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)

Zachary Schrag would like to put the burden of proof for continuation of research ethics review in the Social Sciences on those who advocate for research ethics committees (RECs), and asks that we take the concerns that he raises seriously. I separate his concerns into a principled issue and a number of pragmatic issues. The principled issue concerns the justification for having research ethics committees; the pragmatic issues concern questions such as the effectiveness of review and the expertise of the (...) committee members. I argue that RECs can be justified by their role in improving ethical practice and in reducing wrongs done to research participants. I propose a model of review for doing this, which I think would also address the pragmatic issues raised. I then offer an account of where the UK ethics review system is now and suggest three steps which could improve social science ethics review in the UK and move it in a perhaps more desirable direction. (shrink)

Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A student's tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that no subject (...) is harmed the student can be allowed to learn such lessons as their mistakes may afford them. (shrink)

This is the third in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in balancing the social value of the research it reviews against the risks it imposes on those who take part. The ethics committee's role in assessing the social value of research goes (...) well beyond checking its scientific validity and this assessment may affect the risks ethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work. (shrink)

This is the second in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in assessing the science of the research it reviews. While ethics committees are not specifically constituted to review the science of a project, they must nevertheless assess the social benefits of research (...) and, in this context, have an important role in checking that the science has been properly peer-reviewed. (shrink)

The relationship between sociology and bioethics has been an uneasy one. It has been described as contentious and adversarial, and at least some of the sociologists who have ventured into the territory of medical ethics report back on unfriendly natives. This bioethical ill will toward sociology is not without cause. Sociologists have been quite critical of what they call the bioethical project. Two decades ago - when bioethics was just getting up on its organizational feet - Renée Fox and Judith (...) Swazey leveled the charge of cultural myopia against bioethics, noting that this myopia generally manifests itself in the form of systematic inattention to the social and cultural sources and implications of its own thought. They go on to say ifbioethics is an indicator of the general state of American ideas, values, and beliefs, of our collective self knowledge, and our understanding of other societies and cultures - then there is every reason to be worried about who we are, what we have become, and where we are going. (shrink)

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of (...) separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

The relationship between sociology and bioethics has been an uneasy one. It has been described as contentious and adversarial, and at least some of the sociologists who have ventured into the territory of medical ethics report back on unfriendly natives. This bioethical ill will toward sociology is not without cause. Sociologists have been quite critical of what they call (with not-so-subtle pejorative overtones) the bioethical project.Two decades ago - when bioethics was just getting up on its organizational feet - Renée (...) Fox and Judith Swazey leveled the charge of cultural myopia against bioethics, noting that this myopia generally manifests itself in the form of systematic inattention to the social and cultural sources and implications of its own thought. They go on to sayifbioethics is an indicator of the general state of American ideas, values, and beliefs, of our collective self knowledge, and our understanding of other societies and cultures - then there is every reason to be worried about who we are, what we have become, and where we are going. (shrink)

The relationship between sociology and bioethics has been an uneasy one. It has been described as contentious and adversarial, and at least some of the sociologists who have ventured into the territory of medical ethics report back on unfriendly natives. This bioethical ill will toward sociology is not without cause. Sociologists have been quite critical of what they call (with not-so-subtle pejorative overtones) the bioethical project.Two decades ago - when bioethics was just getting up on its organizational feet - Renée (...) Fox and Judith Swazey leveled the charge of cultural myopia against bioethics, noting that this myopia generally manifests itself in the form of systematic inattention to the social and cultural sources and implications of its own thought. They go on to sayifbioethics is an indicator of the general state of American ideas, values, and beliefs, of our collective self knowledge, and our understanding of other societies and cultures - then there is every reason to be worried about who we are, what we have become, and where we are going. (shrink)

In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered and ensuring that a lay summary of the research will be produced. In this brief report, I argue that all these tasks would be more effectively carried out through a process of patient involvement (PI) in research projects prior to ethical review. Involving patients with direct experience of the topic under (...) investigation brings added value beyond the contributions typically made by lay REC members, who are often not patients themselves. This is because PI tailors the design and conduct of research to the specific interests and concerns of the people who will actually take part in a project and make use of its findings. If a project has PI in its early stages, then a similar input from lay REC members could at best result in duplication of effort and at worst create the potential for conflict. The rationale for lay REC membership will therefore need to change from ‘contributing a patient perspective’ to ‘ensuring transparency and public accountability in REC decisions’. This has implications for addressing more strategic questions about lay REC membership, including who is best recruited to the role and how they should be expected to contribute in practice. (shrink)