Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
Recruiting Human Subjects 
Sample Guidelines for Practice 
JUNE GIBBS BROWN 
Inspector General 
JUNE 2000 
OEI-01-97-00196  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  E X E C U T I V E   S U M M A R Y  
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 nations 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 
investigators 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. 
1 
Recruiting Subjects: Guidelines  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 investigators 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 
2 
Recruiting Subjects: Guidelines  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 Citizens 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. 
3 
Recruiting Subjects: Guidelines  OEI-01-97-00196  T A B L E   O F   C O N T E N T S  
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

4 
Recruiting Subjects: Guidelines  OEI-01-97-00196  I N T R O D U C T I O N  
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 nations 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 investigator-
physician role, and the confidentiality of medical records.  These three issues parallel the 
main recruitment strategies set forth in our companion report:  offering incentives, 
targeting ones 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. 
5 
Recruiting Subjects: Guidelines  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 self-
monitoring.  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. 
6 
Recruiting Subjects: Guidelines  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 guidelines 
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 Presidents Council on Integrity and Efficiency. 
7 
Recruiting Subjects: Guidelines  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 Womens Hospital, prohibits finders 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. 
8 
Recruiting Subjects: Guidelines  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 (finders fees) is unethical.8 
Similarly, the American College of Physicians asserts that these finders 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 patients health, whether research or economic, that may 
affect the physicians 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. 
9 
Recruiting Subjects: Guidelines  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. 
10 
Recruiting Subjects: Guidelines  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.  Patient-
subjects 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: 
11 
Recruiting Subjects: Guidelines  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 
12 
Recruiting Subjects: Guidelines  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 physicians or hospitals 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 doctor-
patient confidentiality...If an investigator plans to recruit subjects that are not his own 
patients or not from his departments 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 subjects 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 
13 
Recruiting Subjects: Guidelines  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 subjects 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 investigators 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 patients 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 individuals 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 
14 
Recruiting Subjects: Guidelines  OEI-01-97-00196  C O N C L U S I O N  
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. 
15 
Recruiting Subjects: Guidelines  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. 
Dua 
Confidential  Other 
Incentives  l 
Records  Guidance 
Role 
referral fees  financial arrangements disclosure to subjects of  for conducting clinical trial Compensation to investigators  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  k  k 
Physicians 
American Academy of  U 
Neurology 
American Academy of  k  k 
Ophthalmology 
American Academy of  k  U  AMA Code 
Orthopaedic Surgeons  of Ethics 
American Academy of  U  U 
Pediatrics 
American Academy of  k  Nuremberg 
Physical Medicine and  laws 
Rehabilitation 
American Association of  k 
Neurological Surgeons 
16 
Recruiting Subjects: Guidelines  OEI-01-97-00196  APPENDIX A 
Dua 
Confidential  Other 
Incentives  l 
Records  Guidance 
Role 
fC du
oo a pfU
referral fees  financial arrangements disclosure to subjects of  r conducting clinical trial mpensation to investigators  l investigator-physician role  otential subjects or identifying /contacting se of medical records  payment to subjects Advertisement/  news briefs  guidance also defers to other 
American College of  U  Declaration 
Emergency Physicians  of Helsinki 
American College of  k 
Obstetricians and 
Gynecologists 
American College of  U  k  U  k  U 
Physicians 
American College of  k 
Radiology 
American College of Surgeons  k  k 
American Geriatrics Society 
American Medical Association  U  k  U 
American Womens Medical 
Association 
American Pharmaceutical 
Association 
American Psychiatric  k  U  k  AMA Code 
Association  of Ethics 
American Society of  k  AMA Code 
Anesthesiologists  of Ethics 
American Society of Plastic  k  k 
and Reconstructive Surgeons 
National Medical Association 
17 
Recruiting Subjects: Guidelines  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.

18 
Recruiting Subjects: Guidelines  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 Womens 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]

19 
Recruiting Subjects: Guidelines  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 Administrations (FDA) Current Informed Consent Regulations,

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

20 
Recruiting Subjects: Guidelines  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 Associations 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 AMAs prohibition of finders fees in clinical research extends beyond its own membership, 
as many other entities require physicians to follow AMAs 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). 
21 
Recruiting Subjects: Guidelines  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 patients 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 patients 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, Tri-
Council 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, Tri-
Council 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. 
22 
Recruiting Subjects: Guidelines  OEI-01-97-00196  APPENDIX C 
18.  University of California-Los Angeles, Selection and Recruitment of Subjects, Investigators 
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. 
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Recruiting Subjects: Guidelines  OEI-01-97-00196