ORCID Profile
0000-0001-9732-3946
Current Organisation
University of Adelaide
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Publisher: Wiley
Date: 09-09-2013
DOI: 10.1111/BIOE.12049
Abstract: 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 ex le, 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.
Publisher: Informa UK Limited
Date: 12-2013
Publisher: SAGE Publications
Date: 12-2010
Publisher: BMJ
Date: 11-2007
Publisher: Informa UK Limited
Date: 06-08-2010
Publisher: BMJ
Date: 19-02-2015
DOI: 10.1136/MEDETHICS-2014-102639
Abstract: Pre-recruitment is the practice of recruiting potential participants to a list of potential research volunteers in general rather than to a specific research project. This is a relatively common practice in commercial medical research as it reduces the time and hence costs of recruitment and makes it possible to be more efficient by recruiting participants who may be useful for a variety of different pieces of research. It focuses on present practices in the UK although the conclusions and suggestions should be read more widely than this, applying in any situation where pre-recruitment is used as a recruitment tool for clinical trials and beyond. Current pre-recruitment practices in the UK clash significantly with what are seen as best practices and ethical guidance with regard to recruiting participants to in idual trials, and insofar as this undermines these practices should be reformed.
Publisher: Springer Science and Business Media LLC
Date: 04-2008
DOI: 10.1007/BF03351294
Publisher: Informa UK Limited
Date: 25-08-2020
Publisher: Springer Science and Business Media LLC
Date: 12-2014
DOI: 10.1007/S40592-015-0022-2
Abstract: It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an ex le, that it is difficult to justify this sharp distinction in practices. While I won't come to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind.
Publisher: Elsevier BV
Date: 08-2019
DOI: 10.1016/J.JVAL.2019.02.011
Abstract: Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost-effectiveness that is prominent and fairly clearly defined.
Publisher: BMJ
Date: 29-01-2016
Publisher: Informa UK Limited
Date: 2012
Publisher: Oxford University Press (OUP)
Date: 09-06-2011
Abstract: It is an uncontested truth that many medical students and practising clinicians dread having to get their research proposal through a research ethics committee. In this paper, the author, a long-standing member of a research ethics committee, offers a practical guide on applying for research ethics approval, detailing common mistakes and flaws in applications, and giving specific guidance on getting through what can seem a daunting process.
Publisher: Informa UK Limited
Date: 02-06-2010
Publisher: BMJ
Date: 11-2007
Publisher: BMJ
Date: 06-2008
Abstract: 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 in idual application to a system involving pre-review by small sub-committees of National Research Ethics Officers (NREAs), 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 in idual 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.
Publisher: SAGE Publications
Date: 03-2007
DOI: 10.1177/174701610700300110
Abstract: In this brief paper I intend to make some distinctions between the activities that research ethics committees are required to undertake as part of their role in protecting research participants. These functions are, identifying ethical issues and risks within research projects, providing advice on how to resolve these issues and risks without compromising the validity of the research and finally, when this cannot be achieved, deciding whether the research should still be allowed to go ahead. Distinguishing these distinct functions allows us to determine what an appropriate membership of a Research Ethics Committee is. I will sketch out the implications of these functions for the appropriate membership of NHS and university based ethics committees in the UK.
Publisher: BMJ
Date: 15-05-2018
DOI: 10.1136/MEDETHICS-2017-104504
Abstract: Direct-to-consumer advertising is banned in Australia, and instead pharmaceutical companies use disease awareness c aigns as a strategy to raise public awareness of conditions for which the company produces a treatment. This practice has been justified by promoting in idual 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 c aign. We will discuss the creation of a nocebo response in this context.
Publisher: BMJ
Date: 07-2008
Publisher: Informa UK Limited
Date: 06-08-2010
DOI: 10.1080/15265161.2010.482630
Abstract: 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.
Publisher: BMJ
Date: 11-2008
Abstract: 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.
Publisher: BMJ
Date: 04-2007
Publisher: BMJ
Date: 09-2007
Publisher: BMJ
Date: 12-12-2012
DOI: 10.1136/MEDETHICS-2012-101074
Abstract: There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion.
Publisher: SAGE Publications
Date: 06-2006
DOI: 10.1177/174701610600200205
Abstract: 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.
Start Date: 2010
End Date: 2010
Funder: Wellcome Trust
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