Research Article
No access
Published Online: 12 January 2015

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

Publication: AIDS Research and Human Retroviruses
Volume 31, Issue Number 1


The advent of HIV “cure” research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV “cure” research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV “cure” research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

Get full access to this article

View all available purchase options and get full access to this article.


The Forum HIV Cure Project: Forum for Collaborative HIV Research 2014.
Volberding P: HIV cure: The target is clearer but not yet close. Ann Intern Med 2014;160:505–506.
Lo B, Grady C, and the Working Group on Ethics of the International AIDS Society: Ethical considerations in HIV cure research: Points to consider. Curr Opin HIV AIDS 2013;8:243–249.
Emanuel EJ, Wendler D, and Grady C: What makes clinical research ethical? JAMA 2000;283:2701–2711.
Shah SK, Persaud D, Wendler DS, et al.: Research into a functional cure for HIV in neonates: The need for ethical foresight. Lancet Infect Dis 2014;14:893–898.
Evans D: What would you do to cure HIV? [Internet]. May 25, 2011 [cited November 10, 2014]. Available from
Eyal N and Kuritzkes DR: Challenges in clinical trial design for HIV-1 cure research. Lancet 2013;382 (9903):1464–1465.
Sugarman J: HIV cure research: Expanding the ethical considerations. Ann Intern Med 2013;159:490–491.
Dubé K, Henderson GE, and Margolis DM: Framing expectations in early HIV cure research. Trends Microbiol 2014;22:547–549.
Tucker JD, Volberding P, Margolis DM, et al.: Words matter: Discussing research towards an HIV cure in research and clinical contexts. J AIDS 2014;67(3):e110-1.
History and Mission: Forum for Collaborative HIV Research 2014.
King NMP, Henderson GE, Churchill LR, et al.: Consent forms and the therapeutic misconception: The example of gene transfer research. IRB: Ethics Hum Res 2005;27:1–8.
Henderson GE, Wolf SM, Kuczynski KJ, et al.: The challenge of informed consent and return of results in translational genomics: E analysis and recommendations. J Law Med Ethics 2014;42(3):344–355.
The SMART Study Group: Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: A randomized trial. Ann Intern Med 2008;149:289–299.
Burman W, Grund B, Neuhaus J, et al.: Episodic antiretroviral therapy increases HIV transmission risk compared with continuous therapy: Results of a randomized controlled trial. J Acquir Immune Defic Syndr 2008;49:142–150.
Routy JP, Boulassel MR, Nicolette CA, and Jacobson JM: Assessing risk of a short-term antiretroviral therapy discontinuation as a read-out of viral control in immune-based therapy. J Med Virol 2012;84:885–889.
Dresser R: When Science Offers Salvation: Patient Advocacy and Research Ethics. Oxford University Press, Oxford, 2001.
Daniels N: How to achieve fair distribution of ARTs in 3 by 5. Background paper for the consultation on equitable access to treatment and care for HIV/AIDS (January 26–27, 2004). 2004.
Macklin R: Ethics and equity in access to HIV treatment—3 by 5 initiative. Background paper for the consultation on equitable access to treatment and care for HIV/AIDS (January 26–27, 2004). 2004.
Rennie S and Behets F: AIDS care and treatment in Sub-Saharan Africa: Implementation ethics. Hastings Center Rep 2006;36:23–31.
WHO: Ethical issues raised by the HIV/AIDS epidemic. 2014.
Rennie S, Sugarman J, and the HPTN Ethics Working Group: HIV prevention trials network ethics guidance for research. 2009.
King NMP: RAC oversight of gene transfer research: A model worth extending? J Law Med Ethics 2002;30:381–389.
Hug K and Hermerén G: Which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies? J Clin Ethics 2012;23:256–271.
Palpant NJ and Dudzinski D: Zinc finger nucleases: Looking toward translation. Gene Ther 2013;20:121–127.
Chapman AR: Addressing the ethical challenges of first-in-human trials. J Clin Res Bioethics 2011;2:113.
Peay HL and Henderson GE: What motivates participation in HIV cure trials? A call for real-time assessment to improve informed consent. J Virus Erad 2015;1:51–53.
Dresser R: First-in-human trial participants: Not a vulnerable population, but vulnerable nonetheless. J Law Med Ethics 2009;37:38–50.
King NMP: Defining and describing benefit appropriately in clinical trials. J Law Med Ethics 2000;28:332–343.
Pentz RD, White M, Harvey RD, et al.: Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer 2012;118:4571–4578.
Henderson GE, Churchill LR, Davis AM, et al.: Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 2007;4:e324.
Anderson JA and Kimmelman J: Extending clinical equipoise to phase 1 trials involving patients: Unresolved problems. Kennedy Inst Ethics J 2010;20:75–98.
London AJ, Kimmelman J, and Emborg ME: Research ethics. Beyond access vs. protection in trials of innovative therapies. Science 2010;328:829–830.
Weinfurt KP: Varieties of uncertainty and the validity of informed consent. Clin Trials 2008;5:624–625.
Kass NE: Early phase clinical trials: Communicating the uncertainties of 'magnitude of benefit' and 'likelihood of benefit.' Clin Trials 2008;5:627–629.
Henrich TJ, Hanhauser E, Marty FM, et al.: Antiretroviral-free HIV-1 remission and viral rebound after allogeneic stem cell transplantation: Report of 2 cases. Ann Intern Med 2014;161:319–327.
Burke W, Evans BJ, and Jarvik GP: Return of results: Ethical and legal distinctions between research and clinical care. Am J Med Genet Part C: Semin Med Genet 2014;166C:105–111.
Wolf SM, Lawrenz FP, Nelson CA, et al.: Managing incidental findings in human subjects research: Analysis and recommendations. J Law Med Ethics 2008;36:219–248.

Information & Authors


Published In

cover image AIDS Research and Human Retroviruses
AIDS Research and Human Retroviruses
Volume 31Issue Number 1January 2015
Pages: 56 - 63
PubMed: 25406579


Published online: 12 January 2015
Published in print: January 2015
Published ahead of print: 22 December 2014
Published ahead of production: 18 November 2014


Request permissions for this article.




    Gail E. Henderson
    Department of Social Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.


    Address correspondence to:Gail E. HendersonDepartment of Social MedicineUniversity of North Carolina School of Medicine333 South Columbia Street, 347 MacNiderChapel Hill, North Carolina 27599-7240E-mail: [email protected]

    Author Disclosure Statement

    No competing financial interests exist.

    Metrics & Citations



    Export citation

    Select the format you want to export the citations of this publication.

    View Options

    Get Access

    Access content

    To read the fulltext, please use one of the options below to sign in or purchase access.

    Society Access

    If you are a member of a society that has access to this content please log in via your society website and then return to this publication.

    Restore your content access

    Enter your email address to restore your content access:

    Note: This functionality works only for purchases done as a guest. If you already have an account, log in to access the content to which you are entitled.

    View options


    View PDF/ePub

    Full Text

    View Full Text







    Copy the content Link

    Share on social media

    Back to Top