Glossary
Institutional review board (IRB)
The committee that reviews and approves human research, including recruitment materials and outreach scripts, to protect participants' rights and welfare.
What does Institutional review board (IRB) mean in clinical research?
FDA regulations define an institutional review board as any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects, with the primary purpose of protecting their rights and welfare.[1] Among the criteria an IRB must find before approving research are that selection of subjects is equitable and that privacy and confidentiality are adequately protected.[2]
Recruitment falls inside the IRB's scope. FDA treats direct advertising for study subjects as the start of the informed consent and subject selection process, and expects the IRB to review advertisements and to make sure the scripts staff use to check basic eligibility on first contact protect prospective subjects' rights and welfare.[3]
Practical note: submit every outreach channel, not just the flyer. Include in the IRB packet:
- Call and voicemail scripts, including any pre-screening questions.
- Text message templates and opt-out wording.
- Patient-facing web pages and advertisements.
- How patients are told an AI assistant is used and how they reach a person. Engage supports both.
Sources
- 1.21 CFR 56.102 Definitions (Institutional Review Boards) · eCFR (FDA), 2026
- 2.21 CFR 56.111 Criteria for IRB approval of research · eCFR (FDA), 2026
- 3.Recruiting Study Subjects: Information Sheet for IRBs and Clinical Investigators · U.S. Food and Drug Administration, 1998Quote: "FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the IRB as part of the package for initial review." Also: "The first contact prospective study subjects make is often with a receptionist who follows a script to determine basic eligibility for the specific study. The IRB should assure the procedures followed adequately protect the rights and welfare of the prospective subjects."