title: HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
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).
  
  
  CONCLUSIONS
  Some PrEP studies reportedly address more ethics considerations than others but, overall, ethics considerations reporting could be much improved. While this review does not allow us to comment on the actual execution of HIV PrEP trials, it is a reminder that optimism generated by potentially effective interventions should not overshadow the importance of ethics in research design and development. Improving ethics reporting might improve the perceived value of PrEP research and subsequent data.
authors.affiliation: Ottawa Hospital Research Institute, Clinical Epidemiology Programme, Ottawa, Ontario, Canada. mkokolo@ohri.ca
authors.forename: Madzouka B
authors.initials: MB
authors.lastname: Kokolo
authors.forename: Dean A
authors.initials: DA
authors.lastname: Fergusson
authors.forename: D William
authors.initials: DW
authors.lastname: Cameron
mesh_terms: D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D016032:Randomized Controlled Trials as Topic
chemical_list: D044966:Anti-Retroviral Agents