Archive for the ‘Research ethics’ Category

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

This week’s HEAL event: Ethics, Embryos and Evidence: A Look back at Warnock and the Human Fertilisation and Embryology Acts

In 2014, Meetings, Reproduction, Research ethics on April 28, 2014 at 9:00 am

This week’s HEAL event is a joint Law School staff seminar/HEAL seminar, to be led by Dr Natasha Hammond-Browning speaking on ‘Ethics, Embryos and Evidence: A Look back at Warnock and the Human Fertilisation and Embryology Acts’. This event will run from 1-2pm in rm 2055/4 (Law), Highfield Campus, on Wednesday 30th April. All welcome.

The law in England and Wales concerning embryo research, the Human Fertilisation and Embryology Act 1990 as amended by the Human Fertilisation and Embryology Act 2008, is considered by many countries to be a model to be followed in outlining their own embryo research legislation. The Act permits embryo research within a defined set of limits, thereby taking a controlled but permissive stance.

Although the legislation carefully controls the research which is undertaken with human embryos, there are many opponents of embryo research who would like to see such work outlawed. This paper examines how the UK legislation come to take such a permissive stance in an area which still raises controversy and around which there is a vast range of diverse ethical opinions. In order to determine how the legal stance that the UK currently has towards embryo research was reached, this paper examines the path to legislation, subsequent reform and considers how diverse ethical opinions were taken into account.

Ben Goldacre & patterns of public policy

In 2014, Research ethics on March 31, 2014 at 8:49 am

“The patterns of public policy … are determined not only by such final decisions as votes in legislatures, … but also by the fact that some subjects and proposals emerge in the first place and others are never seriously considered.” John Kingdon

Hazel Biggs and I enjoyed Ben Goldacre’s recent discussion of ‘Medicine and Money’, part of the Nuffield Theatre’s inaugural Fulcrum Southampton: A point of balance between science and art, held over three days on 21-23 March 2014. His fast-paced impassioned talk focused, unsurprisingly, on the problems regarding the non-reporting of clinical trial data and what this means for medicine, money/government spending, patients, i.e., ‘us’ public in general. When considering exactly what this might mean, and the apathy that sometimes results – it’s not about ‘me’, has little or nothing to do with ‘me’, why is this really a problem etc – he flagged up the ‘dead babies’ problem. That is, the (potential) natal fatalities that have resulted as a result of the precautionary non-use of medicine, due to a lack of knowledge regarding side-effects of use on pregnant women (as clinical trial data was not published), when using the substances in question may have saved many lives. (This write up is inevitably ‘couched’ as – in law – causation would need to be proved: once a Tort lawyer …).

Interestingly, Ben Goldacre tweeted this message last Friday afternoon:

ben goldacre (@bengoldacre) 28/03/2014 15:43
Fab briefing by Parliamentary Office Sci Tech @POST_UK on withheld clinical trials bit.ly/1h0kJIP #alltrials Unimaginable 2 yrs ago

The POSTNOTE referred to is a briefing paper on issues around increasing transparency of clinical trial data. It’s the last part of the tweet that grabbed my attention: ‘unimaginable 2 yrs ago’. It reminded me of John Kingdon’s seminal text on pre-decision public policy processes, in which he provides a compelling and authoritative account of the messy world of public policy formation. His starting point is the question: ‘what makes an idea’s time come?’ He identified two categories of potential factors that may influence agenda setting and consideration of alternatives, namely i) participants, and ii) processes. These categories are further refined into i) participants inside and those outside of Government, and ii) problem recognition, policies/the generation of policy proposals and politics/political events. At crucial points problems, policies and politics meet, are coupled together, and according to Kingdon, it is at these junctures that the ‘greatest policy changes’ emerge.

It may be too early to determine whether or not the activities of those participants outside (see especially All Trials) and inside Government – during this month’s Southampton talk Ben Goldacre credited Dr Sarah Wollaston MP for her pivotal role in bringing this issue to the (agenda) table – together with ‘events’ such as the MHRA reportedly ‘shredding’ documents pertaining to the efficacy of Prozac, after 15 years on file, will inevitably lead to a sustained policy change. But, if anything, this seems more likely now than ever.

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