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.
Registro de origen
Citas copiadas textualmente del registro de origen del método. No se infiere ninguna verificación a nivel de afirmación de ellas.
- 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
Afirmaciones curadas
Afirmaciones persistidas en el libro mayor de evidencia, cada una con su propia evaluación.
Esta vista no inventa una evaluación de afirmación si el libro mayor no tiene ninguna.
Métodos relacionados
Generado a partir del grafo de métodos y mostrado como relaciones sugeridas por la máquina; no se infiere ninguna afirmación de evidencia.