Division of​ Medical Ethics and Law​


Current Research Activity:

The Unintended and Intended Consequences of HIV Cure: A Social and Ethical Analysis

Six years ago, Timothy Brown, a man with HIV infection and leukaemia, received a stem-cell transplant that eventually removed the virus from his body as far as current research techniques can detect. Three years ago, a baby in Mississippi who received aggressive treatment immediately following birth was reported as being the first baby cured of HIV with similar cases recently reported in Canada and South Africa. These cases have launched a field of HIV cure research. On both clinical and public health grounds, the identification of an effective HIV cure would be a great achievement.  It could decrease morbidity and mortality associated with HIV infection, paving the way for comprehensive public health control efforts.  At the same time, curing HIV is best conceived not simply as an absolute medical victory, but also as a social intervention whose meaning and effects are complex and uncertain.

However, like other medical innovations in the past, HIV cure research and early cure implementation are best conceived as social interventions whose meaning and effects are uncertain. History demonstrates that the social meaning of a disease, including how it is represented and policies surrounding treatment and control, changes dramatically when advances in biomedical research transform from incurable to treatable and curable.

Uncertainties about the meaning and impact of HIV cure research underline the need to conduct research that is both theoretical (including historical, conceptual and ethical analyses) and empirical (stakeholders analysis and engagement). A proactive and multidisciplinary exploration of the social and ethical dimensions of HIV cure can inform the conduct of research studies and positively influence how HIV cure is perceived and implemented.

The Centre for Medical Ethics and Law of the Faculty of Medicine and Health Sciences in collaboration with the University of North Carolina, Chapel Hill and the University of North Carolina, Guangzhou have been awarded a 5 year NIH RO1 grant to

  • Develop a historically-grounded theoretical and ethical framework around HIV cure research;
  • Identify and gather data from key informants and stakeholders; and
  • Develop an online social media forum to raise awareness and give voice to concerns regarding HIV cure research.

By doing so it seeks to enhance the ethically responsible conduct of HIV cure research and to facilitate the ethically responsible early implementation of successful HIV cures.


Community Engagement for H3Africa Biobanking Research: The Tygerberg Model 

This project aims to develop and implement a process for involving potential participants in the governance of a biobank at Tygerberg Hospital. The study will be conducted in two parts. Part 1 will develop educational tools which will be used for discussions on biobanking throughout the H3Africa network. Educational pamphlets and an educational DVD on medical research and biobanking research will be developed in conjunction with the community advisory board (CAB) and key stakeholders in biobanking research. We will conduct semi-structured interviews with key stakeholders to ascertain their views on how best to involve the wider Tygerberg community in the governance process. Key themes will then emerge from these interviews which will underpin our approach to developing a CE process for the wider Tygerberg community.

In Part 2 of this project, we will develop the CE process that is informed by themes that emerged from the interviews conducted in part 1 of this study and from empirical studies of CE guidance for other forms of biomedical research in Africa (such as HIV research). It will also be informed by best policy work on CE guidance for genomic research internationally, the limited experience to date with CE for genomic biobanking research in different African settings and the existing literature on indicators for monitoring and evaluating CE. Importantly, it will also be informed by the principle of Ubuntu, an important concept in African philosophy. The results of these research activities will be tempered with the key principles identified in our local interviews and translated into a model CE process that can provide practical guidance for other H3Africa efforts.

Past Research Activity:

​1. Principal investigator – An exploration of the ethical complexities inherent in the collection, use, storage and export of biological samples in research - perspectives from the Western Cape, South Africa.- Research Assistance Grant R20,000 and Strategic Funding grant R100 000 + NRF grant R40 000.

Co-investigators: Dr Theresa Rossouw, Dr Ronell Leech and Nomathemba Sibanda, University of Pretoria, Kelsey February

Phase 1 – semi structured interviews of 200 research participants in Western Cape and Pretoria - completed

Phase 2 – interviews of REC members, Western Cape and Gauteng - completed

Phase 3 – interviews of researchers/pathologists, Western Cape and Gauteng - completed

2. Principal Investigator – The experience of Research Ethics Committees (RECs) with using an accessible short form self-assessment tool. Collaborators: Prof Henry Silverman, University of Maryland, Prof Sue Naidoo, University of the Western Cape.

3. Principal Investigator  Paediatric HIV Disclosure Study - Tygerberg Co investigators: Landon Myer and Des Fransman – School of Public Health, UCT, Prof Mark Cotton, Dept of Paediatrics and Kidcru paediatric HIV Clinic Tygerberg, Prof Leslie Swartz and Prof SA Kagee, Department of Psychology, University of Stellenbosch.

  • Phase 1 complete – Paediatric Disclosure in South Africa: Perspectives of Caregivers on discussing HIV with infected children – presented at the international AIDS conference in Bangkok July 2004.
  • Phase 2 – interviews with health care providers to elicit their perspectives on disclosure - complete.
  • Phase 3 – Collaboration with Department of Psychology – interviews with children - complete Ethnographic study completed. Harry Crossley funding – R15 000. Research Assistance funding - R20 000. Interfaculty grant R100 000.

4. Principal Investigator:2009 - A Randomized 32 week double blind parallel-group, multicentre study to compare the efficacy and safety of initiating treatment with combination (aliskiren/amlodipine) therapy in comparison with the sequential add-on treatment strategies in patients with essential hypertension. Protocol CSPA100A2307 Sponsor : Novartis

5. Principal Investigator - 2008: A phase II, Multicenter, Randomized, Placebo-controlled study to evaluate the Efficacy and Safety of intramuscular Peramivir 600 mg in subjects with uncomplicated acute influenza. Protocol BCX 1812-212 Sponsor: Biocryst. 

6. Principal Investigator - 2007 A phase 3 Open-Label, Single Arm Trial, Evaluating the Safety, Tolerability and Immunogenicity of a subsequent dose of 13-valent pneumococcal conjugate vaccine administered to individuals who participated in Study 6115A 1-500 and Received in this study 13-valent followed by 23-valent pneumococcal polysaccharide vaccine 1 year later. Co-investigator: Dr Michael Pather. Sponsor: Wyeth 

7. Principal investigator: Comprehension of Informed Consent on a Tuberculosis Prevention Study in the Western Cape. Co investigators: Professor Nulda Beyers, Dr Landon Myer, Dr Sharon Kling. Article prepared for publication. Sponsor: MRC

8. Principal Investigator - 2006:  A Phase II, Multicentre, Randomised, Double Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza Co-investigator: Dr Michael Pather  Sponsor: Biocryst

9. Principal Investigator - 2003: Medical research on human subjects in South Africa: A critical assessment of the work of research ethics committees.

10. Principal Investigator - 2003: Informed Consent: Knowledge, Understanding and Perceptions of Patients participating in Prospective Randomised Influenza Vaccines Trials.

11. Sub- investigator 2001- Protocol D153-P507 (National Multi-centre Study)A Prospective, Randomized, Double-blind, Placebo-Controlled Trial to Assess Safety and fficacy of Influenza virus vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Adults Aged 60 Years and Older. Study site: Bishop Lavis Community Health Centre, Western Cape as one of 46 sites in South Africa. Sponsor: Wyeth- Lederle, United States. CRO:QUINTILES 95 patients enrolled.Study closure - November 2001.

12. Sub-investigator 2002- Protocol D153 - P516. A Prospective Randomised Open Label Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted(CAIV-T) with Inactivated Influenza vaccine, Trivalent Types A&B in Adults aged 60 years and older. 108 patients enrolled.Study site: Bishop Lavis Community Health Centre, Western Cape as one of 40 sites in South Africa. Sponsor: Wyeth- Lederle,UK; CRO:QUINTILES. Date of commencement: 1 March 2002

13. Principal Investigator -2003: A Randomised, open label, controlled phase II study to evaluate safety, tolerability and immunogenicity after two different 13-valent pneumococcal conjugate vaccine formulations with or without aluminium phosphate as adjuvant, and after 23-valent pneumococcal polysaccharide vaccine in ambulatory, elderly subjects aged 65 years and older who are naïve to previous 23vps immunisation. Co-investigator: Professor PJT de Villiers Sponsor: Wyeth

14. Principal Researcher - Constraints facing female doctors in private Family Practice in the Western Cape (1995-1997). A descriptive study based on a postal survey.

15. Principal Researcher - HIV Vaccine Trial Participation in the Third World - An Ethical Assessment (1998-1999) Literature Review and philosophical reflection.

16. Principal Investigator - HIV Vaccine Trial Participation - Concerns of Medical Professionals. A descriptive survey - Faculty of Health Sciences, University ofStellenbosch. Published in the South African Medical Journal 2002.

17. Consultant: International AIDS Vaccine Initiative (IAVI)-New York. Brief: Proposal development for an empirical study of Informed Consent - at potential sites for HIV vaccine development in East Africa.​