Forthcoming Practical Framework for Ethics Committees and Researchers on Post-Trial Access to the Trial Intervention and Healthcare

Abstract

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.

The UK Health Research Authority’s forthcoming document Care after research: A framework for NHS RECs seeks to address RECs’ and researchers’ need for practical guidance in the face of various incompatible, yet often individually reasonable views. It prompts RECs to address specific questions about researchers’ plans for the post-trial period; ensure there are plans for transitioning sick participants to healthcare; examine any plans to ensure PTA to the study intervention; and verify that documents for participants explain what will (or will not) happen post-trial, and identify any uncertainty. It allows RECs to decide when PTA to the trial intervention may be feasible or appropriate but, to inform their deliberations, summarises important legal, ethical and practical issues, and key legislation and guidance.

Keywords: research ethics, post-trial access, medical ethics