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RIDS | Health Research Ethics Office
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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/
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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
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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
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Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees (RECs)
.
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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
.
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