An article republished in MedicalBrief on 22 October, Draft Ethics Guidelines for Health Research set up Conflict, by Donrich Thaldar and Ciara Staunton, has been criticised by the National Health Research Ethics Council as well as other concerned health professionals as not being based on fact by. We publish their letters below.
The NHREC writes:
In the article, Thaldar and Staunton maintain that the draft Guidelines on Ethics in Health Research, circulated recently by the National Health Research Ethics Council to relevant stakeholders for comment, create a “confusing” parallel regulatory framework regarding the protection of personal information in South Africa.
The National Health Research Ethics Council (NHREC) is legally mandated in terms of section 72(6) of the National Health Act 61 of 2003 to “determine health guidelines for the health research ethics committees” in South Africa.
These ethical guidelines are a key part of the ethico- legal framework governing health research in South Africa and are revised from time to time to keep abreast with a constantly evolving society, including transformation, new technologies and ways of doing, and new challenges faced by health researchers.
The NHREC has consulted with a range of relevant stakeholders, including registered health research ethics committees, to solicit input on the first draft of the revised ethical guidelines.
Consultation included meeting with the stakeholders at a face-to-face meeting held on 17 August 2023, hosted by the Department of Health. Written comments were also invited from stakeholders, to be considered by the NHREC to inform amendments to the draft guidelines.
It is unfortunate that the opinion piece by Thaldar and Staunton was published prior to the finalisation of the draft guidelines. This opinion piece – not based on fact – seems to have been published in haste to discredit the efforts of the NHREC.
The opinion piece states that the draft ethical guidelines are not aligned with the provisions of the Protection of Personal Information Act 4 of 2013 (POPIA), which is unfounded. The revision process of the guidelines is still under way, with the comments received currently being reviewed with the view to incorporating them appropriately.
It is regrettable that these authors have opted to publish a one-sided and uninformed response in the media outside the NHREC’s structured process for providing written input about the revised guidelines.
As much as the NHREC respects the freedom to express opinions, Thaldar and Staunton’s views are not only inaccurate, but are also premature and thus disrespectful of the NHREC’s clearly communicated processes.
Moreover, their opinions create confusion among the health research community which has followed the prescribed processes for input; e.g., health researchers who may read the opinion piece may not realise that the opinion piece is a technical legal opinion which fails to take cognisance of the broader established ethical research practices governing protection of research participants; and health researchers may believe erroneously that the well-understood existing ethical principles that govern protection of participants are by default misaligned with the provisions of the Protection of Personal Information Act.
To illustrate: although POPIA does not refer explicitly to the term “anonymisation”, it is mentioned in the ASSAf Code of Conduct for Research currently awaiting approval by the Information Regulator.
“Anonymisation” is a long standing and well-established concept in ethical health research guidelines across the globe and has appeared in the previous versions of the research ethical guidelines of the Department of Health.
Furthermore, it is important to note that POPIA does not replace or substitute for the ethical guidelines that govern protection of personal information of research participants, as Thaldar and Staunton seem to suggest. On the contrary, it is clear from section 2 of
POPIA that other legislation that provides more extensive protection than POPIA, prevails:
(a) This Act applies, subject to paragraph (b), to the exclusion of any provision of any other legislation that regulates the processing of personal information and that is materially inconsistent with an object, or a specific provision, of this Act.
(b) If any other legislation provides for conditions for the lawful processing of personal information that are more extensive than those set out in Chapter 3 [of the Act], the extensive conditions prevail. (Emphasis added)
The NHREC played a key role in providing input on the ASSAf Code of Conduct for Research. The draft revised ethical guidelines not only refer extensively to the ASSAf Code (although not yet binding), but also to relevant provisions of POPIA.
The suggestion by the authors that the NHREC does not appreciate the impact and importance of POPIA for protection of the personal information of health research participants, is absurd.
Definitions regarding “anonymisation”, “de-identification” and “pseudonymised” that appear in the draft ethical guidelines, have consistently been well understood by health researchers.
Their usage in the draft ethical guidelines does not support the idea of “a parallel governance framework” for protection of personal information in South Africa, as Thaldar and Staunton suggest.
The ethical guidelines cover a broad spectrum of health research which uses different ways to protect the privacy and identity of research participants.
There are many mechanisms of anonymisation, not all of which lead to de-identification. De-identification is but one mechanism of anonymisation, and the choice of which term to use would depend on the context of the research and how the researchers choose to protect the privacy of the participants.
Some terms are used interchangeably in ethical research environments, e.g. pseudonymised vs coded (which means that a code exists but is kept confidential, whilst the data may potentially be re-identifiable).
The authors appear to conflate the legal and ethical governance frameworks regarding protection of personal information or seem to think that an ethical framework has no existence parallel to the legal framework; yet the complementarity of the two frameworks has always been evident.
The authors’ claim that research participants’ right to withdraw their information cannot apply in the case of anonymised information, is equally puzzling, as this right is expressly described in the draft guidelines as a “limited” right (which is the case where information is anonymised).
The authors appear to overlook the context of the draft ethical guidelines, which aim to harmonise both legal and ethical considerations for protection of personal information.
For example, Thaldar and Staunton state that the ethical guidelines insist that POPIA requires a participant’s consent for data sharing, while the guidelines in fact refer to the informed consent process as part of a research ethics protocol that requires (legal and ethical) consent from the participant for sharing of their personal information.
The ethico-legal context is far more nuanced and complex than a literal interpretation of POPIA’s provisions. This is also the case regarding the authors' interpretation that the guidelines insist that data sharing should occur only if the receiving country has similar legal provisions for data protection.
Again, ethical considerations would require that the personal information of research participants is protected outside South Africa’s borders to the same level that they would be protected in South Africa (as would apply to their other interests in terms of an approved ethics research protocol).
In conclusion, the NHREC would like to draw attention to the two necessary perspectives: the legal and the ethical. The governance of research ethics is not limited to legal compliance but requires the wisdom and competence to consider both perspectives in matters regarding protection of personal information of research participants.
The NHREC focuses on both bioethics and law in health research and it is from this position that the guidelines are being revised.
National Health Research Ethics Council
In a second letter, Professors Theresa Rossouw, Keymanthri Moodley, Annelize Nienaber McKay and Anne Pope write:
We address the regrettable article by Donrich Thaldar and Ciara Staunton, published on 22 October 2023.
The authors of the article argue the draft research ethics guidelines in circulation for review by research ethics committees and researchers, in its current form “will introduce regulatory confusion”.
Thaldar and Staunton claim further that these draft guidelines are contrary to the Academy of Sciences of South Africa’s (ASSAf) proposed Code of Conduct that is under consideration by the Information Regulator in terms of the Protection of Personal Information Act (POPIA).
Rather than engage with the accuracy of their claims, we explain the process of guideline review.
The National Health Research Ethics Council (NHREC), established in 2006 in terms of s 72 of the National Health Act (NHA), is required to set norms and standards for health research and to determine guidelines to facilitate best practice for research ethics committees (research ethics committees oversee the conduct of health-related research in South Africa).
The revision of the guidelines (last updated in 2015) has been prompted by the advent of major changes to the landscape of health research. For example, there have been advances in genetic and genomic research and the innovative research in times of previously unknown viral infections that cause pandemics, as well as research conducted via online platforms.
No existing legislation, including POPIA, gives guidance on these matters.
The NHREC has drafted a proposed set of guidelines that has been circulated widely for comment. The purpose of such wide engagement is to solicit critical review and revision to be considered and appropriately incorporated before the next draft is circulated.
This process of circulation and an iterative approach to finalising the revision provide an opportunity for the research community to be heard and to assist with shaping the final document that will guide ethics review processes in the country for the foreseeable future.
Trust is a fundamental part of research, and it is imperative that the public should not be misled about the integrity of the ethical review process. Academics can be expected to work together to ensure that guidelines are aligned to national legislation and ethical best practice.
The opportunity to comment on shortcomings or other issues is provided via well-established channels. These channels do not include publishing accusatory claims in the press.
The latter conduct does not serve the public interest because it undermines the transparent process that exists for the purpose of achieving a correct revision of the national research ethics guidelines.
In our view, the authors of this article do more to sow confusion among the public and potential research funders and researchers than any iteration of the draft guidelines might do.
In airing their views via the media rather than constructively engaging with the draft guideline as is intended, they bring the NHREC and the South African Department of Health into disrepute.
Nested in the principle of autonomy, academic freedom is a constitutional right enjoyed by academics for the purpose of the public good. Academic freedom, on that account, must be exercised with respect for national sovereignty, responsibility and accountability and in a collegial spirit.
Yours sincerely,
Professors Theresa Rossouw, Keymanthri Moodley, Annelize Nienaber McKay and Anne Pope
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New draft ethics guidelines create confusion