June 2019: United Kingdom Regulatory Update

Make it Public – new consultation launches to help increase public access to research findings

On June 17th the UK’s Health Research Authority (HRA) launched a consultation on their new strategy to help increase public access to research findings. The 12-week consultation targets NHS, university and commercial researchers, as well as funders and patient groups ahead of the publication of its new research transparency strategy later this year.  The HRA is inviting feedback on wide-ranging proposals that seek to ensure that transparency and openness become “second nature” for drug and medical device sponsors who conduct research in the country.  The proposals relate to the HRA’s new “Make it Public” strategy document, which covers all types research involving people, their tissue or personal data, but its initial focus is on clinical trials.  Comments on the strategy document will be accepted until September 6th. An online survey, open to all, will run until September 6th as well as face-to-face workshops in London, Edinburgh, ManchesterCardiff and Belfast.  The HRA is also seeking views from patient groups and research ethics committees. Based on the feedback, the HRA will finalize the strategy later this year and will also publish a plan for implementing it.  The Research Transparency Strategy Group helped to develop the overall vision for the planned strategy.  (Note: Síle Lane from AllTrials is a member of the Research Transparency Strategy Group

The “Make it Public” strategy will focus on three key areas of research transparency:

  1. Registering research projects;
  2. Making research findings public; and,
  3. Letting participants have access to findings from research.

The strategy was prepared in response to the House of Commons Select Committee on Science and Technology’s October 2018 report on research integrity, following which the HRA was asked to play a more proactive role in improving compliance.  The strategy includes proposals to improve compliance, such as: monitoring sponsors’ and researchers’ transparency performance; giving sponsors and researchers feedback on their transparency performance; sharing best practice and celebrating improvement; flagging individual studies where transparency information is overdue; sharing performance data with funders and others; setting the HRA’s own performance targets and reporting on progress.

The strategy also identifies “some possible further steps” the HRA could take to deal with individual sponsors who do not fulfil their research transparency responsibilities. Juliet Tizzard, HRA’s policy director, explained that within the current legislation, the HRA has some powers to take action. For example, it can start publishing an annual “transparency league table” highlighting individual studies for which information is overdue, or it can take into consideration the extent to which sponsors have fulfilled their transparency responsibilities in relation to their previous studies, when reviewing new studies for approval.

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