ObjectiveTo identify issues raised by Research Ethics Committees (RECs) in letters about applications to conduct research involving children. MethodsAnalysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants. ResultsRECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientific design, and confidentiality. RECs focused on children's 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. ImplicationsResearchers 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.Abstract word count: 131 3
A dearth of clinical research involving children has resulted in off license 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 evidenced 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 who are competent to decide for themselves.
Judges articulate their role in controversial cases of medical ethics in terms of deference to Parliament, lest their personal morality be improperly brought to bear. This hides a wide range of law‐making activities, as parliamentary sovereignty is diffused by ‘intermediate law‐makers’, and judicial activity is more subtle than the deference account implies. The nature of litigation raises questions about the contributions of other legal personnel and also the nature of the parties' interests in test‐cases. While judges demonstrate an awareness of some of these issues and anxiety about the constitutional legitimacy of their work, a more nuanced account is needed of their proper role. This may be built on Austin's theory of tacit legislation. It may draw from human rights law. However, considerable work is required before the complexities of hidden law‐making can be properly incorporated into the province of medical jurisprudence.
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.
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