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Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare
  1. Neema Sofaer,
  2. Penney Lewis,
  3. Hugh Davies
  1. Kings College London, Centre of Medical Law and Ethics, The Dickson Poon School of Law, London, UK
  1. Correspondence to Dr Neema Sofaer, Kings College London, Centre of Medical Law and Ethics, The Dickson Poon School of Law, Strand, London WC2R 2LS, UK; neema.sofaer{at}kcl.ac.uk, neema{at}alum.mit.edu

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When research concludes, post-trial access (PTA) to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service (NHS) and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees (RECs) do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial intervention, unplanned financial liabilities for NHS Trusts forced to fund this, negative press and potential to undermine public trust.13,i

One reason for the lack of clarity is controversy over whether and when participants should have access, after the study, to the study intervention. At one extreme is the view that continued access should be ensured when the intervention has benefited the participant or when it has proven safe and effective for the participant population, irrespective of the cost and burden of ensuring continued access. At the other extreme is the view that continued access need never be provided so long as non-availability of the study intervention post-trial was adequately disclosed when participants were invited to participate.6 There is also disagreement about when poststudy access to the study intervention should be considered beneficial for participants. The spectrum ranges from the view that the intervention should be regarded as beneficial for a proposed use only after the …

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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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