HEAL UoS

Posts Tagged ‘consultation’

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

Today’s HEAL meeting : discussing choice at the end of life

In 2012, Death and dying on October 23, 2012 at 3:42 pm

The next HEAL event will be on Tuesday 23 October from 4.30pm in rm 2055/building 4 (Law), led by Hazel Biggs, on the Safeguarding Choice consultation http://www.appg-endoflifechoice.org.uk/pdf/appg-safeguarding-choice.pdf. The consultation – which closes on 20 Nov – is being run by the All Party Parliamentary Group on Choice at the End of Life in partnership with Dignity in Dying, and includes a draft Bill (‘applying’ only to England and Wales).

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.

HEAL’s next meeting: 22 February 2012

In 2012, Death and dying, Meetings on February 17, 2012 at 8:32 am

HEAL’s next meeting will be on Wednesday February 22, 2012, at 1pm in 4/2007, where Hazel Biggs will lead a seminar on ‘The Death Commission’, drawing on the recent Report by the Commission on Assisted Dying. This is a follow up event to last year’s HEAL seminar on the parameters of the Commission’s consultation paper, led by Hazel Biggs, Jonathan Montgomery and Caroline Jones.

This week’s meeting!

In 2012, Human tissue, Meetings on January 24, 2012 at 8:26 am

News of our first 2012 event: Friday, 27 January, at 11am in the staff club, Highfield campus – Hazel, Jonathan and I will be meeting to discuss the Welsh Assembly’s White Paper on a proposed opt-out system for organ donation in Wales. English & Welsh versions of this document and further details about the consultation can be found http://wales.gov.uk/consultations/healthsocialcare/organ/?lang=en

The consultation contains 9 questions, broadly about operational issues of such a system (eg. factors to be taken into account in determining whether someone ‘lives in Wales’, safeguards for those lacking capacity, age restrictions and possible equality impact), and closes on 31 January 2012.

Anyone who would like to join us for this discussion is most welcome.

Clinical Negligence and the NHS

In 2011, NHS on November 15, 2011 at 1:45 pm

In June 2011 the Health Select Committee published a report on Complaints and Litigation in the NHS. It supported the continuation of fault-based compensation, concluding that that ‘the existing clinical negligence framework based on qualifying liability in tort offers patients the best opportunity possible for establishing the facts of their case, apportioning responsibility for errors, and being appropriately compensated’ (Para 157). However, it was very critical of claims management firms, which it thought pushed people into litigation rather than using complaints procedures and unduly contributed to the rising costs of clinical negligence (Para 172). The Government’s response to the report indicates that the Ministry of Justice is working closely with the NHS Litigation Authority (NHSLA) and the Association of Personal Injury Lawyers (APIL) to agree a scheme that will enable a speedier resolution of lower value clinical negligence cases and aims to reduce costs (Para 147). It also notes that the Jackson reforms of civil litigation, being implemented through the Legal Aid, Sentencing and Punishment of Offenders Bill, will have a significant effect in this area (Para 19). The Ministry of Justice is now consulting on the regulation of claims management firms.

The two volumes of evidence to the Select Committee contain a considerable amount of information on concerns about this area of law and practice. The previous parliamentary report by the Constitutional Affairs Select Committee on the (non)existence of a compensation culture is also relevant. The publication of the industry review of the NHSLA is still awaited, as is the implementation of the NHS Redress Act 2006 despite the initial policy announcements from the Department of Health. It does seem clear from the Annual Report of the NHSLA for 2011 that there is a significant increase in both the number of clinical negligence claims received by the NHS and also the money paid out in compensation and legal expenses.

This week’s meeting!

In 2011, Capacity, Meetings, Mental Health on September 26, 2011 at 8:45 am

On Wednesday 28 September, we’re meeting at 4pm in room 2007/4 (Law, Highfield) to discuss the ‘Adults With Incapacity (Scotland) Act 2000 – Consultation On Certification Of Incapacity For Medical Treatment, with a view to formulating and submitting a response on behalf of HEAL.

This consultation seeks views on four issues on Adults with Incapacity (Scotland) Act 2000 Part 5 in relation to medical treatment. The issues are:  1.widening the range of institutions which can offer training; 2.whether dentists should be required to undertake training for this purpose; 3.whether multiple section 47 medical treatment certificates should be required in some circumstances; 4.and whether other medical practitioners not specified should be enabled to certify incapacity for medical treatment.

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.