What South Africa NHREC Ethics in Health Research Guidelines 2024 - Biobanking and Genomics requires
The South African Ethics in Health Research: Principles, Processes and Structures Guidelines (3rd edition, 2024) are issued by the National Health Research Ethics Council (NHREC) under the National Health Act 61 of 2003 and represent the authoritative ethical framework for health research in South Africa. The 2024 edition was published in 2024 and applies to all research conducted in South Africa or by South African researchers involving human subjects, human biological material, and identifiable human data. Chapter 4 specifically addresses Research with Human Biological Material including biobanking and genomic research and requires written informed consent, ethics committee approval, and material transfer agreements for cross-border movement of biological material. The Guidelines operate within the legal regime of the National Health Act 61 of 2003, the Protection of Personal Information Act 4 of 2013 (POPIA), the Regulations Relating to Research with Human Subjects, and the Material Transfer Agreement for Human Biological Material (issued by the Department of Health, 2018). The Guidelines establish heightened safeguards for genomic research including specific consent procedures for whole-genome sequencing and the return of incidental findings. Heritable human genome editing remains prohibited in research conducted in South Africa under Chapter 4. The Guidelines also implement the Nagoya Protocol on Access and Benefit-Sharing for genetic resources accessed from indigenous and local communities and require benefit-sharing where applicable. The NHREC oversees the network of Research Ethics Committees registered under the National Health Act and approves training and accreditation for committee members.
Pillar: Biotech & Genomics · Authority: National Department of Health and National Health Research Ethics Council · Version: 1.1.0 · Last updated:
Primary source: https://www.health.gov.za/wp-content/uploads/2024/05/NDoH-2024-Health-Research-Guidelines-3rdEdition-v0.1.pdf
SHA-256 integrity: 06ec478f9645fa781a9fdfc27f5ae427708714c8d4544189b5af5e8d9eb9f145
Primary Citations — 7 traced to source
- Department of Health (South Africa) - Ethics in Health Research: Principles, Processes and Structures Guidelines (3rd edition, 2024) - authoritative ethical framework for health research in South Africa.
- NHREC 2024 Guidelines - Research with Human Biological Material including biobanking and genomic research requires written informed consent and ethics committee approval.
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