HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.

<h4>Background</h4>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 concer...

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Autores principales:	Madzouka B Kokolo, Dean A Fergusson, D William Cameron
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/dc74887e0452484db3ba5dc2c059eec3
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spelling	oai:doaj.org-article:dc74887e0452484db3ba5dc2c059eec32021-11-18T06:48:34ZHIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.1932-620310.1371/journal.pone.0022497https://doaj.org/article/dc74887e0452484db3ba5dc2c059eec32011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21850229/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Discussion</h4>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.Madzouka B KokoloDean A FergussonD William CameronPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 8, p e22497 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Madzouka B Kokolo Dean A Fergusson D William Cameron HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
description	<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Discussion</h4>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.
format	article
author	Madzouka B Kokolo Dean A Fergusson D William Cameron
author_facet	Madzouka B Kokolo Dean A Fergusson D William Cameron
author_sort	Madzouka B Kokolo
title	HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
title_short	HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
title_full	HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
title_fullStr	HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
title_full_unstemmed	HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.
title_sort	hiv pre-exposure prophylaxis (prep)--a quantitative ethics appraisal.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/dc74887e0452484db3ba5dc2c059eec3
work_keys_str_mv	AT madzoukabkokolo hivpreexposureprophylaxisprepaquantitativeethicsappraisal AT deanafergusson hivpreexposureprophylaxisprepaquantitativeethicsappraisal AT dwilliamcameron hivpreexposureprophylaxisprepaquantitativeethicsappraisal
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HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.

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