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

Madzouka B Kokolo¹, Dean A Fergusson, D William Cameron

¹Ottawa Hospital Research Institute, Clinical Epidemiology Programme, Ottawa, Ontario, Canada. mkokolo@ohri.ca

|August 19, 2011

Summary

Preventive oral antiretroviral therapy, or HIV pre-exposure prophylaxis (PrEP), shows promise in reducing HIV infection. However, reporting on ethics in PrEP research design needs significant improvement for greater transparency and trust.

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Area of Science:

Public Health
Medical Ethics
Clinical Research

Background:

Preventive oral antiretroviral therapy, known as HIV pre-exposure prophylaxis (PrEP), is supported by strong evidence for reducing HIV infection risk.
Previous PrEP clinical trials faced premature closure due to ethical concerns, yet research has continued.
This study critically appraises the reporting of ethical considerations within PrEP research documentation.

Purpose of the Study:

To systematically evaluate the extent to which ethical considerations are reported in the documentation of HIV pre-exposure prophylaxis (PrEP) clinical studies.
To identify specific areas of ethical reporting that are well-addressed and those that require improvement in PrEP research.

Main Methods:

A systematic quantitative ethics appraisal was performed using Ezechiel Emanuel's eight principles.
A checklist of 101 evidence-based ethics items was developed and applied to study protocols.
Two independent reviewers assessed eleven clinical controlled PrEP studies against the checklist, synthesizing findings using adjusted percentages.

Main Results:

On average, 58% of the 101 ethics items were reported across the evaluated PrEP study documents.
Reporting varied significantly among studies and across different ethical principles.
Social value considerations were least reported (43%), while informed consent and favorable risk-benefit ratio were most reported (75%).

Conclusions:

The reporting of ethical considerations in HIV pre-exposure prophylaxis (PrEP) research documents is inconsistent and could be substantially enhanced.
While this appraisal focuses on documentation, it underscores the necessity of prioritizing ethics in research design, even with promising interventions.
Improved ethics reporting has the potential to increase the perceived value and credibility of PrEP research and its findings.