• Application form: Research involving human participants (FHS013 - 30.05.2022)
• Checklist for new protocol applications
• New Protocol Applications - Pointers for Reviewers [Download]
• Preparing a Synopsis - Pointers for Researchers (FHS014 - 16.02.2022)
• Preparing the Research Protocol - Pointers for Researchers (FHS015hlp - 16.02.2022)
• Application form: Undergraduate student research projects (FHS021 - 16.02.2022)
• Checklist for undergraduate student applications
• Application form:  Registering databases, registries or repositories (FHS020 - 16.02.2022)
• Application form: Health-Related Case report or Case Series (FHS033 - 16.02.2023)
• Requirements to conduct research at Red Cross War Memorial Children's Hospital [Download]
• Application form 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 (Form A)

• Preparing an amendment - Pointers for researchers (FHS006hlp - 16.02.2022)
• Study amendment form (FHS006 - 16.02.2022)
• Staff amendment form (FHS007 - 16.02.2022)

• Annual progress report - Pointers for researchers (FHS016hlp - 16.02.2022)
• Annual progress report form (FHS016 - 28.02.2022)
• Annual progress report form for record reviews / audits / repositories / databases / registries (FHS017 - 16.02.2022)
• Final report - record reviews / audits / repositories / databases / registries (FHS019 - 16.02.2022)
• Study closure report (FHS010 - 16.02.2022)

• Preparing an internal adverse event or unanticipated problem report - Pointers for researchers (FHS008hlp - 16.02.2022)
• Internal Adverse Event or Unanticipated Problem reporting form (FHS008 - 16.02.2022)
• Reporting form for safety information (FHS009 - 16.02.2022)
• Study deviation form (FHS011 - 16.02.2022)
• Study exception form (FHS012 - 16.02.2022)
• Study exceptions and study deviations - pointers for researchers (FHS011hlp - 16.02.2022)

• Research Access to students (DSA 100)
• Access to UCT Staff for Research Purposes (HR194a and HR194b)

• 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

• 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, 2015
• 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).
• Payment of trial participants in South Africa – South African Health Product Regulatory Authority SAHPRA guidelines (2018).
• 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)

• Belmont Report
• Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects
• Declaration of Helsinki 2013
• 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

• 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

• Submission and HREC Meeting Dates 2023

• Fee Structure

Please refer to the Application forms and templates section of this webpage for all latest application forms.

No – only prospective review is considered. Therefore, please submit your project for approval before commencing any research activities