Oftentimes, the only way for potential research subjects to learn about a new clinical trial is through recruitment materials. These materials, such as flyers, advertisements, and letters, are an important part of a research study, and are considered to be the beginning of the informed consent process. While neither the Office of Human Research Protection (OHRP) nor the Food and Drug Administration (FDA) address subject recruitment in their regulations, both require that an IRB review methods and materials used to recruit study subjects. The question becomes, then, what materials must you submit to the IRB for review? Read this whitepaper to learn more.
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