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HRPP Policy - Recruitment of human subjects
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
A criterion for approval of research is that selection of subjects is fair and equitable. The IRB evaluates this criterion by considering both the selection criteria and proposed plans for recruitment of subjects for each research study. Recruitment represents the beginning of the consent process; as such, all recruitment methods and materials must meet ethical guidelines and must be reviewed and approved by the IRB before recruitment begins.
The IRB must ensure that recruitment methods and materials, including payment amount and timing of disbursement to subjects, are not coercive, misleading, or unduly influential. If the circumstances of the research could give rise to any level of undue influence (e.g., payment for subjects' participation, instructors recruiting their own students, supervisors recruiting their direct reports, health care professionals recruiting their own patients), the study team must provide appropriate safeguards and/or assurances that the decision to participate will not affect the relationship.
Recruitment materials directed to potential subjects must be reviewed and approved by the IRB prior to use to ensure they are not unduly influential or misleading. Materials directed to other audiences (e.g., materials given to health care providers, teachers, or schools who will facilitate recruitment of subjects; news articles not intended for recruitment of subjects; financial page information for investors) and listings on clinical trial websites which provide basic information limited to title, purpose, study summary, basic eligibility criteria, locations, and contact information do not need to be reviewed by the IRB.
Recruitment materials must include information prospective subjects need to determine their eligibility and interest. Materials should be written in a language understandable to the subjects, and may not:
- Emphasize the payment or payment amount by such means as larger or bold type
- Include exculpatory language
- State or imply certain favorable outcomes or other benefits beyond what is outlined in the informed consent document and the protocol
- Claim that an investigational drug, biological product, 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, biological product, or device
- Use terms such as "new treatment" or "new drug" without explaining that the test article is investigational
- Promise free medical treatment when the intent is only to say that subjects will not be charged for taking part in the study
- Include a coupon or other incentive from the sponsor for a discount on the purchase price of the test article once it has been approved for marketing.
Recruitment methods are described and justified in the IRB application, including:
- identification of potential subjects
- plans for contacting potential subjects
- payment arrangements for subjects' participation
- potential undue influence
Recruitment materials directed to potential subjects are attached to the IRB application.
For FDA-regulated research, the IRB must review and approve the final versions of any printed, audio, or video advertisements; however, the IRB may review and approve the wording prior to taping or final design.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II.3.C
- Element III.1.E
- 45 CFR 46.111
- FDA Guidance: Recruiting Study Subjects Information Sheet, Guidance for Institutional Review Boards and Clinical Investigations
- IU Policy on Drawings, Games, and Prizes
- OHRP Guidance: Clinical Trial Website: When is IRB review required and what should IRBs consider with reviewing?