UAB Policy on Selection and Recruitment of Subjects in Research
The investigator will consider equitable selection of subjects in the research design and provide information on the targeted research population for the IRB to make its determinations. Such information will include population characteristics (e.g., age, sex, race, ethnicity), anticipated number of enrollees, inclusion/exclusion criteria, and additional information as requested by the IRB.
The IRB will evaluate enrollment procedures; recruitment processes, including any advertisements; and participation arrangements for clinical studies as each relates to:
All recruitment materials (e.g., flyers, or other printed materials, letters to potential subjects) will receive review and approval by the IRB prior to distribution. As part of sound study design, investigators should assess enrollment and recruitment practices for fairness and equitable selection. Investigators will provide information to the IRB to make the above determinations.
Advertising intended to be seen or heard by prospective subjects to solicit enrollment into a study will receive IRB review and approval prior to dissemination. Advertisements that are easily comparable to an approved informed consent document may undergo review and approval using the expedited review procedure. For advertisements, the IRB will review the information content and the mode of communication to determine that the procedures are not coercive. The IRB will review the final copy of printed advertisements to assess the relative size and type used and other visual effects. For audio and video advertisements, the IRB will review the final taped version. However, the IRB may approve the script of the advertisement prior to taping to preclude re-taping because of inappropriate wording. Subsequent approval of the final taped version may be approved via expedited review.
IRB review of advertisements should assure that advertisements do not:
Advertisements to recruit subjects should be limited to information prospective enrollees need to determine their eligibility and interest. When appropriately stated, the following items may be included in advertisements:
Listings of clinical trials on the internet will receive IRB review and approval before posting to a web site except when the system format limits the information provided to the following basic content:
The IRB will review payment arrangements to participants. Both the method of payment and proposed method and timing of disbursement will be assessed to limit the risk of coercion, undue influence, or inequitable selection of subjects. Information concerning payments, including the amount and schedule of payments, will be set forth in the informed consent document. The IRB will determine that:
The following payment arrangements will not be allowed:
Payments from an investigator or sponsor to a person for referral of potential subject (i.e., finder’s fees) are permissible when the payment is not to a person in an authority relationship with the prospective participants (e.g., professor-student, employer-employee, or physician-patient) and the IRB judges that such payments will not increase the risk of coercion or undue influence upon investigators or participants. Bonus payments from a sponsor to an investigator based on the rate or timing of recruitment are not allowed. Investigators will provide information on payment arrangements for the IRB to make the above determinations.
Approved on March 1, 2010, by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP