Comparar métodos

	Processo de Submissão a Comitê de Ética	Avaliação de Risco-Benefício em Protocolos de Pesquisa
Área	Ética em pesquisa	Ética em pesquisa
Família	Process / pipeline	Process / pipeline
Ano de origem	1991	1979
Autor original	U.S. Department of Health and Human Services; International research oversight organizations	U.S. Department of Health and Human Services; International research ethics community
Tipo	Guideline	Framework
Fonte seminal	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.109.	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.
Outros nomes	IRB application, REC application, ethics approval, protocol submission	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio
Relacionados	5	5
Resumo	Submitting a research protocol to an ethics committee (IRB, REC, or equivalent) is a mandatory procedural gateway in human subjects research. The application process requires researchers to document their study design, justify scientific rationale, disclose risks and benefits, provide participant protections (informed consent forms), and address ethical considerations. The submission includes a completed ethics application form, protocol document, consent forms, researcher CVs, and evidence of institutional support. This standardized process enables ethics committees to conduct rigorous, timely, and consistent review before research commences.	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.