This week, the National Ethics Capability Committee had the pleasure of hosting Professor Jonathan Montgomery (UCL), Chair of the Nuffield Council of Bioethics and the Health Research Authority in England. In the midst of his quite busy schedule, he was able to give two very relevant talks to a general audience (as advertised on this blog and the CENTRES mailing list). One was on the changing landscape of data confidentiality, and the other on the ethics of CRISPR and related gene editing technologies. For those who were unable to make it but are interested in what the preeminent professor had to say, I’ll give a brief summary of the highlights of his talks.
Developments in Confidentiality & Use of Patient Data in the National Health Service – Implications for Singapore
Building on a recent Nuffield Council report, Montgomery underlined the growing challenge of managing ‘biodata’ responsibly. He astutely noted that biodata goes beyond classical health data, expanding into areas like physical behaviours, family circumstances, consumer choices or data from biosamples gathered for non-clinical purposes. The wealth of biodata has led to a great amount of interest among researchers in using it to learn more about how to promote health and well-being in society. But that research needs to balance respect for participants’ interests and rights against ensuring that socially valuable research can be conducted effectively.
Montgomery was critical of the old paradigm of promising subjects great control over their data. Managing such control has proven to be technically and logistically difficult. Instead, researchers should work to build public trust that, as stewards of the data, they are managing it responsibly and conscientiously. He offered helpful suggestions of greater stakeholder involvement in research design, provision of ‘access reports’ to subjects on who has accessed their data, and avoiding a one-size-fits-all question on whether to opt-in or opt-out of research on one’s biodata that is both ethically and operationally dubious.
The NHS in the UK made some serious missteps in building trust in biodata research (e.g., the intense opposition to the NHS care.data repository programme); the suggestions offered by Montgomery therefore may be a means by which Singapore can ensure public buy-in and avoid scandal as it similarly engages in big data research.
Ethical Challenges in CRISPR Research
The second of Montgomery’s talks focused on another Nuffield Council project that is currently underway, studying the ethical implications of genetic editing technologies. Gene editing has elicited a number of concerns about integrity of the personal genome and consistency of oversight of different technologies, but there is as yet no national or global consensus on its use.
Montgomery noted several parallels and lessons learned from the Nuffield Council’s work on mitochondrial replacement therapy. Even a relatively narrow-scope report can be interpreted by the public quite broadly, so one must be careful in how one frames one’s analysis. Indeed, the debate over mitochondrial replacement therapy became reframed from “why should we allow this strange new technology” to “why should we deny families in need this potentially beneficial great new technology” – a shift that may also occur in more general debates over gene editing.
CRISPR-cas9, as one of the most cutting edge gene editing techniques, has garnered the most public attention, but Montgomery urged us to not focus too much on a given technique, but rather the broader ‘technology’ – knowledge, practice and application – surrounding it. This leads to the important question of trust and who should ensure the technique is deployed responsibly: scientists, the government, the public, or the free market? In the UK, commentators were very sceptical of a market-based solution (as their healthcare system is primarily government-run), with some arguing that existing research and clinical regulations may be adequate for oversight. Trust in scientists was mixed, but since the early debates over IVF their ability to engage in public discourse over technological innovations has improved. A notable exception is the genetically modified food debate, which interestingly has led some commentators to be sceptical that deference to public opinion is appropriate. Instead, they recommend a “mature conversation” where the scientists’ views are presented frankly, even when they are not popular.
Several other themes emerged from the public commentary on the Nuffield Council’s project. These include: the technology, while not entirely new, may ‘disrupt’ the norm through making gene editing cheaper and more efficient than ever; conflicts of interest may emerge from scientists promoting gene editing who may also profit from it; the safety bar is unclear, as permanence of the intervention is questionable; and the entire debate lies in the shadow of larger ethical quandaries of eugenics, dual-use and the perceived failure of genetically modified crops.
Neither Montgomery nor the Nuffield Council are proposing final solutions to these quandaries. Their aim, rather, is to foster robust public debate over the proper next course of action as research using genetic modifications (and eventually clinical use) advances.