ELEMENT II.3.C.

A criterion for approval of research is that selection of participants is equitable. The IRB or EC should evaluate whether research submitted for review satisfies this criterion. IRB or EC members should understand how to apply this criterion. In evaluating this criterion, IRB or EC members should consider both the selection (inclusion and exclusion) criteria and the proposed plans for recruitment of participants. IRB members should evaluate whether selection criteria and recruitment practices meet this criterion.

Recruitment methods, including advertisements, and participant payment arrangements affect the equitable selection of participants and an appropriate consent process.

A research study might have fair selection criteria, but use recruitment methods or payment arrangements that lead to inequitable selection. For example, recruitment methods, advertisements, or payment arrangements that target economically disadvantaged participants can lead to unfair selection of participants despite reasonable selection criteria. Therefore, the IRB or EC should evaluate whether recruitment processes, advertisements, and payment arrangements affect the equitable selection of participants.

Recruitment methods, advertising materials, and payment arrangements also represent a part of the consent process. Recruitment methods and advertisements are the beginning of the consent negotiations; payments for participation are provided to reimburse participants for their time, effort, or other expenses. Recruitment methods, advertisements, or payment arrangements that are misleading, inaccurate, exculpatory, coercive, or unduly influential violate ethical requirements for consent. Therefore, the IRB or EC should review proposed recruitment processes and advertising materials to judge whether they fulfill the requirements for consent.

Payment arrangements can place participants at risk of coercion or undue influence or cause inequitable selection. Two situations should be examined: finder’s fees and recruitment bonuses. A finder’s fee or referral is a payment from the researcher or sponsor to a person who refers a prospective participant. Recruitment bonuses are payments from the sponsor to a researcher or organization based on the rate or timing of recruitment. For example, a sponsor might contract to pay the researcher or organization a fixed fee for each participant but promise an additional payment if more than a certain number of participants are enrolled in the first week or if the site has the highest enrollment at the end of the month. Policies and procedures should describe acceptable and unacceptable payment arrangements among the sponsor, organization, researcher, and those referring research participants.

Regulatory and guidance references

DHHS: 45 CFR 17.92, 45 CFR 46.111(a)(3), 45 CFR 46.116, OHRP Guidance on Written Institutional Review Board (IRB) Procedures
DoD: Instruction 3216.02 11., Dual Compensation Act, 24 U.S.C 301, DoD 3216.2, para. 4.4.4; SECNAVINST 3900.39D, para. 6a(6)
DOJ: 28 CFR 512.11(4,5)
FDA: 21 CFR 56.111(a)(3), 21 CFR 50.20, 21 CFR 56.111(a)(3), FDA Information Sheets: Frequently Asked Questions: Informed Consent Document Content, Frequently Asked Questions: IRB organization, A Guide to Informed Consent, Recruiting Study Subjects, Payment to Research Subjects
ICH-GCP: 3.1.8
VA: VHA Directive 1200.05(3), 3
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Sufficient Information to Determine Whether the Criteria for Approval are Met

Required written materials

Essential requirements:
1. Policies and procedures describe the process to evaluate the equitable selection of participants.
  1. Applications include information that allows the IRB or EC to determine whether selection of participants will be equitable, such as:
    1. The purposes of the research.
    2. The setting in which the research will be conducted.
    3. Whether prospective participants will be vulnerable to coercion or undue influence.
    4. The selection (inclusion/exclusion) criteria.
    5. Participant recruitment and enrollment procedures.
    6. The amount and timing of payments to participants.
  2. In order to approve research, policies and procedures have the IRB or EC determine that selection of participants is equitable.
  3. In making an assessment about whether selection of participants is equitable, policies and procedures have the IRB or EC take into account:
    1. The purposes of the research.
    2. The setting in which the research will be conducted.
    3. Whether prospective participants will be vulnerable to coercion or undue influence.
    4. The selection (inclusion/exclusion) criteria.
    5. Participant recruitment and enrollment procedures.
    6. The influence of payments to participants.
  4. Policies and procedures have the IRB or EC review:
    1. The information contained in the advertisement.
    2. The mode of its communication.
    3. The final copy of printed advertisements.
    4. The final audio or video taped advertisements.
  5. Policies and procedures have the IRB or EC review advertising to ensure that advertisements do not:
    1. State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.
    2. Include exculpatory language.
    3. Emphasize the payment or the amount to be paid, by such means as larger or bold type.
    4. Promise “free treatment” when the intent is only to say participants will not be charged for taking part in the investigation.
  6. Policies and procedures have advertisements limited to the information prospective participants need to determine their eligibility and interest, such as:
    1. The name and address of the researcher or research facility.
    2. The purpose of the research or the condition under study.
    3. In summary form, the criteria that will be used to determine eligibility for the study.
    4. A brief list of benefits to participants, if any.
    5. The time or other commitment required of the participants.
    6. The location of the research and the person or office to contact for further information.
  7. Applications include the amount and schedule of all payments.
  8. Policies and procedures have the IRB or EC review payments to determine that:
    1. The amount of payment and the proposed method and timing of disbursement neither is coercive nor presents undue influence.
    2. Credit for payment accrues as the study progresses and not be contingent upon the participant completing the entire study.
    3. Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
    4. All information concerning payment, including the amount and schedule of payments, is set forth in the consent document.
  9. Policies and procedures describe acceptable and unacceptable payment arrangements for the sponsor, organization, researcher, and those referring research participants.
  10. Policies and procedures on payment arrangements address the acceptability of payments in exchange for referrals of prospective participants (“finder’s fees” or “referral fees”).
  11. Policies and procedures on payment arrangements address payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”).
When following DoD requirements:
1. DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:
  1. Are prohibited from influencing their subordinates to participate in research involving human participants.
  2. Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel.
  3. May participate in separate human participant research recruitment sessions.
2. For greater than minimal risk research involving DoD-personnel, when recruitment and consent occurs in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
  1. Must not have a conflict of interest with the research or be a part of the research team.
  2. Must be present during human participant recruitment, monitoring that the recruitment and informed consent explain that participation is voluntary and that the information provided about the research is consistent with the IRB-approved script and materials, including digitally provided materials.
  3. Should be available to address DoD-affiliated personnel’s concerns about participation.
3. When research involves U.S. military personnel, policies and procedures require limitations on dual compensation:
  1. Prohibit an individual from receiving pay of compensation for research during duty hours.
  2. An individual may be compensated for research if the participant is involved in the research when not on duty.
  3. Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.
  4. Non-Federal persons may be compensated for research participating other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.
When following DOJ requirements:
1. Policies and procedures indicate that for research conducted within the Bureau of Prisons:
2. The selection of participants within any one organization must be equitable.
3. Incentives may not be offered to help persuade inmate participants to participate. However, soft drinks and snacks to be consumed at the test setting may be offered.
4. Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research participants who are both:
  1. No longer in Bureau of Prisons custody.
  2. Participating in authorized research being conducted by Bureau employees or contractors.
When following FDA regulations:
1. Policies and procedures have the IRB or EC review advertising to ensure that advertisements do not:
  1. Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling.
  2. Use terms, such as “new treatment,” “new medication,” or “new drug,” without explaining that the test article is investigational.
  3. 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.
When following VA requirements:
1. For VA facilities:
  1. The facility Director must ensure that a procedure is in place to review and approve recruiting media, including documents, flyers, and advertisements for research that is not VA research prior to being posted or distributed in any form within or on the premises of a VA facility. Posting or distributing may include announcing, distributing, publishing, or advertising the study either electronically, by hard copy, or other means to anyone, including Veterans, clinicians, or other staff.
  2. Policies indicate that IRBs (even an internal VA IRB) no longer have authority to approve non-Veteran enrollment into VA studies, but must be done by the R&D Committee.

Common types of materials that may be used to meet the element

Application form
Reviewer checklist

Outcomes

IRB or EC members determine that selection of participants is equitable.
IRB or EC members determine that advertisements:
- Provide prospective participants with sufficient opportunity to consider whether to participate.
- Do not include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the researcher, the sponsor, or the institution, or its agents from liability for negligence.
IRB or EC members determine that payment arrangements:
- Provide prospective participants with sufficient opportunity to consider whether to participate.
- Minimize the possibility of coercion or undue influence of participants.
- Based on the timing or rate of participant enrollment (often known as bonus payments or finder’s fees), are prohibited unless they are judged not to interfere with providing prospective participants with sufficient opportunity to consider whether to participate and do not increase the possibility of coercion or undue influence on researchers or participants.

Proceed To: ELEMENT II.3.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.3.C.