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Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare

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Footnotes

  • Funding A Wellcome Trust grant (088360) to NS funded (1) drafting Care after research and executing the consultation process; (2) the sixth consultation session; (3) a systematic review (written with Daniel Strech) and ethics research that informed various sections of the framework document; and (4) writing this Editorial. A Brocher Foundation grant to NS and PL funded the seventh consultation session. Two grants from Centre of European Law, King's College London to NS for research assistance informed the briefing in the framework document on guidelines, legislation and position statements. Part of this work was undertaken by NS as a Caroline Miles Visiting Scholar at the Ethox Centre, University of Oxford. HD was Research Ethics Advisor to the National Research Ethics Service during the development of Care after research and the writing of this Editorial.

  • Contributors NS wrote and revised the drafts of this paper. PL and HD commented on the paper. All authors approved the final version.

  • Competing interests None.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • i There is a dearth of information on types, rates and mechanisms of care after research in the UK. However, limited UK information suggests that some REC-approved documents for recruiting participants lack appropriate plans, some participants expect but lack PTA to the study intervention, and some NHS Trusts have been forced to fund post-trial access to the study intervention (sources include examples of anonymised protocol and informed consent extracts from applications submitted to a North London REC and verbal reports made by many REC members and chairs involved in the consultation process). Wide variations in rates of reporting plans for post-trial access to the study intervention have been reported in informed consent forms and protocols for US-sponsored antiretroviral trials.4 ,5

  • ii These together reviewed 5560 applications between 1 April 2011 and 31 March 2012. Source: personal communication between NS and Health Research Authority staff.

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