This report is presented to the UKCRD Programme partners for consideration. The recommendations cannot be adopted by researchers or sponsors until the recommendations have been accepted, and the necessary actions taken by the relevant UKCRD Programme partners.
The HRA will continue to work to provide more clarity to the research sector on methods for finding and contacting potential participants, ideally by way of guidance agreed across all the relevant organisations UK-wide. Researchers are asked to review their current practice, and align with that guidance. Researchers should implement amendments to their studies where needed to align with that guidance. UKCRD Programme partners should agree a plan for consistent adoption of the guidance.
The authors of this report have heard suggestions from some researchers for other changes to legislation or policy that we have not incorporated into recommendations, because we do not believe they are in line with current expectations of most patients based on the evidence available at this moment in time. We propose that the recommendations in this report are taken forward first, with ongoing engagement with patients and the public. This engagement could inform a further set of recommendations in the future, and potentially an extension within legislation, consistent with the common law duty of confidentiality. Any such extension should be based on patient and public expectations around specific scenarios, developed and agreed by the HRA, the National Data Guardian, and DHSC (and devolved administrations where relevant). This activity should combine deliberative engagement with diverse groups of people, wider public communication activities led by behaviour change experts, increased transparency about research and the use of data, and surveys to gauge public views. We recommend that these activities include testing and iteration in real-world settings before any national adoption. NHS organisations should also seek opportunities to create more alignment between care delivered through research and care outside research, and to explain why research addresses treatment uncertainties. We recommend that as well as a formal public consultation run by DHSC, medical research charities should also play a key role in public-facing work, because of the trusted links they have created with patient groups. We strongly recommend that engagement, involvement, and communication with the public is coordinated across organisations through the UKCRD Programme partners to make sure that activities are integrated and aligned across organisations and with public expectations.