The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)

This article explores how the type of consent given for organ donation should affect the judgement of a patient's overall benefit with regards to donation of their organs and the pre-mortem interventions required to facilitate this. The findings of a qualitative study of the views of 10 healthcare professionals, combined with a philosophical analysis inform the conclusion that how consent to organ donation is given is a reliable indicator only of the strength of evidence about views on donation and subsequent (...) willingness to undergo pre-mortem interventions. It is not an indicator of the strength of actual desire to donate. Clinical management of living patients prior to donation after circulatory death must therefore respect the values, wishes and beliefs of the potential donation after circulatory death donor. Our participants, however, suggested that the information currently provided is sufficient to authorise donation and that this consent, however provided, was sufficient to proceed with pre-mortem interventions. Respect for autonomy underpinned this ‘all or nothing’ approach. Although the legal requirements for donation authorisation and the protection of patients without capacity are clear, practice and policy regarding consent in donation after circulatory death may be based on donation following brainstem death where the patient is already dead when the family is approached. Custom and practice in donation after circulatory death may need to be revised to protect the interests of the dying potential donor. (shrink)

The question of whether individuals retain interests or can be harmed after death is highly contentious, particularly within the context of deceased organ retrieval, retention and use. This paper argues that posthumous interests and/or harms can and do exist in the Konkomba traditional setting through the concept of ancestorship, a reputational concept of immense cultural and existential significance in this setting. I adopt Joel Feinberg’s account of harms as a setback to interests. The paper argues that a socio-culturally sensitive regulatory (...) framework does not necessarily exclude the donation of human biomaterials for transplant and science research. Indeed, when customary values are explored with open-mindedness and sensitivity it may be shown that such donation can form part of the important customs of some communities in this jurisdiction. Accordingly, a context-appropriate governance framework could utilise the cultural value of ancestorship as an incentive to encourage organ donation in the Ghanaian traditional setting. (shrink)