Risk-Benefit Assessment in Research Protocols
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.
원본 기록
방법의 원본 기록에서 그대로 복사된 인용입니다. 이로부터 수준별 검증이 추론되지 않습니다.
- 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. · URL
- U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.102(a). · URL
- International Council for Harmonisation. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1). Good Clinical Practice E6(R2). · URL
- U.S. Department of Health and Human Services, Office for Human Research Protections. (2019). Risk and Benefit Assessment in Research. National Institutes of Health. · URL
큐레이션된 주장
각각 자체 평가와 함께 증거 원장에 유지된 주장입니다.
원장에 주장 평가가 없는 경우 이 보기에서는 주장 평가를 만들지 않습니다.
관련 방법
방법 그래프에서 생성되었으며 기계가 제안한 관계로 표시됩니다 — 증거 주장이 추론되지 않습니다.