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	Ansökningsprocess för etikprövningsnämnden	Risk-Benefit Assessment in Research Protocols
Ämnesområde	Forskningsetik	Forskningsetik
Familj	Process / pipeline	Process / pipeline
Ursprungsår	1991	1979
Upphovsperson	U.S. Department of Health and Human Services; International research oversight organizations	U.S. Department of Health and Human Services; International research ethics community
Typ	Guideline	Framework
Ursprungskälla	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.
Alias	IRB application, REC application, ethics approval, protocol submission	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio
Närliggande	5	5
Sammanfattning	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.