Web Postings providing details of eligibility criteria and study procedures in lay language, those describing potential benefits of the research (as opposed to the specific aims or scientific objectives of the research), and descriptions of compensation all would be viewed by the IRB as elements of an advertisement. Advertisements for recruiting are designed (at least in part) to solicit a response from potential participants, and hence provide contact information to reach individuals responsible for entry into that study. Statements such as "To see if you are eligible to participate, call..." or "For more information about participating in this study, contact..." would be viewed by the IRB as elements of an advertisement. A generic statement such as "Speak to your doctor if you are interested in participating in a cancer clinical trial" or "To hear more about the research efforts of the Department of Radiation Oncology..." would not, in and of itself, constitute an advertisement for recruiting.
Please note that there is no reason why researchers should not employ web-based or other recruiting mechanisms. However, researchers are reminded that any such advertisements require IRBMED review and approval, and when modified the IRBMED must approve the modification. If an advertisement or posting is modified, the research would have to provide the IRBMED with the text of the modified advertisement before it was posted on the website. If the text on the website is identical to text being used in flyers or newspaper advertisements, then the IRBMED only needs to receive one ad with appropriate indications that this ad will be displayed as a flyer in the department's waiting rooms, as an ad in the local news, and on the departmental website.
With these elements in mind, we believe that the IRB can do its assigned job of reviewing patient recruitment advertisements without putting an undue burden on investigators or departments. Please let us know if you have any questions or comments. Thanks for your ongoing commitment to the protection of human research participants.
The IRBMED requires that advertisements include the IRBMED number of the study. On a case-by-case basis, the IRBMED may waive this requirement, particularly for national advertisements of multi-site studies.
For additional information, refer to FDA guidelines about recruiting study subjects.