Professor Michael Selgelid is the Director of the Monash Bioethics Centre (formerly named Centre for Human Bioethics), and he also regularly provides expert advice to a number of international bodies, including the World Health Organization (WHO).
Last year, Professor Selgelid was commissioned to write a White Paper for the US Government on the ethics of ‘gain-of-function research’, and in 2016 he contributed to discussions relating to the response to the Zika virus in Latin America with the Pan-American Health Organisation (PAHO).
Monash Arts spoke to him about his work and how bioethics and ethical considerations play into large-scale health crises.
What is bioethics and where does your work fit into the bioethics discipline?
Ethics in general is concerned with questions about what ought to be done, or what should be done. Bioethics in particular is concerned with ethical questions that arise in the life sciences, medicine and healthcare.
My own research largely focuses on public health ethics, especially ethical issues associated with infectious diseases.
This has included things like pandemic planning and/or ethical issues that arise in the context of particular kinds of diseases. I’m usually most interested in policy-oriented questions about such matters.
You recently worked on a response to the Zika virus. What did that work involve and who did you work with?
I participated in a consultation about ethical issues associated with the Zika crisis which has mainly affected South American countries. The consultation, held in Washington DC, was organized by The Pan American Health Organisation (PAHO), which is the regional office of the World Health Organization (WHO) for the Americas.
Since that time, I have also been appointed to WHO’s Emergency Committee regarding Zika, which, among other things, considered questions about whether the 2016 Olympic Games in Brazil should have been postponed, canceled, or moved to another location (due to concerns about the international spread of the virus).
One thing that’s become clear from numerous consultations that I’ve been doing with the World Health Organization over the years is that different diseases or different epidemics raise different ethical issues. Sometimes there’s overlap but sometimes very different issues arise. Ebola brought up questions that were quite specific to the Ebola crisis and, likewise, Zika has brought up issues that are quite specific to the Zika crisis.
A lot of the discussion and recommendations regarding Zika pertained to the rights and freedoms of women. One of the main things that needs to happen with regard to Zika is that women need to be empowered to make their own informed decisions about their pregnancies. At the PAHO meeting there was quite a strong consensus about this.
What were the ethical issues to arise from the Ebola crisis then? How were they different?
With Ebola, one of the big questions concerned the use of unregistered medications that had never previously been used or tested in humans, and the study of the use of such medications in the context of an outbreak emergency.
Normally you would never use interventions that haven’t previously been used or tested in humans on patients, but such interventions were used on Ebola patients, and then that led to the WHO convening an ethics panel that got a lot of international attention.
The panel was asked: “is it ethically permissible to treat patients with interventions that have never been previously used or tested in humans in an outbreak emergency such as Ebola? And if so, then under what conditions would this be ethically permissible?”
The panel unanimously agreed that, yes, this would be ethically permissible assuming certain conditions are met – such as informed consent, favourable risk-benefit analysis, etcetera. We furthermore concluded that, when such interventions are used, it is important that this be scientifically studied so we can learn more about whether or not they’re safe and effective.
That led to all kinds of additional ethical questions regarding the design of scientific studies of the use of drugs or vaccines in the emergency scenario concerning Ebola in particular. Would placebo-controlled studies, for example, be ethically acceptable?
These questions were quite different from previous questions that had been the focus of other ethical debates about infectious diseases, like influenza. Some of the other ethical issues associated with Ebola, like with questions about quarantine, or dangers for health workers in treating patients, involved more overlap.
This is something we’ve learned about infectious disease ethics. In much of WHO’s past work on infectious disease ethics, there was a disease-by-disease focus and we made guidelines or guidance documents on ethics in each case (like ethics in influenza, or ethics in tuberculosis).
The Ebola crises then highlighted that we need some guidelines about ethics in outbreaks and epidemics more generally, and we have since been working on that. In fact, we hosted a meeting that contributed to development of a (recently published) WHO guidance document on ethics in outbreaks and epidemics at the Monash Prato Centre in November 2015.
In 2015, you were asked to produce a White Paper for the US government. What did that involve?
I was commissioned by the US Government to write a White Paper providing ethical analysis of gain-of-function research. Gain-of-function research involves the creation of pathogens (disease-causing agents) that are more contagious or deadly than naturally occurring strains.
Sometimes there might be important public health reasons for conducting this kind of research, but creating especially dangerous pathogens also raises concerns about biosafety: the dangerous pathogen created might escape from a lab or there might be a lab accident that leads to someone being infected, and events like these might lead to public health crises.
Another worry is that published gain-of-function research studies might provide aspiring bioterrorists with recipes for making dangerous biological weapons.
In October 2014 the US Government called for a “pause” (i.e. a temporary moratorium) on the conduct and funding of gain-of-function research involving influenza virus, SARS virus and MERS virus. They asked any research institutions that had already received US Government funding for this kind of research to put a stop to it for the time-being; and they likewise asked that those who were doing, or might plan to do, this kind of research with their own private funding to voluntarily put it on hold.
During this “pause”, they initiated a “deliberative process”, and as part of this deliberative process, they commissioned quite a substantial risk-benefit analysis of gain-of-function research, especially involving those particular pathogens. The National Institute of Health (NIH) also commissioned me to write an ethical analysis White Paper as part of the deliberative process to inform the NSABB (National Science Advisory Board for Biosecurity), which was responsible for drafting relevant policy recommendations to be sent to the White House.
They asked me to do three things in particular. One: To provide a review of the literature on ethical issues associated with gain-of-function research. Second: To identify relevant ethical and decision-making frameworks that might be brought to bear on policy and decision-making about gain-of-function research. Third: to develop a policy and decision-making framework for NSABB to consider when making policy recommendations.
I produced the White Paper and reported on findings at relevant NSABB meetings in September 2015 and January 2016. I also participated in a public symposium on this topic convened by US National Academies of Sciences in Washington DC in March 2016.
The NSABB has since completed its final report and sent it to the White House. The White House will presumably be making policy informed by that report shortly. One of their main concerns is to develop policy regarding the funding of this kind of research: whether or not to fund it or the conditions under which to fund it. The White Paper they asked me to produce was largely meant to inform ethical issues regarding funding policy in particular.
Can you tell us about future projects and what you might be working on in the coming years?
Gain-of-function research is a subset of ‘dual-use research’ (i.e. research that can be used for both good and bad purposes), which has long been, and will likely continue to be, of interest to me.
There have been a series of highly controversial cases of dual-use research. Years ago at ANU we produced a report on ethical and philosophical issues associated with dual-use life science research for the Department of Prime Minister and Cabinet. I was also involved in a related project on dual-use life science research with the World Health Organization, for which I drafted the ethics section of their relevant guidance document on Responsible Life Science Research. Dual-use research poses problems that are getting more and more important – and getting more and more attention. These issues are very difficult, and they’re not going to go away.
I also plan to pursue more research on ethical issues associated with vector-borne diseases (e.g. malaria, Zika, dengue – which are spread by mosquitoes); and antimicrobial drug resistance – which is widely acknowledged to be one of the greatest threats to global public health during the coming decades.