Question:

I am a new study coordinator at a clinical research site. The local newspaper is planning to run a story on a new clinical trial that will highlight the development of an exciting new drug and the work done by our principal investigator in the drug development process. Does the IRB need to review this news story before publication? What about recruitment ads?

Response:

While the regulations do not specifically address the requirement for review of advertisements and other recruitment materials, FDA outlines its expectations for IRB in their guidance document on subject recruitment. FDA considers recruitment as the start of the informed consent process; and, therefore expect IRBs to review the advertising to “assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol.”

FDA guidance specifically excludes news stories from the requirement for IRB review.  In general, materials such as news articles that are not directed at the potential subject population and are not being used for the purpose of recruiting participants. However, in our WCG white paper, Subject Recruitment Materials: Understanding the Requirements for IRB Review, we note: “News stories such as a glowing profile of a principal investigator in a local paper talking about their exciting new study, or interviews with patients or study subjects, may be perceived as recruitment materials…Strict attention to not promoting an investigational drug should be observed.” This is an area where you may want to exercise caution and contact the IRB for assistance in determining if the material needs to be submitted for review.

On the other hand, advertisements to be used for recruitment are clearly subject to review by the IRB.  According to FDA guidance, the IRB needs to review the final copy of printed advertisements “to evaluate the relative size of type used and other visual effects.” The FDA also expects the IRB to review final audio and video advertisements and may review the wording ahead of time to minimize the need to re-tape the ad.