Centre for Medical Ethics and Law
Principal investigator– Community Engagement for H3Africa Biobanking Research: The Tygerberg Model
Phase 1 – Development of an educational tool and interviews with the community & stakeholders.
Development of educational pamphlets and DVD on medical research and biobanking research.
- The educational DVD has been completed and is being used in patient education sessions – see https://youtu.be/QjSfIA6_bfc
- A series of five educational pamphlets have been developed, namely (1) What is Medical Research, (2) What is Genetic Research, (3) What is Genomic Research, (4) What is a Biobank, (5) Questions about Research and Biobanking. These are available in English and will shortly be available in Afrikaans and isiXhosa.
- Interviews with community members (in progress), community advisory board (CAB) members (completed and biobank stakeholders (completed).
Phase 2 – Analysis of the interviews and development of key principles and guidelines.
- Interviews will be analysed, key themes will emerge and community engagement guideline will be developed.
Principal investigator– Ethical and Social Implications of HIV Cure Research
Phase 1 - Literature review at sites
- University of North Carolina, Guangzhou – China, Centre for Medical Ethics and Law, Stellenbosch University.
- Pilot study: 15 Qualitative Interviews completed.
- Brocher Foundation seminar – 5-7 May 2014, Geneva, Switzerland
Phase 2 – Empirical research
- 25 key informant interviews, South Africa – completed.
- An educational video and information brochures have been produced to inform patients about HIV cure research – see https://youtu.be/oNfw9n5nBtU.
- The educational video was subjected to an assessment of efficacy in a before and after study – completed: 92 patients interviewed at Tygerberg Hospital and at the University of Kwa-Zulu Natal, and a further 23 patients interviewed at Tygerberg.
Phase 3 – Empirical research
- 26 stakeholder interviews were completed, and 2 focus group discussions have been conducted. This data has been analysed and will be published in peer-reviewed journals shortly.
- Stakeholder education, engagement and dialogue, with the aim of developing an online forum, is in progress.
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 – ongoing.
Past research activity:
1. 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.
2. 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.
3. 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
4. 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.
5. 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
6. 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
7. 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
8. Principal Investigator - 2003: Medical research on human subjects in South Africa: A critical assessment of the work of research ethics committees.
9. Principal Investigator - 2003: Informed Consent: Knowledge, Understanding and Perceptions of Patients participating in Prospective Randomised Influenza Vaccines Trials.
10. 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.
11. 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
12. 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.