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.
Izvorni zapis
Citati kopirani doslovno iz izvornog zapisa metode. Ne impliciraju nikakvu provjeru na razini tvrdnje.
- 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
Uređene tvrdnje
Tvrdnje pohranjene u knjigu dokaza, svaka s vlastitom procjenom.
Ovaj prikaz ne izmišlja procjenu tvrdnje kada knjiga dokaza nema nijednu.
Povezane metode
Generirano iz grafa metode i prikazano kao strojno predložene relacije — ne implicira se nikakva tvrdnja dokaza.