Code of Ethics.

9. American College of Emergency Physicians

“Policy Statement: Code of Ethics for Emergency Physicians,” June 1997, and “Policy

Statement: Gifts to Emergency Physicians from the Biomedical Industry,” reaffirmed March 1997.

Recruiting Subjects: Guidelines 18 OEI-01-97-00196 
APPENDIX B 

10. American College of Obstetricians and Gynecologists

Code of Professional Ethics of the American College of Obstetricians and Gynecologists,

approved 1997.

11. American College of Physicians

Annals of Internal Medicine Position Paper-- Ethics Manual, 4th edition, April 1999.

[http://www.acponline.org/journals/annals/01apr98/ethicman.html, accessed December 1999]

12. American College of Radiology

Code of Ethics, approved Sept. 1998. [http://www.acr.org/f-appcrit.html, accessed December 1999]

13. American College of Surgeons

Statements on Principles, 1996-98. [http://www.facs.org/fellows_info/statements/stonprin.html, accessed

December 1999]

14. American Geriatrics Society

Position Statement: “Research and Geriatric Medicine,” revised May 1999, and “Informed

Consent on Human Subjects with Dementia,” approved May 1998.

15. American Medical Association

Current Opinions of the Council on Ethical and Judicial Affairs, A-99 Edition.

16. American Medical Women’s Association

Principles of Ethical Conduct, approved 1990. 

[http://www.amwa-doc.org/publications/Position_Papers/ethicalconduct.htm, accessed December 1999]

And, Resolution: “Research,” adopted 1990, 1995, 1997. 

[http://amwa-doc.org/publications/Resolutions/research.htm, accessed December 1999]

17. American Psychiatric Association

The Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry (and

Addendums), 1998 Edition.

“Guidelines for Assessing the Decisionmaking Capacities of Potential Research Subjects with

Cognitive Impairment,” 1997.

18. American Society of Anesthesiologists

“Guidelines for the Ethical Practice of Anesthesiology,” amended October 1997.

[http://www.asahq.org/standards, accessed December 1999]

Recruiting Subjects: Guidelines 19 OEI-01-97-00196 
APPENDIX B 

19. American Society of Plastic and Reconstructive Surgeons

Code of Ethics for the American Society of Plastic and Reconstructive Surgeons, 1998. 

[http://www.plasticsurgery.org/profinfo/resource, accessed December 1999]

20. National Medical Association 

NMA Policy Database, “Pharmacogenetics in Drug Development,” amended 1988, “Black

Investigators in Clinical Trials,” approved 1990, “Pharmaceutical Research,” approved 1990, and 

“Revision of the Food and Drug Administration’s (FDA) Current Informed Consent Regulations,”

1995. [http://nmanet.org/hq/reference/policies.asp, accessed December 1999]

Recruiting Subjects: Guidelines 20 OEI-01-97-00196 
APPENDIX C 

Endnotes

1. Department of Health and Human Services, Office of Inspector General, Recruiting Human

Subjects: Pressures in Industry-Sponsored Clinical Research, OEI-01-97-00195, June 2000.

2. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of

Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy

Statement--Ethical Conduct for Research Involving Humans, Public Works and Government

Services Canada, 1998. 

The three Canadian councils that co-authored the Tri-Council Policy Statement are the three

major Federal agencies responsible for funding Canadian medical research. Funding from these

agencies is contingent upon recipients’ compliance with the Policy. 

3. The American Medical Association’s Council on Ethical and Judicial Affairs focused on many

of the issues discussed in this report in its most recent bi-annual discussion of emerging ethical

issues in the medical profession. Specifically, it raised concerns about financial incentives given to

investigators and about the dual doctor/investigator role. V. Foubister, “Clinical Trial Pay

Troubling Topic at CEJA Forum,” AMA News, 27 December 1999; 42(48): 8-9.

4. Pelligrino, E.D. and Relman, A.S., “Professional Medical Associations--Ethical and Practical

Guidelines,” Journal of the American Medical Association,1999;282(10):984.

5. American College of Physician, “Research--Clinical investigation,” Annals of Internal

Medicine Position Paper--Ethics Manual, 4th edition. 

[http:www.acponline.org/journals/annals/01apr98/ethicman.html, accessed September 1999] 

6. University of Rochester Research Subjects Review Board, “Incentive Payments in Clinical 

Trial Agreements--ORPA Internal Policy and Practice.” 

7. St. Vincent Mercy Medical Center (Toledo, OH), “Position Statement Regarding Additional 

Payments for Ongoing Clinical Trials.” 

8. American Medical Association, “Fee Splitting: Referrals to Health Care Facilities,” Current 

Opinions of the Council on Ethical and Judicial Affairs, E-6.03, A-99 Edition. 

The AMA’s prohibition of finder’s fees in clinical research extends beyond its own membership, 

as many other entities require physicians to follow AMA’s code of ethics in its entirety. For 

example, under Ohio state law, violation of the AMA Code of Ethics can be grounds for 

physicians losing their licensure. Ohio Revised Code Annotated: Occupations--Physicians; 

Limited Practitioners, ch. 4731, sec.22 (1998). 

Recruiting Subjects: Guidelines 21 OEI-01-97-00196 
APPENDIX C 

9. American College of Physicians, “Research--Clinical investigation,” Annals of Internal 

Medicine Position Paper--Ethics Manual, 4th edition. 

[http: www.acponline.org/journals/annals/01apr98/ethicman.html, accessed September 1999] 

10. American Academy of Pediatrics, “Specific Aspects of Protocol Design: Recruitment,” 

Policy Statement: Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric 

Populations 1995; 95(2). 

11. Moore v. the Regents of the University of California, 51 Cal. 3d 120; P.2d 479. This case 

involved a patient (Moore) suing his physician for using his cell line, without his permission, to 

create a lucrative commercial product. The discussion from that case states: 

...a physician who treats a patient in whom he also has a research interest has potentially conflicting 

loyalties. This is because medical treatment decisions are made on the basis of proportionality--weighing 

the benefits to the patient against the risks to the patient...A physician who adds his own research interests 

to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, 

benefits to the patient. The possibility that an interest extraneous to the patient’s health has affected the 

physicians judgment is something that a reasonable patient would want to know in deciding whether to 

consent to a proposed course of treatment. It is material to the patient’s decision and, thus, a prerequisite 

for informed consent. 

12. Partners HealthCare System, Inc., “Incentives and Rewards for Recruitment of Patients and 

Referral to Clinical Investigators,” Partners Human Research Committee Policies and 

Procedures: Recruitment of Research Subjects, prepared April 7, 1999, p.3. 

13. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of 

Canada, Social Sciences and Humanities Research Council of Canada. “Conflict of Interest,” TriCouncil Policy Statement--Ethical Conduct for Research Involving Humans, Section 4, Public 

Works and Government Services Canada, 1998. 

14. Memorandum from the University of California-Los Angeles Executive Vice Chancellor, 

“Disclosure of Possible Conflict of Interest to Human Research Subjects,” April 20, 1999. 

15. Ethics Subcommittee of the American Academy of Neurology, “Position Statement: Ethical 

Issues in Clinical Research in Neurology,” Neurology 1998; 50:594. 

16. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of 

Canada, Social Sciences and Humanities Research Council of Canada. “Conflict of Interest,” TriCouncil Policy Statement--Ethical Conduct for Research Involving Humans, Section 4, Public 

Works and Government Services Canada, 1998, p.2.8. 

17. Medical College of Ohio Research Office, “Study Subject Recruitment.” 

Recruiting Subjects: Guidelines 22 OEI-01-97-00196 
APPENDIX C 

18. University of California-Los Angeles, “Selection and Recruitment of Subjects,” Investigator’s 

Manual for the Protection of Human Subjects 1997, p.6-3. 

19. American Academy of Family Physicians, “Confidentiality, Patient/Physician,” Compendium 

of AAFP Positions on Selected Health Issues. 

[http://www.aafp.org/policy/17.html, accessed September 1999] 

20. American Medical Association. “Disclosure of Records to Data Collection Companies,” 

Current Opinions of the Council on Ethical and Judicial Affairs, Section E-5.075, A-99 Edition. 

Recruiting Subjects: Guidelines 23 OEI-01-97-00196