Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?
Journal of Medical Ethics 2008 March; 34(3): 188-192
The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility.
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Post-Trial Access to Tested Interventions: The Views of IRB/REC Chair, Investigators, and Research Participants in a Multinational HIV/AIDS Study Pace, Christine; Grady, Christine; Wendler, David; Bebchuk, Judith D.; Tavel, Jorge A.; McNay, Laura A.; Forster, Heidi P.; Killen, Jack; Emanuel, Ezekiel J. (Espirit Group, 2006-09)