Links
National Research Ethics Guidance
- Department of Health: Ethics in Health Research: Principles, Structures and Processes, 2004
- Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Second Edition, 2006. Department of Health, Pretoria, South Africa.
- Guidelines for Approval of Health Research in the Western Cape
- MRC Guidelines on Ethics for Medical Research –HIV Preventive Vaccine Research Book 5 2005
- National Health Act 61 of 2003
International Research Ethics Guidance
- Belmont Report
- Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Declaration of Helsinki 2008
- US Common Rule Subparts A-E 2009
- UNAIDS-AVAC Good clinical participatory guidelines for Biomedical HIV Prevention Trials 2010
- UNAIDS Ethical Considerations in Biomedical HIV Prevention Trials 2012
- TB Good Particiaptory Practice Guidelines for TB Drug Trials 2012
- HPTN Ethics Guidance 2009
Registration of Clinical Trials Undertaken in South Africa
- How to register
- Further information about the South African National Clinical Trial Register
International Regulatory Requirements
- ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1) 1996
- ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the Pediatric Population E11 2000
- The Association of the British Pharmaceutical Industry (ABPI): Clinical Trial Compensation Guidelines Reprinted 1994.
- ABPI guidelines for Phase 1 Clinical Trials 2012
- ABPI guidelines for Phase 1 Clinical Trials for Insurance and Compensation in Clinical Trials 2012
Participants' Rights in Human Research
- The South African AIDS Initiative (SAAVI) has produced a Participant's Bill of Rights for preventive HIV Vaccine Trials
Faculty of Health Sciences – Health and Safety Handbook
- Keep safe hand book for students and researchers working and learning at sites off-campus
Online Research Ethics Training
- Training and Resources on Research Ethics Evaluation (TRREE)
- Global Health Trials
- Family Health International Research Ethics Training Curriculum Second Edition
- Family Health International Research Ethics Training Curriculum for Community Representatives
- NIH Office for Extramural Research Protecting Human Research Participants
- ERECCA Enhancing Research Ethics Capacity and Compliance in Africa
- Human Research Ethics Training for the Social Sciences and Humanities