hiv pre-exposure prophylaxis (prep)—a quantitative ethics appraisal暴露前预防艾滋病毒(预科)u2014u2014定量道德评价.pdfVIP

HIV Pre-Exposure Prophylaxis (PrEP)—A Quantitative Ethics Appraisal 1 1,2 1,2 Madzouka B. Kokolo *, Dean A. Fergusson , D. William Cameron 1 Ottawa Hospital Research Institute, Clinical Epidemiology Programme, Ottawa, Ontario, Canada, 2 University of Ottawa at The Ottawa Hospital, Ottawa, Ontario, Canada Abstract Background: There is now strong evidence that preventive oral antiretroviral therapy can moderately reduce likelihood of HIV infection. This concept is called HIV pre-exposure prophylaxis (PrEP). Premature closures of some previous PrEP clinical trials, secondary to ethical concerns, did not stop research. We aimed to appraise the extent of ethics considerations reporting in PrEP study documents. Methods: We conducted a systematic quantitative ethics appraisal, grounded in PrEP literature and using eight principles proposed by Ezechiel Emanuel. We developed an a priori checklist of 101 evidence-based ethics items. We obtained protocols for eleven of nineteen clinical controlled studies identified. Two reviewers independently appraised study documents against the checklist. Ethics appraisal was synthesized using adjusted percentages of items reported. Results: On average, 58% of the 101 ethics items were mentioned or addressed in documents, with variations noted both across studies and across principles. Considerations pertaining to social value were least reported (43% of checklist items, on average) whereas considerations related to informed consent and favorable risk-benefit ratio were most reported (75% of checklist items, on average). Discussion: Some PrEP studies r