Sunday, 26 August 2007
Economic & Social Research Council Grant Bid: Real Issues in Research Ethics
It is now recognised that all research involving human subjects raises ethical issues and ought to be reviewed by an independent research ethics committee.1 However research ethics committees are in a difficult position, they must make highly contested decisions about whether research is ethical and can be allowed to proceed, often in a limited time frame with minimal support. Given the complexity of ethics and diversity of moral viewpoints, there is no straightforward way for committees to make these decisions, nonetheless through the process of debate and deliberation many issues have been resolved and commonly accepted answers found. However research ethics committees still encounter applications that either because of the cutting edge nature of the science involved or because of the ethical complexity of the project they find difficult to come to a decision on. There is a considerable literature on specific issues in the ethical conduct of research. However it is not clear how much of that literature addresses the ethical issues that research ethics committees actually find pressing, since it has primarily been written by ethicists who may have no practical connection with the practice of research ethics review or may only have been exposed to the workings of a limited number of committees. This is particularly important because research ethics committees deal with cutting edge ethical issues, conflicts between competing principles and the application or potential application of new technologies and techniques.
This is important both from the point of view of protecting participants rights and safety but also from the point of view of safeguarding and promoting good quality science, since ethics committees may err on the side of caution given a particularly contentious issue.
The aim of this study is to generate ethically interesting case studies based on actual cases drawn the experiences of research ethics committee members themselves both in the clinical context and in the non-clinical context. These case studies will then be analysed ethically to identify the significant ethical principles and concerns in play and to come to some decisions about the cases.
The cases will be published online and the discussion will likewise be made available to feed these topics back to the research ethics committees. It is also anticipated that these will be a valuable support and asset for those who are providing training for both researchers and research ethics committee members.
Outcome: Not Yet Submitted.
The concept of community in bioethics – Wellcome Trust Satellite Conference of the International Association of Bioethics 2010 Congress – Singapore
This was a conference that I was invited by the Wellcome Trust to organise for them, given my involvement in and coordination of the philosophy in bioethics network of the international association of bioethics. It focused on how the concept of community is and might be used in different contexts of bioethics, such as research ethics, organ transplantation, resource allocation etc and asked whether this is sustainable.
Research Ethics in the EU: What is done and how it could be done better two day conference
This conference is funded via the income from the EU Research Ethics Textbook contract that the Centre for Professional Ethics won, and I was involved in. It was a two day event, focusing in the first day on fundamental philosophical issues at the heart of research ethics, and on the second day on the role of autonomy and informed consent in research ethics in the face of the significant empirical evidence that informed consent is in practice rarely achieved.
Philosophy and Research Ethics Workshop
This was a collaborative application involving members of the philosophy department at Leeds University and myself to host a workshop which aimed to bring together academics with a philosophical interest in research ethics and research ethics committees. In this first workshop our intention is to try and get a feel for what questions require answers and what strategies are available for approaching them. We were looking for specifically philosophical work, rather than the sort of practical considerations which are the stock in trade of many research ethics committees. There is a risk at present that research ethics could become too caught up in pragmatic issues, and lose sight of the deeper philosophical issues raised in the context of research ethics.
Funding Body: Wellcome Trust
Ethical Issues in Infectious Disease Control Workshop
Infectious diseases constitute a major public health problem, and planning and responding to them, rightly, remains central to public health policy and practice. However, many of the steps taken to prevent and control these diseases raise significant ethical questions. For example, contagious disease can be spread from the person infected to others, and this raises special problems about harm prevention and reduction that are not usually faced in routine clinical practice. Ethical Issues in Infectious Disease Control will bring together academics and practitioners from a variety of disciplines to provide a framework for rigorous debate on these ethical issues.
The ways in which many infectious diseases, such as measles, tuberculosis and HIV, are caused and transmitted are reasonably well known. Despite this methods of controlling the spread of these diseases continue to pose serious ethical issues. In addition, new diseases, or new variants of existing ones, raise additional questions stemming from uncertainties about their virulence and the ways in which they may develop. By focusing on the ethical challenges raised by many different infectious diseases Ethical Issues in Infectious Disease Control will make a major addition to elucidating the themes that are likely to be important when new pandemics arise.
Funding Body: Wellcome Trust
Justice and Human Enhancement workshop
This workshop organised as part of the Manchester workshops in political philosophy focused on a specific neglected issue in the debate about the moral permissibility of human enhancement – namely that of the implications for justice.
Networking and capacity building for academic research ethics committees
Proposal within FP7, Science in Society, 188.8.131.52: "Networking and capacity building activities to support ethics committees"
bid for funding for an EU-wide project under the Seventh Framework Programme (Science in Society, 184.108.40.206., “Networking and capacity building for research ethics committees”), which will promote dialogue and the exchange of information and expertise between members of academic research ethics committees within and among EU member states. While networks currently exist to promote communication between members of national ethics committees and between regional or local ethics committees engaged in ethical review of clinical research (NEC forum and EUREC, respectively), there are no current European networks in existence which address the needs of committees which review non-clinical research, such as those based in academic institutions. Such committees encounter specific challenges, not least in relation to the review of research in emerging technologies, and as such require a platform of their own if best practise in ethical review is to be achieved.
The objective of this project is to promote coordination and consistency in the review of protocols submitted to non-clinical research ethics committees across the different member states. We propose to create a forum which can be accessed and used by members of such research ethics committees in all member states to post and acquire information about practises and procedures and to communicate experiences relating both to general governance issues and to the particular ethical challenges arising from research in emerging technologies for which existing European or national guidelines are inadequate. While EUREC was established in 2005 to provide networking opportunities for the clinical REC sector, no supports exist yet for the non-clinical REC sector. This is a particularly pressing problem in an era in which increasingly sophisticated ethical expertise is required to evaluate the effects of rapidly advancing technologies. The creation of a European network specifically dedicated to the operation of non-clinical research ethics committees would redress this problem and would serve to complement the work currently carried out by EUREC.
Our intention is to create a web-based platform for the exchange of information between members of RECs within member states and between peers engaged in ethical review across a number of different member states. The function of this electronic exchange would be threefold: first, it would provide members of non-clinical RECs with access to current European, national and local documentation (in the English language) pertaining to the review of research involving human subjects. Second, it would provide an opportunity for online research ethics training for such committees, based on the European Textbook on Ethics in Research being developed by Keele University. Third, it would provide an opportunity for interested members to exchange information and, by means of online discussion fora, to discuss practises and procedures and to learn from the experience of peers in other jurisdictions. A needs assessment for this research ethics sector will be conducted on the basis of these contributions.
The creation of this network would require a collaborator from each of the participating member states. The collaborator would be responsible for the provision of an up-to-date summary of the operation and governance of ethical review of non-clinical research in the member state in question, including a contact list of relevant RECs. Funding would be made available for the preparation of such a survey. In addition, collaborators would be required to provide documents highlighting salient ethical issues in research in their respective member states, which the project coordinators will make available in original and English translation on the web site.
Application Under Consideration
BIOETHICS 2.0: Bespoke E-Learning Solutions for Embedding Ethics in Science and Medicine
This was a collaboration with Anthony Mark Cutter, Senior Lecturer in Governance and Bioethics, Centre for Professional Ethics, University of Central Lancashire, Professor Alan Gillies, Computer Sciences, University of Central Lancashire & Dr. Rebecca Bennett Centre for Social Ethics and Policy, Manchester University
The aim of this project is to use interactive and collaborative so-called Web 2.0 technologies to develop new tools to engage students and the wider community in considering bioethical issues. However before this can successfully be done it will be necessary to identify priority issues and topics within the field. For this purpose, Bioethics 2.0 will conduct a Delphi study with experts from within bioethics, medicine and life sciences with the aim of identifying priority topics and desirable delivery methodologies within the fields. This will include identifying common core topics. This research methodology has been successfully deployed for needs analysis in relation to distance learning in a number of contexts. Where many professional bodies mandate training in ethics, the development of such resources is imperative.
Granting Body & Scheme: Wellcome Trust, E-Learning grants programme.
Outcome: Under consideration.
The Elderly and Cancer Research Participation.
In Europe and the U.S. over 60% of cancer occurs in the elderly (≥65 years) population. However US studies have shown that elderly cancer patients only represent about 22% of patients enrolled in phase II clinical studies. There are clear problems with this, primarily that drugs developed to aid cancer may not effective with the patient group who are taking those drugs. There are two arms to this project. The first is quantitative and survey based, and aims at finding what barriers to the enrolment of elderly cancer patients in the minds of researchers conducting clinical trials, members of ethics committees who consider clinical trials and finally the elderly themselves. This information is important because unless researchers, ethics committees and the elderly are in synch with their attitudes towards the enrolment of elderly in clinical trials it is unlikely that recruitment is going to improve. The second arm of the project is theoretical and looks at the ethical arguments both for and against the enrolment of the elderly in to clinical trials. There are significant parallels here with the literature on the under enrolment of both children and women in clinical trials. Many of the arguments are the same, such as those concerning the potential vulnerability of the participants (primarily children though it has been argued that due to the increased risks of toxicity for women), concerns with the potential worries about quality of consent (in this case only children) and those addressing the need for there to be good evidence that these drugs are going to be effective with these particular groups. However there are specific issues that apply only to the elderly such as issues of intergenerational justice and issues to do with the role of elderly in our society.
Granting Body & Scheme: ESRC: New Dynamics of Ageing programme
Outcome: Not funded.
2006: Forward Thinking Project, Northern Ireland.
This project aims to harness the community of inquiry (Philosophy for Children) teaching methodology to interest young people (Key stage 3) in the engagement with and discussion of contested scientific ideas and techniques such as the use of stem cells, cloning, genetic modification, human enhancement etc. This will be supported by C2K, which provides a virtual (online) learning environment, LearningNI, connecting all of the Northern Ireland schools. These discussions will be integrated into the citizenship & science curriculum. The project will run for three years in 30 schools in Northern Ireland, resulting in 30 teachers trained in this teaching methodology. I developed the idea for this grant, did most of the initial grant writing, then approached appropriate people both from inside the University of Ulster (School of Education) and outside (Belfast Education board) to be involved. This ensured that the project would fit into the existing curriculum.
Granting Body & Scheme: Wellcome Trust, Engaging Science grants programme.
Amount: £155877 over 3 years.