The conduct of clinical trials involving placebo in developing countries in the presence of an existing effective treatment triggered an intense debate on the standard of care to be provided to those populations. Charges of exploitation of vulnerable groups and double standards have been raised by several scholars. In response to these concerns, the Declaration of Helsinki was revised in 2000, 2008 and 2013, eventually endorsing the golden standard instead of the local standard of care. The European Union adopted a (...) strategy on the Marketing Authorization of medicinal products tested in third countries, improved with Regulation 536/2014 on clinical trials on medicinal products for human use. Additional rules have been enacted by other international organizations. The present paper has the aim of analyzing scope and content of existing international and regional standards on placebo. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (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)

In 1997 a debate broke out about the ethical acceptability of using placebo as a comparative alternative to establishe effective treatment in trials conducted in developing countries for the purpose of preventing perinatal HIV-transmission. The debate has now been going on for more than five years. In spite of extensive and numerous attempts at resolving the controversy, the case seems far from being settled. The aim of this paper is to provide an updated account of the debate, by identifying empirical (...) arguments employed in the controversy and by critically assessing their use in the debate. A notion of resolution of moral conflicts will be introduced that makes it possible to give a more positive verdict on the moral results of this controversy. Finally, the procedural problem of safe-guarding the selection of empirical arguments against undue forms of normative bias will be addressed. (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)