Janet Wisely – HRA update

ICR Ethics & GCP Forum – Part 4 of 5

Janet Wisely of the Health Research Authority started the afternoon session with a discussion of some of the HRA’s wider activities since its founding just over a year ago, with a vision of working with others to transform the UK into a more attractive place to conduct clinical research. She specifically spoke about the desire to look for practical solutions across the entire process, rather than simply moving problems from one place to another.

Although the HRA has regulatory functions, Janet highlighted that they try not to present themselves as a regulator, because their goal is rather to standardise behaviours and processes. They have a role to deliver, but also a role to influence the activities of other stakeholders from sponsors and funders to researchers and the public. This should result in less researchers finding it easier to do high-quality ethical research, while taking less resource to get studies started.

She listed a number of specific areas that will be addressed in their 2013-14 business plan, which should be published shortly, including:

  • NRES
  • IRAS
  • s251
  • TOPS

The National Research Ethics Service has transformed the ethics review landscape in the UK, reducing inefficiency and moving from nearly 200 RECs to 69 in England. At a high level, they are meeting performance targets. They are piloting an Ethics Officer function, which should give ethics committees a “corporate memory”, ensure that ethics committees don’t waste time on unnecessary or duplicate activities. In parallel with this, they are also looking at how the dataset required for proportionate review might be reduced without compromising the quality of decisions. Early feedback on this pilot is that this appears to be working where the protocol and patient information are of a high standard. Looking at timelines, they are aiming to reduce the submission deadline for Phase I studies outside the NHS to only 7 days before the meeting.

Janet reiterated Janet Messer’s comments earlier in the day on the new technology platform for the IRAS application portal. The dataset is being thoroughly reviews, taking out the boundaries so a greater proportion can be contained in a single submission. Also, applicants will be able to cite prior peer review of the science behind a study, which might make enable a REC to make a quicker decision.

Moving on to advice, Janet discussed some decision tools (due late in April 2013) to help researchers answer common questions, such as “is this research, do I need to apply?” Commenting on a point made earlier in the meeting, she discussed whether specific ethics approval would be required to provide published documents (eg, summary research findings, protocols etc.) to participants; she stated that approval would not be necessary for this.

A project is also in progress to develop a new website for the HRA, as part of a communications strategy. A number of public dialogue projects are also underway, with a view to scoping public involvement to inform future policies.

The NIGB will close at the end of March 2013, and responsibility for patient data sharing under Section 251 will be transferred to the HRA.

The TOPS over-volunteering prevention service will move to the HRA from April 1st 2013, which enables to commercial Phase I units to check whether health volunteers are putting the science and their own health at risk by entering multiple early phase studies too frequently. This system will use a person’s NHS number or passport number to flag up any over-volunteering.

Janet reiterated the list of active projects that had been mentioned by Janet Messer earlier in the meeting, highlighting the guidance on increasing the transparency of publication by making more consistent use of study number and study title all the way through to publication.

She also highlighted a point made by Janet Messer earlier in the meeting that 68% of REC responses were initially “provisional” although they went on to be approved. In 2012, 1000 applications (over 15%) were not technically valid when submitted, which can produce chaos and knock-on delays in parallel systems (eg, ethics and R&D).

Discussing risk-adaptive behaviour, Janet discussed the distinction between low-risk and established studies, where the challenges are broadly understood, and more novel studies that raise more complex issues at the forefront of ethics debate, which would reasonably require more debate by RECs. Not recognizing these studies can skew the performance metrics.

She summarized that the HRA is looking for simple solutions and quick wins alongside medium-term deliverables and an even more fundamental review, to improve the research journey in the UK.