Section 3 establishes Institutional Review Board (IRB) and Independent Ethics Committee (IEC) responsibilities. IRB/IEC composition + qualifications + procedures + meeting documentation + records; protocol review + initial + continuing + amendment review; emergency procedure review; risk-benefit assessment + safeguards + subject protection. Informed Consent process: voluntary + informed + capacity + understanding + documentation + signed; process not document; information sheet content (purpose + procedures + alternatives + risks + benefits + confidentiality + compensation + insurance + contact + voluntariness + withdrawal); witness + impartial witness if subject illiterate; legally authorised representative for minors or incapacitated subjects; re-consent on new information or protocol amendment; ICH E6(R3) emphasises participant-centric communication + plain language + electronic consent (eConsent) per Annex 2 considerations + multimedia + comprehension verification. Vulnerable populations: minors + pregnant + cognitively impaired + prisoners + employees + students + economically disadvantaged + military personnel + critically ill + indigenous; specific procedural safeguards + assent + parental permission + ombudsperson + extra IRB review; Declaration of Helsinki 2024 alignment; FDA 21 CFR Part 50 (Informed Consent) + Part 56 (IRBs) + Part 50.50-Subpart D (Children) + Part 21 CFR Subpart C (Pregnant) + EU CTR 536/2014. Continuing review at least annually + safety event triggers. Coordinates with FDA + EMA + PMDA + national ethics committees + WHO + WMA Declaration of Helsinki + CIOMS International Ethical Guidelines + Belmont Report. ICH E6 + IRB/IEC + Informed Consent + Vulnerable applies.
This control maps to 4 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 4 it maps to, and the evidence behind each claim, over MCP and REST.