Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

In this paper we set forth what we believe to be a relatively controversial argument, claiming that 'bioethics' needs to undergo a fundamental change in the way it is practised. This change, we argue, requires philosophical bioethicists to adopt reflexive practices when applying their analyses in public forums, acknowledging openly that bioethics is an embedded socio-cultural practice, shaped by the ever-changing intuitions of individual philosophers, which cannot be viewed as a detached intellectual endeavour. This said, we argue that in order (...) to manage the personal, social and cultural embeddedness of bioethics, philosophical bioethicists should openly acknowledge how their practices are constructed and should, in their writing, explicitly deal with issues of bias and conflict of interest, just as empirical scientists are required to do. (shrink)

As in science, so in bioethics: if prohibiting conflicts of interest is not feasible, rigorous requirements for disclosure can at least manage them.

Much has been written in the last decade about how we should understand the value of the sociology of bioethics. Increasingly the value of the sociology of bioethics is interpreted by its advocates directly in terms of its relationship to bioethics. It is claimed that the sociology of bioethics (and related disciplinary approaches) should be seen as an important component of work in bioethics. In this paper we wish to examine whether, and how, the sociology of bioethics can be defended (...) as a valid and justified research activity, in the context of debates about the nature of bioethics. We begin by presenting and arguing for an account of bioethics that does justice to the content of the field, the range of questions that belong within this field, and the justificatory standards (and methodological orientations) that can provide convincing answers to these questions. We then consider the role of sociology in bioethics and show how and under what conditions it can contribute to answering questions within bioethics. In the final section, we return to the sociology of bioethics to show that it can make only a limited contribution to the field. (shrink)

For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics (...) committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices. (shrink)

Recent decades have seen the emergence of two new fields of inquiry into ethical issues in medicine. These are the fields of bioethics and of health and human rights. In this critical review of these fields, the author argues that bioethics, partly because it has been construed so broadly, suffers from quality control problems. The author also argues that the field of health and human rights is superfluous because it does nothing that cannot be done by either bioethics of the (...) law. (shrink)

Recent years have seen the emergence of a new brand of moral philosopher. Straddling the gap between academia on the one hand, and the world of law, medicine, and politics on the other, bioethicists have appeared, offering advice on ethical issues to a wider public than the philosophy classroom. Some bioethicists, like Peter Singer, have achieved wide notoriety in the public realm with provocative arguments that challenge widely held beliefs about the relative moral status of animals, human foetuses and newborn (...) babies. Other bioethicists practice their trade with greater protection from public scrutiny, confining their thoughts to committees in government circles, universities, charitable institutions, or hospitals. But what exactly is it that bioethicists have to offer in such contexts? What sort of expertise do bioethicists have that justifies their employment on these committees, or the time and space accorded to their views on television and the radio, or in newspapers and magazines? In spite of being an expanding group of professionals who attract large sums of private and public funding, bioethicists are sometimes met with suspicion or even hostility, both inside and outside academia. One common criticism is that the presence of bioethicists is unproductive in practical bioethical debate. In light of this criticism one might wonder why the relevant funding bodies have not spotted the hoax and withdrawn their funding. Certainly, if bioethicists.. (shrink)