Legal and Ethical Aspects of Post-Trial Access to Trial Drugs, Health Care and Information. (360G-Wellcome-088360_Z_09_Z)

The ethics and oversight/regulation of PTA are of great and increasing social significance, particularly as a growing proportion of clinical research, which primarily benefits resource-rich countries, is conducted in resource-poor countries. Legislation/guidance is inconsistent, ambiguous or silent about many aspects of PTA. Criticisms of the demanding stance of the influential Declaration of Helsinki (2000) has generated a contentious revision (2008). PTA has many stake-holders with strong and often conflicting interests; some (commercial sponsors) are more powerful than others (e.g. participants in resource-poor countries). The various ethical/legal/practical arguments generated by research stake-holders have not been collected systematically and have received little scrutiny. Research Ethics Committees (RECs) may be unprepared to evaluate plans regarding PTA in the protocols that they review; this may be costly for sponsors, researchers, participants and society. I will draw on my background in philosophy, social science and research governance and work with experts to: collect the arguments for/against moral obligations regarding PTA; develop an informed/even-handed view; build a database of PTA legislation/regulations/guidance to donate to UNESCO s global, open-access database; conduct a comparative legal analysis; propose any necessary reforms; and develop guidelines in collaboration with the UK s National Research Ethics Service to enable RECs to assess PTA plans.