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Process / pipelineethical-evaluation

Tathmini ya Hatari-Nafuu katika Itifaki za Utafiti

Tathmini ya hatari-nafuuu ni tathmini ya kimfumo ya madhara na manufaa yanayoweza kutokea ya utafiti uliopendekezwa, ambao huandikwa katika maombi ya kamati ya maadili. Ripoti ya Belmont (1979) ilianzisha kanuni ya ukarimu-yaani, kuongeza manufaa huku ikipunguza madhara-kama msingi mkuu wa maadili ya utafiti. Mifumo ya udhibiti (45 CFR 46.111 nchini Marekani, na sawa na hizo katika maeneo mengine) inahitaji kamati za maadili kuhakikisha kuwa hatari ni za busara ikilinganishwa na manufaa yanayotarajiwa kabla ya kuidhinisha utafiti. Tathmini hii si hesabu rahisi (hatari + manufaa) bali ni uamuzi wa ubora unaojumuisha uwezekano, ukubwa, na usambazaji wa madhara na manufaa.

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Vyanzo

  1. 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. link
  2. 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). link
  3. International Council for Harmonisation. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1). Good Clinical Practice E6(R2). link
  4. U.S. Department of Health and Human Services, Office for Human Research Protections. (2019). Risk and Benefit Assessment in Research. National Institutes of Health. link

Jinsi ya kunukuu ukurasa huu

ScholarGate. (2026, June 4). Systematic Evaluation of Research Risks and Benefits for Ethics Review. ScholarGate. https://scholargate.app/sw/research-ethics/risk-benefit-assessment

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Imerejelewa na

ScholarGateRisk-Benefit Assessment in Research Protocols (Systematic Evaluation of Research Risks and Benefits for Ethics Review). Imepatikana 2026-06-17 kutoka https://scholargate.app/sw/research-ethics/risk-benefit-assessment · Seti ya data: https://doi.org/10.5281/zenodo.20539026