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Table 1 HPTN Ethics Guidance Points

From: HIV prevention research and COVID-19: putting ethics guidance to the test

Number

Summary

1

Those engaged in HIV prevention research must be committed to designing and implementing high-quality scientific research and research ethics practices throughout the research process

2

HIV prevention research should prioritize efforts that address public health needs, reduce health inequities, and are locally relevant

3

Relevant communities should be actively engaged throughout the research process to help ensure that HIV prevention research is appropriate as well as scientifically and ethically sound

4

HIV prevention research should seek to develop local capacity and establish collaborative partnerships

5

HIV prevention research should be designed to minimize risks and maximize benefits to study participants and their communities, while remaining scientifically sound

6

Each site involved in HIV prevention research should develop, implement, and document appropriate informed consent, assent, permission, and re-consent processes tailored to the needs of participants

7

HIV prevention researchers should assess, monitor, and respond to the social, cultural and other factors that may place research participants at heightened risk

8

Independent ethics review committees in host countries should review HIV prevention research

9

HIV prevention researchers should partner with key stakeholders to provide a package of effective, comprehensive, and sustainable prevention services to all participants in HIV prevention research

10

HIV prevention researchers should strive to provide care and treatment to participants that exceed local standards of medical services yet does not impose undue influence to participate in research

11

HIV prevention researchers and sponsors should ensure that appropriate mechanisms for independent data and safety monitoring are in place

12

HIV prevention researchers should plan for the timely communication of HIV prevention research results to scientific audience as well as participants, affected communities, and other stakeholders in a manner that promotes understanding and trust

13

HIV prevention researchers should endeavor to ensure that the investments made in developing capacity will continue to provide benefits and opportunities for local researchers and communities after research ends

14

HIV prevention researchers should seek to facilitate continuity of prevention services and care for participants who still require it after research participation has ended

15

HIV prevention research seeking to establish the efficacy of an intervention must have at minimum a preliminary plan regarding post-trial access to interventions proven to be safe and effective, which offer meaningful benefit for research participants and their communities