HIV Vaccine Info-line


Ethical issues


Principal Investigator: Graham Lindegger (PhD)
Project coordinator: Catherine Slack (MA)
Administrator: Jacintha Toohey
First funding cycle: SAAVI-funded: Jan – Dec 2002
Second funding cycle: SAAVI-funded: Jan 2003 – Dec 2005
Third funding cycle  SAAVI-funded: Jan 2006 to Dec 2008
Fourth funding cycle: Wellcome Trust funded: April 2009 to Jan 2013
Staff: 4  

Publications, conference presentations & outputs
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HAVEG works with a range of stakeholders to facilitate the ethical conduct of HIV vaccine trials in South Africa. We undertake empirical and conceptual research, capacity building and consensus building.  Our focus areas include:

The obligations of sponsor-investigators to address the healthcare problems of participants are controversial, including responsibilities to those who become HIV-infected while on trials.  HAVEG has critically examined this issue and participated in national and international forums to move towards consensus. We are exploring the implications of new prevention technologies for the standard of prevention in trials and have produced a position on fair payment for South African trial participants.  

Current funding (April 2009-April 2013), from the Wellcome Trust: is directed at a comprehensive review of ethical guidelines and practice regarding care and prevention in HIV vaccine trials.


  1. Essack, Z., Slack, C., Koen, J., Gray, G. (2010). HIV prevention responsibilities in HIV vaccine trials: Complexities facing South African researchers. South African Medical Journal, 100(1), 45-48.
  2. Slack, C., & Stobie, M. (2008). Response to “HIV vaccine trials: Reconsidering the therapeutic misconception and the question of what constitutes trial related injuries”. Developing World Bioethics, 8(2), 159-161.
  3. Koen, J., Slack., C., Barsdorf, N., & Essack., Z. (2008). Payment of clinical trial participants can be ethically sound: Moving past a flat rate. South African Medical Journal (98), 926-931.
  4. Slack, C., Stobie, M., Milford, C., Lindegger, G., Wassenaar, D., Strode, A., & IJsselmuiden, C. (2005). Provision of HIV treatment in HIV preventive vaccine trials: A developing country perspective. Social Science and Medicine, 60 (6), 1197-1208.
  5. Tucker, T., & Slack, C. (2003).  Not if, but how?  Caring for HIV-1 vaccine trial participants in South Africa.  The Lancet, 362, 955.

While consent is accepted as an ethical imperative for trials, there are some complex and contested aspects, such as how to “test” understanding or be “culturally sensitive”. We investigated a range of methods to assess understanding, in collaboration with site staff and CABs, including forced choice checklists and qualitative “narratives”. We have explored the implications of culture for consent practices. We have also explored role-player dilemmas around consent.  


  1. Bull, S & Lindegger, G. (2011). Ensuring consent to research is voluntary: How far do we need to go? Open Peer Commentary. The American Journal of Bioethics, 11 (8), 27-28.
  2. Lindegger, G., & Van Loon, K. (2009). Informed consent in clinical trials: Perceptions and experiences of a sample of South African researchers. Health SA Gesondheid, 14(1), 1-7.
  3. Lindegger, G., Milford, C., Slack, C., Quayle, M., Xaba, X. & Vardas, E. (2006). Beyond the checklist: Assessing understanding for HIV vaccine trial participation in South Africa. JAIDS, 43(5), 560-566.
  4. Lindegger, G. (2005). Informed consent in HIV Vaccine trials. In P Kahn (Ed.) AIDS Vaccine Handbook: Global perspectives (2nd edition). New York: AIDS Vaccine Advocacy Coalition (AVAC)
  5. Lindegger, G., & Richter, L. (2000).  HIV vaccine trials: Critical issues in informed consent. South African Journal of Science, 96, 313 - 318.

The participation of children raises complex ethical and legal issues. We have assisted to develop a rigorous yet accommodating framework for child trials through inputs to national ethical guidelines, the National Health Act (2003) and human subjects regulations. We have hosted 2 national forums to debate protections in 2003, and 2007. We have developed a tool for stakeholders to help them understand and apply the law for child research, plus numerous legal memos and fact sheets.


  1. Strode, A. & Slack, C. (2011). Using the concept of ‘parental responsibilities and rights’ to identify adults able to provide proxy consent to child research in South Africa. South African Journal of Bioethics and Law, 3(2), 55-58.
  2. Slack, C. (2011). Why we don’t need a relative risk standard for adolescent HIV vaccine trials in South Africa. Open Peer Commentary. The American Journal of Bioethics, 11(6), 1-2
  3. Strode, A., Slack, C., & Essack, Z. (2010). Norms for child consent in South African law: Implications for researchers, service providers and policy-makers. South African Medical Journal, 100(4): 247-9.
  4. Strode, A., & Slack, C. (2009). Sex, Lies and Disclosures: Researchers and the reporting of underage sex. Southern African Journal of HIV Medicine, 10(2), 8-10.
  5. HAVEG (2007). A Legal Directory of the legal rights of minor research participants including children and adolescents. SAAVI (2007).
  6. Slack, C., Strode, A., Fleischer, T., Gray., G., & Ranchod., C. (2007). Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa. BMC Medical Ethics, 8, 5.
  7. Slack, C., Strode, A., & Mamashela, M. (2007). Ethical-legal challenges in enrolling adolescents in HIV vaccine trials. Southern African Journal of HIV Medicine, 27, 12-13.
  8. Strode, A., Slack, C., Wassenaar, D., Singh, J. (2007). One step forward, two steps back: Requiring ministerial approval for all “non-therapeutic” health research with minors. South African Medical Journal. 97, 200-202.
  9. Strode, A., Slack, C., Grant, K., & Mushariwa, M. (2005). Ethical and legal challenges in enrolling adolescents in medical research in South Africa: implications for HIV vaccine trials. South African Journal of Science, 101, 224-228.
  10. Slack, C., & Kruger, M. (2005). The South African Medical Research Council's Guidelines on Ethics for Medical Research: Implications for HIV-preventive vaccine trials with children. South African Medical Journal, 95 (4), 269-271.

HAVEG was also funded by the Global Campaign for Microbicides in 2008 to explore ethical-legal complexities common to HIV vaccine and microbicide adolescent trials.


  1. Essack, Z., Slack, C., & Strode, A. (2008). Overcoming key obstacles to adolescent involvement in HIV vaccine and microbicide trials: A roadmap for stakeholders. Global Campaign for Microbicides: 2008.
  2. Essack, Z., Slack, C., & Strode, A. (2008). Towards a roadmap: Summary of identified ethical-legal complexities in adolescent HIV vaccine and microbicide research. Global Campaign for Microbicides: 2008.

For updated chapters on privacy rights, and mandatory reporting obligations, in child research, view the documents below.

Are you designing or reviewing adolescent research in South Africa? For a memo that sets out current ethical-legal norms for the conduct of adolescent prevention research, please click here. (pdf format, 195 kb)

For more on this overall project within which this ethico-legal work is embedded, please go to

HAVEG collaborated with the Interim National Health Research Ethics Committee (INHREC) and the Medical Research Council (MRC), to develop the MRC Guidelines on medical ethics: HIV preventive vaccine research. We held national forums to raise awareness on the framework in 2002 and 2004. We developed a resource manual for CABs and site counsellors to help them understand the ethical legal complexities in 2002 and revised this manual in 2005. We have developed tools for RECs on the implications of new legislation for research.


  1. A PDF of the ethical guidelines for HIV preventive vaccine trials is available at
  2. Essack, Z., Koen, J., Barsdorf, N., Slack, C., Quayle, M., Milford, C., Lindegger, G., Ranchod, C., & Mukuka, R. (2010). Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa. Developing World Bioethics, 10(1), 11-21.
  3. Understanding phase I and II HIV vaccine trials in South Africa: The Basics. A Resource Manual for trial site counsellors and CABs. HAVEG, UKZN.
  4. Strode, A., Grant, C., Slack, C., & Mushariwa, M. (2005). How well does South Africa’s National Health Act regulate research involving children? South African Medical Journal, 95 (4), 265-266.
  5. Strode, A., Slack, C, & Mushariwa, M. (2005). An evaluation of South Africa’s ethical-legal framework and its ability to promote the welfare of trial participants involved in HIV vaccine research. South African Medical Journal, 95 (8), 598-601.
  6. Slack, C., Lindegger, G., & Vardas, E. (2002). Are the ethical issues in HIV vaccine trials any different? Continuing Medical Education, 20, 9, 596-7.

HAVEG worked closely with this working group of the WHO-UNAIDS African AIDS Vaccine Programme, in collaboration with the WHO-UNAIDS HIV Vaccine Initiative between 2002 and 2011. The ELH is explored beneficence based arguments for researchers’ obligations to ensure treatment in HIV prevention trials. It also researched the capacity of RECs in selected African countries to review HIV vaccine trial protocols, reported to UNAIDS on the ethical-legal framework in such countries, published policy suggestions for the ethical enrolment of rural women in HIV vaccine trials and on the intellectual property issues arising in HIV vaccine trials. AAVP ELH provided training opportunities to build capacity in ethical review. An inventory of research ethics committees in 15 selected African countries was developed, spurred the development of the more interactive MARC project by COHRED and SARETI, which provides a self-updating interactive map of all traceable RECs in Africa – see For more information on the AAVP ELH and ELH publications, please contact



Ms Jacintha Toohey is the project administrator.
Tel: + 27 33 260 6166.
Fax + 27 33 260 6167
Email: or

HAVEG comprises a diverse team of persons with expertise in behavioural sciences, health research, ethics (general, comparative, and bioethics), and law and human rights.

Behavioural sciences and ethics
Prof Graham Lindegger is the Principal Investigator of HAVEG. He was the Head of the School of Psychology, University of KwaZulu-Natal, Pietermaritzburg, from 2001-2004 and has a long history of bringing social science expertise to health and ethics issues. He has published widely on issues related to informed consent in HIV vaccine trials. Email:

Ms Catherine Slack isa clinical psychologist and project manager for HAVEG. Her interests include standard of care; informed consent and child/ adolescent participation in trials. She has researched the ethical-legal framework for AIDS research in South Africa and developed tools to help role-players apply ethical-legal norms for HIV prevention trials. She is also part of the WHO-UNAIDS Ethics, Law and Human Rights Collaborating Centre of the African AIDS Vaccine Program (AAVP) and as part of this group she has been involved in researching the needs of research ethics committees in selected African countries and developing training activities and resources for stakeholders committed to the welfare of participants in HIV prevention trials. She was part of the expert panel that assisted to draft the UNAIDS/WHO (2007) guidance document: Ethical considerations in biomedical prevention trials. She is a member of the National Health Research Ethics Council (NHREC) in South Africa, a committee established in terms of South Africa’s National Health Act (2003) in order to set national norms and standards for research ethics in South Africa.  Email:

Ms Zaynab Essack is a research psychologist and a researcher at HAVEG. She has a background in research psychology, with experience in social science research.  She has taught and coordinated data analysis/research design modules for undergraduate students and has lectured data analysis and quantitative research design at postgraduate level.  Her primary interests include appropriate benefits and standard of prevention in HIV prevention trials, and the inclusion of adolescents in these trials. Email:


Ethics (Bioethics, general, professional, comparative)
Prof Carel IJsselmuiden is Director of the Council on Health Research for Development (COHRED) based in Geneva. He has an extensive research record in Africa, and substantial teaching experience in health research ethics, epidemiology and public health. He was formerly professor and head of the School of Health Systems and Public Health at the University of Pretoria and is now and adjunct Professor in the School of Psychology, UKZN. He is a founding and senior executive member of the South African Research Ethics Training Initiative (SARETI), funded by the NIH Fogarty International Center. Email:

Prof Doug Wassenaar is acting Head of School of Psychology, UKZN. He is principal investigator of the NIH/Fogarty funded South African Research Ethics Training Initiative (SARETI). He has teaching and research experience in professional ethics and teaching and consulting experience in health research ethics. He is the chair of the WHO-UNAIDS AAVP Ethics Law and Human Rights (ELH) Working Group and ensures that HAVEG activities are coordinated with African partners working towards an ethical-legal support framework for HIV vaccine trials in Africa. He is member of the Biomedical Ethics funding committee of the UK Wellcome Trust, a reviewer for the European Union’s Ethical Review Process and is chair of the Research Ethics Committee of the Human Sciences Research Council (HSRC) and the Biomedical Research Ethics Committee (BREC) at the University of KwaZulu-Natal. He is on the advisory boards of several African research organisations and research ethics initiatives, including the West African Bioethics Initiative and research ethics programs in Kenya and Malawi. Email:

Prof Nhlanhla Mkhize was previously Head of the UKZN School of Psychology and has expertise in cultural factors in moral and ethical decision-making. He is an expert in African value systems and their relevance to health research, has consulted for a KEMRI health research ethics programme in Kilifi, Kenya, and was a keynote speaker at the PRIM&R international conference. He is Deputy Co-PI of SARETI. Email:

Ms Nicola Barsdorf is a Ph.D. candidate at the Centre for International Health, University of Bergen, Norway. Her thesis provides an account of South Africa’s duty to support health research for the global poor. Her interests include the ethics of global health research and HIV prevention research ethics. She has a background in health sciences, research ethics and bioethics and has researched obligations to trial participants, gender issues, voluntariness, and social harms in HIV vaccine trials in Africa. She just completed a fellowship in the Department of Bioethics at the National Institutes of Health, USA. She holds an MHS in International health from Johns Hopkins Bloomberg School of Public Health where she was a Fogarty African Bioethics Trainee. She was formerly the project coordinator for the Ethics, Law and Human Rights (ELH) Working Group of the WHO/UNAIDS African AIDS Vaccine Programme (AAVP). She lectured research ethics at the University of KwaZulu-Natal and coordinated and taught in the South African Research Ethics Training Initiative (SARETI) module on Informed Consent. Email:

Ms Melissa Stobie was a Senior Lecturer in Ethics at the University of KwaZulu-Natal. She recently became the recipient of a PhD scholarship at Dublin City University, Ireland, where she is working on the role of emotions in health care ethics decision-making. She is a member of the International Association of Bioethics and the International Network on Feminist Approaches to Bioethics. Email:

Law and Human Rights
Adv Ann Strode is an advocate of the supreme court of South Africa and senior lecturer in the Faculty of Law (UKZN, Pmb), and independent legal consultant. She has been involved in the ethical-legal implications of HIV vaccine trials since 1998, and has experience in capacity building, health policy and materials development. Her research interests include a critique of the legal framework for child research in South Africa. Email:

Ms Catherine Grant is an admitted attorney and has been an independent law and human rights consultant since 2000.  She has worked in the field of health and human rights (in particular in relation to HIV and AIDS) since 1996, for a wide range of organisations including local and international non-profit organisations; government departments, donor agencies and academic institutions. Her work includes research, policy development, advocacy, training and materials development around health and human rights issues. Email:


SAAVI is financially supported by

SA Medical Research Council
South African Department of Health
Italian Co operation
Istituto Superiore di Sanità
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Last updated: 12-Nov-2014