Make It Public – new strategy marks step change in making health research findings available to the public

The Health Research Authority (HRA) is today (30 July) launching a new strategy to ensure information about all health and social care research – including COVID-19 research - is made publicly available to benefit patients, researchers and policy makers.

The COVID-19 pandemic has highlighted the importance of sharing details of research taking place - to understand the virus and find the tests, treatments and vaccines - so that results can inform best quality care and preventive measures. This also means researchers do not duplicate efforts and can build on each others’ work while the public can see what research is going on. 

Now the new Make it Public strategy aims to build on this good practice and make it easy for researchers to be transparent about their work.

The strategy, delivered by the HRA in partnership with NHS Research Scotland (NRS), Health and Care Research Wales and Health and Social Care Northern Ireland, is about making transparency ‘the norm’ in research and making information more visible to the public. New measures set out in the strategy – will improve transparency and openness in health and social care studies, by:

• Expecting researchers to plan how they will let research participants know about the findings of the study from the beginning
• Introducing additional monitoring to check that researchers are reporting results and to collect information about study findings
• Making information on individual research projects – and their transparency performance – available to the public
• Introducing a system to consider past transparency performance when reviewing new studies for approval and in the future introducing sanctions

The strategy was developed with oversight from a UK-wide expert group, chaired by Professor Andrew George, and shaped by a public consultation held last summer. Through the strategy, the HRA is committed to both helping researchers to be transparent, and taking action where standards are not met. Professor George said:

“During the public consultation, we heard from hundreds of researchers and sponsors, patients and participants, funders and registries who, like us, feel passionately about transparency and openness in research. It is time for change; better support and encouragement for researchers and research sponsors, greater visibility for patients and the public and fair consequences for those who don’t take transparency seriously.”

Professor Chris Whitty, Chief Medical Officer for England, when introducing the strategy said:

“Transparency and openness is essential in making the most of the commitment of patients, service users and healthy volunteers who take part in research. By disseminating research findings widely, we also enable further research and provide a strong evidence base for commissioning services and making health and care policy. The Make it Public strategy signals our ambition for research transparency in the UK. Its vision of trusted information from health and social care research studies being publicly available for the benefit of all is one that we can all share.”

The new strategy is in response to a report published by the House of Commons Science and Technology Committee in 2018, which identified gaps in reporting for clinical trials: 20% of clinical trials carried out in the UK do not appear on a public registry*, and 25% of clinical trials of medicines don’t publish results on time**.

Organisations across the health and social care research sector – research funding bodies, hospitals and medical charities – are supporting the strategy.

Juliet Tizzard, Director of Policy at the HRA, said:

“The Make it Public strategy is not just a strategy for the Health Research Authority. It has been shaped by those it will affect and is based on a vision that everyone involved in health and social care research can sign up to – that trusted information from health and social care research studies is publicly available for the benefit of all. We are now working with patients, researchers, funding bodies and others to design the detail, so that the strategy creates lasting change across all health and social care research in the UK.”

Professor Kieran Walshe, Director of Health and Care Research Wales, said:

“We are pleased to have contributed to the UK joint consultation on the Make it Public strategy. It’s vital that we help increase public access to research findings to ensure volunteers not only know the results of the research they have taken part in but also how it might help them or their family and friends in the future.”

Research participant Lynn Laidlaw from Edinburgh who took part in the consultation, is backing the final strategy.

Lynn said: “People living with conditions, and healthy participants, who take part in research fundamentally deserve to know the results and whether it will affect their care and treatment in the future. Informing them is essential, without their participation the research wouldn’t have been possible. 

“I took the time to get involved with the #MakeItPublic consultation and the Edinburgh workshop as I have participated in quite a few research studies, but I’ve never been told the outcome of these. This makes me feel a mixture of sadness and anger and I’ve decided not to take part in any more research if the researchers don’t plan to share the results at the end of the study. 

“A culture change is needed. I support the sanctions proposed in this strategy to ensure that everyone can access important information about research and the results of studies. No one wants research to succeed more than patients, but we need to be included if it’s to be successful.’

The HRA now begins work to implement the new strategy, starting with clear guidance for researchers and sponsors, an enhanced monitoring programme to ensure public reporting and informing study participants and, further in the future, introducing sanctions into the research approvals process.

For more information go to www.hra.co.uk/makeitpublic.

 

* Denneny C, Bourne S, Kolstoe SE ‘Registration audit of clinical trials given a favourable opinion by UK research ethics committees’ BMJ Open 2019;9:e026840. doi: 10.1136/bmjopen-2018-026840

**EU Trials Tracker, EBM DataLab, University of Oxford. Data for clinical trials on the EU Clinical Trials Register with UK sponsor as at 3 June 2019