The IRB must review all forms of direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study.
Direct advertising includes, but is not necessarily limited to:
- Bulletin boards,
- Posters, and
- Flyers that are intended for prospective subjects.
Not included are communications intended to be seen or heard by health professionals, such as "dear doctor" letters and doctor-to-doctor letters, news stories, and publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.
When direct advertising is to be used, the IRB should review the information contained in the advertisement and the mode of its communication in order to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol. The IRB should review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. When advertisements are to be taped for broadcast, the IRB should review the final audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording. The review of the final taped message prepared from IRB-approved text may be accomplished through expedited procedures. The IRB may wish to caution the clinical investigators to obtain IRB approval of message text prior to taping in order to avoid re-taping because of inappropriate wording.
No claims should be made, either explicitly or implicitly, that the drug, biologic, or device 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. Such representation would not only be misleading to subjects but would also be a violation of the FDA's regulations concerning the promotion of investigational drugs and investigational devices.
Advertising for recruitment into investigational drug, biologic, or device studies should not use terms such as "new treatment," "new medication," or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" leads study subjects to believe they will be receiving newly improved products of proven worth.
Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
Generally, FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements. It should be noted, however, that FDA does not require inclusion of all the listed items:
- the name and address of the clinical investigator and/or research facility,
- the condition under study and/or the purpose of the research,
- in summary form, the criteria that will be used to determine eligibility for the study,
- a brief list of participation benefits, if any (e.g. a no-cost health examination),
- the time or other commitment required of the subjects, and
- the location of the research and the person or office to contact for further information.