Human Research Ethics
Information on Health Sciences research on human participants.
Important Notice - Research Ethics Training Requirements for Researchers and Students
Please read the important training notification before applying for new ethics submissions.
Overview
All health research involving human participants must be reviewed and approved by an accredited human research ethics committee prior to the start of any research activities in accordance with the National Health Act No 61.2003.
It is a legal and institutional requirement for all persons associated with the University of Cape Town Faculty of Health Sciences to obtain appropriate ethical approval from the Human Research Ethics Committee before commencing any research activity involving human participants.
Application forms and templates
- FHS013 application form: Research involving human participants
- Checklist for new protocol applications
- New Protocol Applications - Pointers for Reviewers [Download]
- FHS014hlp Preparing a Synopsis - Pointers for Researchers
- FHS015hlp Preparing the Research Protocol - Pointers for Researchers
- FHS021 Application form: Undergraduate student research projects
- Checklist for undergraduate student applications
- FHS020 Application form: Registering databases, registries or repositories
- FHS035 Application form: Health-Related Case report or Case Series
- FHS036 Application Form: Health Research Using Cell Lines
- FHS037 Application Form: Reciprocal approval of minimal risk research already approved by another South African Research Ethics Committee
- FHS038 Application form: Honours student research project application
- Application form to conduct research at Red Cross War Memorial Children's Hospital [Download]
- Requirements to conduct research at Red Cross War Memorial Children's Hospital [Download]
- Form A: Ministerial consent for non-therapeutic research with minors <18 years of age
Open
- FHS006 - Protocol Amendment form: Study amendment form for any changes made to the study
- FHS006hlp Preparing an amendment - Pointers for researchers
- FHS007 - Staff amendment form - Any staff changes that occures on the study.
Closed
- FHS016 Annual progress report form - Annual renewal for an approved study
- FHS016hlp Annual progress report - Pointers for researchers
- FHS017 Annual progress report form - Annual Renewal for record reviews / audits / repositories / databases / registries
- FHS019 Final report form - For all record reviews / audits / repositories / databases / registries
- FHS010 Study closure report - for all studies that is completed
Closed
- FHS008 - Internal Adverse Event or Unanticipated Problem reporting form
- FHS008hlp - Preparing an internal adverse event or unanticipated problem report - Pointers for researchers
- FHS009 - Reporting form for safety information - Investigator Brochure, Safety Information, DSMB Report, Hold on Study Activity
- FHS011 - Study deviation form
- FHS011hlp - Study exceptions and study deviations - pointers for researchers
- FHS012 Study exception form
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Guidelines and Policies
- HREC Standard Operating Procedures
- UCT research ethics code for research involving human participants
- UCT policy for ethics clearance and permission to engage UCT staff and/or students or their data in research
- Register of ethics approvals for research conducted under the auspices of UCT
- Code for UCT research ethics committee members
- Appeal to Ethics in Research Committee: standard operating procedure
- UCT policy for responsible conduct of research
- UCT policy and procedures for breach of research ethics codes and allegations of misconduct in research
- Eligibility for Expedited Review of US Federally-funded Research - Pointers for Researchers
Closed
- National Health Act 61 of 2003 National Regulations Relating to Research with Human Participants R719 of 2014
- Department of Health: Ethics in Health Research: Principles, Structures and Processes,2024
- Department of Health: Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Third Edition, 2020.
- Department of Health: Application for Ministerial Consent for Non-Therapeutic Research with Minors (Form A)
- Payment of trial participants in South Africa – National Health Research Ethics Council guidelines (2012).
- SAHPRA guidelines on payment of trial participants: time, inconvenience and expense (TIE)
- Guidelines for Approval of Health Research in the Western Cape
- Application to Conduct Research in Public Schools Within the Western Cape
- MRC Guidelines on Ethics for Medical Research –HIV Preventive Vaccine Research Book 5 2005
- Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa
- National Guidelines for Community Advisory Groups for Research (2012)
Closed
- Belmont Report
- Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Declaration of Helsinki 2024
- Declaration of Taipei 2016
- 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 Participatory Practice Guidelines for TB Drug Trials 2012
- HPTN Ethics Guidance 2009
- ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1) 1996
- ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the Paediatric Population E11 2000
- ABPI guidelines for Phase 1 Clinical Trials 2012
- ABPI guidelines for Phase 1 Clinical Trials for Insurance and Compensation in Clinical Trials 2012
- HIV Research Vaccine Trials Network Participant's Bill of Rights for HIV Vaccine Trials
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Ethics training resources
Training and Resources on Research Ethics Evaluation (TRREE)
"TRREE” is a free and open access online training program on research ethics and regulation. TRREE's learning material is currently available in English, French, German, Polish and Portuguese. The training is modular. It includes an introduction to research ethics (module 1), a module on the role and responsibilities of Research Ethics Committees (module 2.1), several modules on the national regulation in given countries from the North and the South (module 3) and a detailed module on informed consent (module 4).
- 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
- Human Research Ethics Training for the Social Sciences and Humanities
- Research Ethics Online Training developed by the Global Health Network e-Learning Centre
- TCPS2 training - The HREC recommend this training for colleagues who are non-compliant https://tcps2core.ca/welcome
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Meeting and Submission dates
Fee Structure
Human Research Ethics FAQs related to Research Involving Human Participants
Please refer to the Application forms and templates section of this webpage for all latest application forms.
Closed
No – only prospective review is considered. Therefore, please submit your project for approval before commencing any research activities
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