‘Significant progress’ has been made in medical research regulation and governance over the past 5 years, according to a report of an Academy of Medical Sciences workshop published this week.
Leading figures from the world of UK medical research attending the workshop in November 2016 strongly supported the development of the Health Research Authority’s new system – HRA Approval – which brings together the assessment of legal compliance and the ethics review into one streamlined system for the NHS in England. Since the workshop, HRA Approval has fully bedded in, with good user feedback about the ease of setting up studies.
Delegates at the workshop, which was co-sponsored by the Wellcome Trust and Cancer Research UK, also discussed other challenges facing the system, including clinical trial regulations, patient involvement and engagement, and the use of patient data in research. The HRA’s Confidentiality Advisory Group (CAG) was applauded for the progress it has made in facilitating access by researchers to confidential patient information in a structured way that can be explained to the public.
Dr Janet Messer, Director of Research Systems, Standards & Approval at the HRA“we are very pleased that the report has recognised the hard work that colleagues at the HRA have put into developing ways to relieve the burden and complexities of health research regulation in the UK. “We are already seeing very encouraging data that suggests that the time it takes from applying for approval to recruiting patients can now be much shorter. “The report rightly points out that there remain areas for improvement. Since the workshop we have made progress with NHS Trusts and sponsors in adapting to new ways of working, and on identified issues such as revision to model contracts. The HRA has recently begun a programme of service improvement work to further join up our internal processes.”
An Academy of Medical Sciences’ review in 2011 ‘A new pathway for the regulation and governance of health research’ led directly to the setting up of the Health Research Authority. The HRA’s establishment was one of a series of recommendations to transform and streamline the way research is governed in the UK. The workshop in November 2016 discussed progress 5 years on from the report, highlighting areas where improvements are still needed and identifying new challenges.
Proportionality
A recurring issue was the need for a proportionate approach to health research regulation. Workshop attendees were concerned that principles and guidelines should not be interpreted and implemented as inflexible rules and instead there should be a culture of discretion applied in their interpretation.
HRA assessment is intrinsically proportionate to the nature of each study, and each applicant is given instructions on proportionate arrangements for study set-up with NHS sites.
Since 2010, research ethics committees (RECs) have offered a proportionate review system that provides a faster ethical review of research studies that have minimal risk, burden or intrusion for research participants. New applications are reviewed via email correspondence, teleconference or at a face to face meeting by a sub-committee rather than at a full REC meeting. This system has successfully reduced timelines for eligible studies, and further improvements have been made after a pilot scheme last year. As part of the HRA’s continuous improvement we are looking at ways in which we can take a more proportionate approach in other areas of our work.
In January we updated our best practice guidance for researchers on consent and participant information sheets, to reinforce the application of proportionality to providing information to potential research participants when seeking consent, and encourage researchers to make participant information sheets (PIS) more accessible for all types of research.
Trial timelines
The report also recommends that the HRA should work with funders and sponsors to develop effective end-to-end trial timelines that include metrics which span the whole system and start from the moment of grant award. We are already looking at how we collaborate with funders and others to combine data on timelines.
Good Clinical Practice
Forum delegates also agreed that communication is needed from regulators on how Good Clinical Practice guidelines should be implemented, to ensure they are not over-interpreted.
An issue frequently raised by researchers with us is the inappropriate and rigid application of requirements for GCP training. Researchers and other staff involved in the conduct of clinical trials are being required, inappropriately and often disproportionately, to undertake GCP training when they do not conduct research in the field of clinical trials of investigational medicinal products (CTIMPs) or where their involvement in the trial is minimal and entirely within their professional expertise. Along with the MHRA we have developed a joint statement to try and address this and are currently seeking support from organisations across the UK for this approach.
The full report "Regulation and governance of health research: five years on - FORUM meeting report can be found on the AMS website.