No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science through increasingly close (...) ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (shrink)

Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.

In the United Kingdom, there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university (...) research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

In the last 25 years writing in bioethics, particularly in medical ethics, has generally claimed that action is ethically acceptable only if it receives informed consent from those affected. However, informed consent provides only limited justification, and may provide even less as new information technologies are used to store and handle personal data, including personal genetic data. The central philosophical weakness of relying on informed consent procedures for ethical justification is that consent is a propositional attitude, so referentially opaque: consent (...) is given to specific propositions describing limited aspects of a situation, and does not transfer even to closely related propositions. Assembling genetic data in databases creates additional difficulties for ethical justification. This is not because genetic information is intrinsically exceptional, but because the merger of genetic and information technologies make it possible to assemble massive quantities of complex information that defeat individuals' best efforts to grasp what is at stake, or to give or withhold informed consent. The future agenda for bioethics will need to take account of both these limitations of appeals to informed consent. (shrink)

The human body is becoming hot property, a resource to be “mined,” “harvested,” patented, and traded commercially for profit as well as scientific and therapeutic advances. Under the new entrepreneurial approach to the body old tensions take on new dimensions—about consent, the fair distribution of tissues and products developed from them, the individual and cultural values represented by the body, and public policy governing the use of organs and tissues.

Genetic testing in the workplace is a technology both full of promise and fraught with ethical peril. Though not yet common, it is likely to become increasingly so. We survey the key arguments in favour of such testing, along with the most significant ethical worries. We further propose a set of pragmatic criteria, which, if met, would make it permissible for employers to offer (but not to require) workplace genetic testing.

The ArgumentCell lines and other human-derived biological materials have since 1980 become valuable forms of patentable matter. This paper revisits the much-critiqued legal caseMoore v. Regents of the University of Cahfornia, in which John Moore claimed property rights in a patented cell line made from his spleen. Most work to date has critiqued the text of the decision and left the relevant scientific and technical literature unexamined. By mapping out the construction of discontinuity and continuity between human body and cell (...) line in this literature, this paper provides a novel critique of the Moore case regarding the source and mobilization of scientific information in the decision. At the same time, the elisions of the case are used to move to a larger set of questions. Comparative material from the history of the first widely used cell line, HeLa, and a discussion of the relation of the scientific and economic value of cell lines, are aimed at analysis of how new objects such as patented human cell lines come into existence through science and law, and what kinds of definitions and practices make them valued objects of contention in the first place. (shrink)

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC (...) members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants. (shrink)

This article seeks to establish that the social sciences have an important contribution to make to the study of ethics. The discussion is framed around three questions: (i) what theoretical work can the social sciences contribute to the understanding of ethics? (ii) what empirical work can the social sciences contribute to the understanding of ethics? And (iii) how does this theoretical and empirical work combine, to enhance the understanding of how ethics, as a field of analysis and debate, is socially (...) constituted and situated? Through these questions the argument goes beyond the now commonly cited objection to the over‐simplistic division between normative and descriptive ethics (that assigns the social sciences the ‘handmaiden’ role of simply providing the ‘facts’). In extending this argument, this article seeks to establish, more firmly and in more detail, that: (a) the social sciences have a longstanding theoretical interest analysing the role that a concern with ethics plays in explanations of social change, social organisation and social action; (b) the explanations that are based on the empirical investigations conducted by social scientists exemplify the interplay of epistemological and methodological analyses so that our understanding of particular substantive issues is extended beyond the conventional questions raised by ethicists, and (c) through this combination of theoretical and empirical work, social scientists go beyond the specific ethical questions of particular practices to enquire further into the social processes that lie behind the very designation of certain matters as being ‘ethical issues’. (shrink)

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)