Which entity is primarily responsible for protecting human subjects in research?

• A. Institutional Review Board (IRB)
• B. Principal Investigator (PI)
• C. Intergroup (IG)
• D. Clinical Trials Research Nurse (CTRN)

Answer: (A)

The key idea is that protecting people who participate in research is ensured by independent oversight that reviews and monitors the study design and conduct. An Institutional Review Board reviews study protocols before any participants are enrolled to make sure the risks to subjects are minimized and reasonable in relation to potential benefits, that the informed consent process is clear and adequate, and that privacy and confidentiality protections are in place. The IRB also considers protections for vulnerable groups, monitors ongoing safety through continuing reviews, and requires changes if new risks arise or if procedures need to be adjusted.

The principal investigator has the responsibility to conduct the study properly, obtain informed consent, and implement the protocol at the study site, but the formal, ongoing protection of participants comes from the IRB’s oversight. The other roles listed aren’t designated bodies for safeguarding subjects in the regulatory sense: one is a clinical researcher role, and the others are not responsible for ethical review and ongoing protection of participants.