HEAL UoS

Posts Tagged ‘research’

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

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

DH Consultation on the futures of the HFEA and HTA

In 2012, Reproduction on July 2, 2012 at 9:00 am

The Department of Health launched today a consultation on the future of two key regulators, the Human Fertilisation and Embryology Authority and the Human Tissue Authority as part of the Coalition Government’s plan to cut the number of arm’s-length bodies and reduce bureaucracy announced in Liberating the NHS: Report of the arm’s-length bodies review (2010). The Public Bodies Act 2011 provided powers to transfer the functions of the HFEA and HTAto other bodies, but not to abolish them. Substantive change to the terms of the regulatory framework would require further legislation. The consultation runs until 28 September.

The logic of streamlining is that providers of health care are subjected to overlapping licensing/registration and inspectorate regimes that might be better co-ordinated, or possibly integrated into a single scheme of regulation under the umbrella of the Care Quality Commission (as in the preferred option). One test of this will be public confidence in the CQC, which has been criticised by the Public Accounts Committee and  seems likely to receive further adverse scrutiny in the report of the Mid Staffordshire NHS Foundation Trust Public Inquiry in the Autumn.

The research approval functions in relation to embryo research may no longer need to be separated out from the wider system of research ethics committees, supported by the Health Research Authority, as under the Human Tissue Act 2004 where the HTA licenses tissue storage but specific projects are approved by RECs. The preferred option in the consultation adopts this approach.

The consultation does not address the policy making functions of the two authorities. One important historical role of the HFEA has been to develop principled approaches to difficult ethical issues raised by assisted reproductive technologies. Work under way includes a national donation strategy, chaired by Professor Sheila Maclean, and work on public consultation on the use of techniques to prevent mitochondrial disease. It is not clear where such deliberative engagement and policy work will fit into the new regulatory landscape. Parliamentarians have expressed concern over the ‘democratic deficit’ in leaving such considerations to non-elected groups but this consultation document does not set out the thinking on the best way to resolve them in the future.

Jonathan Montgomery is Chair of the Health Research Authority but the views expressed here are personal only.

Sociological take on donor conception

In 2012, Reproduction on May 7, 2012 at 6:58 am

Just a quick Bank Holiday message: here’s an interesting video by Prof. Carol Smart of the Morgan Centre, Manchester Uni, on ‘Legal cases involving donor conception’ as part of the ESRC Relative Strangers project that Carol and Dr Petra Nordqvist are currently undertaking. Please note their amendment – under the media link – re the terminology of ‘primary’ and ‘secondary’ parent in light of a recent Court of Appeal case, A v B and anor [2012] EWCA Civ 285, which you can read here.

Looking back five years: egg donation for research

In 2006, Reproduction on September 1, 2011 at 3:01 am

In September 2006 the Human Fertilisation and Embryology Authority launched a consultation, ‘Donating eggs for research: safeguarding donors’, asking whether or not egg donation for research purposes should be permissible, and if so, how could donors be best protected?

For a brief overview of the consultation, see this Bionews commentary: http://www.bionews.org.uk/page_12842.asp; and for a summary of the BMA’s Medical Ethics Committee’s views, see Veronica English’s follow up piece: http://www.bionews.org.uk/page_37900.asp.

In February 2007, the HFEA announced its decision to permit ‘altruistic’ donation for research purposes – see the Report.