By Lindsay A. Abraham, JD, CIP and Glenn Veit, JD, CIP
Materials used in the recruitment of potential study participants such as advertisements, flyers, and letters are an important and integral part of a research study. They are often the only way for a potential subject to learn about a new clinical trial. Some materials can also be a good tool to provide general information about a study for subjects to consider prior to entering the informed consent process.
The process of study participant recruitment is not specifically addressed in the regulations of either the Office of Human Research Protection (OHRP), which oversees federally-funded research, or of the Food and Drug Administration (FDA), which oversees research which is intended to be submitted in support of a product marketing application. However, both OHRP and FDA regulations require that an Institutional Review Board (IRB) “…shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered…” by the respective regulations. In addition, both OHRP and FDA have consistently indicated in guidance that the IRB is expected to review the methods and materials that investigators propose to use to recruit study subjects. The question that then arises is: What materials does the IRB have to review?