Janet Messer – Changes in R&D approval

ICR Ethics & GCP Forum – Part 2 of 5

Janet Messer of the Health Research Authority gave an update on the changes to R&D approval and a pilot of an HRA assessment of research in the NHS. This continues the history around site-level assessment, from the research passport systems, the transfer of site assessment from RECs to site R&D, proportionate review and co-ordinated approval systems such as CSP. The underlying theme has been around recognising how research ethics and NHS R&D can work together more effectively. This is an area where Janet said the UK has been at the forefront.

However, Janet noted that at present 65% of applications to RECs result in a provisional opinion at the first consideration, increasing timelines. There is also a discussion to be had around the use of waiting time before REC meetings. On the NHS side, there have been major improvements to CSP timelines in 2012, although there is still local variation and a lack of clarity over how long the process should take. When the HRA was founded in 2012, it was envisaged that they should help the two groups work more effectively together. This specifically includes increasing the reliability and flow of review through centralisation where possible and by reducing unnecessary waiting times, enabling local support and delivery by making it easier to plan ahead through the recruitment window.

The HRA is currently running a feasibility study on whether a single HRA assessment of research is achievable. This will run until the end of Spring 2013, including several small pilots of new processes. Decisions on potential next steps will take place later in 2013. Janet said that this has the potential to radically simplify how we approve research (particularly with one eye on the proposed EU Regulation), and to enable greater focus and support for delivering research. While this work has focused on England, care has been taken to make the arrangements compatible to be applied UK-wide.

Janet highlighted that this is not simply placing current activity onto a new platform, with all processes around REC review and NHS R&D review being radically considered. Within the initiative, working groups from RECs and R&D have been discussing new ideas, with these being tested and refined in small-scale pilots. Care is also being taken to involve other stakeholders wherever possible.

Validation of applications

A great deal of attention is going into validation of applications to improve quality at the point of entry to the system, recognising that the quality of applications, particularly from academics and students, are not always of the highest quality. The pilot is considering how to validate an application once, with the result being suitable for both ethics and R&D. Ultimately, the goal is to do things in a proportionate way, with assessments being done by the most appropriate person and removing any unnecessary duplication, and providing the sponsor with a single point of contact wherever possible, reducing the amount of time-consuming negotiation on a per-site level.

The scope of the initiative includes NHS management arrangements, ethical opinions and legal compliance, to identify and resolve any issues that can be resolved centrally, looking to minimise local variation and also to free up local NHS staff to focus on study set-up and patient recruitment. This could also include coordination of resources from the clinical research networks.

Janet went on to speak about the quality of sponsors, with variability within the non-commercial sector having an impact on review timelines (which, in turn, have a knock-on impact on timelines for commercial sponsors). More discussion also needs to be had around non-commercial funding of research, which can take several years before the approval process can even begin. The quality of researchers is also an issue, with training and assessment of the competency of researchers being a key factor in research quality. However, Janet drew the line at trying to sort out the issues relating to the wider reorganisation of the NHS!

Other HRA topics

Bringing together other updates from the HRA, Janet mentioned that the IRAS system is moving to a new technical platform, both to support these changes and also to enable the REC and R&D applications to be integrated wherever possible. The current system involves many iterations of form-filling, based on the poorer quality of protocols when it was developed. The new system will involve fewer forms, with attention going into the education and the improvement of the quality of protocols in the first place! Janet also mentioned an attempt to introduce the concept of “Good research practice”, particularly for academic researchers whose studies are not “clinical” in nature, but who still need to conduct their research to the highest level of quality. Touching on the topic of transparency, Janet promoted the use of a study’s IRAS number as a unique identifier to be used in all discussions relating to the study.

Janet closed with a call for everyone involved in research to play their part in unblocking and improving the current system.

A delegate asked whether it was time to “professionalise” ethics committees; Janet responded that there are several areas (eg, patient information sheet) that could be addressed by professionals prior to more general review by an ethics committee.