SOPs & Guidelines
HREC SOPs and Ethics Guidelines
Stellenbosch University Health Research Ethics Guidance
- HREC (2023). Terms of Reference and Standard Operating Procedures V6. Health Research Ethics Committee, Stellenbosch University. Approved by Senate 09 June 2023.
- HREC (2016). HREC guideline for maximum paediatric blood volumes for research purposes
- Paasche-Orlow, Taylor & Brancati (2003). Readability Standards for Informed-Consent Forms as Compared with Actual Readability. N Engl J Med, 348: 721-6.
- Paache-Orlow et al. (2003). Readability Standards for IC - PowerPoint summary
- TRUST (2019). Global Code of Conduct for Research in Resource-Poor Settings. Additional information available at: http://www.globalcodeofconduct.org/
National Health Research Ethics Guidance
- South African Health Products Regulatory Authority. Guideline for Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model..01 July 2022
- Department of Health (2020). South African Good Clinical Practice: Clinical Trial Guidelines (3rd edition). Pretoria, South Africa
- Material transfer agreement South Africa 1.1 December 2020
- Department of Health, National Health Act, 2003 (Act No. 61 of 2003) – Material Transfer Agreements (MTA) of Human Biological Materials – Government Gazette - 20 July 2018
- Department of Health (Version1, June 2018). South African Health Product Regulatory Authority. Post Clinical Trial Access (PTA)/Continued Access (CA) for Clinical Trials. Department of Health: Pretoria, South Africa
- Department of Health (2024). Ethics in Health Research: Principles, Processes and Structures (3rd edition). Department of Health: Pretoria, South Africa [effective 21 May 2024]
- South African National Health Act 61 of 2003
- Department of Health (2015). Application for Ministerial Consent for Non-Therapeutic Research with Minors (Form A). Department of Health: Pretoria, South Africa
- Provincial Health Research Committee (2013). Guidelines for Approval of Health Research in the Western Cape. Western Cape Government: South Africa
- NHREC (2013). Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees (RECs). National Health Research Ethics Council (NHREC): South Africa
International Health Research Ethics Guidance
- Twelve tips to avoid ethical pitfalls when recruiting students as subjects in medical education research. 30 July 2017
- Final rule: Federal Policy for the Protection of Human Subjects [Common Rule]. Effective on 19 Jan 2018.
- World Medical Association (2013). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
- CIOMS (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organisations of Medical Sciences and WHO: Geneva
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
- RinGs (2015). The ethics of health systems research: Selected guidelines and studies
- H3Africa (2013). Guidelines for Informed Consent. H3Africa Working Group on Ethics and Regulatory Issues for the Human Heredity and Health (H3Africa) Consortium
- Final Framework for African genomics and biobanking_SC_February 2017 .pdf