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HRPP Policy - Recruitment of human subjects
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Research Protection Program (HRPP)
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 generally 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 trial 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 in the IRB application, including:
- identification of potential subjects
- plans for contacting potential subjects
- payment arrangements for subjects’ participation
- potential undue influence
Recruitment resulting from word of mouth, basic trial listings, or recruitment databases or registries generally do not require IRB review.
Recruitment materials directed to potential subjects are attached to the IRB application.
In general, the IRB must review final recruitment materials. 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. For non-FDA regulated research, the IRB may, at its discretion, approve recruitment plans and materials that include various images and/or various text options which are intended to be combined to create a variety of different recruitment materials without requiring review of each final recruitment material utilizing the approved image and text options.
As outlined within Instruction 3216.02, for research involving U.S. military personnel, additional protections and procedures are in place
- Superiors of service members are to follow specific procedures in order to minimize undue influence, including
- Not being permitted to influence the decision of their subordinates
- Not being present at the time of recruitment
- Having a separate opportunity to participate, when applicable
- When recruitment occurs in a group setting, the IRB must appoint an ombudsman.
- Requiring limitations on dual compensation, including
- Prohibiting an individual from receiving pay of compensation for research during duty hours
- An individual may be compensated for research if the participant is involved in the research when not on duty
- Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw
- 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.
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
Text further clarified within sections 2.0, 2.1, and 3.1. Section 3.1 further revised to indicate recruitment which generally does not require IRB review. Added reference to Recruiting Human Subjects IU guidance and revised name of OHRP guidance in section 6.0.Back to top
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II.3.C
- 45 CFR 46.111
- DOD Instruction 3216.02 – Protection of Human Subjects and Adherence to Ethical Standards in DOD-Supported Research
- FDA Guidance: Recruiting Study Subjects – Information Sheet, Guidance for Institutional Review Boards and Clinical Investigation
- IU Policy on Drawings, Games, and Prizes (FIN-ACC-640)
- OHRP Guidance: IRB Review of Clinical Trial Websites
clinical trial, device, drug, human subject, informed consent, institutional review board (IRB), investigational biologic/drug/device/test article, recruitment, regulatory agencies, research, sponsor, test article
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