The following discussion is derived from the Information Sheets issued by the Food and Drug Administration as a guidance for investigators and Institutional Review Boards:

Direct advertising for research subjects, i.e. advertising that is intended to be seen or heard by prospective subjects, is not in and of itself an objectionable recruitment practice. Direct recruiting advertisements are seen as part of the informed consent and subject selection processes. IRB review is necessary for advertising materials to ensure that the information is not misleading to subjects. This is especially critical when a study may involve subjects who are unlikely to be vulnerable to undue influence.

When direct advertising is to be used, the IRB should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent form and protocol. The IRB should review the final copy of printed ads to evaluate not only the verbal content, but the relative size of type used and other visual effects. When ads are taped for broadcast, the IRB should review the final audio or video tape.

No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation -- remember that this usually is the experimental question under study, so no forgone conclusions may be implied. Claims also cannot be made that the test article is known to be equivalent or superior to any other drug, biologic or device. Such claims would not only be misleading, but would also be a violation of the FDA's regulations concerning the promotion of investigational drugs or 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" implies that all study subjects will be receiving newly marketed 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. IRBs should consider if the promise of treatment without charge is coercive to financially constrained subjects. Ads may state that subjects will be paid, but should not emphasize the payment or the amount to be paid.

Generally, the 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 ads. The inclusion of these items is not required, however.

• 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 the eligibility for the study;
• A brief list of participation benefits, if any (e.g., no-cost health examination);
• The time or other commitment required of the subjects;
• The location of the research and the person or office to contact for further information.