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.

References
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

References

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.

1 May 2018

What can socio-legal studies contribute to medical law? Thoughts from a workshop in Paris


By Edward Dove

Socio-legal studies is a multi-, inter-, or trans-disciplinary academic field that investigates the nature, form, and function of law, legalities, and legal institutions through social science methods and methodologies. The approaches can be empirical, statistical, or conceptual (e.g. exploring law through the perspective of a conceptual approach such as feminism, actor network theory, or governmentality). While socio-legal studies has long been employed in diverse areas of law such as criminal law, refugee and asylum law, property law, and contract law, its operation in medical law seems to be more limited.[1] In part, this may be because medical law is still a nascent discipline, but it may also be that scholars have not thoroughly considered how socio-legal studies can enrich the study of the social and legal worlds of medical practice and health research.

I reflected on this overarching question while attending a day-long workshop in April 2018, co-organised by Professor Emilie Cloatre (Kent Law School) and Dr Olivier Leclerc (CNRS/Centre de Recherches Critiques sur le Droit). The workshop was organised with a view to:
a) exploring the methods, traditions, and theories of socio-legal studies in France and the UK, and
b) reflecting on what ‘socio-legal studies in context’ means for research traditions and forms of knowledge produced.

The nature and future of socio-legal studies

The workshop was divided into four sessions. In the first three, short papers were given by speakers, followed by discussions. In the final session, early career scholars (including doctoral candidates) offered short overviews of their research projects, with particular attention to the methodological and conceptual approaches adopted.

I particularly enjoyed the presentation in the first session from Professor Rosie Harding (University of Birmingham) on ‘The Presence and Futures of Socio-Legal Studies’. Speaking in her capacity as current Chair of the Socio-Legal Studies Association, Prof Harding observed that socio-legal studies has grown in the UK into a diverse, multi- and transdisciplinary strand of legal studies and social science. While there is much to laud regarding the growth of the field since the 1980s, the future is somewhat cloudy. ‘Brexit’ may move European research funding out of the UK’s reach and regulatory divergence may make cross EU collaborative work more difficult. Moreover, the UK research funding environment increasingly emphasises measurable impact; this might thwart contributions of social sciences and humanities research. Nonetheless, Prof Harding argued that socio-legal scholars are well placed to embrace the new difficulties and can work together to forge a brighter future than one might otherwise anticipate.

The take-home messages

In listening to the excellent presentations, three ideas came to mind regarding the ways in which socio-legal studies can contribute to medical law.

First, it offers opportunity to explore how medical law works at particular crossroads of human interactions in the so-called ‘real world’. Self-evidently, socio-legal studies is predicated on looking at law in context – moving beyond the written text and exegesis of code, judgment, and book and into the messy world of daily life. This phenomenological approach encourages the researcher to uncover how the law is shaped by everyday practices and to capture and understand subjective experience. Medical law is a prime site for empirical and conceptual investigation in human places and spaces where this messiness and complexity is particularly acute (and so law might be under most pressure). The wards, consulting rooms, operating theatre, and civil servant desk allow the intrepid researcher to consider the ways in which law structures – or does not structure – human action and interaction. Consider the recent cases of Charlie Gard and Alfie Evans. What, for example, do these cases imply for the long-standing reign of the best interests test? Socio-legal accounts of such difficult decisions and cases would reveal how law is structured by the actions that govern the individual and group undertaking medical (and research) duties.

Second, socio-legal studies can offer a richer theoretical understanding of law and how it is expressed and experienced in healthcare and health research contexts. That is, it can illuminate the nature of law through theoretical development (e.g. sociological studies of law, legal pluralism, legal consciousness) and through theorising from empirical findings (e.g. a grounded theory approach that builds theory through the data). For example, through empirical investigation of the practices of NHS research ethics committees (RECs), we come to better understand how law shapes and is shaped and experienced by those ‘on the ground’, be they regulators, REC members, researchers, or sponsors. In the same way, socio-legal studies help us to test theories that scholars propose as explanations for why certain laws have emerged and why they are structured in certain ways. For example, regulatory theory might suggest that the Medicines and Healthcare products Regulatory Agency (MHRA) is designed to operate in the public interest as a risk-based regulator. But is this really the case? Theory helps inform the inquiries that enable us to explore the ways in which law (and regulation) is shaped, works, and develops in specific contexts.

Lastly, socio-legal studies can enable scholars to provide empirical evidence to policymakers, regulators, legislators, the judiciary, academics, NGOs, and practitioners that can lead to reform. By investigating how law is applied, expressed, and experienced in the real world, be it through secondary data analysis, surveys, interviews, or observation, scholars are afforded opportunities to provide decision-makers with evidence that informs discussion of policy and evaluation of legislative and regulatory reform. In this way, the medical law scholar can demonstrate real-world impact and influence change in society. An example of this can be found in medical law’s sister discipline, public health law. Temple University’s Center for Public Health Law Research engages in public health law research and ‘legal epidemiology’ methods, which include legal mapping and policy surveillance. Through these socio-legal methods, the Center maps and evaluates the impact of law on health, identifying laws and policies that can improve health, increase access to care, and create or remove barriers to health.

Moving beyond the ‘what’

Medical law cannot sustain itself alone on inquiries into what the law is on a particular issue – doctrinal analysis driven by descriptive questions – what we might call a tyranny of the ‘what’. Scholars must also branch out to ask and answer evaluative questions, investigating whether the law is fit for purpose, whether it is as effective or just as it purports to be, and whether it adequately achieves its stated aims.

Medical law also requires explanatory questions to be asked, investigating the underlying causes behind, for example, why there is compliance (or not) with rules and regulations. In teasing out the ‘what’, ‘whether’, ‘how’, and ‘why’ questions, scholars of medical law not only will deepen their knowledge of the discipline and round it out, they will also contribute to a richer intellectual endeavour that can improve the regulation of medical practice, the quality of healthcare delivery, and the facilitation of ethical health research that benefits society.

Medical law is a multi-layered tapestry of rules, norms, principles, standards, and legal devices that a) governs the relationships among healthcare professionals, patients, participants, government, and society, and b) influences the functioning of healthcare and health research. As a nascent but established sub-discipline within law, it warrants well-rounded scholarship that investigates the what, how, and why – the doctrinal, the empirical, and the socio-legal. Socio-legal studies offers this. It reveals particular insights when we are at the crossroads of health and illness, and of professions and values, namely through charting the interconnecting roles of law, theory, and practice as experienced in real life, at both micro and macro levels. And, it illuminates particular challenges in medical law that we must understand better. Arguably, the Gard and Evans cases suggest that the authority and all-encompassing nature of the best interests test might still not be enough – in law and practice – to reflect a changing set of values, expectations, and needs. As lawyers, do we properly understand how best interests is actually working on the ground? Without question, socio-legal studies and medical law have much to contribute each other; in bringing them together, scholars can forge research excellence and real-world impact that improve our collective health and wellbeing.



[1] This is a relative, rather than absolute, claim of limited application. See e.g. Emilie Cloatre, Pills for the Poorest: An Exploration of TRIPS and Access to Medication in Sub-Saharan Africa (Palgrave McMillan, 2013), which uses ethnographic case studies in Djibouti and Ghana, and insights from actor-network theory, to explore the links between intellectual property and access to medication. Also, the Socio-Legal Studies Association, the UK organisation that promotes and supports the work of socio-legal academics, regularly features socio-legal research in medical law at its annual conferences.

27 April 2018

Should We All Give Up Eating Meat to Save the Planet?



'Should We All Give Up Eating Meat to Save the Planet?', was an event held recently in the Red Theatre at Summerhall as part of the Edinburgh International Science Festival (EISF) on the 6th April 2018.

I have recently been conducting interviews with researchers, policymakers and those working for NGOs asking them about sustainable diets, and how sustainability criteria might be incorporated into existing dietary advice. These interviews showed me how, even among those who work in this area, there is a lot of uncertainty about applying the concept of sustainability to the food system in general and individual diets in particular. Public interest in nutrition and environmental research public is high but sustainable diets are a new and relatively unfamiliar idea, so they seemed an ideal topic to discuss.

The event was structured around two short (15min) presentations based on current environmental and nutrition research, followed by a 30 minute question and answer session that allowed audience members to ask questions about, or comment further on, specific issues covered in the two talks. The overall aim of the event was introduce participants to research in these areas, and encourage them to think about the impacts their own diets might have on the environment. Between the talks and the discussion session, there was also a short break to serve a selection of sustainable snacks, provided by Edinburgh Larder.

I gave the first talk which outlined the environmental impacts of food production and consumption, focusing on the greenhouse gas emissions associated with the production and consumption of food. Such data shows very clearly that the foods with the greatest impact are red meat, particularly from sheep and cows. The second talk was given by Pamela Mason, a nutritionist who has recently co-authored a textbook on sustainable diets. She outlined the health impacts of the average British diet and outlined why we need to reduce our consumption of red and processed meat, eating less but better meat. One element of these changes, Pamela suggested, should be the development of sustainable dietary guidelines to advise both individuals and those in charge of public procurement, i.e. meals in schools, hospital and care homes.

The discussion session was lively and a range of divergent views were expressed, but the tone remained constructive throughout. Topics raised included: insects and in-vitro meat as alternative sources of protein; why are the GHG emissions for lamb are so high and whether changing the diet of sheep can mitigate this; is it possible to include fish in a sustainable diet; and the need for new regulation to drive reductions in food-related GHG emissions. Feedback on the event was largely favourable: ‘Very knowledgeable presenters. Really enjoyed the snack. Informative but not judgemental’. Many respondents seemed to have particularly appreciated the opportunity to ask questions and discuss these issues in more detail: ‘The long discussion was good and allowed a variety of points of view to be aired’.  

Funding for this event was provided by a University of Edinburgh CAHSS Knowledge Exchange and Impact grant, the Wellcome Trust Liminal Spaces project and Edinburgh School of Law Research Support grant.

Isabel Fletcher's slides from the event can be found here.
Pamela Mason's slides from the event can be found here.



6 February 2018

Fractionis Panis

Fractionis Panis 2015
Giclee print on Hahnemuhle Pearl 56 x 36cm
By Emma Barnard

The invitation came to become a member of the AERG through my involvement on the Arts and Ethics Subcommittee for the World Congress in Bioethics held in Edinburgh in 2016. My artwork fits within the CT1 group - Approaches to Understanding Patient Experiences and Medical Texts

‘Some doctors believe they have a duty to preserve life at all costs. There is no such duty’.
Doctors who play God
Dr Richard Nicholson
Guardian, 08/03/02

Collaborative work as an artist with surgeons and their patients over several years has produced much artwork and many questions. The issue that I wanted to focus upon for the work that I chose to exhibit at the world congress and also for the AERG ‘Fieldworks’ exhibition in Berlin is the notion that medicine is becoming the new religion and more significantly, how the patient views their surgeon as a miracle worker, a saviour figure. A large part of my work as an artist working within medicine has involved spending time with patients of Mr Mike Papesch FRACS and Mr Paul Stimpson FRCS ENT Consultant Surgeons who specialise in head and neck cancers.

After observation of the consultation I invite the patient into another consulting room where we discuss their experience as a patient. Here they are free to express their thoughts and feelings about being in the medical environment, a particularly vulnerable time for them. On their printed photographic portrait often they write just one word eg ‘surreal’, ‘routine’ or perhaps an illustration of how they feel eg a drawing of a boiling kettle, this work is dependant upon their individual experience. Repeatedly I have witnessed them discussing and illustrating on their portrait their thoughts of the surgeon as ‘a miracle worker, a saviour figure’. When facing a potential life limiting disease surgeons have been gifted the power to prolong life. This situation is exacerbated when a person has no faith and time on earth is all that they can hope for, naturally they desire to extend this time. In the main and due to many reasons, the patient has a passive part in the relationship dynamics and displays much reverence to the consultant who holds the power to heal.

When investigating how this relationship might be visualised I explored the Catholic faith for the similarities with the ritualistic nature of both. Very little appears to be written on this subject but here I reference journalist Oliver Clerc’s book ‘Modern Medicine: The New World Religion, in it he raises some really interesting points such as:
‘Medicine has become the religion of modern times. Since Louis Pasteur, the deep Christian founder of modern day medicine and father of vaccines, the beliefs and practices of traditional Christianity have been transferred into medicine: physicians have taken the place of priests; the search for health replaces the quest for salvation; the hope of physical immortality (through cryonnisation, cloning and genetic manipulation) will soon take over hope of eternal life; vaccination plays the same initiatory role as baptism; and a hypothetical universal vaccine shall save all mankind from illness, tomorrow, just as the Saviour atoned for the sins of the world’.

In the Middle Ages, doctors blamed amongst other things, sin for ill health and subsequent cures involved prayer.

The intention of my work for the AERG is to highlight this phenomenon of projection and transfer of religious content that takes place within medicine.

Dr Nicholson R. Doctors who play God
Clerc O. (2014), Modern Medicine; The New World Religion, America, Personhood Press (back cover)

Bio
Emma Barnard is a visual artist specialising in lens based media and inter-disciplinary practice and research within Fine Art and Medicine. Her work deals with social commentary, seeking to highlight contemporary issues and encourage debate surrounding them.

Her "Patient As Paper" (co-founded with Mr Mike Papesch FRACS, consultant ENT surgeon) artwork is currently being exhibited widely in galleries, universities and hospitals in England and internationally. It has been presented at several conferences within the medical and medical humanities fields, and most recently at University College London, Medical School and in a series of presentations at Surrey University for the Department of Health Sciences. The experience Emma has gained through several years of working with consultant surgeons and their patients from various disciplines, including ENT and Psychodermatology, is now influencing the field of medical education. At King's Medical School in London Emma has led a highly successful pilot project to introduce art into medical education, undertaken in conjunction with a critical care consultant and a 4th yr. medical student. Most recently she has taught on a pilot project within the Department of Medical and Health Sciences at Surrey University and has led on workshops for students on the MBBS Stage 2 GP Longitudinal Placement, GKT School of Medical Education.