方法对比

	研究方案中的风险-效益评估	临床试验注册
领域	研究伦理	研究伦理
方法族	Process / pipeline	Process / pipeline
起源年份	1979	2005
提出者	U.S. Department of Health and Human Services; International research ethics community	World Health Organization; International Committee of Medical Journal Editors
类型	Framework	Requirement
开创性文献	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.	World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement.
别名	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio	trial registration, prospective registration, ClinicalTrials.gov, trial registry
相关	5	5
摘要	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.	Clinical trial registration is the prospective documentation of a trial's key information (hypothesis, design, population, outcomes) in a public registry before enrollment begins or results are known. In 2005, the World Health Organization established the requirement that all clinical trials be registered in an internationally recognized registry before participant enrollment. The International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in major medical journals in 2005, updated in 2015. Primary registries include ClinicalTrials.gov (U.S.), ISRCTN (UK), EudraCT (EU), and others operating under WHO oversight. Registration serves to prevent selective outcome reporting, reduce publication bias, and enhance research transparency.