Ethics

HPTN has a Commitment to Ethical Research

The HIV Prevention Trials Network (HPTN) has the mission of conducting HIV prevention research at the highest scientific and ethical standards.  To meet this goal, the HPTN Ethics Working Group (EWG) works within the protocol development structure to ensure necessary attention and review ethical aspects in the development process of HPTN concepts, protocols and manuscripts.

The EWG includes experts in the field of ethics of human subjects’ research as well as HPTU site staff who serve as a resource to protocol teams.  The EWG provides practical recommendations as well as state of the art information to protocol teams.  The EWG also provides guidelines and strategies for enhancement of ethics capacity at research sites, with a particular emphasis on the understanding of informed consent by potential participants.

HPTN Ethics Guidance for Research (Revised June 10 2009)

 

HPTN Ethics Working Group

Overview

The Ethics Working Group (EWG) is a resource for the HPTN regarding the ethical aspects of research. The EWG engages representatives from diverse fields, areas of expertise, and geographic regions. These representatives include ethicists, social scientists, HPTN investigators, community working group members, and other Network members as well as experts in conducting research with vulnerable women, adolescents, sex workers, and drug user populations

Specific Aims

  • To provide ethics review of concepts and protocols in development
  • To provide expertise and technical assistance to the HPTN in implementing components of the Ethics Guidance for Research, including, for example, research ethics training and capacity building (for research teams, sites, and community groups) and improving the informed consent process
  • To be available to rigorously evaluate these efforts, working with the Behavioral and Social Sciences Working Group as appropriate, including descriptive data collection and ethics effectiveness assessments
  • To serve as a resource for information and material that facilitates ethical research practices, which may include serving as a liaison with other entities/networks conducting HIV prevention research.

Ethics Working Group Contacts

  • Jeremy Sugarman, Chair, Johns Hopkins University, Berman Institute of Bioethics and Department of Medicine
  • Elizabeth Greene, FHI 360

 

Ethics Guidance

A brief description of  the 2003 HPTN Ethics Guidance Document was published in the BMJ, “Ethics Guidance for HIV Prevention Trials.”(1)  In addition, several members of the EWG wrote about the process of producing the guidance document and how it fits into HPTN research in an article published in IRB: Ethics & Human Research:  "Back to the Rough Ground: Working in International HIV Prevention as Ethical Debates Continue." (2)

A number of developments over the last five years have prompted this revision of the HPTN ethics guidance document including new scientific findings and the increased availability of antiretroviral treatments. The revised Ethics Guidance for Research was completed June 10, 2009.  This revised guidance document aims to facilitate HPTN’s mission by raising awareness of the associated ethical considerations, engaging network members at all levels in discussion about those considerations, and facilitating the integration of ethical considerations into the design and implementation of HPTN research.

HPTN Ethics Guidance for Research (Revised June 10 2009)

HPTN Ethics Guidance for Research (2003)

1 Reproduced with permission from the BMJ Publishing Group.  This article originally appeared in BMJ 2003, vol. 327, no. 7410, p. 340.

2 ©The Hastings Center. Reprinted by permission. This article originally appeared in IRB: Ethics & Human Research, vol. 25, no. 2 (2003)

 

Partnering for Care

In 2004, the Prevention Leadership Group (PLG) of the HIV Prevention Trials Network (HPTN) recommended that the Network strive to improve the standard of care that exists at HPTN sites and to document efforts, activities, and accomplishments towards this end. The PLG charged the Ethics Working Group to develop, with community input, a survey to document alliances already in place and to assess what the HPTN is doing at each site to provide or facilitate HIV-related care and, ultimately, other health-related care partnerships. The Partnering for Care project was undertaken to meet this objective. A description of the methods and overall findings from the project can be found in Part I of the report.

Project Report, Part I: Overall Findings

Project Report, Part II: Case Studies