David Leslie Harold Hunter

Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research

The Human Tissue Act 2004 in the United Kingdom clearly represents not a principled approach but instead a compromise, a pragmatic approach which balances several different ethical considerations against each other. In regards to the use of tissue in research it has left much of the more difficult decisions to be made by research ethics committees on a case by case basis. In particular it is now the role of research ethics committees to decide whether research can be carried out using human tissue where no consent was given for the use of this tissue in research. Likewise research ethics committees are now charged with approving of human tissue banks which then need no further ethical approval to carry out research solely using tissue from that bank. There has however been little guidance in regards to the decisions these committees must make. This paper aims to delineate these decisions and offer some philosophical guidance to research ethics committees in making these decisions.

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of research ethics review being put in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the researcher to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research

At the 5th International Conference on Priorities in Health Care in Wellington, New Zealand, 2004, one resonating theme was that for priority setting to be effective, it has to include clinicians in both decision making and the enforcement of those decisions. There was, however, a disturbing undertone to this theme, namely that doctors, in particular, were unjustifiably thwarting good systems of prioritising scarce healthcare resources. This undertone seems unfair precisely because doctors may, and in some cases do, feel obligated by their professional ethics to remain uninvolved either in deciding priorities and in some cases in enforcing them. I will argue that the professional role of a doctor ought not be considered inconsistent with the role of a priority setter or enforcer, as long as one crucial element is in place, a rationally coherent and broadly justifiable regime for prioritising healthcare. Given this I conclude both that prioritisation and doctoring are not incompatible under certain conditions, and that the education of healthcare professionals ought to include material on distributive justice in healthcare

Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research.

The current system of ethical review for medical research in the United Kingdom is changing from the current system involving large committees of 7–18 members reviewing every individual application to a system involving pre-review by small sub-committees of National Research Ethics Officers , who have a remit to approve studies if they believe there are no material ethical issues imposed by the research. The reliability of this new system depends on the reliability of the NREAs and in particular the ability of small groups to effectively identify and appropriately assess the seriousness of all the material ethical issues that may be posed by an application. There is anecdotal evidence to suggest that many individual research ethics committee members have had experience of believing that a study presents no material ethical concerns, then on reaching the committee and discussing the application they realise that the committee feels it does present significant ethical concerns. If this is the case then this casts doubt on the reliability of NREAs or small groups to effectively identify ethically problematic research and appropriately respond to this to protect research participants. In this paper we describe a small questionnaire based piece of research carried out to assess how common this and other relevant experiences are

Direct-to-consumer advertising is banned in Australia, and instead pharmaceutical companies use disease awareness campaigns as a strategy to raise public awareness of conditions for which the company produces a treatment. This practice has been justified by promoting individual autonomy and public health, but it has attracted criticism regarding medicalisation of normal health and ageing, and exaggeration of the severity of the condition in question, imbalanced reporting of risks and benefits, and damaging the patient–clinician relationship. While there are benefits of disease awareness promotion, there is another possible adverse consequence that has not yet been rigorously considered: the possibility of inducing a nocebo response via the campaign. We will discuss the creation of a nocebo response in this context.

A recurring objection to the exploration, development and deployment of radical new technologies is based on their implications with regards to social justice. In this article, using synthetic biology as an example, I explore this line of objection and how we ought to think about justice in the context of the development and introduction of radically new technologies. I argue that contrary to popular opinion, justice rarely provides a reason not to investigate, develop and introduce radical new technologies, although it may have significant implications for how they ought to be introduced. In particular I focus on the time dependency of justice objections and argue that often these function by looking only at the implications of the introduction of the technology at the point of introduction, rather than the more important long-term impact on patterns of distribution and opportunity.

This paper is, in part, a response to the model of university-based human subjects ethics review described by Bryn Williams-Jones and Soren Holm in Research Ethics Review [1] and the current ethical review process at the University of Ulster [2]. In this paper the two predominant systems of ethical review within UK universities are described. It is argued that each of these systems has significant deficiencies. Having suggested why these two models are less than ideal, a “third way’ of ethical review is proposed that encapsulates the strengths of these two models while avoiding the weaknesses.