Comparar métodos

	Evaluación de Riesgos y Beneficios en Protocolos de Investigación	Exención del consentimiento informado en investigación
Campo	Ética de la investigación	Ética de la investigación
Familia	Process / pipeline	Process / pipeline
Año de origen	1979	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	Framework	Guideline
Fuente seminal	The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.	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	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio	consent waiver, waived consent, exempt from consent, research without consent
Relacionados	5	5
Resumen	A risk-benefit assessment is a systematic evaluation of the potential harms and benefits of a proposed research study, documented in ethics committee applications. The Belmont Report (1979) established the principle of beneficence—maximizing benefits while minimizing harm—as a cornerstone of research ethics. Regulatory frameworks (45 CFR 46.111 in the U.S., equivalent in other jurisdictions) require ethics committees to determine that risks are reasonable in relation to anticipated benefits before approving research. This assessment is not a simple calculation (risks + benefits) but a qualitative judgment incorporating probability, magnitude, and distribution of harms and benefits.	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.