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 article focuses on the governance and ethical conduct of research within the domain of social work and social care. Globally, research in this domain appears less well regulated than those in the domains of health care. Within the United Kingdom, the Westminster government is implementing a Research GovernanceFramework for Social Care in England (RGF Social Care). This article locates this development in a broader global context and uses as an example a regionally based implementation to explore some potential issues (...) that arise from the governance and ethical framework in social work and social care. The proposed system is located with English local authorities. Various models are emerging: single department; corporate; dual or multi-council collaborations; cross-sector collaborations. Whatever the merits of the organizational form adopted, the influence of different cultures upon the form of governance and ethical regulation adopted is significant. (shrink)