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.
Avota reģistrs
Atsauces kopētas tieši no metodes avota reģistra. Tās nenozīmē nekādu apgalvojumu līmeņa verifikāciju.
- 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
Kurēti apgalvojumi
Apgalvojumi saglabāti pierādījumu reģistrā, katram ar savu novērtējumu.
Šis skatījums neizgudro apgalvojumu novērtējumu, ja reģistrā tā nav.
Saistītās metodes
Ģenerēts no metodes grafika un parādīts kā mašīnas ieteiktas attiecības — netiek izvirzīts neviens pierādījumu apgalvojums.