手法を比較

	脆弱な集団を対象とする研究	インフォームド・コンセントの免除
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1979	1991
提唱者	U.S. Department of Health and Human Services; World Health Organization; International research ethics community	U.S. Department of Health and Human Services; International research ethics guidelines
種類	Guideline	Guideline
原典	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Subparts B, C, D.	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.116(c).
別名	vulnerable subjects, special populations, vulnerable groups, additional protections	consent waiver, waived consent, exempt from consent, research without consent
関連	5	5
概要	Vulnerable populations are groups with limited capacity to protect themselves due to age, cognitive ability, institutional dependency, or social circumstances. Regulatory frameworks in the U.S. (45 CFR 46 Subparts B, C, D) and internationally identify specific vulnerable populations—children, prisoners, pregnant women, cognitively impaired individuals—and mandate additional ethical protections beyond standard informed consent. These protections include obtaining informed consent from surrogate decision-makers (parents, guardians), additional assurances of minimal risk, and enhanced monitoring for safety. Research ethics committees apply heightened scrutiny to studies involving vulnerable populations and may deny approval if special protections are inadequate.	A waiver of informed consent permits research to proceed without obtaining prospective written or verbal consent from participants. This exception to the standard informed consent requirement applies to specific low-risk research scenarios where obtaining consent is impractical, unnecessary, or would compromise research validity. In the U.S., the regulations (45 CFR 46.116) specify four criteria that must be met for an IRB to approve a waiver; similar criteria apply in the UK (Research Ethics Committee) and EU jurisdictions. Waivers are not automatic; researchers must request them explicitly and justify them to the ethics committee, which determines whether the criteria are met.