The Belmont Report, published in 1978, mandated the establishment of institutional review boards (IRBs), outlined protocol design criteria, and required that written informed consent be provided to all research subjects.

• A. True
• B. False
• C. Partially
• D. Not specified

Answer: (A)

The Belmont Report centers on protecting people in research by applying three ethical principles—respect for persons, beneficence, and justice—and shows how those principles translate into how studies are reviewed and conducted. This is why its influence is seen in the establishment of independent review processes (IRBs) to oversee research proposals and ensure protections for participants. Informed consent is a direct reflection of respect for persons: participants should be adequately informed and freely agree to participate. The report also discusses designing studies so that risk is minimized and benefits justified, and that subject selection is fair—high-level guidance that shapes protocol planning. While the formal creation of IRBs and the requirement for written consent were later codified in regulations, the Belmont Report laid the ethical groundwork that made those practices standard. So the statement aligns with the report’s impact on oversight and consent, making the assertion true.