• Ethics

We have all become used to the rapid change around us, and with it, the shifting landscape of medical ethics. It appears, however, that the acceleration phase of change in biomedical sciences is only just beginning, and we need to be prepared for new challenges ahead. This issue of the journal considers several of them: in epigenome editing,1 in bioprinting2 and in cryonics.3 With all of these developments, we need to be doing our ethical thinking proactively rather than reactively; and we need to consider not only what we think the ethical problems might be but what frameworks we have for arguing how we should address them. There are several approaches that could be taken4 each with their own advantages and limitations.

The most fun—and the one we are perhaps best at—is to consider hypothetical scenarios, the ethical controversies associated with them, and the arguments and counterarguments for various forms of resolution.5 A criticism of this approach is that sometimes it focuses too far on the future, without paying enough attention to indications that ethical problems are already presenting themselves.6 Hillenbrink and Wareham consider the implications of the recent case study of a 2-year-old girl who has been cryogenically preserved (about 500 ‘patients’ are known to have been so preserved in the world; she is the youngest known of these).3 In particular, they consider the impact on the life and mourning process of her sibling. They suggest we consider not only the ‘prudential and societal ethical arguments [for cryonics, but also] how the choice for crypopreservation can affect the lives of those that survive the crypoperserved patient’. With this in mind, we perhaps need to consider whether consent for such a process needs to be sought not only from the individual wishing to be preserved, but from those surviving it; the autonomous rights of the deceased/preserved individual need to be balanced with those of the living. Hillenbrink and Wareham use the current case study to draw attention to a so-far neglected ethical issue; imagining scenarios in the future enable us to anticipate problems and prepare for them, through consultation, guidance and regulation.

While hypothetical scenarios are helpful, particularly in considering the potential impacts and ethical challenges of discrete technologies, when we consider more complex innovations (with myriad possible outcomes) scenario experiments are limited: we cannot prepare for what we cannot imagine. For these technologies, many advocate the so-called ‘precautionary principle’. This has been variously defined from ‘limiting the use of a new technology until it has been fully tested’ to ‘a positive duty for stakeholders to act to prevent or mitigate any potential harm’.4 7 Its utility has been debated8 9 with many pointing out that at one extreme it would be paralysing, and at the other self-evident. The European Parliament argues that ‘even the strictest interpretation of the precautionary principle does not require or advocate any specific measure (such as a ban). It does, however, call for informed, transparent and accountable decision-making, reflecting the different conditions of scientific uncertainty….’10 . When considering rapidly advancing and potentially transformative technologies—such as bioprinting^[1] adhering to the European parliament’s guidance seems prudent: we must consider what regulations are currently in place and, in view of the uncertain possibilities ahead, adapt these to mitigate against unintended and possibly harmful effects.

This is particularly challenging when one considers, as Moss does2, the liminal (or ‘in between’) space between research and treatment.11 While patients are routinely enrolled in stage I and II clinical trials (where their treatment is a planned stage of the research12) the bioprinting approach is so highly individualised that ‘it challenges the creation of evidence, specifically robust, population-level evidence, that is, relied on for regulation’.2 She argues that we must critically evaluate regulatory systems to ensure that they protect patients, but do not delay the technology’s successful transition into clinical practice.

Transitioning technological changes and biomedical research safely and ethically into clinical practice requires full collaboration between scientists, clinicians and ethicists: too often these three groups are siloed, with ethicists being consulted post hoc, rather than being integrated into the research. This prevents them integrating ethical questions into the research programme (eg, evaluating the impacts of interventions on people’s agency or societal relationships) alongside the more physiological health outcomes being evaluated. Without working directly with scientists, ethicists can also sometimes fail to fully understand the nuances (and potential positive and negative impacts) of the work being done. Alex and Winkler’s paper is an antithesis to this.1 Their research group benefits from ‘a close connection to the National Centre for Tumour diseases as a Top Oncological Centre and from the expertise in the combination of theory-driven ethical analysis with empirical social research (qualitative and quantitative).’13 This collaboration appears to allow them to comprehensively ethically evaluate epigenomic editing with genomic editing, not only elucidating the risks of (and the severity therein) of the different approaches but proposing criteria for assessments in the future, delineating where particular care should be taken, including referencing a future hypothetical scenario.1

And so we come to our final tool (for this article) for anticipating ethical issues in research: Palm and Hansson have proposed that an ethical technology assessment is routinely used with a preliminary nine-item checklist to assess whether ethical issues need to be considered.14 The items are such that most technological or biomedical research would qualify: a full ethical assessment should be instigated if the intervention might, for example, ‘Impact on human values’ or create issues associated with ‘sustainability’, ‘privacy’ or ‘control, influence and power’. This checklist might go some way towards nudging scientists and medics to involve ethicists in their work. Alex and Winkler have shown the benefits of integrating ethical considerations into medical research from its initiation, and this example should be emulated: other areas of ‘ futuristic’ but fast-approaching medical advances include early cancer detection,15 prevention and treatment of dementia16 and of course the use of Artificial Intelligence in medicine.17 Like the authors in this journal, we need to ensure we are transparent about our ethical concerns and nurture an environment of open debate. We must help contribute to regulations which can be iterated as new information appears and consider how these regulations apply to both research and treatment. And we must do our best to fully understand medical research being conducted and integrate with our scientific colleagues to work together from the outset. Only if we do this will we be able to appropriately anticipate the ethical issues and prepare for the future.