A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply…

In the United States, the Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is responsible for protecting the rights and welfare of human research subjects. According to both the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulations, the IRB must review and approve all materials used to recruit potential participants. This oversight ensures that recruitment methods are not coercive, do not make unsubstantiated claims, and present information in a non-misleading manner. This requirement applies to all clinical investigations involving human subjects, including medical device studies, regardless of whether the device is used within its approved indication.

A. A scientific review board: A scientific review board evaluates the scientific merit and feasibility of a study protocol, not the ethical aspects of patient-facing materials like recruitment advertisements.

B. The FDA: The FDA sets the regulations that require IRB review of recruitment materials but does not directly approve these materials for most individual studies. This responsibility is delegated to the IRB.

C. The Office for Human Research Protections (OHRP): OHRP provides oversight for federally-funded research and interprets human subject protection regulations, but it does not approve study-specific documents. This is the function of the local or central IRB.

1. U.S. Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 56, Section 109 (21 CFR § 56.109(a)). This regulation states, "An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations." This authority explicitly covers recruitment materials and processes.

2. U.S. Food and Drug Administration (FDA). (2015). Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Recruiting Study Subjects. This guidance document clarifies, "All recruitment materials and advertisements must be reviewed and approved by the IRB. The IRB should review the information contained in the advertisement and the mode of its communication to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and the protocol."

3. U.S. Department of Health & Human Services (HHS). Code of Federal Regulations Title 45, Part 46, Section 111 (45 CFR § 46.111(a)(3)). This section of the "Common Rule" requires that for research to be approved, the IRB must determine that the "selection of subjects is equitable." The review of recruitment materials is essential to making this determination.