Our commitments in detail
We plan to implement the 10 commitments in the strategy through a number of different projects. Those projects are described below, with an expected timeline. Some projects are linked to our IT systems redevelopment where timelines are not yet defined.
Reviewing our guidance and standard conditions for approval
Linked to strategy commitments:
- Being clear about what we expect of sponsors and researchers and what they can expect of us
- Supporting good practice through guidance, learning and clear communication
| Projects | Timeline |
| Review and update existing guidance on our website and in the Integrated Research Application System (IRAS) to clarify research transparency requirements and best practice | October 2020 |
| Review and update the information we give to successful applicants to clarify research transparency requirements | December 2020 |
| Develop learning modules on research transparency for researchers, sponsors and HRA staff | December 2020 |
| Further refine our guidance by undertaking user research to gather insights about the best format to present information | March 2021 |
| Change the question in IRAS so that applicants are asked how and when they will inform participants about the study findings | TBC |
Provide enhanced individual study information through our website
Linked to strategy commitment:
9. Publishing or sharing accessible information about individual studies and their findings
| Projects | Timeline |
| Improve and expand the Research Summaries site for providing information about approved studies | Spring 2021 |
| Add lay summaries of research findings to individual approved studies on our website | 2021-2022 |
| Add information about support from the Confidentiality Advisory Group for individual approved studies on our website | 2021-2022 |
| Add research transparency performance information for individual approved studies on our website | 2021-2022 |
Running an engagement programme, using the Make it Public brand
Linked to strategy commitments:
6. Rewarding and celebrating good practice
2. Supporting good practice though guidance, learning and clear communication
| Projects | Timeline |
| Continue to promote research transparency through the Make it Public campaign | Ongoing |
| Hold the first research transparency annual meeting one-year on from the strategy launch | Summer 2021 |
| Publish the first annual research transparency report, with performance data added over time | Summer 2021 |
Establishing ongoing monitoring on study reporting and developing a framework for measuring performance
Linked to strategy commitments:
4. Reminding researchers and sponsors when their reporting is due
7. Taking action where researchers and sponsors do not fulfil their research transparency responsibilites
| Projects | Timeline |
| Pilot and develop a standard dataset for the final report with stakeholder input, starting with clinical trials of medicines | TBC |
| Develop processes and commence manual follow-up of final report for information, analysis and reporting | December 2020 |
| Design and implement automated reminders and electronic submission of final reports | TBC |
Carrying out an options appraisal on a model for UK clinical trials registration
Linked to strategy commitment:
8. Ensuring that all clinical trials taking place in the UK are registered before the first patient is recruited, unless the sponsor has permission to delay this to a later stage.
| Projects | Timeline |
| Carry out an options appraisal for a model for UK registration of clinical trials | October 2020 |
Align expectations across funders, regulators, and publishers
Linked to strategy commitment:
5. Working with research funding bodies, other regulators and publishers to make sure that expectations around research transparency are consistent and aligned
| Activities | Timeline |
| Establish a stakeholder forum to facilitate alignment of research transparency requirements | 2021-2022 |
Introducing sanctions into the approvals process
Linked to strategy commitment:
7. Taking action where researchers and sponsors not fulfill their research transparency responsibilities
| Projects | Timeline |
| Develop a policy for how we will assess performance against research transparency requirements and how that will be used when reviewing new studies for approval | 2021-2022 |
| Introduce research transparency performance assessment into review of new studies | 2021-2022 |