Objectives—While clinical practice is complicated by many ethical dilemmas, clinicians do not often request ethics consultations. We therefore investigated what triggers clinicians' requests for ethics consultation. Design—Cross-sectional telephone survey.Setting—Internal medicine practices throughout the United States.Participants—Randomly selected physicians practising in internal medicine, oncology and critical care.Main measurements—Socio-demographic characteristics, training in medicine and ethics, and practice characteristics; types of ethical problems that prompt requests for consultation, and factors triggering consultation requests. Results—One hundred and ninety of 344 responding physicians (55%) reported requesting ethics (...) consultations. Physicians most commonly reported requesting ethics consultations for ethical dilemmas related to end-of-life decision making, patient autonomy issues, and conflict. The most common triggers that led to consultation requests were: 1) wanting help resolving a conflict; 2) wanting assistance interacting with a difficult family, patient, or surrogate; 3) wanting help making a decision or planning care, and 4) emotional triggers. Physicians who were ethnically in the minority, practised in communities under 500,000 population, or who were trained in the US were more likely to request consultations prompted by conflict. Conclusions—Conflicts and other emotionally charged concerns trigger consultation requests more commonly than other cognitively based concerns. Ethicists need to be prepared to mediate conflicts and handle sometimes difficult emotional situations when consulting. The data suggest that ethics consultants might serve clinicians well by consulting on a more proactive basis to avoid conflicts and by educating clinicians to develop mediation skills. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

Clinical Study Agreements can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet adequate (...) ethical standards. This is a failing that can have serious consequences.Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator’s freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. (shrink)

The practice of nonphysician ethicist-consultants giving ethics advice concerning the appropriate medical treatment of patients in hospitals is a relatively recent development. Although only a minority of hospitals make substantial use of any formal ethics consulting service, the number is growing and apparently will continue to do so. Indeed, at least among urban teaching hospitals, some sort of ethics consulting service is increasingly commonplace.

In the past twelve to eighteen months, another perceived threat to the safety of America's blood supply has arisen. The fear is that Creutzfeldt-Jakob disease will join hepatitis, HW and AIDS in the public and medical consciousness as the 1990s next infectious disease epidemic. A particular kind of ethical dilemma has arisen causing much debate and consternation for hospitals, regulators, and blood suppliers, and has elicited a remarkably varied response.CJD is a rare but uniformly fatal neurological disease: it affects the (...) brain and the rest of the central nervous system. Its incidence in the population of the developed world is about one per million per year, although some geographic anomalies exist. CJD manifests itself in two broad ways. First, the disease is associated with symptoms of mental deterioration and dementia, including memory loss, anxiety, and cognitive impairment. Second, CJD is also associated with a range of neurological symptoms, including muscle rigidity, seizures, tremors, muscle twitching, and spasticity, as well as problems with muscle coordination and unsteady gait, sometimes resulting in total disability. (shrink)

In the past twelve to eighteen months, another perceived threat to the safety of America's blood supply has arisen. The fear is that Creutzfeldt-Jakob disease will join hepatitis, HW and AIDS in the public and medical consciousness as the 1990s next infectious disease epidemic. A particular kind of ethical dilemma has arisen causing much debate and consternation for hospitals, regulators, and blood suppliers, and has elicited a remarkably varied response.CJD is a rare but uniformly fatal neurological disease: it affects the (...) brain and the rest of the central nervous system. Its incidence in the population of the developed world is about one per million per year, although some geographic anomalies exist. CJD manifests itself in two broad ways. First, the disease is associated with symptoms of mental deterioration and dementia, including memory loss, anxiety, and cognitive impairment. Second, CJD is also associated with a range of neurological symptoms, including muscle rigidity, seizures, tremors, muscle twitching, and spasticity, as well as problems with muscle coordination and unsteady gait, sometimes resulting in total disability. (shrink)

El libro “Aventuras de la epistemología ambiental” de Enrique Leff nos presenta un análisis crítico de las concepciones del ambiente a las que nos han habituado las ciencias normales y el perfil de un nuevo saber ambiental. El autor se plantea el objetivo de ofrecernos elementos para “irrigar” lo que llama “el territorio de la naciente epistemología ambiental”.Mis primeras miradas al libro me hicieron pensar que las verdaderas aventuras epistemológicas de Leff se hallarían en sus publicacione..