Waiver of Informed Consent in Research
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.
원본 기록
방법의 원본 기록에서 그대로 복사된 인용입니다. 이로부터 수준별 검증이 추론되지 않습니다.
- 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). · URL
- U.S. Department of Health and Human Services, Office for Human Research Protections. (2019). Waiver or Alteration of Informed Consent. National Institutes of Health. · URL
- U.S. Food and Drug Administration. (2015). Guidance for Industry: Waiver or Alteration of Informed Consent for in vitro Diagnostic Device Studies Using Leftover Human Specimens. · URL
- Health Research Authority. (2021). Guidance for Applicants: Research Without Consent. UK Research Ethics Service. · URL
큐레이션된 주장
각각 자체 평가와 함께 증거 원장에 유지된 주장입니다.
원장에 주장 평가가 없는 경우 이 보기에서는 주장 평가를 만들지 않습니다.
관련 방법
방법 그래프에서 생성되었으며 기계가 제안한 관계로 표시됩니다 — 증거 주장이 추론되지 않습니다.