HRPP Manual Section 6-5

Selection of Subjects and Recruitment

Revised Common Rule (2018 Requirements)

“(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.” 45 CFR 46.111(2018 Requirements)

Pre-2018 Common Rule and U.S. Food and Drug Administration Requirements

“(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, [handicapped or, DHHS] mentally disabled persons, or economically or educationally disadvantaged persons” 45 CFR 46.111(Pre-2018 Requirements), 21 CFR 56.111

The Michigan State University (MSU) Institutional Review Board (IRB) shall determine that selection of subjects is equitable. In assessing the selection of subjects for a research study, the IRB considers the following factors:

Whether selection of subjects meets regulatory requirements and/or whether the selection of subjects meets ethical principles as outlined in the Belmont Report
Purpose of the research
Requirements of the proposed study design
Setting in which research would be conducted
Subjects’ susceptibility to risk
Whether prospective subjects would be vulnerable to coercion or undue influence
Likelihood that the proposed benefits will be realized by the subjects
Practicability of the proposed research
Fairness and equitability of the proposed research design, including inclusion and exclusion criteria
Subject recruitment and enrollment procedures
The amount and timing of payments to subjects, including whether recruitment processes, advertisements, and payment arrangements affect the equitable selection of subjects
Influence of payments to subjects
Whether someone is receiving payment for recruiting subjects

Recruitment

Subjects should not feel obligated or in any way pressured to participate in the research study. Subjects should be provided with an accurate description of the research and should not be given false promises. The potential research subject’s wishes shall govern and if they indicate that they do not want to participate, their wish must be respected.

For studies subject to the Revised Common Rule (2018 Requirements), the IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative if the IRB determines that the regulatory criteria for the exception are met. See HRPP Manual 6-4-E “Informed Consent Exception for Screening, Recruiting, or Determining Eligibility.”

Research Involving Students as Participants

If students will be recruited and extra credit or course credit will be offered for research participation, an alternative option that is equivalent in time, effort, and points needs to be offered to students who choose not to participate in the research. If the PI is not the instructor, the PI must work with the instructor(s) to ensure that this requirement is met. Students must not be penalized for deciding not to participate in research.

Payment of Subjects

Paying research subjects in exchange for their participation is a common and, in general, acceptable practice. Payment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits or risks; it is a recruitment incentive. Payment for participation may raise difficult questions that should be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration. In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent. Payment for participation in research should be just and fair. However, the specifics of each protocol will influence how those determinations are made. Both researchers and the IRB needs to be familiar with the study population and the context of the research in order to make reasonable judgments about how compensation might affect participation.

Payments to subjects must comply with state and federal laws and university requirements (e.g., tax reporting, Internal Revenue Service). Prizes/awards given to subjects based on chance (e.g., entering into a drawing) must comply with raffle or lottery laws (e.g., State of Michigan). The MSU Office of the General Counsel or the Office of the Controller may be contacted with questions regarding payment or reimbursement.

There is no cash limit on awards/reimbursement that all subjects receive. However, compensation to subjects should never be so high as to constitute an undue influence to participate in research (e.g., accept a risk that they would not otherwise accept).

If any type of payment will be offered (e.g., compensation, incentives), the payment amount, proposed method, and timing of distribution will be evaluated during the review of the study to assess the appropriateness and to assure that it is not coercive or present undue influence. The assessment will include the following considerations:

The payment amount, method, and timing of distribution:
- Will not unduly influence the subject to participate in a research study or accept a research risk in which they would otherwise decline
- Are reasonable based upon the complexities and inconveniences to subjects of the study
- Are reasonable based upon the particular subject population
For multiple visits or assessments, the credit for payment accrues as the study progresses and is not contingent upon the subject completing the entire study
Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn
All information concerning payment, including the amount and schedule of payments, is set forth in the consent form

Payments in exchange for referrals of potential subjects (i.e., finder’s fees) or payments designed to accelerate recruitment that are tied to the rate and timing of enrollment (i.e., bonus payments) are prohibited unless:

they are judged not to interfere with providing prospective participants with sufficient opportunity to consider whether to participate and
they do not increase the possibility of coercion or undue influence on researchers or participants.

The guidance provided by the U.S. Food and Drug Administration (FDA) Information Sheets Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators – 2018 is also used in the review of payment amount, method and timing for studies to which FDA policies and procedures apply.

Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study.
Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.

In studies of considerable duration or that involve multiple interactions or interventions, is recommended that payment be prorated for the time of participation in the study rather than delayed until study completion, because the latter could unduly influence a subject’s decision to exercise their right to withdraw at any time. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions, there might be payment after every two sessions.

If advertisements are proposed to be used, the IRB reviews the following:

Information contained in the advertisement
Mode of its communication
Final copy of printed advertisement
Final audio/video taped advertisement
Advertisements posted on websites
If a QR code is used, the corresponding website information in its’ final form must be submitted

If investigators would like to use advertisements in their recruitment practices, the advertisements must be limited to information prospective participants need to determine their eligibility and interest, such as.

The name and contact mechanism of the investigator, study team, or research facility
The purpose of the research or condition under study
In summary form, the criteria that will be used to determine eligibility for the study
Straightforward and truthful description of the risks and/or benefits to the subject from participation in the study
The location of the research or research facility and the person or office to contact for further information
Time or other commitment required of subjects

Advertisements may not:

Include IRB endorsement of research studies either in recruitment materials or consent forms
Include exculpatory language
Emphasize the payment or amount to be paid, by such means as larger or bolder type
State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent form and the research study
Promise “free treatment” when intent is only to say subjects will not be charged for taking part in the investigation

In addition to the above criteria, the following recommendations from guidance provided by the FDA Information Sheets Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators – 1998 are followed for research to which FDA regulations and policies apply:

No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Such representation would not only be misleading to subjects but would also be a violation of the agency's regulations concerning the promotion of investigational drugs [21 CFR 312.7(a)] and of investigational devices [21 CFR 812.7(d)].
Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" leads study subjects to believe they will be receiving newly improved products of proven worth.
Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
Generally, the FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements. It should be noted, however, that the FDA does not require inclusion of all of the listed items.
- the name and address of the clinical investigator and/or research facility;
- the condition under study and/or the purpose of the research;
- in summary form, the criteria that will be used to determine eligibility for the study;
- a brief list of participation benefits, if any (e.g., a no-cost health examination);
- “the time or other commitment required of the subjects; and
- the location of the research and the person or office to contact for further information.

Advertisements for research regulated by the FDA may not:

Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling
Use terms such as “new treatment,” “new medication,” or “new drug” without explaining that the test article is investigational
Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing

Applicability of the Revised Common Rule (2018 Requirements)

See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.

Additional Considerations

For research studies subject to the requirements of the U.S. Department of Defense and the U.S. Department of Justice, see the following sections of the Human Research Protection Program Manual:

2-2-A U.S. Department of Defense
2-2-C U.S. Department of Justice

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 1-22-2015. Revision 4 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 5 approved by Associate VP Research Regulatory Support on 12-11-2025.

Human Research Protection Program Office of Research Regulatory Support