HIV/AIDS Vaccine Ethics Group (HAVEG), University of Natal

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Ethical issues

HIV/AIDS Vaccine Ethics Group (HAVEG), University of KwaZulu-Natal
E-mail: HAVEG@ukzn.ac.za

Principal Investigator
Prof Graham Lindegger (PhD) lindegger@ukzn.ac.za
Project coordinator
Catherine Slack (MA Clin Psych) slackca@ukzn.ac.za
Administrator
Jacintha Toohey Tooheyj@ukzn.ac.za or haveg@ukzn.ac.za
Tel:+ 27 33 260 6166 Fax: +27 33 260 6167.

The HIV/AIDS Vaccines Ethics Group (HAVEG) is based at the School of Psychology, University of KwaZulu-Natal, Pietermaritzburg.

We aim to facilitate the ethical conduct of HIV vaccine trials in South Africa, through empirical and conceptual research, and training.

Publications and outputs
Please click here

HAVEG publications

HAVEG promotes 3 main issues in trials: (i) sound informed consent, (ii) a fair balance of risks and benefits for participants and communities, and (iii) the optimal participation of adolescents.

Informed consent

Voluntariness is an under-analysed and under-researched component in research ethics, even while it is typically advanced as a crucial part of authentic informed consent. We are collaborating with UKZN researchers at CAPRISA, and the NIH Department of Bioethics, to investigate experiences of autonomy and voluntariness.

IRB approval requirements are increasing the length and complexity of consent forms. We are collaborating with an international ethics researcher, Dr Nancy Kass, on a study comparing a standard consent procedure to a simpler more interactive consent procedure.

Impending South African law will require that children should join with their parents in providing formal consent to research participation when they are “capable of understanding” We are exploring consent/ assent distinction conceptually and working with sites to develop tools to assess adolescent understanding.

Fair benefits

The South African regulatory authority, the Medicines Control Council, requires trial participants to be paid R150 (about 20 $ US) per trial visit. We are undertaking a critical review of current models of payment and developing a position on fair payment for trial participants.

Ensuring that participating communities receive benefits from research is a core requirement for ethical research. We are conducting conceptual research into fair benefits for HIV vaccine trials, including an exploration of the notion of “over-research”. We are also interviewing stakeholders to explore this issue empirically.

A number of prevention trial results will yield results soon. We are developing a paper on the implications of such results (e.g. microbicides, PREP) for the standard of prevention to be offered to participants in South Africa.

In addition, and at no cost to SAAVI, HAVEG will continue to work with the African AIDS Vaccine Programme to develop a resource paper exploring beneficence-based arguments for treatment access in HIV vaccine trials.

Adolescent participation

The South African legal framework for child research currently sets out broad norms and standards with little guidance on application, for example, adolescents enrolled in HIV vaccine trials may make disclosures of abuse that trigger mandatory reporting requirements. We are developing tools to assist researchers to recognise and apply their legal obligations.

For a copy of a legal directory of all laws impacting on child research in South Africa, click here.
For a copy of a brief table setting out the impact of the impending National Health Act (2003) on research, click here.
For a copy of a brief resource spelling out the implications of those sections of the Children's Act (2005) implemented recently click here.
For a copy of a table of proposed ethical norms/ standards for adolescent prevention trials, click here.

We are also contributing to a better framework for child participation by participating in guideline development, inputs to regulations, and advocacy to remove obstacles to child involvement in trials and to strengthen protections for child participants.

Consultation with communities in preparation for adolescent HIV vaccine trials can improve the research and its acceptability. We are researching cultural and community perspectives of consent processes for adolescent trials.

In the past (August 2003) we held a national stakeholder forum on the inclusion of children in HIV vaccine trials. View the report on this forum here. A follow-up HAVEG consultative forum on child participation was held in August 2004, and a full report can be found here, with summaries in isiZulu and seSotho.

In addition to our 3 main focus areas, we also aim to strengthen the ethical-legal framework for trials. We have collaborated with the National Health Research Ethics Committee (NHREC) and the Medical Research Council (MRC) to draft and finalize the MRC Guidelines on medical ethics: HIV preventive vaccine research. The focus was on an adaptation of the UNAIDS (2000) Ethical considerations in HIV preventive vaccine research to reflect contextual considerations, including cultural issues and behavioural implementation. These South African Guidelines on HIV preventive vaccine research were published in 2005.

We also aim to raise awareness of the ethical-legal complexities in trials. HAVEG participates in a range of activities to promote understanding and debate on key ethical issues, including conferences and community-based meetings. After canvassing sites to find out what material support they require, we have revised resource materials to help site staff (e.g., educators, CABs) to help prospective participants to make decisions about participation.

HAVEG has also participated in and contributed to three training workshops for the Ethics, Law and Human Rights working group of the WHO/HVI African AIDS Vaccine Programme, (see links) held in Lagos in 2002, Kampala in 2003 and Dakar in 2005. The target participants were members of African RECs who have or are likely to be involved in ethical review of HIV vaccine trials in the near future. A further AAVP training workshop is planned for 2008, contact corbella@ukzn.ac.za

Since HAVEG's inception, we have hosted numerous distinguished ethics and scientific experts to assist in our deliberations, including: Dr Ruth Macklin (Albert Einstein College of Medicine, New York), Dr Ron Bayer (Columbia University), Dr Godfrey Tangwa (University of Yaounde, Cameroon) Prof. Salim Abdool Karim (University of KwaZulu-Natal) Prof. Terry Lovat (University of Newcastle, Australia), Prof. S Benatar (UCT), Prof. U Schüklenk, T Fleischer JD LLM (UCT), Dr Sharon Cassol (MRC), Dr Reidar Lie (NIH Department of Clinical Bioethics), Prof. Mariana Kruger (University of Pretoria), Dr Nancy Kass (Johns Hopkins University), Seema Shah JD (US NIH Dept of Bioethics).

We also provide support to AAVP Ethics, Law and Human Rights (ELH) group
HAVEG works closely with this working group of the WHO-UNAIDS African AIDS Vaccine Programme, in collaboration with the WHO-UNAIDS HIV Vaccine Initiative. The ELH has researched the capacity of RECs in selected African countries to review HIV vaccine trial protocols, has reported to UNAIDS on the ethical-legal framework in such countries, has 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 provides training opportunities to build capacity in ethical review. An inventory of research ethics committees in 15 selected African countries is available. For more information on the ELH, please contact the ELH Chair, Prof Doug Wassenaar, through the project manager, Nicole Corbella corbella@ukzn.ac.za Phone +27 33 2606165; Fax +27 33 2606065.

In 2007 HAVEG is being funded by the Global Campaign for Microbicides to host an international consultation on the ethical and legal complexities of adolescent participation in preventive HIV vaccine and microbicide trials.

HAVEG staff:
Administration
Ms Jacintha Toohey is the project administrator.
Tel: + 27 33 260 6166.
Fax + 27 33 260 6167
Email: haveg@ukzn.ac.za or tooheyj@ukzn.ac.za

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: lindegger@ukzn.ac.za

Ms Catherine Slack is the Project Coordinator for HAVEG. She is a clinical psychologist and has published and taught in HIV vaccine research ethics and professional ethics. She is a member of the South African National Health Research Ethics Council (NHREC) and is a consultant to the WHO/UNAIDS Ethics Law and Human Rights Working Group of the African AIDS Vaccine Program. She was contributor to the UNAIDS 2007 working group revising the UNAIDS (2000) guidance document Ethical considerations in HIV preventive vaccine research. Her research interests include interpersonal processes that enhance understanding for consent, participation of adolescents in trials, and standard of care in HIV prevention research. Email: slackca@ukzn.ac.za

Ms Chitra Ranchod is a researcher at HAVEG and has a background in research psychology. She has experience in social science research and has taught in career psychology, statistical data analysis and research ethics. Her main area of interest is optimising adolescent participation in HIV vaccine trials. Email: ranchod@ukzn.ac.za

Ms Zaynab Essack is a researcher at HAVEG. She has a background in research psychology, with experience in social science research. She has taught and co-ordinated data analysis/research design modules for undergraduate students and has lectured data analysis and quantitative research design at postgraduate level. Her primary interest is in exploring the appropriate standard of care offered to volunteers in HIV prevention trials. Email: essack@ukzn.ac.za

Ms Jennifer Koen is completing her research internship at HAVEG towards professional registration in research psychology. She is also working with HAVEG on her Masters thesis examining stakeholder perceptions of exploitation in research, and research-related benefits to communities. Her interests include the ethics of health-related research in developing countries, the standard of care offered to research participants and fair payment to participants in clinical research. Email: koenj@ukzn.ac.za

Rev Richard Mukuka is a research psychology intern and has interest in the interface between cultural ideas of personhood and people’s response to HIV/AIDS. He has taught psychology topics at both undergraduate and postgraduate levels. He is researching cultural and community perspectives of the consent process for adolescent HIV vaccine trials. Email: mukukar@ukzn.ac.za

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: carel@cohred.ch

Prof Doug Wassenaar is based at the 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). 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: wassenaar@ukzn.ac.za

Ms Melissa Stobie is a senior lecturer in comparative and applied ethics in the School of Philosophy at the University of KwaZulu-Natal. She is South Africa's country representative for the International Network on Feminist Approaches to Bioethics, is a founding member and board member of the Ethics Society of South Africa and a faculty member of the South African Research Ethics Training Initiative (SARETI). She is also an international member of the British Society for Ethical Theory Email: stobieML@ukzn.ac.za

Prof Nhlanhla Mkhize is acting deputy 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: mkhize@ukzn.ac.za

Nicola Barsdorf is a PhD candidate in bioethics and the University of Bergen, Norway. She was formerly the project coordinator for the Ethics, Law and Human Rights (ELH) Working Group of the WHO/UNIADS 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. She is a Fogarty African Research Ethics Fellow for which she is conducting independent research into community perceptions of sponsor/investigator obligations to HIV vaccine trial participants. Email: barsdorf@ukzn.ac.za

Law and Human Rights
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: strodea@ukzn.ac.za

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: kittyb@mweb.co.za

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