In our December edition, we provided a high-level summary of responses to the startling inclusion of HHGE – as a “matter-of-fact” topic area – in the 2024 South Africa Ethics in Health Research Guidelines. We include below selected text from the Guidelines and from the important editorial by Ramsey et al. arguing that the “…current wording for HHGE for research purposes in the guidelines should be deleted in its entirety.” We are not aware of any new action by the South Africa NDoH but assess that this issue deserves close monitoring and further engagement by the global community.
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South African Ethics in Health Research Guidelines: Principles, Processes and Structures
2024 Third Edition
4.3.2 Heritable human genome editing
Research on heritable human genome editing (HHGE) holds significant potential for addressing genetic diseases and improving human health. It also presents ethical challenges that require careful consideration and deliberation. A framework for analysing the protocol emphasises responsible and cautious practices.
a) Scientific and medical justification
HHGE research must have a clear and compelling scientific and medical rationale, focusing on the prevention of serious genetic disorders and immunity against serious diseases. The potential benefits to individuals and society should outweigh the risks and uncertainties associated with HHGE.
b) Transparency and informed consent
Researchers must maintain transparency throughout the research process, ensuring that participants and stakeholders are well-informed about the goals, methods, and potential implications of HHGE. Informed consent must be obtained from all parties involved, including prospective parents and individuals whose genetic material is used in the research.
c) Stringent ethical oversight
HHGE research should be subject to rigorous ethical review by health research ethics committees to evaluate its ethical implications. Ethical oversight should especially be illuminated by the right to freedom of scientific research, the right to access to healthcare, the best interests of prospective children, and the dignity of all individuals involved.
d) Ongoing ethical evaluation and adaptation
Ethical scrutiny of HHGE research projects should be a continuous process that adapts to evolving circumstances. This entails regular re-evaluation as new information emerges and as the technology progresses.
e) Safety and efficacy
Researchers must prioritize safety in all HHGE experiments, with thorough assessments of potential risks and strategies for mitigating them. The research should demonstrate a high level of scientific rigor and provide evidence of the technique’s efficacy.
f) Long-term Monitoring
Researchers should commit to ongoing monitoring of individuals born as a result of HHGE interventions to assess their health, wellbeing, and potential unforeseen consequences.
g) Legal compliance
Researchers must adhere to all relevant laws governing HHGE research. In particular, researchers must adhere to the fourteen-day rule, and must obtain the necessary ministerial permission to conduct research on embryos.
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In the context of a number of other commentaries and analyses, we note again the editorial titled Heritable human genome editing in South Africa – time for a reality check [South Africa Medical Journal, Early Online -2024-11-29] by Michele Ramsay, Michael Pepper, Jantina de Vries, Safia Mahomed and Eleni Flack-Davison.
The editorial is well structured and provides discussion of the “origins of the current controversy” and its consequences. One contextual clarification in the piece is around public consultation processes leading to the inclusion of the HHGE language in SA guideline referenced above:
“…A draft of the guidelines released for public comment in 2023 did not include text on HHGE. A subsequent draft released early in 2024 included the section on HHGE with a brief window for comment. It is unclear why the National Health Research Ethics Council (NHREC) chose not to consult widely with topic experts to ensure that the text of the guidelines was appropriate, considering the national legal context, ethical concerns and international recommendations and guidelines for HHGE. It is unfortunate that this situation has arisen. The misguided wording in the current guidelines may serve to precipitate a troubling change in opinions in favour of permitting or promoting HHGE in SA…”
More important is the editorial’s clear-thinking conclusion:
…What should happen next?
Revision of the NHREC guidelines
The NHREC must clarify its view on HHGE. We note the recent press release that was circulated to ethics committees around the country by the chair of the NHREC on 8 November 2024. But this does not sufficiently address nor resolve the controversy, and the press release has no legal standing. The current wording for HHGE for research purposes in the guidelines should be deleted in its entirety. The underlying premise of section 4.3.2 of the guidelines appears to rest on the fact that there will be prospective parents, prospective children and individuals born because of HHGE research interventions specifically, which is problematic and inconsistent with the law. In addition, this current ambiguity in wording blurs the line between HHGE research and clinical application.
In summary, we assess this to be an extremely important, troubling and unresolved matter with global implications. We will continue to monitor for any further analysis, and, hopefully, action!
Center for Genomic Medicine Governance, Ethics & Policy 