Ethics at the ready

It is a cliché to say that you can never be too prepared, but at the same time, it is true that we have sometimes found ourselves unprepared to deal with the ethical issues that modern science delivers.

In the EPPiGEN project funded by the Wellcome Trust, we have focused on the issue of ethical preparedness as it relates to the development and mainstreaming of genomic medicine, but the ideas we have developed hopefully have a wider application.

Recent history is littered with examples of unwelcome experiences for which we have been unprepared, and as a result, we are now familiar with the use of the term preparedness in relation to unwanted and unexpected events such as pandemics, natural disasters and financial collapse. Clearly, it is important to be better prepared for such eventualities, and the healthcare setting has not been immune from events that are judged harshly and deeply regretted in retrospect.

Public inquiries such as the recent Infected Blood Inquiry, and the current COVID-19 Inquiry, have demonstrated that things could and should have been done better, even allowing for the need to respond to severe threats, be that the onset of HIV and AIDS or a global pandemic. The past provides us with a clear justification for committing time and effort to future preparedness, and while we can and must learn from the mistakes of the past, their very existence tells us that we should be more alert to the possibility of doing better in the future.

Putting aside the unwelcome and unexpected, we have been drawn to considering if and how one can be ethically prepared in relation to the planned for and welcome development of innovative scientific or health technologies. We are interested in the idea of developing, securing and embedding a sense of preparedness to recognise, acknowledge and respond to ethical issues that might arise even when change is welcome and carefully engineered. It is our claim that developing an appreciation of the ethical aspects of any project is an early and then ongoing responsibility of researchers, policymakers and practitioners.

It is a mistake to consider that this is solely the domain of ethics committees and regulators, although they will have an important part to play. Having developed and tested a technology we then need to embed it within a health service which will take responsibility for what happens next, and sometimes ethical challenges are, if not inevitable, then at least probable.

We define ethical preparedness as follows:

'In its abstract form, we define ethical preparedness as a state from which one is able to identify and articulate ethical issues in a timely and ongoing manner, and where (ideally) one has the tools and the skills/experience available to address them. In the absence of the latter one must know whom to consult and engage with in order to avail of appropriate expertise...'

The agent in this context is the practitioner or the scientist rather than the institution within which they operate or the bodies that preside over them. As such our idea of preparedness develops as one which requires the skill and experience to be developed with and by the people doing the day job. We are much less interested in policies and guidelines than we are in the culture and practices that could encourage and support the flourishing of individuals, such that they take responsibility for and succeed in becoming ethically prepared for the work they do.

Clearly, influential bodies can play a part in this process, and a recent example of good practice is the way in which the Human Fertilisation and Embryology Authority encouraged and supported public and professional consultation and debate in the years preceding the introduction of mitochondrial donation.

It is worth remembering, however, that this body was itself born of our previous unpreparedness in the field of reproductive medicine, with the birth of the first 'test tube baby' revealing how we were not ready to respond to the ethical challenges posed by this rapidly developing field of scientific research and medical practice. While the Warnock report resulted in the construction of a complex and bespoke regulatory framework governed by law, work would be needed on an ongoing basis to ensure that scientists and clinicians felt confident to advance their field within the boundaries set.

We now realise that as time goes on ethical issues do not necessarily disappear or get resolved, and for this reason, it is important to embed some sort of ongoing process to ensure that the workforce remains alert to new or recurring challenges. As we have come to understand, off-the-shelf solutions will not always work in areas of medicine where ethical challenge remains a possibility. For this reason, we have developed an account of ethical preparedness that sees the endeavour as ongoing and at some level day to day.

So, for example, in the field of genomic medicine, it was not enough that in the early days of the mainstreaming project bodies such as Genomics England established in-house ethics committees and interrogated the whys and wherefores of the big ethical issues. What is needed now is a way to support ethical discussions and decision-making within a busy and overstretched NHS.

One example of such ongoing support is the long-established Genethics Forum, which brings together practitioners and academics to discuss everyday challenges and specific cases encountered by people working in the NHS. This is a space where practitioners can meet with one another and with interested academics to discuss at a very practical level the ethical issues raised by their work. Over time they can develop their skills in holding and responding to those issues thereby avoiding the tendency to see regulations as the source of ethical answers.

In line with our view that preparedness cannot be passed down from above, but rather needs to be developed from the bottom up, we commend all those who acknowledge and embrace the need to conduct moral labour in their working day, and we urge those with the power to 'make the rules' to do so in conjunction with the people who will need to operate under them.