Comparar métodos

	Aprobación Ética Retrospectiva	Exención del consentimiento informado en investigación
Campo	Ética de la investigación	Ética de la investigación
Familia	Process / pipeline	Process / pipeline
Año de origen	1991	1991
Autor original	U.S. Department of Health and Human Services; International research ethics community	U.S. Department of Health and Human Services; International research ethics guidelines
Tipo	Guideline	Guideline
Fuente seminal	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.101(b).	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).
Alias	retroactive approval, post-hoc ethics approval, IRB exemption determination, delayed ethics review	consent waiver, waived consent, exempt from consent, research without consent
Relacionados	5	5
Resumen	Retrospective ethics approval is the ethics committee's review and determination regarding research conducted or data collected before ethics approval was obtained. This situation arises when researchers collect data without advance ethics review (intentionally, out of oversight, or due to institutional gaps) and then seek ethics approval before analysis or publication. Retrospective approval is generally disfavored; regulations and guidelines strongly recommend prospective review (approval before data collection). However, retrospective determination of exemption (finding that data already collected meets exempt criteria under 45 CFR 46.104, similar frameworks in other jurisdictions) or retrospective approval with specific justifications may be possible. Understanding when retrospective approval can be obtained—and its limitations—is important for researchers facing this ethical and regulatory challenge.	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.