IRB requirements for advertising to study subjects

Don’t forget: Any advertising for the recruitment of study subjects requires Institutional Review Board (IRB) approval. The IRB needs to review the information contained in the advertisement and the method of communication, to determine that the procedure for recruiting subjects affords adequate protection.

Advertisements used to recruit subjects are seen as an extension of the informed consent process. Based on FDA regulation and OHSU IRB policy, any advertisement used to recruit subjects should be limited to:

• The names and address of the clinical investigator and/or research facility and the IRB number of the study.
• The condition under study and/or the purpose of the research
• In summary form, the criteria that will be used to determine eligibility
• A brief, truthful description of the benefits or burdens (payments, no cost treatment, percentage of subjects will receive placebo)
• The time commitment required
• The location of the research and who to contact for further information

These requirements apply regardless of whether the advertisement is in print, on the radio, on television, or on the Internet (Craigslist, Clintrials, etc.). It is not required that the IRB number be read aloud for radio and TV ads.

Tips for text:

• Do not use the phrase “Free Medical Treatment”
• Do not call the intervention a new treatment, medication, drug, device, etc.
• If the study is for an investigational drug, describe the study arms in the following manner: “You will receive a pill (or patch, injection, etc.). This pill (or patch, injection, etc.) may contain the study drug, an inactive substance call a placebo. You have a 1 in “X” chance of receiving the study drug”.
• When submitting an advertisement for review, indicate the media used and whether any subsequent advertisements in different media are planned.
• Don’t claim that the drug or device is safe or effective, or that the drug or device is equivalent or superior to any other drug or device.

These requirements apply regardless of whether the advertisement is in print, on the radio, on television, or on the Internet. If you’d like an example of an approvable ad, please contact your managing analyst.