Centre for Medical Ethics and Law​

​​0007507890C-849x565.jpgResearch

Current Research Activity:

​​​

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.​