Hazel Biggs

What do research ethics committees say about applications to conduct research involving children

Objective To identify issues raised by research ethics committees (RECs) in letters about applications to conduct research involving children. Methods Analysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants. Results RECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientific design and confidentiality. RECs focused on childrens status as “vulnerable”. They sought to ensure that children would be protected, that appropriate written language would be used to communicate with children and that an appropriate person would give consent for children to participate. Implications Researchers should be attentive to issues of potential vulnerability when preparing applications. REC letters may be improved by giving clear and explicit reasons for their opinions.

The Ageing Body

In 1999 there were 10.6 million older people aged 65 and above in the UK, representing 18.11 per cent of the total population. Estimates suggest that by 2021 there will be in excess of 12 million such people. Predictions that over the next 30 years the number of people over 65 in Britain will increase by 50 per cent are regarded as broadly accurate, confirming that the proportion of the population that has retired from contributing to the economy is increasing year on year. Similar percentage figures apply to most other western countries and statistics like these have been used to describe a ‘demographic time bomb’ that will lead to the collapse of economies and state welfare provision as more and more older people make ever greater demands on welfare resources.

Competent minors and health-care research: autonomy does not rule, okay?

A dearth of clinical research involving children has resulted in off-licence and sometimes inappropriate medications being prescribed to the paediatric population. In this environment, recent years have seen the introduction of a raft of regulation aimed at increasing the involvement of children in clinical trials research and generating evidence-based medicinal preparations for their use. However, this regulation pays scant attention to the autonomy of competent minors. In particular, it makes no provision for the ability of competent minors to consent to participate in medical research and is therefore at odds with best ethical practice. This article explores the tensions between law and ethics in relation to clinical research involving minors and concludes that greater respect should be given to the autonomy of those minors who are competent to decide for themselves.

Children and health-care research: best treatment, best interests and best practice

In order for children to receive the best possible medical treatment, it is essential that research is conducted to discover safe and effective interventions and dosages. This article focuses on the legal and ethical implications of recruiting into health-care research minors who are not competent to consent. It considers the role played by best interests in obtaining valid parental consent for the participation of children in research, both at common law and under the Regulations that govern clinical trials of medicinal products. In doing so it questions the legality of parental consent to childrens involvement in research, and identifies some inconsistencies in parental understandings of best interests in relation to medical research and treatment.

From dispassionate law to compassionate outcomes in healthcare law, or not

Health-care law presents numerous challenges to the conception of the law as a dispassionate arbiter of disputes or protector of rights. Issues relating to end-of-life care, the assessment of mental capacity and decision-making for those who lack capacity, amongst others, epitomise the complex nature of health-care law. They also raise globally applicable questions about discrimination, or equal protection, as well as concerns for relief of suffering, the assessment of best interests and the exercise of individual autonomy. This paper will evaluate the extent to which laws traditional objectivity (dispassion) is undermined by the introduction of concerns about compassion into judicial and executive decisions. Focusing primarily on the law in England and Wales, but with reference to multi-jurisdictional case-law and international instruments, it will consider whether the law provides compassionate approaches and outcomes in end-of-life decision-making, and the implications of compassion for legal certainty.

Assisted Suicide for People with Depression: An Advocate's Perspective

Assisted suicide is a topical issue which has been brought to public attention recently through international cases and legislation. In particular, a recent case in the Netherlands concerning the assisted suicide of a depressed patient, and the pro assisted suicide legislation in Oregon, raise disturbing issues especially for advocates representing people with mental or terminal illness. The justifications for assisted suicide for both groups appear similar since both are vulnerable. Their vulnerability stems either from physical and emotional exhaustion caused by disease or mental distress and depression (J. Griffiths, 1994), which is often concomitant with physical disease (J. Billings, S. Block, 1994). Therefore, it is valuable to analyse the issues raised by assisted suicide for people with depression in either group. The arguments for assisted suicide are manifold, but the way in which society responds highlights inherent assumptions regarding the quality of life of people with depression. The limited rights and protections for people with mental disabilities in Britain emphasise the necessity for ethical inquiry and advocacy on behalf of these individuals. However, a conflict may arise for the advocate who opposes the ultimate outcome, death, yet values legal representation of the stated desires of the client.

Memories of Ken Mason

John Kenyon Mason (19 December 1919-26 January 2017), CBE, MD, LLD, FRCPath, DMJ, FRCPE, FRSE, and known as Ken Mason to us all, was Regius Professor of Forensic Medicine at the University of Edinburgh from 1973-1985 and thereafter Emeritus Professor of Forensic Medicine and Honorary Fellow in the School of Law at the University of Edinburgh. A formal obituary to Professor Mason is published in the Scotsman (http://www.scotsman.com/news/obituaries/obituary-professor-ken-mason-medical-jurisprudence-pioneer-1-4357181). We offer some personal tributes to our friend and colleague.

“Consensual” sexual activity between doctors and patients : a matter for the Criminal Law?

This chapter offers the beginnings of an exploration of what counts as exploitative sexual activity between a doctor and patient and of what role (if any) the criminal law should play. The issue of maintaining sexual boundaries between health care professionals and patients has become a significant matter of concern in recent years following several high profile scandals. Ethical and regulatory guidance takes the position that any engagement in sexual activity with a patient by a doctor is inappropriate and damaging. In this chapter, we first explore why this might be the case and whether sexual activity between doctor and patient is always exploitative. We consider whether consent can ever really freely be given in the context of this relationship. Does the imbalance of power between doctor and patient mean that the health care professional always effectively thwarts the patient’s capacity to give free consent to sexual activity? Secondly, we assess whether criminal law should be utilised to deal with cases where sexual activity with a patient amounts to wrongful, harmful behaviour on the part of the doctor.

Assisted dying: Reflections on the need for law reform

this debate. The following chapters discuss more pertinent topics and their concrete implications: facing death, the evil of death, the interests of the dead and dealing with the dead are all serious and well-defined philosophical issues, with practical implications. For example, Scarre uses the case of archaeology to discuss how we should deal with human remains or with the wishes of the dead. These issues are treated thoroughly and fairly in the book. Overall the book offers a comprehensive and thorough survey of this fascinating philosophical field.

In whose best interests: who knows?:

Leslie Burke challenged the GMC guidelines on withholding and withdrawing artificial nutrition and hydration because he wanted to ensure that food and fluids were not withdrawn from him at a time when he might still be cognisant. This article reviews the case and the judgments at first instance and in the Court of Appeal. In the interests of patient autonomy it argues that the patient is best placed to decide what is in her or his best interests and that the first instance decision was an appropriate response to Mr Burkes challenge.