In July 1997, the voting representatives at the National Consensus Conference on Bioethics in Health Research voted unanimously to adopt the proposed Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. This vote represented the culmination of a three-year journey towards the development of a coherent and cohesive framework for the ethical review of health research involving human subjects in Uganda.Attendees at the NCC included both voting representatives and non-voting participants. Voting representatives had been designated by the (...) institutional entity with which they were affiliated to represent that entity at the NCC and to voice the concerns and opinions of the entity and its constituents. (shrink)

In July 1997, the voting representatives at the National Consensus Conference on Bioethics in Health Research voted unanimously to adopt the proposed Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. This vote represented the culmination of a three-year journey towards the development of a coherent and cohesive framework for the ethical review of health research involving human subjects in Uganda.Attendees at the NCC included both voting representatives and non-voting participants. Voting representatives had been designated by the (...) institutional entity with which they were affiliated to represent that entity at the NCC and to voice the concerns and opinions of the entity and its constituents. (shrink)

Human beings are essentially vulnerable in the view that their existence qua humans is not given but construed. This vulnerability receives basic protection from the State, expressed in the form of the universal rights all citizens are meant to enjoy. In addition, many individuals fall prey to destitution and deprivation, requiring social action aimed at recognising the specific harms they suffer and providing remedial assistance to palliate or remove their plights.Citizens receive protection against their biologic vulnerability by means of an (...) in rem right to health [care], which is more an attitude of protection than a specific programme. When individuals become susceptible, that is, biologically weak or diseased, they also increase their predisposition to additional harm, and require social actions to treat their demeaned condition. Such assistance takes the form of positive healthcare rights.Research on human beings has been slow to observe that the subjects recruited are susceptible, especially so if research is done in less developed countries. By mislabelling them as vulnerable – a characteristic they share with all humans – sponsors avoid registering the deprivation these people suffer, and the ethical obligation to offer them remedial help.The distinction between vulnerability and susceptibility also marks the difference between being intact but fragile – vulnerable – and being injured and predisposed to compound additional harm – susceptible. Awareness of this difference should give additional force to the rejection of double standards in research ethics. (shrink)

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland (...) version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

The treatment of the control group in externally sponsored clinical trials is the issue of one of the most heated debates in international research ethics. The paradigmatic cases are the mother-to-child HIV-transmission trials that took place in 16 developing countries in 1997, where the control group received a placebo while proven treatment was available in industrialized countries. From this circumstance results the controversy as to whether the sponsor and researchers of externally sponsored trials have to supply a treatment that is (...) usually not available in the host country. From the beginning of the debate the controversial level of treatment has been called “standard of care”. However, besides the disagreement about the quality of the care that has to be supplied, there is as yet no widely accepted clear meaning of this concept. This article examines the fundamental ambiguity of the term and its formal function as an ethical criterion including suggestions on its further use. (shrink)