Recruitment of Research Participants Guidance

Version Date: December 7, 2015

UW–Madison IRBs review study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants, and to ensure that the proposed methods adequately protect the rights and welfare of participants.

Advertisements

IRBs will consider whether recruitment processes, including advertisements could affect the equitable selection of participants, or be unduly coercive or misleading. IRBs will consider the content, design and mode of communication of any advertisements in making this determination. The IRBs will review advertising to ensure that advertisements do not:

• State or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.
• Include exculpatory language.
• Emphasize the payment or amount to be paid, by such means as larger or bold type.
• Promise, "free treatment" when the intent is only to say participants will not be charged for taking part in the investigation.

In addition, advertisements should generally be limited to providing only information prospective participants need to determine their eligibility and interest in a study, such as the following which the IRBs may review:

• The name and address of the researcher or research facility.
• The purpose of the research or condition under study.
• The criteria that will be used to determine eligibility for the study (in summary form).
• A brief list of benefits, if any.
• The time or other commitment required to participate.
• The location of the research and the person or office to contact for additional information.

When FDA requirements apply to a study, the IRB will also review advertising to specifically ensure that advertisements:

• Do not make claims inconsistent with FDA labeling about the drug, biologic, or device under investigation.
• Do not use terms like "new treatment", "new medication" or "new drug" without explaining that the test article is investigational.

Participant Compensation

IRBs allow compensation for research participants with some limitations. Compensation should not be excessive relative to the nature of the research, in order to avoid inequitable selection of participants or undue inducement to participate. In addition:

• Compensation should not be withheld contingent on the participant's completion of the study.
• In most cases involving continued participation, compensation should be given on a reasonable prorated basis to avoid the impression that the investigator is coercing the participant to continue in a study or is punishing the participant for non-compliance.
• IRBs typically allow reimbursement for research-related expenses such as the cost of transportation and parking and loss of wages.
• All information concerning payment, including the amount and schedule of payments, must be in the informed consent form.
• When FDA requirements apply to a study, the IRB will not allow compensation to include coupons for discounts on the product being investigated, once it has been approved for marketing.

Information regarding how to process payment for research participants at UW–Madison can be found here: http://www.bussvc.wisc.edu/acct/policy/human_subjects/humanpol.html

Payments for Recruitment Referrals

Payments for the referral, recruitment or enrollment of potential research participants in human research studies are generally only permitted when such payments:

1. Are equal to the direct costs incurred by the individual or entity referring, recruiting or enrolling the participants (these costs may be specified in research agreements between the sponsor and the University); or
2. Payments reflect the fair market value of services performed and are commensurate with the efforts of the individual(s) performing the participant referral, recruitment, or enrollment activities.

The following are not permitted:

1. Finder's fees for the identification and referral of participants.
2. Recruitment bonuses or incentives tied to the timing or rate of enrollment or number of participants enrolled.
3. Linking payments to successful research outcomes.

See Also:

• Subject Recruitment and Screening Procedures Guidance Index
• IRB Guidance: Community Based Research Review Practices
• IRB Guidance: Research in K-12 Schools
• IRB Guidance: International Research