1 February 2019

Social Norms and Health: is a cross-disciplinary vision possible?

Shared ideas about how we should behave have an important influence on our health. How we maintain our appearance, what we eat, how we move around our neighbourhoods and what we do to look after ourselves when we are ill, are all affected by ideas about what is appropriate behaviour. This will vary considerably depending on, amongst other things, our age, ethnicity, gender, religion and social status. Such matters of individual preference are shaped by the ideas of those around us – by our parents, teachers, friends and neighbours. Such conventions are not formal rules, like laws or regulations, and so going against them may, at times, result in little more than social awkwardness, but they nevertheless, shape our behaviour. In other cases, social norms may be so strongly entrenched that flouting or ignoring them might come at great cost.

Sociologists and social psychologists often refer to such informal conventions as ‘social norms’. One sociologist defined a norm as: ‘a statement specifying how a person is, or persons of a particular sort are, expected to behave in given circumstances – expected, in the first instance, by the person that utters the norm. What I expect of you is what you ought to do.’ [1]

This definition raises questions about the dual aspects of norms. On the one hand a norm can describe what a particular kind of person might do, an average response to a specific situation. But norms also have a prescriptive aspect – a norm is not just an average response, but how a person is supposed to behave in given circumstances. To make this distinction clear, some authors reserve the term ‘social norm’ for these prescriptive (‘normative’) expectations, and use the term ‘descriptive norm’ for other less demanding requirements.[2] However, whether individuals’ behaviour corresponds to any set of expectations is always an open question that needs empirical investigation.   

As a bioethicist and a sociologist interested in the ethics of public health, we think that norms may provide additional description and explanation of people’s health-related behaviours to those used in current health policy. Neither approaches which explain everything in terms of individual choice (ignoring the contexts in which those choices are made), nor those that see individuals as blindly responding to their environments seem entirely satisfactory. Thinking about the operation of social norms in relation to health allows us to develop better understandings of people’s behaviour, and explain how certain behaviours are important to our identities.

In order to develop these ideas further we organised an interdisciplinary workshop in early September 2019. Our participants included ethicists, psychologists and social scientists. These researchers presented their work on topics such as the cost of beauty practices, healthy eating behaviour, public health campaigns on anti-microbial resistance, toilet use and vaccination refusal. Over two days we listened to this diverse and very rich range of collection of case studies and discussed our very different theoretical approaches to norms. As with many interdisciplinary conversations, one early challenge was to be clear about the terms we were using – including what we meant by the term ‘norm’. We also found that some disciplines allow researchers to develop strongly normative conclusions, whereas in other areas description is much more highly valued.

At the end of the event we felt like we had only just begun to address a complex topic and were left with a series of questions for further investigation. These include:
  • Given that various disciplines define and approach social norms differently, how do we achieve cross-disciplinary dialogue?
  • To what extent should we take a critical or normative approach to social norms?
  • When and how do norms change, and can we direct these processes?
  • Should we design public interventions that work with existing norms? Or, should we also aim at changing them?
  • What happens when norms conflict?

[1] George Homans (1974) Social Behavior: its elementary forms (2nd edition) (New York: Harcourt, Brace & World).
[2] Christina Bicchieri (2017) Norms in the Wild: How to Diagnose, Measure, and Change Social Norms (Oxford: Oxford University Press)

28 November 2018

Mason Institute advises Scottish government on organ donation policy

On Tuesday 27th November 2018 MI Deputy Directors and policy portfolio leads, Emily Postan and Annie Sorbie, attended the Health and Sport Committee to provide evidence on our MI consultation response to the Human Tissue (Authorisation) (Scotland) Bill. This Bill makes provision for the authorisation of the removal and use of parts of the body of a deceased person for transplantation and other purposes.  Significantly, it proposes that Scotland move from the current ‘opt-in’ system, in which an individual’s organs may be used for transplantation only when they (or, after their death, a close relative) have explicitly authorised this, to one of ‘deemed authorisation’. Under the proposed law, adults who have not formally registered their wishes will be deemed to have authorised the use of their organs for transplant purposes, with some exceptions for particular groups of persons and types of body parts. Under the new law the option to ‘opt-out’ of donation will be placed on a statutory footing (as will a third option of explicitly ‘opting in’).   
In our MI consultation response we had outlined our broad support for the policy objectives of the Bill, but emphasised that legislation is but one step towards improving donation and transplantation rates, and that a holistic package of regulatory, social and ethical measures are necessary to secure these objectives. These include the need for far-reaching public information programmes, training and resourcing of transplant coordination professionals, and comprehensive evidence-gathering about the impacts of the legislative changes. 
Also giving evidence in this meeting of the Committee were Professor Alison Britton, Professor of Healthcare and Medical Law and Convenor of the Health and Medical Law Sub Committee for the Law Society of Scotland, and Dr Calum MacKellar, Director of Research at the Scottish Council on Human Bioethics.
In her oral evidence Dr Postan was able to answer the Committee’s questions on several issues. 
The Committee was interested in the question of how the respective interests would be weighed and met under the new legislation, particularly whether relatives’ wishes might, in practice, often override those of deceased persons as they do under the current law. Under the proposed law, relatives will not have a legal entitlement to override the express or deemed wishes of the deceased, but if they present evidence that the most recent views of the deceased differ from those registered or deemed to hold, then this will be taken into account. Dr Postan suggested that providing guidance to transplant coordinators, to support them in judging what counts as reasonable evidence of changed wishes, could be of great value and noted the risks of sending mixed messages to family members about their degree of their involvement in decision-making when the deceased person’s wishes are not ambiguous. Along with the other witnesses she emphasised the need for a far-reaching communications and training strategy to support the changes in culture and expectations that will be needed if the new law is to function as intended. 
Dr Postan responded to the Committee’s questions about the protection of adults lacking capacity under the proposed law by suggesting that as currently drafted the law perhaps reflects too binary a conception of capacity and that it ought to be interpreted in a way that is consistent with the recognition under the Adults with Incapacity (Scotland) Act 2000 that capacity can fluctuate and should be assessed in a context specific manner and that individuals should be supported to make decisions when they can. 
The Committee reflected concerns of some consultees about the ethics and legality of also making pre-death procedures (preparatory to donation) subject to ‘deemed authorisation’. Dr Postan responded that even though these procedures might not be for the clinical benefit of the patient, as long as they are minimally invasive and do not cause discomfort or hasten death, they may be seen as being in the best interests of the patient (and therefore both lawful and ethical), insofar as they are a necessary and anticipated part of fulfilling their wishes to act as donors. 
This work exemplifies the MI’s commitment to bringing our interdisciplinary approach and research to bear on practical questions. If you would like to bring a consultation to our attention or to discuss the possibility of working with us on a particular policy matter, please get in touch with us by emailing Emily Postan and Annie Sorbie.

26 November 2018

Claims over human genome editing: scientific irresponsibility at its worst

The announcement made today, that the world’s first genome-edited babies have been born in China, is of grave ethical concern. 

In evaluating this news, we should first remember that these claims have not yet been scientifically validated through peer reviewed publication and independent scientific review. Yet whether or not the veracity of these reports is eventually borne out, making such claims, in a way that seems deliberately designed to provoke maximum controversy and shock value, is irresponsible and unethical.

Human genome editing is a highly contested, still emerging technology. While it holds tremendous potential for benefit, its development must be carefully governed via a process of inclusive global discussion amongst all those concerned. Instead, the covert application of human genome editing followed by this cavalier announcement of the work as a fait accompli puts at risk the entire future of this crucial technology. It threatens to jeopardise the relationship between science and society as well as causing damage to China’s international scientific reputation, and might potentially set the global development of valuable therapies back by years. Good science is not just about generating knowledge in a vacuum; context and consequences are vitally important, and the consequences of this irresponsible action may be dire indeed.

Furthermore, leaving aside the wider scientific and social consequences, the research in itself is deeply ethically problematic. Every scientific and ethical statement issued to date (notable examples of which include those from the US National Academies of Science and the UK's Nuffield Council on Bioethics) has emphasized the need for further research before genome editing is ready for clinical application to human embryos. The premature application of this experimental procedure involved exposing the children to as-yet uncharacterised, poorly understood risks. This might be justifiable where there are huge benefits to be gained, as for example where children would otherwise suffer a life-threatening, otherwise incurable disease. The claim made by those responsible for the research, however, is that the babies have been genome-edited in an attempt to make them immune to HIV. The lifetime risk of contracting HIV is extremely low in the first place; there are other means of prevention; and it is no longer an incurable, inevitably terminal disease. Putting these children at such drastic risk for such a marginal gain is unjustifiable. And playing with children's health and families' hopes in order to use them as a means for a cheap publicity stunt is nothing short of disgraceful.

Sarah Chan is Director of the Mason Institute for Medicine, Life Sciences and the Law; Chancellor's Fellow in the Usher Institute for Population Health Sciences, University of Edinburgh; and Co-Principal Investigator on the Wellcome Trust-funded Centre for Biomedicine, Self and Society

Author's declaration: The views expressed in this statement are my own as an academic working on the ethics of human genome editing, and do not reflect any official position of the Mason Institute, my employer or any organisations with which I am associated.

12 October 2018

Alternatives to Physician Dismissal of Vaccine Refusers

Despite robust evidence that routine immunization is safe and effective in averting a range of vaccine-preventable diseases and related complications, some parents refuse some or all vaccines for their children. Indeed, vaccine refusals have increased in the last decade; short of refusals, parents are increasingly delaying vaccines for their children, or are seeking alternative immunization schedules.[1] Given the challenges that vaccine refusers may present for physicians, some clinicians simply dismiss refusers (and their families) from their practice.[2] While dismissal data is not readily available for most jurisdictions, dismissal of patients by physicians is a growing phenomenon which the American Academy of Pediatrics seems to have recently endorsed.[1] Kathryn Edwards, Director of the Vanderbilt Vaccine Research Program, has defended the move as follows:

A number of pediatricians feel so strongly that if they [patients and their physician] don’t agree on vaccines, which are so basic to the delivery of care and have made such a big difference in children’s lives, how will they agree on a number of other things they’ll need to discuss?”[4]

However, it is important to recall that both parents and physicians have legal responsibilities when it comes to treatment decisions respecting children.

The starting point, of course, is that patients can refuse medical treatment, regardless of the harm that might come to them.  Similarly, in the absence of conflict between them, parents can refuse vaccines for their children, and the state will not normally interfere.[5] The law generally assumes that parents making healthcare decisions for their children will act in the children’s best interests. If conflict arises, and court direction as to the lawfulness of the treatment is requested, then a best interests analysis will be undertaken by the court, and a decision imposed.[6] In the UK vaccination cases heard to date – which rely on expert evidence to variable degrees – courts have consistently permitted the vaccinations to be administered.[7] Given the proven track record of vaccination, and the many salutary public health outcomes of broad vaccination, a parent ought to have a very high threshold to meet in making a case that routine vaccination is not in the child’s best interests.

For their part, physicians owe duties to individual patients and to the broader public, and failures to properly meet those duties can lead to liability. Under tort law, physicians can be held liable for the provision of information, advice, or treatment that fails to meet the accepted standard, and that causes foreseeable harm to someone in close enough proximity. For a patient to make an informed choice about vaccination, good information must be provided in comprehensible formats; both content and presentation need to be tailored to fit the parent’s/patient’s needs and capabilities, and it should not be presented in an adversarial manner.[8]

Physicians also have responsibilities – and can face sanctions for their breach – under their professional regulations and codes of conduct.[9] Most pertinent for present purposes, the GMC’s Good Medical Practice (2013) states:

62.         You should end a professional relationship with a patient only when the breakdown of trust between you and the patient means you cannot provide good clinical care to the patient.[9]

While this instruction might seem rather vague, and opens the possibility of dismissal for a wide range of reasons, the GMC has expanded in its guidance, Ending your Professional Relationship with a Patient (2013), stating:

3.            In rare circumstances, the trust between you and a patient may break down, for example, if the patient has: been violent, threatening or abusive to you or a colleague; stolen from you or the premises; persistently acted inconsiderately or unreasonably; made a sexual advance to you.[10]

The guidance is clear that dismissal will be rare and should only be undertaken in the most extreme cases. Moreover, in adopting this ‘nuclear’ option, physicians must not discriminate against patients by allowing personal views to affect treatment decisions.[11] If physicians base their dismissal on a conscientious objection to treating those who refuse to follow advice or to sufficiently provide for the health of their children, then they must explain to patients their objection.[12] However, given the nature of Article 52, it is not clear that this ground for dismissal is open to the physician, and it is a ground that, in any event, ought to be clearly and strongly circumscribed in availability.[13]

Parenthetically, the Canadian Medical Protective Association (CMPA) has offered professional advice with respect to dismissal in the vaccine context; it summarizes the physician’s legal responsibilities as: (1) obtaining appropriate consent to vaccinate; (2) documenting any refusal; and (3) refraining from dismissing refusers.[14] It further emphasises that:

Physicians should make every effort to continue to care for patients in the existing doctor-patient relationship in accordance with current standards of care.[14]

Given this legal and regulatory landscape, there is significant uncertainty around the scope to justifiably dismiss vaccine refusers (and their family). An alternative to dismissal, and one that better meets the physician’s broader patient and public health responsibilities, is to contact child protection agencies, or make applications to the court for an order with respect to the lawfulness of the intervention. While this may effectively end the doctor-patient relationship, it has the benefit of ensuring that the child will at least (most likely) get vaccinated.

Ultimately, while vaccine refusers can be frustrating for physicians to counsel in the surgery, it is important to avoid overly strong or strident messaging, which is often perceived as attacks on beliefs, making it unlikely that the refuser will hear the message. Strategies for preserving the doctor-patient relationship – which at least offers the possibility that the parent might be led to a vaccine-accepting stance – include the following:

·        Accept: Accept and embrace the parent refuser, no matter their decision; make them know their opinions are valued and they are being heard; this builds trust.

·        Acknowledge: Acknowledge that the refuser has good intentions and affirming that both the parent and the physician want the child/patient to be safe, healthy, and happy can be very powerful.

·        Actively Listen: Never assume or guess why the parent is refusing vaccines. Instead, through dialogue, elicit underlying vaccine concerns. Listening to the parent’s/patient’s responses is key.

·        Avoid Confrontation: Minimize confrontational approaches, adversarial stances, and overtly pressurized tactics. Do not emphasize or repeat ‘myths’ as this may reinforce the myth in the refuser’s mind.

·        Advise: Remember that physicians are (trusted) advisors. Thus, patients should be advised not only of the personal benefits of vaccination, but also the public health issues implicated, including the full range of risks and responsibilities.

·        Annotate: Document in the chart the refusal (or reasons for hesitancy) and that the risks and responsibilities have been reviewed.

While theoretically possible, patient dismissal for vaccine refusal should not be adopted lightly. Dismissal (of a family) for vaccine refusal has a complex array of professional, ethical, legal, and public health considerations.[15] It is in neither the best interests of the child patient nor the community to dismiss vaccine refusers. The most powerful tool for combatting vaccine refusal is a good doctor-patient relationship, the maintenance of which is at the heart of the physician’s legal and ethical responsibilities.

[1] K Edwards, J Hackell, et al. ‘Countering Vaccine Hesitancy’ (2016) 138 Pediatrics e20162146.
[2] O Yaqub, S Castle-Clarke et al., ‘Attitudes to Vaccination: A Critical Review’ (2014) 112 Social Science & Medicine 1-11
[3] C Hough-Telford, D Kimberlin et al., ‘Vaccine Delays, Refusals, and Patient Dismissals: A Survey of Pediatricians’ (2016) 138 Pediatrics e20162127.
[4] T Haelle, ‘AAP speaks out on dismissal of vaccine-refusing patients, vaccine hesitancy’, Pediatric News, 30 August 2016, at https://www.mdedge.com/pediatricnews/article/112056/vaccines/aap-speaks-out-dismissal-vaccine-refusing-patients-vaccine.
[5] B (A Child: Immunisation) [2018] EWFC 56 (Fam). See also BMA, Parental Responsibility (2006); Medical protection Association, Parental Responsibility (2012).
[6] Re C and F (Children) [2003] EWHC 1376 (Fam).
[7] LCC v A, B, C & D (Minors by their Children’s Guardian) K,S [2011] EWHC 4033 (Fam); F v F [2013] EWHC 2683 (Fam); Re M and N (Parental Responsibility: Immunisations) [2016] EWFC 69 (Fam); London Borough of Barnet v SL [2017] EWHC 125(Fam); B (A Child: Immunisation) [2018] EWFC 56 (Fam).
[8] Montgomery v Lanarkshire Health Board [2015] UKSC 11.
[9] GMC, Good Medical Practice (2013).
[10] GMC, Ending your Professional Relationship with a Patient (2013).
[11] GMC, Good Medical Practice (2013), Article 59.
[12] GMC, Good Medical Practice (2013), Article 52.
[13] S Harmon, ‘Abortion and Conscientious Objection: Doogan–A Missed Opportunity for an Instructive Rights-Based Analysis’ (2016) 16 Medical Law International 143-173.
[14] CMPA, How to Address Vaccine Hesitancy and Refusal by Patients or their Legal Guardians (2017).

[15] For more, see N MacDonald, S Harmon, et al., ‘Is physician dismissal of vaccine refusers an acceptable practice in Canada? A 2018 overview’ (2018) Paediatrics & Child Health, at https://academic.oup.com/pch/advance-article/doi/10.1093/pch/pxy116/5112977.

Regulation as Play: Sandboxes as the new regulatory space in health research?

The metaphor of the ‘regulatory space’ is now in widespread use in many sectors of regulation, and its appeal is strong for the interpretative flexibility that it brings and the kinds of questions that it raises. For example, what kinds of spaces exist? Who occupies such spaces, and what happens within them? Are these fixed and unchanging with clear roles and responsibilities?, or can they be more open, flexible and permissive? Ultimately, what does regulation look like in these spaces, and what can it become?

These are the kinds of questions that have occupied us for the last few years as part of our Liminal Spaces project, funded by Wellcome. This project explores a range of regulatory spaces that exist in the health research context. Our overarching objective is to effect lasting change in health research regulation across all fields of biomedicine, by transformative reconceptualisation and reorientation of current approaches away from legalistic, cautious and risk-driven paradigms. In other words, while there are many examples in health research regulation of the so-called Command & Control model of regulation – imagine the caricature of the Regulator with the Big Stick, legal authority, an inspectorate function, and the threat of criminal sanction for non-compliance as typified by the embryo research framework or clinical trials regimes– we have been exploring richer ways to understand the regulatory spaces that are possible and desirable across the wide range of activities that make up human health research.  

We have argued elsewhere that because of the inherent complexities in health research, and the multiple regulatory spaces that must be navigated to realise the social value from research – such as tissue management, data protection and sharing, ethics review and regulatory compliance – there is an unmet need to recognised the role of regulatory stewardship  For us, regulatory stewardship involves ‘guiding others with prudence and care across one or more endeavours—without which there is risk of impairment or harm—and with a view to collective betterment’. This answers, in part, one of the questions above about who needs to occupy regulatory spaces to help other actors engage with the complexities and to deliver on the promises of robust ethical research. 

But we are also interested in the nature of these regulatory spaces themselves, in particular when, whether and how these spaces can promote more flexible and imaginative ways of delivering supportive regulation while not unduly hindering the exploration of novel pathways for innovation. An emerging idea that reflects this is the notion of the regulatory sandbox, initially developed in the field of financial services . Most recently, the UK’s Information Commissioner’s Office has launched a public consultation for such an approach for data protection (closing date 12 October 2018 

“The ICO sandbox will be a safe space where organisations are supported to develop innovative products and services using personal data in innovative ways. They won’t be exempt from complying with data protection law, but they will have the opportunity to engage with us; drawing upon our expertise and advice on mitigating risks and data protection by design, whilst ensuring that appropriate protections and safeguards are in place.”

This approach has resonance with many of the findings from our Liminal Spaces project. For example:

-        Our empirical engagement with stakeholders through a Delphi study shows strong support for co-production of regulatory paradigms, and a move away from a Them and Us approach (Delphi publication forthcoming);
-        Our use of the lens of liminality to understand regulation better has revealed the importance of paying more attention to the processual nature of regulation, that is, involving the dynamic processes of interaction of affected actors over time, and the purposive reimagining of regulation as a collective enterprise (Laurie, 2017) and Taylor-Alexander et al, 2016;
-        Our work points to the crucial importance of having a Representative of Order in liminal spaces – i.e. those typified by uncertainty and transition and change – to lead participants through such spaces towards a valuable end point, even when uncertainty might reign as to precisely what that destination might look like.

Taken together, I would cast these elements and the example of the regulatory sandbox as an instance of Regulation as Play. This deliberately counter-intuitive term might seems frivolous, but it reflects deep thinking in the literature about the importance of play for human beings at all stages of life, especially when play is seen as ‘a process, not a thing…. that it begins in anticipation and hopefully ends in poise…in between you find surprise, pleasure, understanding — as skill and empathy — and strength of mind, body, and spirit.” (Eberle, first issue editorial, American Journal of Play).

Moreover, there are links between play literature and some key ideas from the field of liminality. One such idea is that of anti-structure that happens in liminal moments. As the famous liminality scholar, Victor Turner wrote about the work of the play scholar Sutton-Smith:

“Brian Sutton-Smith borrowed a term which I had earlier applied to “liminality” (and other social phenomena and events), namely, “anti-structure” (meaning the dissolution of normative social structure, with its role sets, statuses, jural rights and duties, etc.) and related it to a series of experimental studies he has been making of children’s (and some adult) games both in tribal and industrial societies…He writes: ‘The normative structure represents the working equilibrium, the ‘antistructure’ represents the latent system of potential alternatives from which novelty will arise when contingencies in the normative system require it. We might more correctly call this second system the protostructural system [he says] because it is the precursor of innovative normative forms. It is the source of new culture.’” (See V Turner, From Ritual to Theatre, PAJ Books, 1982, pp.18-19)

Turner further posited that we might actively seek antistructure, either because:

1.         …we have an overdose of order, or
2.         …because we have something to learn through being disorderly (ibid, p.17).

It is in these senses that I suggest initiatives such as the regulatory sandbox ought to be cast as Regulation as Play. Indeed, some initial work has been done on the role of play in the realm of responsible research and innovation. Regulatory sandboxes provide safe spaces where the imagination can take a more prominent role as opposed to the more typical ‘safe’ regulatory spaces that are too often obsessed with risk management and minimisation. As such, these new regulatory spaces are to be welcomed and explored fully in the genuine spirit that is the very embodiment of play. Our work continues as to how such approaches might be translated into the health research sphere.  

18 July 2018

Debate, not 'designer babies' hyperbole, is what we need in genome editing

by Sarah Chan 
This week saw the publication of a much-awaited report from the Nuffield Council on Bioethics on human genome editing (Nuffield Council on Bioethics, 2018). Genome editing has been hailed as one of the great revolutionary technologies of our time. Its potential for human health applications, via somatic or heritable genetic modification, is simultaneously one of the most exciting and most controversial possibilities it offers. This report, from a body widely regarded as the UK’s de facto national bioethics advisory commission, thus represents an important milestone in the evolving discourse.
While there were perhaps no great surprises in the approach taken by the Nuffield Council Working Party or the overall tenor of their findings, the Report, as well as its complex and nuanced discussion of wide-ranging issues, achieved a number of very valuable things.
First, though not unexpected, its conclusion that there was no principled reason to rule out heritable genome editing in and of itself allows us to move forward to consider the much more ethically significant questions of what sorts of applications of genome editing, with what purposes and under what conditions, ought to be acceptable. On this, the Report highlighted two important principles: that the use of genome-edited embryos or gametes to create future persons should only be done where it is “intended to secure the welfare of and is consistent with the welfare of” (ibid.xvii) the future persons who might be born; and that, taking into account existing social inequities and the potential for genome editing to reinforce these, it “should be permitted only in circumstances in which it cannot reasonably be expected to produce or exacerbate social division or the unmitigated marginalisation or disadvantage of groups within society” (ibid.). That the report was embedded within these far broader social considerations and explicitly signalled the need to address them is among its most useful contributions.
Likewise, acknowledging (as the Report did) that there is no ‘bright line’ by which we can easily distinguish therapeutic applications from so-called ‘enhancement’ uses of technology enables us to open up a more genuine conversation about welfare and wellbeing, the diverse sorts of ‘good lives’ that we should be concerned to support as a society, and how we ought to be deploying our resources in order to do so. It is worth noting that in this, the Nuffield Council differed somewhat from the findings of probably the most significant other policy report so far, that of the US National Academies of Science, Engineering and Medicine (2017). The Academies’ report took the position that clinical research trials of heritable genome editing might be permissible only for “preventing a serious disease or condition”, with “reliable oversight mechanisms to prevent extension to [other] uses” (ibid., 6). Separating out the concept of ‘enhancement’ for further discussion, they did not rule out enhancement applications altogether, but cited “public discomfort” and the need for “public discussion” before any further steps in this direction, concluding that “genome editing for purposes other than treatment or prevention of disease and disability should not proceed at this time” (ibid., 7).
The Nuffield Report’s refusal to endorse a categorical distinction between therapy and enhancement constitutes a practical recognition that a mantra of “therapy yes, enhancement no” will be of little use when the definitions of therapy and enhancement themselves are and will remain contested. While we might be able to point out ends of the spectrum that would be deemed ‘clearly therapy’ or ‘clearly enhancement’ as a matter of common sense, questions are likely first to arise over the grey area (the “liminal space”, we might say) of technological interventions and their intended purposes. The Council’s position thus permits the application of meaningful evaluative criteria in relation to potential uses of genome editing, rather than relying on problematic semantic categorisations to draw artificial hard lines around what is or is not permitted.
Finally, and as expected, the Nuffield Report reiterated the need for “broad and inclusive societal debate” (Nuffield Council, xviii). The need for public engagement on this topic has been a distinctive feature of other policy statements on genome editing, including the aforementioned US Academies’ report and the Hinxton Group Consensus Statement. While important questions remain to be answered about the forms and scope that such engagement should take, the Council’s recommendation that this debate should precede any moves towards potential policy change is unarguable.
In the face of these measured but important contributions, the response of the majority of mainstream media to the Council’s findings was all the more disappointing. With a few commendable exceptions, the papers overwhelmingly resorted to tabloid-style headlines about how ‘designer babies’ would soon be on the way, rather than focusing on the important principles of welfare and social justice that the report identifies. Traducing the report’s conclusion that “none of the considerations raised yields an ethical principle that would constitute a categorical reason to prohibit heritable genome editing interventions” (ibid.) as a “green light for designer babies” might be characterised as over-simplification at best; at worst, a shallow, misleading and disingenuous attempt at sensationalist copy-selling.
The response from those opposed to heritable genetic modification was likewise disappointing, if predictable: disappointing not in the fact of its opposition per se (opinions and reasons, after all, may differ) but the way in which this opposition was framed and grounded. 
For example, Marcy Darnovsky, of the US Center for Genetics and Society, dismisses the report’s 183 pages of thoughtful, wide-ranging consideration as “bioethics-lite” ‘tick-boxing’. She frames one of the strengths of the Council’s approach – avoiding categorical statements of what is ‘right’ or ‘wrong’ and instead choosing to open up discussion about what actually matters – as a weakness, and claims that “it seems strange for supporters of heritable genetic modification” to acknowledge the technology’s potential to exacerbate inequities. It only seems strange, though, if head-in-the-sand bioethics that refuses to engage with real concerns is what we are looking for! The ‘ostrich approach’ is not what we ought to expect from the Nuffield Council, nor is it what they gave us. If this has confounded Darnovsky’s expectations, so much the better.
David King, director of the UK’s Human Genetics Alert and another vociferous opponent, also resorts to invoking the ‘designer babies’ trope, before attempting to tell “the people of Britain” what they want: “The Nuffield Council doesn't even bother to say no to outright designer babies. The people of Britain decided 15 years ago that they don’t want GM food. Do you suppose they want GM babies?”
Collapsing all possible uses and motivations for using genome editing into the catchphrase ‘designer babies’ is a singularly unhelpful contribution to the debate.  In setting out to evoke a kneejerk reaction via politically-loaded language, it aims to reduce the debate to a bombastic lowest common denominator: what we might call the bioethical equivalent of mudslinging. It also, crucially, forecloses the possibility of any further discussion over what sorts of uses of genome editing might meet the morally important criteria of improving individual welfare and promoting equitable social benefit. In light of the lengths to which the Nuffield report goes to consider these highly significant issues, as well as the widespread commitment to dialogue and engagement that was reiterated in the report, this approach is worse than recalcitrant. 
In other words, if one didn’t want to have a reasoned, nuanced and inclusive discussion, then this would be exactly the way to go about not having it. Indeed, if we take seriously not just the stated need for public engagement in shaping the governance of genome editing, but the moral and political justifications for why this engagement is ethically required, we might go so far as to say this strategy for intervening in the debate is itself unethical, in that it is more likely than not to stifle meaningful discussion. 
Publics are neither ignorant nor stupid. Recent experience with the public dialogue on genetic technologies conducted by the Royal Society, for example, has demonstrated amply the ability of publics to engage in a thoughtful and sophisticated way with the complex ethical issues raised by contemporary genomics and genome editing. A common refrain in relation to genome editing is that bioethics has been grappling with the issues around heritable genetic modification for over 40 years, since the era of recombinant DNA and Asilomar. The kinds of discussions that are occurring in contemporary engagement forums illustrate that publics have not been inert for those four decades; instead they have been robustly and alertly considering, weighing and responding to the ongoing development of scientific and ethical scholarship during that time.
Given this, the heavy-handed insistence by some on rewinding to old and hackneyed tropes in the current discussion shows what I can only class as a basic lack of respect for the many and diverse publics, not just of Britain but globally. It is an attempt to railroad people into a certain narrow account of what they should think, rather than giving them opportunities to think for themselves – or indeed express the thinking that they have already been doing on this subject. 
Moreover, in invoking science-fiction imaginaries as the starting point for debate, it goes against the Nuffield Council’s very sensible position of “start with reality”. The reality with which we should start is that we face exciting but still emerging scientific possibilities, and we as publics are being encouraged to discuss them widely, consider different perspectives, and engage in the collective endeavour of public bioethical discourse. This will be very far from an easy, ‘bioethics-lite’ process: we will need to attend to questions of how and where such discussions take place, not only within the UK but globally; who sets the terms for engagement; how to be appropriately inclusive; and what we do with the results of this. 
All of this will require us to work together with openness and respect to develop robust, socially and ethically responsible processes for moving from engagement to governance. Shouting about ‘designer babies’, though, is not the way to achieve it.

Sarah Chan is Director of the Mason Institute for Medicine, Life Sciences and the Law; Chancellor's Fellow in the Usher Institute for Population Health Sciences, University of Edinburgh; and Co-Principal Investigator on the Wellcome Trust-funded Centre for Biomedicine, Self and Society

Acknowledgments: The thoughts that have contributed to the writing of this post were shaped, amongst other things, by my participation in a workshop on genome editing (16-18 July) hosted by the Centre for Social Ethics and Policy at the University of Manchester (with colleagues including Annie Austin, Iain Brassington, Sarah Devaney, Simona Giordano, John Harris, Søren Holm and Alex Mullock), together with colleagues from the Centre for Biomedical Ethics at the National University of Singapore (Markus Labude, Tamra Lysaght, Owen Schaefer, Vicki Xafis), as well as Silvia Camporesi (Department of Global Health and Social Medicine, King's College London) and Catherine Mills (Monash Bioethics Centre, Monash University). I would also like to thank my Mason Institute colleagues, particularly Agomoni Ganguli-Mitra, for helpful comments on the draft text.

National Academies of Sciences, Engineering, and Medicine. (2017). Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
Nuffield Council on Bioethics. (2018). Genome editing and human reproduction: social and ethical issues. London, UK: Nuffield Council on Bioethics. (http://nuffieldbioethics.org/wp-content/uploads/Genome-editing-and-human-reproduction-FINAL-website.pdf)

4 June 2018

Ethics and liminality in humanitarian innovation

by Matthew Hunt

Spending time at the Mason Institute as a visiting fellow in January 2018 afforded me opportunities to engage with members of the MI team and Liminal Spaces project, including prompting me to think about connections between their work on liminality and my own interests in the ethics of humanitarian innovation. In this blog post I reflect on the ways that thinking about humanitarian innovation as occurring in a liminal, in-between space helps foreground its ethical dimensions and signals the need for ethical attentiveness across the cycle of identifying, developing, implementing and diffusing innovations.

Humanitarian health organizations provide care and services to communities affected by war, disaster and epidemics, as well as to people who have been displaced by these events or who experience systematic exclusion. A particularly acute challenge for humanitarians relates to the responsibility to ensure that their interventions are effective and efficient, and to get better at helping those in need. This challenge has several layers: humanitarian action is widely dispersed, occurs in diverse settings, involves disparate actors, is temporally constrained and reactive to events, and is carried out in contexts of elevated and fluctuating risk. As a result, common mechanisms such as formal research and quality improvement initiatives may be more difficult to apply, though are becoming increasingly sophisticated and systematized. A related phenomenon has been the rise of the humanitarian innovation movement. Its origins are linked to a 2009 ALNAP report (Ramalingam, Scriven & Foley), with a key inflection point being the 2010 Haiti earthquake. Since then, each major humanitarian crisis has been associated with the uptake of new innovations and, in particular, novel information and communication technologies. The humanitarian innovation movement has also catalyzed developments such as new funding structures (e.g. Humanitarian Innovation Fund, Transformational Investment Capacity program), humanitarian innovation services and labs within and outside humanitarian agencies, and closer collaborations among humanitarians, the tech sector, and networks of online volunteers. Together, these developments have contributed to changes in how humanitarian action is being carried out, as well as shifts in the language and culture of humanitarian action as innovation became a prominent paradigm in the field (Betts and Bloom, 2014).

The emphasis placed on innovation, and the range of structures put in place to foster it, has contributed to many tangible changes in humanitarian action and the promise of more to come. Examples in humanitarian healthcare projects include point-of-care diagnostics, biometrics for refugee registration and health records, early warning of infectious disease outbreak, live mapping of people injured in an earthquake, 3D printing of prosthetic components in austere environments, and cold chain technology for vaccines, through the use of drones to deliver aid supplies or ferry patient samples to distant laboratories. While there have been efforts to articulate ethical principles for humanitarian innovation (Sheather et al, 2016; Betts and Bloom, 2014), on the whole, the connection between values and innovation has received limited discussion. As described by Sandvik, Jacobsen and MacDonald, a fast pace of innovation “can be observed with respect to many forms of humanitarian technology and humanitarian action based on the use of digital data. Yet, these practices are commonly framed in a humanitarian innovation language in which the possibility that humanitarian principles could be compromised is omitted.” (2017, p. 3)

It is here that the metaphor of liminality can be helpful in signaling the need for attention to ethical values and commitments in domains of action such as humanitarian innovation which lie between the more bounded – and regulated - domains of research and practice. Such attention is not only needed at the point where a new approach is being rolled out in a humanitarian project, but throughout its development and through to its evaluation and scale up. While acknowledging the benefits of developing new or refining existing processes and products, humanitarians and their partners should be attentive to how values and innovation intersect. The uncertainty and risks associated with trialing new innovations in a crisis setting should not be taken lightly. The experimental nature of humanitarian innovation is reflected in a description of the 2010 Haiti earthquake as a “living laboratory” for new technology deployments (Knight Foundation, 2011, p. 15). Settings of conflict, disaster or epidemic are inescapably tumultuous, strained and insecure environments. Introducing emergent technologies or other innovative approaches in these settings can make important contributions and improve responsive to the needs of local populations. They also raise ethical concerns (Hunt et al, 2016), such as widening asymmetries of power or undermining the dignity of individuals receiving assistance. Humanitarian organizations and their innovation partners should thus carefully consider how innovations relate to the principles of humanity, independence, impartiality and neutrality, and avoiding harm, demonstrating respect, protecting and sustaining dignity, being accountable, and promoting justice, amongst other ethical commitments. To achieve this goal, humanitarian organizations will need to demonstrate ethical attentiveness in the liminal space of humanitarian action, extending “a temporally continuous thread of attention” (Springer, 2013, p. 141) and critical self-awareness of the “social fabric of action.. taking stock of relationships, background expectations, and the ways in which [they] could come across” (p. 9). Ethical attentiveness across the innovation cycle is thus critical for promoting humanitarian innovation that is responsive to and upholds ethical commitments.

Matthew Hunt, PT, PhD, is an Associate Professor at McGill University in Montreal, Canada. He conducts research related to global health, ethics and rehabilitation, and co-leads the Humanitarian Health Ethics Research Group. In January 2018, he was a visiting scholar at the Mason Institute, University of Edinburgh. matthew.hunt@mcgill.ca


Betts, A., & Bloom, L. (2014). Humanitarian innovation: The state of the art. UN.

Hunt, M., Pringle, J., Christen, M., Eckenwiler, L., Schwartz, L., & Davé, A. (2016). Ethics of emergent information and communication technology applications in humanitarian medical assistance. International health, 8(4), 239-245.

Knight Foundation. (2011). Media, information systems and communities: Learning from Haiti. https://knightfoundation.org/reports/media-information-system-and-communities-lessons-h

Ramalingam, B., Scriven, K., & Foley, C. (2009). Innovations in international humanitarian action. ALNAP 8th Review of Humanitarian Action.

Sandvik, K. B., Jacobsen, K. L., & McDonald, S. M. (2017). Do no harm: A taxonomy of the challenges of humanitarian experimentation. International Review of the Red Cross.

Sheather, J., Jobanputra, K., Schopper, D., Pringle, J., Venis, S., Wong, S., & Vincent-Smith, R. (2016). A Medecins Sans frontieres ethics framework for humanitarian innovation. PLoS medicine, 13(9), e1002111.

Springer, E. (2013). Communicating Moral Concern: An Ethics of Critical Responsiveness. MIT Press.