The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

With rapid advances in the biosciences, bioethics has become an important, if not vital part of a comprehensive bioscience education. Students who successfully complete a course in bioethics will be better equipped for writing manuscripts for publication, preparing research proposals for funding bodies and completing applications for research ethics committees. Given the importance of both grant writing and successful publication in a bioscience career, bioscience students who do not receive training in bioethics will be disadvantaged. Graduates who move into careers (...) other than research, such as science policy, administration or education, will also benefit from the inclusion of bioethics in their bioscience education because they will need to consider the ethical issues that arise in the context of policy, public relations and public health. Given the importance of including bioethics in a bioscience education, this paper presents the findings of an empirical study that was designed to evaluate the different ways to design and deliver a bioethics module for bioscience students. The study considers the aims and objectives; the teaching, learning and assessment strategies and the content of a ‘bioethics for bioscience’ module. At a more fundamental level, the study explores why bioethics should be taught, at what level bioethics should be delivered, how much time should be committed to the teaching of bioethics and the core topics that should be included in a bioethics module. (shrink)

This article examines some of the controversial issues emerging from the privatization of biomedical research and commercialization of biotechnology. The aim is to identify the dominant social, political, and ethical risks associated with the recent shift from academic to corporate science and from the increasing emphasis on investing in research projects that will result in the award of a monopoly patent. Identifying these risks may ultimately assist policy makers in designing new policies or reforming existing practices that will come closer (...) to achieving an equitable balance between science pursued for the advance of knowledge and science pursued for patents and profit. The discussion may also assist the research directors or managers of biopharmaceutical companies in designing corporate policies that will optimize the balance between the serendipity of scientific discovery and the discipline of strategic business planning. (shrink)

This document is designed to give guidance on assessing researchers in bioethics/medical ethics. It is intended to assist members of selection, confirmation and promotion committees, who are required to assess those conducting bioethics research when they are not from a similar disciplinary background. It does not attempt to give guidance on the quality of bioethics research, as this is a matter for peer assessment. Rather it aims to give an indication of the type, scope and amount of research that is (...) the expected in this field. It does not cover the assessment of other activities such as teaching, policy work, clinical ethics consultation and so on, but these will be mentioned for additional context. Although it mentions the UK’s Research Excellence Framework, it is not intended to be a detailed analysis of the place of bioethics in the REF. (shrink)