IRBMED - UMMS

Guidance:

Advertising--General Information

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements; postings on websites; brochures in a patient waiting area; communications to referring physicians designed to be passed on to potential subjects; and automated telephone message systems that play outgoing recruitment messages to patients while they are on hold or that are programmed for study subject triage and intake. Yet another form would be a press release designed to publicize a trial that is open to new subject accrual.

By federal law, the IRB is required to protect the welfare of human subjects participating in research and, specifically, to determine that the selection of subjects to participate in the project is equitable and free from coercion. As an essential part of this process, the IRB must review and approve any advertisement for recruiting subjects to a research project before it can be distributed to potential participants. FDA guidance advises that, "The IRB should review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects."

Distinguishing Between Press Releases and Subject Recruitment

Academic medical centers, by their nature, function in an open environment where physicians strive to make their research widely known to the community. How then are we to know what is an advertisement (or other recruiting mechanism) that requires IRB scrutiny before it can be released and what is 'business as usual?'

Advertisements for recruiting are usually study-specific and not generic statements about research conducted in a particular setting (e.g., Surgery Department) or for a given group of diseases (e.g., cardiovascular disease). Advertisements for recruiting are designed to be conveyed to potential participants, either directly or through an intermediary such as a referring physician. The fact that something is accessible on a website does not in and of itself make it an advertisement intended to be conveyed to a potential participant. (Click here for IRB guidelines for non-study specific advertising.)

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.