Links and guidelines

 

NHREC Registration of Clinical Trials undertaken in South Africa

South African National Clinical Trial Register

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_SC_February 2017 .pdf

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 of UFS.


FACULTY CONTACT

Central Information Office
T: +27 51 401 3739
F: +27 86 579 5154

E: StudentAdminFHS@ufs.ac.za

Student Administration
Faculty Administration

Health sciences block next to contact

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