Breadcrumb Home Faculties Medicine Research Health Research Ethics Office SOPs & Guidelines SOPs & Guidelines HREC SOPs and Ethics Guidelines Stellenbosch University Health Research Ethics Guidance No fault compensation insurance for clinical trial and/or human volunteers studies, Clinical Trial Presentation 2025, Fagma Jordaan, Client Executive, Stellenbosch 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 paediatrics 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 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 (Version 1 , 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_February2017 .pdf
