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Process / pipelineconsent-procedures

Kughairishwa kwa ridhaa yenye taarifa katika utafiti

Kughairishwa kwa ridhaa yenye taarifa huruhusu utafiti kuendelea bila kupata ridhaa ya awali iliyoandikwa au ya mdomo kutoka kwa washiriki. Ubaguzi huu kwa mahitaji ya kawaida ya ridhaa yenye taarifa unatumika kwa hali maalum za utafiti wa hatari ndogo ambapo kupata ridhaa ni vigumu, hakuhitajiki, au kungeathiri uhalali wa utafiti. Nchini Marekani, kanuni (45 CFR 46.116) zinaainisha vigezo vinne ambavyo lazima vitimie ili IRB kuidhinisha kughairishwa; vigezo sawa vinatumika Uingereza (Kamati ya Maadili ya Utafiti) na maeneo ya EU. Kughairishwa si moja kwa moja; watafiti lazima viombe waziwazi na kuvithibitisha kwa kamati ya maadili, ambayo huamua kama vigezo vimetimizwa.

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Vyanzo

  1. U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.116(c). link
  2. U.S. Department of Health and Human Services, Office for Human Research Protections. (2019). Waiver or Alteration of Informed Consent. National Institutes of Health. link
  3. U.S. Food and Drug Administration. (2015). Guidance for Industry: Waiver or Alteration of Informed Consent for in vitro Diagnostic Device Studies Using Leftover Human Specimens. link
  4. Health Research Authority. (2021). Guidance for Applicants: Research Without Consent. UK Research Ethics Service. link

Jinsi ya kunukuu ukurasa huu

ScholarGate. (2026, June 4). Criteria and Application of Waiver of Informed Consent in Human Subjects Research. ScholarGate. https://scholargate.app/sw/research-ethics/waiver-of-informed-consent

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Imerejelewa na

ScholarGateWaiver of Informed Consent in Research (Criteria and Application of Waiver of Informed Consent in Human Subjects Research). Imepatikana 2026-06-19 kutoka https://scholargate.app/sw/research-ethics/waiver-of-informed-consent · Seti ya data: https://doi.org/10.5281/zenodo.20539026