Journal of medical ethics
-
Journal of medical ethics · Apr 2004
The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.
The World Medical Association's revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable.
-
On 23 September 2002, the Belgian law on euthanasia came into force. This makes Belgium the second country in the world (after the Netherlands) to have an Act on euthanasia. Even though there is currently legal regulation of euthanasia in Belgium, very little is known about how this legal regulation could be translated into care for patients who request euthanasia.
-
Journal of medical ethics · Apr 2004
The ethics of research related to health care in developing countries.
The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons need to be given for not giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world.
-
Journal of medical ethics · Feb 2004
Potential research participants' views regarding researcher and institutional financial conflicts of interest.
Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants. ⋯ The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants.
-
Clinical Study Agreements (CSAs) 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. ⋯ 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.