The FDA Information Sheet: “Recruiting Study Subjects presents guidelines for the format of study advertisements. Advertisements should include the following: (1) the name and address of investigator and facility or institution; (2) the condition under study or the purpose of the research; (3) the inclusion and exclusion criteria; (4) the study procedures; (5) the time or commitment required; (6) any monetary payments or reimbursement, but should not emphasize this provision; (7) the location of the research; and (8) the name of the person to contact for further information. Yale University policy states that the protocol number must also be included on the advertisement, as designated by the respective IRB (nursing, social sciences, biomedical). In addition, advertisements should exclude the following: (1) catchy words such as “free” or “exciting,” or (2) the promise of an individual health benefit. Advertisements must never be misleading, but clearly state the purpose of the research and that research participation is being solicited. This list of inclusions and exclusions should be adhered to when developing all types of media advertisements.
Flyers, posters, and brochures are typically placed in strategic locations in order to target the appropriate subject populations. The investigator should obtain approval from the sites where these materials will be posted prior to posting or distribution. Evidence of this approval may be required by the Yale University IRBs.