Advertising for Research Subjects - Office of Human Research Protection Guidelines

One method of recruiting subjects is through advertisements (e.g., posted notices and newspaper or magazine ads). Advertising for research subjects is not, in and of itself, an objectionable practice. When advertising is to be used, however, the FDA requests that IRBs review the information contained in the advertisement, as well as the mode of its communication, to determine whether the procedure for recruiting subjects affords adequate protection. IRB review is necessary to ensure that the information is not misleading to subjects, especially when a study will involve persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged.

The FDA believes that any advertisement to recruit subjects should be limited to: (1) the name and address of the clinical investigator; (2) the purpose of the research, and, in summary form, the eligibility criteria that will be used to admit subjects into the study; (3) a straightforward and truthful description of the incentives to the subject for participation in the study (e.g., payments or free treatment); and (4) the location of the research and the person to contact for further information [FDA IRB Information Sheet: "Advertising For Study Subjects"(1989)].

If a study involves investigational drugs or devices, no claims should be made, either explicitly or implicitly, that the drug or device is safe or effective for the purposes under

investigation, or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects, but would also violate FDA regulations concerning the promotion of investigational drugs [21 CFR 312.7(a)] and investigational devices [21 CFR 812.7(d)].