Subject:  Advertising for Study Subjects. 

The HRAC is responsible for ensuring the equitable selection of research subjects [21 CFR 56.111 (a)(3); 45 CFR).]. In fulfilling this responsibility, HRACs should review the methods that investigators use to recruit subjects. One method of recruiting subjects is through advertisements. 

Advertising for research subjects is not in and of itself an objectionable practice. However, when advertising is to be used, the HRAC should review the information contained in the advertisement, and the mode of its communication, to determine that the procedure for recruiting subjects affords adequate protection.  

FDA requires that an HRAC review and have authority to approve, require modifications in, or disapprove all research activities covered by the HRAC regulations [21CFR 56.109; 45 CFR).]. FDA expects an HRAC to review all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The protocol, the consent form, and the investigator’s brochure have consistently been cited as specific examples of documents that the HRAC should review.  

Advertisements used to recruit subjects should be seen as an extension of the informed consent and subject selection processes [21 CFR 50.20, 21 CFR 50.25, 21 CFR 56.111 (a)(3); 45 CFR).]. Institutions should, therefore, require HRAC review of such advertisements. HRAC 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 HRAC is responsible for assuring that appropriate safeguards exist to protect the rights and welfare of research subjects [21 CFR 56.111(b); 45 CFR.]  

Generally, FDA believes that any advertisement to recruit subjects should be limited to:

1. The name and address of the clinical investigator and/or the research facility

2. The purpose of the research

3. The eligibility criteria that will be used to admit subjects to the study

4. A straightforward and truthful description of the benefits or burdens (e.g., payments,     no cost treatment, placebo control) to the subject for participating in the study

5. The time or other commitment required from the subject

6. The location of the research and the person to contact for further information

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 also be a violation of the FDAs regulations concerning the promotion of investigational drugs [21 CFR 312.7 (a)] and of investigational devices [21 CFR 812.7 (d); 45 CFR)].