When we launched the Make it Public strategy in July 2020, we committed to support the research sector to always be transparent by making it easy and the norm. We also said that we will take measures to make information from research public. Now 18 months on, changes are moving at pace. Naho Yamazaki, Head of Policy and Engagement looks at the progress and impact of our work on research transparency.
At our recent Make it Public conference I spoke about what we have done to realise the vision for research transparency laid out in our Make it Public strategy. To prepare for this I had to take a step back and look over the road already travelled. It highlighted the great strides we have made and are still making to increase transparency across the health and social care research landscape.
When we were developing the Make it Public strategy, we found that 30 per cent of clinical trials were not registered. Even now, this is the case for more than 10 per cent of clinical trials. Our consultation asked what we could do to ensure 100 per cent registration.
In our strategy we made a commitment to register all clinical trials on behalf of sponsors, ensuring full registration of all UK clinical trials in a single location.
We introduced automatic registration for trials approved through combined review at the beginning of the year. To do this we’re working in partnership with ISRCTN, which is a World Health Organization (WHO) recognised UK registry. We will roll this out to other types of clinical trials in the future.
Automatic registration makes it the ‘norm’ because it happens as a matter of course.
Seeing the whole picture
We’ve always known that access to a complete and unbiased evidence base reduces research duplication and waste. Never was this clearer than during the current pandemic, where making research information public helped to build on knowledge and foster collaboration. We publish summary information of all research reviewed by a Research Ethics Committee on our website but for COVID-19 research, we made sure that the summary of these were published within three days of approval.
We also know, however, that there are times when sponsors may wish to delay registering a trial or having their research summary published on our website, for instance to protect commercially sensitive information. They can apply to us to do this and we review these requests individually.
From the end of January, we will bring the rules around deferring registration of clinical trials in line with best practice.
Studies that ask to defer registration and publication of a research summary on our website will now be asked to upload some limited information in a WHO recognised registry. This will give a fuller picture of research taking place in the UK.
We’ll also introduce a cap on the time a deferral can be in place. This will be 30 months after the end of a study, to give more timely access to the outcomes of research and the data behind it. By introducing new rules, we are setting the balance between research transparency and protecting commercially sensitive information.
Making clear reporting easier
It’s always been a requirement that studies submit a report to Research Ethics Committees 12 months from the end of the study. In September last year, we introduced a new standard final report to make it easier to report on and measure transparency across research.
In the report we ask whether researchers have fulfilled their transparency requirements. We also ask for a plain language summary of results. The summaries go onto our website so research participants can easily find and understand the outcome of the studies.
Since September, 320 final reports have been submitted, almost 90 per cent of those included a lay summary in the report. Information from these reports can be search on our research summary pages.
Feeding back to participants becomes the norm
When we were developing the Make it Public strategy, we found that almost 90 per cent of researchers said they will communicate their results to participants but didn’t. We want to change that.
We’ve updated the question we have in IRAS, the application portal, asking researchers how they will inform participants at the end of the study.
Rather than ‘will you tell participants?’ we ask ‘how will you tell participants?’, setting the tone that this is expected; that telling participants about results is the norm.
Our final report asks if the researcher has done what they committed to do at the start.
We know that this is an area that still needs a lot of work. Participants give their time and access to their data, they want to be treated as active partners, not passive recipients. We also know that most researchers want to be transparent but would like help to be able to do that. Our published guidance on writing a lay summary of results can support them in doing this. We have a new e-learning module to help researchers write better plain language summaries.
The culmination of all of this is to give everyone a more complete picture of research in the UK, improving the quality of research, increasing the impact, and reducing avoidable waste. There is more to do and we will continue to work with the Make it Public campaign group we have established and wider stakeholders to embed research transparency across health and social care research.
Dr Naho Yamazaki, Head of Policy and Engagement.