Acentral promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research as well as ad hoc groups and individuals have offered approaches to governance of this research. While there are similarities among (...) these governance models and they are in principle easily endorsable, in this paper I raise a set of concerns related to their implementation, suggesting areas where gathering data may facilitate more appropriate oversight. Next, I suggest areas that seem to have been neglected as these governance models have been developed so that they may be on the agendas of those seeking to revise these models in the future. Finally, I describe how some of the concerns that have arisen in considering the appropriate governance of stem cell research may be useful in science and translational research more broadly. (shrink)

The paper examines the attainment and adequacy of informed consent in an ethnographic–discursive study on gynecological visits involving doctors, patients, and nurses. Starting from a theoretical discussion on informed consent and the principles upon which it relies, the paper highlights the changes and the adjustments that these principle undergo in practice, from the planning of the research till later stages of the researcher’s fieldwork and data recording. Analyses first focus on the informed consent as a written artifact and show how (...) the description of the study indexes the prospective participants’ identity, as well as, it works in favor of the researcher’s (or, other institutional representatives such as the managers of the Hospital) accountability. Then, the authors focus on instances of audio and video recorded doctor–patient–nurse interactions in which information is reformulated by the doctors, in such a way as to anticipate and/or respond to the nurses’ and patients’ concerns with regards the project (such as, the risk of exposure to the public). The analysis of these episodes carry ethical implications, in that they alert that patients, nurses, and doctors may be not equally knowledgeable about the project and that they can be conceded unequal opportunities to have their interpretations and identity performances acknowledged and inscribed on the tape. (shrink)

It is largely undisputed that nurses should obtain consent prior to nursing care procedures. This article reports on a qualitative study examining the way in which nurses obtain such informed consent. Data were collected through focus group discussion and by using a critical incident technique in order to explore the way in which nurses approach consent prior to nursing care procedures. Qualified nurses in two teaching hospitals in England participated in the study. An analysis of the data provides evidence that (...) consent was often not obtained by those who participated in the study and that refusals of care were often ignored. In addition, participants were often uncertain how to proceed with care when the patient was unable to consent. Consent prior to nursing care procedures is an essential but undeveloped concept, for which a new ethos is required. (shrink)

ABSTRACT This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues (...) emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged. (shrink)

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should be mindful of (...) the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)