HIC Policy

 

SUBJECT: Advertising for Research Participants BACKGROUND The FDA requires that an Institutional Review Board (IRB) review and have the authority to approve, require modifications in, or disapprove all research activities covered by the IRB regulations [21 CFR 56.109(a)]. The IRB reviews, as part of this process, the methods that investigators propose to use to recruit subjects. One method of recruiting subjects is through advertisements. Direct advertising for research subjects, i.e. advertising that is intended to be seen or heard directly by prospective subjects, is not in and of itself an objectionable recruitment practice. It is seen as part of the informed consent and subject selection process [21CFR 50.20, 50.25, 56.111(a)(3) and 812.20(b)(11)]. IRB review is necessary to ensure that information is not misleading to subjects. This is especially critical when a study may involve vulnerable subjects such as those with acute or severe physical or mental illness or persons who are educationally or economically disadvantaged. HIC Policy The WSU IRB will review the final copy of printed advertisements to evaluate the content, relative size of type used, and graphics. When advertisements are to be taped for broadcast, the IRB will review the final audio or video tape. The IRB is willing to review the wording of the advertisement prior to taping to preclude re-taping because of inappropriate content. The review and approval of a taped message prepared from IRB approved text may be accomplished through expedited procedures. If a clinical investigator decides to begin advertising for subjects after a study has received IRB approval, the advertising may be considered as an amendment to the ongoing study and may receive expedited approval. Advertising should not imply a certainty of favorable outcome or benefits beyond what is outlined in the informed consent. No claims should be made that the drug, biologic or devise 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, biologic or device. The terms "new treatment", "new medication" or "new drug" should not be used without explaining that the test article is investigational. Advertisements should not promise "free medical treatment", when the intent is only to say that subjects will not be charged for taking part in the investigation. Advertisements may state that the subjects will be paid, but should not emphasize the payment or the amount to be paid. Advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. Advertisements should include the following: The name and address of the clinical investigator and the identity of the research facility. The condition under study and/or the purpose of the research. The criteria, in summary form, that will be used to determine eligibility for the study. A brief list of the benefits of participation, if any (e.g., a no-cost health examination) The time or other commitment required of the subjects The name of the person or office to contact for further information. Approved by Steering Committee 3/18/98 Approved by All IRB Committees 3/18/98 Administrative Approval 4/25/98