HRPP Policy - Recruitment of human subjects

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