Data Management and POPIA

POPIA Code of Conduct for Research
UFS supported software for research
How to write a Data Management Plan

Ethics demonstration videos

Links to other University Health Sciences Research Ethics Committees

• University of Kwazulu-Natal
  
• University of Cape Town
  
• Stellenbosch University
• University of Witwatersrand, Johannesburg
• University of Pretoria
• Sefako Makgatho Health Sciences University
• Walter Sisulu University
• Nelson Mandela University
  

Links and guidelines

• NHREC Registration of Clinical Trials undertaken in South Africa
  
• South African National Clinical Trial Register
• South African Good Clinical Practice: Clinical Trial Guidelines
• South African Ethics in Health Research Guidelines
• TRREE online research ethics training
• Free State Provincial Department of Health research approval [National Health Research Database (NHRD)]
• NHREC (2013) - Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees (RECs). National Health Research Ethics Council (NHREC): South Africa (GL16)

The HSREC functions in compliance with, but not limited to, the following documents and guidelines:

• The SA National Health Act, No 61 of 2003  (GL03)
• Department of Health: Ethics in Health Research: Principles, Structures and Processes, 2015 (GL04)
• 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 (GL05) 
• World Medical Association (2013). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects  (GL06)
• 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.(GL07)
• The Singapore Statement on Research Integrity
• H3Africa (2013). Guidelines for Informed Consent. H3Africa Working Group on Ethics and Regulatory Issues for the Human Heredity and Health (H3Africa) Consortium
• CIOMS (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organisations of Medical Sciences and WHO: Geneva (GL11)
• ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1) 1996 (GL12)
• ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the Paediatric Population E11 2000 (GL14)
• ICH Harmonised Tripartite Guideline: Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Tripartite (GL13)
• Final Framework for African genomics and biobanking (February 2017)
• Guidelines of the SA Medicines Control Council as well as Laws and Regulations with regard to the Control of Medicines;
• Terms of Reference and Standard Operating Procedures of the HSREC at UFS.