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Posts Tagged ‘Nuffield Council on Bioethics’

HEAL cited in NCOB Report on ‘Children and clinical research: ethical issues’

In 2015, Gratuitous self-promotion, public consultations, Research ethics on September 7, 2015 at 9:00 am

We’re delighted to say (somewhat belatedly) that HEAL was cited in the Nuffield Council on Bioethics’ Report on ‘Children and Clinical research: ethical issues’, published in May 2015. The Children and Clinical Research Working Party was set up in 2013 with the following terms of reference:

1. To consider whether the current systems for regulating clinical research strike the right balance with respect to: Promoting understanding of childhood conditions and the availability of evidence-based treatments for children The role children themselves should play in research decisions; and The proper protection of child participants

2. To consider, as may be necessary: how it may be ensured that appropriate priority is given to research that is most likely to benefit children how the ethical acceptability of research projects should be determined, and the role of the various parties involved, including parents, in protecting children’s welfare the relevance of a child’s ‘best interests’ or capacity to ‘benefit’ in the context of consent to research, as opposed to treatment the importance of the international context any other aspects of the direct or indirect regulation of clinical research in children that may be relevant.

3. To draft a report and make recommendations as appropriate.

In order to respond to the Consultation Paper (one of a number of evidence gathering activities), HEAL members met in October 2013 to discuss and draft a co-ordinated response (in a meeting colloquially referred to as ‘Experimenting on children?’). Our response can be read here: HEAL response to NCOB Children and Clinical Research ethical issues FINAL.

HEAL’s contributions were quoted at para 2.8 in a section on Research proposed in traumatic, highly emotional, or sensitive situations:  “… research into the use of drugs or sexual relationships, where involvement of the parents or other family members may be problematic” (fn 112); and cited at para 2.10, fn 118, with regard to: ‘The challenging question of parental involvement in decisions about young people’s participation in such research was highlighted by respondents to the Working Party’s consultation both in the UK and in Africa’.

It is clear that the NCOB has actively sought to ensure the voices of children are heard as part of the consultation and the findings, from the cover of the Report (link above) provided by drawings from children on their views and perspectives on research, to short films, and in the media coverage.  One of the summary findings – that ‘research should always be carried out with children, not on children’ – may seem obvious, yet it is vitally important for children to be involved in research as subjects rather than objects if we are to treat them with the dignity and respect that we, in turn, expect as adults.

Caroline Jones

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Bioethics as a Governance Practice

In 2015, Annual Lecture on May 15, 2015 at 3:33 pm

Jonathan Montgomery gave the inaugural lecture in the annual series of the Centre for Health Ethics and Law on 7 May 2015. Lecture organiser, Associate Professor A.M. Viens said, “We are extremely pleased to welcome Professor Montgomery back to Southampton to deliver the inaugural annual lecture for the Centre for Health, Ethics and Law. His contribution to the development of health care law, both academically and in his public service, is unrivalled in the UK. In recognition of these contributions, the annual lecture series will be named in his honour.”

Jonathan considered different ways of understanding bioethics; as a subject, a discipline, a field, an enterprise, and a governance practice. He suggested that the last was a neglected perspective that deserved greater consideration. He offered a brief history of bioethics governance in the UK, noting that it was a mixture of bodies charged with general oversight, bodies with responsibility for specific sectors, and ad hoc groups convened to look at single issues. He suggested that Bioethics Governance, envisaged by the UNESCO Universal Declaration on Bioethics (2005), had generally been understood as being developed in response either to fears that science was advancing faster than ethical reflection (as exemplified by the establishment of the Nuffield Council on Bioethics in 1991), or to scandal (as demonstrated by the governance of health research through statements of principle, ethics committees, and research governance frameworks). He argued that it was also important to see Bioethics Governance as a response to pluralism (when society is not in agreement about bioethical issues but it is necessary to achieve some degree of closure, at least temporarily, to take regulatory decisions). However, if the idea of Bioethics Governance was to be distinguished from more general political decision-making, he suggested it was additionally necessary to see it as a response to claims of relativism (that there was no basis for distinguishing between views). Bioethics Governance denied that this should determine decisions, looking for some form of public reason or deliberative processes to provide legitimacy for regulatory decisions. A satisfactory account of Bioethics Governance would need to recognise the contingency of the circumstances in which questions arose, explain the legitimacy of the exercise of power that it involved, and show that regulatory responses were effective, efficient and proportionate. In conclusion, bioethics could properly be considered in each of the ways outlined, but characterising it as a governance practice brought issues that needed further examination into the spotlight.

His slides can be seen here:
Bioethics as a Governance Practice

Experimenting on children?

In 2013, Meetings, Research ethics on October 9, 2013 at 7:51 am

Of course the real title of this blog post is, or should be, something along the lines of ‘today’s HEAL meeting: discussing the NCOB’s consultation on ‘Children and clinical research’: a ‘vulnerable’ group and a lacuna in the law?

On 7 August 2013, the Nuffield Council on Bioethics launched its consultation on the ethical issues arising from involving children in clinical research. As noted by the NCOB, there is a lack of clarity around some questions regarding children’s participation in clinical research. For example, there is no reported case law on whether Gillick competency  applies in a clinical research setting, although the legal position for clinical trials for new medicines IS clearly laid out in the relevant regulations (see further MHRA for links to the different versions of the regs and further context), such that children under 16 cannot – in law – make their own decisions about participating in a clinical trial (consent of a parent with parental responsibility is required).

There are complicating factors, including practical and financial issues – ie what will companies fund, in the short and long term? And, more obviously, questions about ‘best interests’ for the children in question – when children have been and are perceived as  a ‘vulnerable’ group (on vulnerability in health care, see further Biggs and Jones, forthcoming 2014, and 2013).

The call for evidence can be be read at http://www.nuffieldbioethics.org/children-and-research/children-and-research-call-evidence. We’re meeting in rm 2055, Law, Highfield, from 3.15pm today, and looking forward to a great discussion.

Caroline Jones

Forthcoming HEAL events

In 2013, Meetings on September 30, 2013 at 11:50 am

Just a brief post today with two dates for your diaries:

1.  We will be discussing the Nuffield Council on Bioethics’ consultation on Children and Research, accessible here, on Wednesday 9 October, from 3.15pm until 5.15pm in room 2055/4, Highfield campus.

2. Jonathan Montgomery  will be speaking on ‘What is Medical Law “For”?’, from 4-6pm on Wednesday 30 October in 2007/4, Highfield campus. Sadly Jonathan is leaving us Southampton to move to the Faculty of Laws at UCL this autumn, so this is his last seminar as a fully-fledged HEAL member (but he will, of course, retain strong links to HEAL and the School, not least through our ongoing Hidden Lawmakers programme).

 

Caroline Jones

World first – UK Govt to back mitochondrial donation/replacement

In 2013, Genetics, Reproduction on June 28, 2013 at 7:50 am

The news this morning is again covering the mitochondrial donation/replacement debates, after Professor Dame Sally Davies, the Chief Medical Officer, announced yesterday that draft regulations will be published later in 2013 for public consultation, with the intention that the final version of the proposed regulations will be debated in Parliament in 2014.

These developments have been the subject of a number of consultations in the UK in recent years. The Government announcement focuses – understandably – on the HFEA’s consultations in 2011, on the safety and efficacy of the procedures, and in 2012, the public dialogue on the support or concerns held regarding the use of such procedures for ‘treatment cycles’ in humans (as opposed to research only, where the resulting embryos cannot be developed beyond 14 days due to restrictions on embryo research). However, the Human Genetics Commission first reported its conclusions in 2010 (HGC, since closed under the Arms’ Length Bodies Review of quangos); and in June 2012 the Nuffield Council on Bioethics published its report following public consultation.

In a shameless plug, in a recently published article Jones and
Holme consider some of the issues raised by mitochondrial donation/replacement. See further Jones and Holme,’Relatively (im) material: mtDNA and genetic relatedness in law and policy’, Life Sciences, Society and Policy 2013, 9:4, open access link: http://www.lsspjournal.com/content/pdf/2195-7819-9-4.pdf (alternatively, try http://www.lsspjournal.com/content/9/1/4).

Nuffield Council on Bioethics’ Report on Mitochondrial donation: a brief precis

In 2012, Genetics, Reproduction on June 12, 2012 at 1:16 pm

Today sees publication of the Nuffield Council on Bioethics’ Report on mitochondrial donation, entitled ‘Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review’, available here. An executive summary is also provided. As a very brief precis, taken from the executive summary, the NCOB Working Party has concluded that

  • Due to the health and social benefits to individuals and families of living free from mitochondrial disorders, and where potential parents express a preference to have genetically-related children, on balance we believe that if these novel techniques are adequately proven to be acceptably safe and effective as treatments, it would be ethical for families to use them, if they wish to do so and have been offered an appropriate level of information and support

 

  • Given the above and subject to the appropriate oversight, we believe that as a research objective it is ethical to gather further information about pronuclear transfer and maternal spindle transfer in order that they can be considered for treatment use.

The Working Party was also clear that use of mitochondrial donation ‘does not indicate, either biologically or legally, any notion of the child having either a ‘third parent‘, or ‘second mother‘; nor should mitochondrial donors have the same status as gamete donors (ie not to be mandatorily identifiable); and that long-term follow-ups of children born following (future) use of such techniques should be committed to by families, and supported by the creation of a centrally-funded register of these procedures, available to researchers.

 

mtDNA in Manchester: Exploring mitochondrial donation

In 2012, Genetics, Reproduction on May 16, 2012 at 8:23 am

Last week I participated in a fascinating Interdisciplinary Dialogue event around ‘The genetic family in question’ at the Morgan Centre for the Study of Relationships and Personal Life at Manchester University, organised by Dr Petra Nordqvist. This was linked to her project with Prof. Carol Smart on ‘Relative Strangers’ (the subject of last week’s blog post).

Coincidentally, both Dr Rebecca Dimond (Cardiff) and I offered papers on mitochondrial donation, so we were fortunate to have an entire afternoon session dedicated to considering the policy, law, social and other potential implications raised by these developing techniques – these are currently lawful for research purposes only (ie not lawful for use in the treatment of patients), following a licensing decision by the HFEA in 2005. Rebecca talked us through some insightful aspects of her interviews with family members with mitochondrial conditions, whereas my focus lay with the law and policy issues that may arise if Regulations are introduced to make lawful the use of these techniques in treatment. This area is, of course, subject to considerable attention in 2012 with the Nuffield Council on Bioethics due to publish its Report soon, and the HFEA in conjunction with Sciencewise-ERC due to undertake public dialogue later this year.

Our abstracts are below … a further post will follow on the morning’s session soon.

Relatively (im)material? mtDNA and genetic relatedness in legal discourse – Dr Caroline Jones

Mitochondrial donation poses the latest regulatory challenge for policy-makers in the context of assisted conception. In 2012 the Nuffield Council on Bioethics and the Human Fertilisation and Embryology Authority are consulting on ethical issues raised by this technique; including the potential relationships created by the use of three parties’ genetic material and the associated ramifications (eg whether or not there is a need to establish records of such donations and, if so, to whom should information be provided?) Hence, this technique poses both novel and familiar questions about ‘the genetic family’. This paper will explore the construction of the relative (in)significance of mitochondrial DNA in recent parliamentary debates, and current policy and consultation documents, in order to reflect on the ways in which the role of genetic connections – or lack thereof – are mediated in legal discourse and policy formation.

Who is the ‘third parent’? Mitochondria donation and implications for identity and kinship – Dr Rebecca Dimond

What is the link between mitochondrial DNA and a person’s identity?  What relationship does a woman have to a child conceived using her donated mitochondria?  These are key questions that the Nuffield Council on Bioethics have asked in exploring the ethical issues surrounding emerging techniques to prevent inherited mitochondrial disorders. There is currently no cure for mitochondrial disease but experimental reproductive technologies have now been developed which can allow women with mitochondrial disease to have children free from the disease. The technique involves replacing faulty mitochondria during an IVF cycle with healthy mitochondria from a donated egg. As the donated mitochondria (which contain a small number of genes) would be inherited by future generations, this technique requires a change in the law in order for it to be offered to patients and this has prompted calls for evidence by the Nuffield Council and HFEA. By drawing on interviews with patients with mitochondrial disease and media representations of the ‘three parent embryo’, in this presentation I consider how these techniques raise fundamental questions of identity and kinship.

Donor conception: interesting times

In 2012, Genetics, News, Reproduction on April 10, 2012 at 10:26 am

In the late 1990s the wisdom of choosing sperm donation/donor conception as the focus of my research was something that I was questioned about more than once. It was seen as a ‘dated’ subject; after all it wasn’t about the latest technological developments or indicative of where science or policy might go next. But, those concerns fell by the wayside in the early 2000s when this field hit centre stage once again, and it shows no signs of letting up a decade or so later. A cursory glance at the news in the last week or so gives rise to a range of stories:

  • From the ‘world first’ recommendation, in Australia, from the Victorian Parliament’s Law Reform Committee that all donor conceived people should have access to donor information, and where needed anonymity should be revoked retrospectively; further commentary and links are available on Bionews.

 

  • ‘Children of sperm donors should be told’ read one headline in The Independent (02 April, 2012; ie they should be informed about the mode of their conception – it does not seem that those interviewed were asked questions about the donor’s identity per se). 

 

  • The Nuffield Council on Bioethics is seeking written submissions of evidence by 15 May 2012 on ‘information disclosure’.

 

 

  • And last, but not least, ‘British sperm donor “fathered 600 children” was the lead headline for the Sunday Times (08 April, 2012); on 10 April 2012 this was ranked the ‘most read’ article in The Sunday Times on-line. This story later appeared in The Telegraph: ‘British man “fathered 600 children” at own fertility clinic’.  

Sometimes the ‘old’ questions or supposedly ‘settled’ issues give rise to the most interesting conundrums, in health care policy and law and beyond.

Jonathan Montgomery to Chair Nuffield Council on Bioethics

In 2012 on February 2, 2012 at 10:05 am

Jonathan MontgImageomery has been appointed the new Chair of the Nuffield Council on Bioethics. Jonathan is Professor of Health Care Law at the University of Southampton and Chair of Hampshire Primary Care Trust. Jonathan will begin his 5-year term on 12 March 2012.

“I was delighted to be invited to take on this role,” said Professor Montgomery. “The Council has made an outstanding contribution over its first twenty years; informing public opinion and influencing policy and practice in areas of vital interest to our society. I relish the prospect of being part of its work over the next five years. Bioethics touches all of our lives and we need to think clearly and rigorously about using our scientific knowledge responsibly and for the benefit of us all. The Council has established itself as a pre-eminent source of wise advice in the UK and internationally. It will be a privilege to join it.”

Professor Montgomery will take over from Albert Weale, ESRC Professorial Fellow and Professor of Political Theory and Public Policy at UCL. See further the Nuffield Council on Bioethics’ site.

Bioethics is a crowded space

In 2012 on January 20, 2012 at 1:21 pm

There have been calls for a national bioethics commission in the UK for many years, including from Sir Ian Kennedy in his Reith Lectures, Unmasking Medicine in 1980. They have been resisted for just as long, mainly (e.g. as explored in Parliament in the debate on an amendment proposing such a commission in 2008) on the basis that there were already bodies working in this terrritory, including the Human Genetics Commission, the Human Fertilisation and Embryology Authority and the Nuffield Council on Bioethics.

In the light of the disbanding of the Human Genetics Commission at the end of March 2012 and the announced intention of the Government to dissolve the Human Fertilisation and Embryology Authority it will be interesting to see how organised bioethics develops. The announcement of two separate consultations on aspects of mitochondrial disease shows one of the problems of co-ordinating activity in the crowded space of the current system.

The Department of Health has identified the need for public consultation on the use of new techniques, which alter the mitochondrial DNA of an egg or embryo,  in assisted conception to prevent the transmission of serious mitochondrial disease. It has asked the Human  Fertilisation and Embryology Authority to undertake this consultation and  issued a call for evidence, to be submitted by 15 March 2012.  The core group to consider the issues, which includes HEAL member Anneke Lucassen, has been asked ‘to collate and summarise the current state of expert understanding on the safety and efficacy of methods to avoid mitochondrial disease through assisted conception.’ 

On the same day, the Nuffield Council on Bioethics also issued a call for evidence (by 24 February 2012) for its own work in the area. It has established a working group   ‘(a) to identify and examine ethical issues relevant to the clinical use of techniques of in vitro mitochondrial transfer, (b) to elaborate these issues with a view to stimulating and informing further discussion, deliberation and debate, and (c) to prepare a report on the above, to be delivered in Spring 2012.’

These concurrent enquiries into the area have different concerns and the fact that they call for evidence on the same day cannot be accidental. The HFEA’s interest is expressed to be primarily about safety in order to suppport its responsibility to make licensing decisions and the NCoB is concerned about broader ethical issues. However, it might be considered that the overlapping processes point to the value of more explicit co-ordination of actitivies. It is reminiscent of the oddity that we saw in the 199os when both the Department of Health and the Nuffield Council on Bioethics undertook work on Xenotransplantation.