The 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) helps ensure necessary attention and review of the ethical aspects of research in the development of HPTN concepts and protocols as well as research implementation.


The EWG includes experts in the field of ethics of human subjects’ research as well as the HPTN Leadership and Operations Center which serves as a resource to protocol teams. The EWG provides practical recommendations as well as state-of-the-art information to the Network.

 

HPTN Ethics Guidance for Research

updated December 2021

HPTN Orientación ética para la investigación

Actualizado en diciembre de 2021

 

HPTN Ethics Working Group

JS

Jerome Singh

Chair

 

Overview

The Ethics Working Group (EWG) informs the design and implementation of HPTN research. Members of the EWG actively participate in the review of new concepts and protocols and each HPTN protocol team includes an EWG representative to assist with the ethical issues that may arise in real-time.

 

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
  • 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 Guidance

The EWG developed the HIV Prevention Trials Ethics Guidance for Research as a resource for researchers and communities involved with HIV prevention research. A brief description of the 2003 HPTN Ethics Guidance Document was published in the BMJ, “Ethics Guidance for HIV Prevention Trials” [MacQueen KM et al., 2003]. 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" [MacQueen KM, Sugarman J, 2003]. A description of the 2009 update of the document is described in an article published in the Journal of Medical Ethics, “Developing Ethics Guidance for HIV Prevention Research: The HPTN Approach” [Rennie 2010]. Due to further advances in HIV prevention science, emerging scholarship and changing guidelines the Ethics Guidance Document was again revised; the revised current version was reviewed and approved by the HPTN Executive Committee in February 2020.

 

Selected Activities

Members of the EWG have helped to develop practical approaches to ethical issues that arise in HPTN research, including developing participant safety plans for research in difficult settings [Sugarman, 2018] and handling post trial access issues [Paul, 2018]. Furthermore, the EWG has engaged in both conceptual and empirical scholarship to help inform the ethics of HIV prevention research. This includes work-related to research involving people who inject drugs [Sugarman, 2014; Dawson 2016], the benefits of participating in HIV prevention research [Sugarman, 2015], community engagement [Macqueen, 2015], international research ethics review [Sexton, 2014], and consent [Hanrahan, 2015]. Finally, in addition to their individual scholarship related to HIV-related ethics issues, HPTN ethics experts play a major role in deliberations about ethical issues in HIV prevention science outside the HPTN. This has included debates about the appropriate standards of prevention, a comprehensive review of the ethical considerations of molecular phylogeny research, and HIV cure research with special consideration of risk of HIV transmission after treatment interruption [Julg et al].

 

Ethics Working Group Contacts

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

 

References

Dawson L, Strathdee SA, London AJ, Lancaster KE, Klitzman R, Hoffman I, Rose S, Sugarman J. Addressing ethical challenges in HIV prevention research with people who inject drugs. J Med Ethics 2016; 44: 149-158. doi: 10.1136/medethics-2015-102895. PMID: 27114469.

Hanrahan D, Sexton P, Hui K, Teitcher J, Sugarman J, London AJ, Barnes M, Purpura J, Klitzman R. Linguistic and cultural challenges in communication and translation in US-sponsored HIV prevention research in emerging economies. PLoS One 2015;10: e0133394. doi 10.1371/journal.pone.0133394. PMID: 26225759.

Julg B, Dee L, Ananworanich J, Barouch DH, Bar K, Caskey M, Colby DJ, Dawson L, Dong KL, Dubé K, Eron J, Frater J, Gandhi RT, Geleziunas R, Goulder P, Hanna GJ, Jefferys R, Johnston R, Kuritzkes D, Li JZ, Likhitwonnawut U, van Lunzen J, Martinez-Picado J, Miller V, Montaner LJ, Nixon DF, Palm D, Pantaleo G, Peay H, Persaud D, Salzwedel J, Salzwedel K, Schacker T, Sheikh V, Søgaard OS, Spudich S, Stephenson K, Sugarman J, Taylor J, Tebas P, Tiemessen CT, Tressler R, Weiss CD, Zheng L, Robb ML, Michael NL, Mellors JW, Deeks SG, Walker BD. Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting. Lancet HIV. 2019 Apr;6(4): e259-e268. doi: 10.1016/S2352-3018(19)30052-9. Epub 2019 Mar 15. Review. PubMed PMID: 30885693; PubMed Central PMCID: PMC6688772.

MacQueen KM, Bhan A, Frohlich J, Holzer J, Sugarman J; Ethics Working Group of the HIV Prevention Trials Network. Evaluating community engagement in global health research: the need for metrics. BMC Med Ethics 2015; 16: 44. doi:10.1186/s12910-015-0033-9. PMID: 26126899.

MacQueen KM, Karim Q, Sugarman J on behalf of the Ethics Working Group of the HIV Prevention Trials Network. Ethics Guidance for HIV Prevention Trials. BMJ 2003; 327 (7410): 340.

MacQueen KM, Sugarman J. Back to the rough ground: working in international HIV prevention as ethical debates continue. IRB: Ethics & Human Research 2003; 25(2): 11-3. )

Paul A, Merritt MW, Sugarman J. Implementing post-trial access plans for HIV prevention research. J Med Ethics 2018; 44: 354-358. doi: 10.1136/medethics-2017-104637. PMID: 29487116.

Rennie S, Sugarman J and the HIV Prevention Trials Ethics Working Group. Developing ethics guidance for HIV prevention research: the HPTN approach. J Med Ethics 2010; 36: 810-815. PMID: 21112940.

Rennie, S., Chege, W., Schrumpf, L.A. et al. HIV prevention research and COVID-19: putting ethics guidance to the test. BMC Med Ethics 22, 6 (2021). https://doi.org/10.1186/s12910-021-00575-w

Sexton P, Hui K, Hanrahan D, Barnes M, Sugarman J, London AJ, Klitzman R, for the HIV Prevention Trials Ethics Working Group. Reviewing HIV-related research in emerging economies: the role of government reviewing agencies. Dev World Bioethics 2014; 16: 4-14. doi: 10.1111/dewb.12072. PMID: 25388003.

Sugarman J, Barnes M, Rose S, Dumchev K, Sarasvita R, Viet HT, Zeziulin O, Susami H, Go V, Hoffman I, Miller W. Development and implementation of participant safety plans for international research with stigmatized populations. Lancet HIV 2018; 5: e468-e472. doi: 1016/S2352-3018(18)30073-0. PMID: 29950284.

Sugarman J, Rose S, Metzger D. Ethical issues in HIV prevention research with people who inject drugs. Clin Trials 2014; 11: 239-45. PMID: 24127238.

Sugarman J, Stalter R, Bokoch K, Liu T, Donnel D. Positive social impacts related to participation in an HIV prevention trial involving people who inject drugs. IRB: Ethics and Human Research 2015; 37: 17-19. PMID: 26247080.