Research Regulation SpecialistMatthew Sanderson
The world of information governance (IG) in health and care research can often feel murky, shrouded in nuance and clouded by uncertainty. This is especially true for those who are new to research and learning how research governance requirements sit alongside IG rules.
As part of the Health Research Authority’s (HRA) work to support the UK Clinical Research Delivery (UKCRD) programme, throughout the summer of 2025 we are working to bring greater clarity to these uncertainties by:
- making visible the criteria for how information governance is reviewed at study wide review
- improving training for study wide reviewers and making this visible
- clarifying ‘good practice’ standards for information governance evidence in IRAS submission for sponsor and sites
Why is our work important?
IG in healthcare is vital for protecting people and their data, nowhere more so than in research where people’s health data must be securely accessed while still enabling important research to be carried out.
Good IG practices support the trust that is built between patients and their healthcare providers. This trust must carry over into research taking place within the health service. Where there is a loss of trust in the system there is a risk of duplication of review, delay, cost and loss of capacity. All of which harm the ability of the NHS to provide the best research and care opportunities to patients.
The HRA is committed, with our partner organisations in the devolved nations and other stakeholders, to ensuring that the systems and processes for planning, preparing, approving and delivering research are ones that NHS service users and organisations can trust.
We recognise the need to further publicise and strengthen the established system in which sponsors design good IG practices into their studies - in a way that review bodies can assess and approve centrally.
This means sites can be assured and not feel obliged to duplicate the review locally.
This work forms part of the HRA’s core mission to make it easy to do the right thing in research, with all study-wide reviewers playing a role in supporting a system that works efficiently and transparently so that people can trust both the process and the outcomes of health and care research.
Recap on our work so far
In 2022, we published a survey that was completed by 179 NHS and HSC organisations across the UK.
The results of this survey told us many things, but one of the main findings was that many NHS research sites are conducting duplicative IG reviews.
In 2024, we responded to the results of that survey by publishing a blog outlining the seven proposals that we think will help sites to take assurances from our IG review.
Our priorities
From the seven proposals we made, we have prioritised the three pieces of work that we think will have the most immediate impact this summer whilst we work on the other proposals in the longer term:
These are:
- making visible the criteria for how information governance is reviewed at study wide review
- improving training for study wide reviewers and making this visible
- clarifying ‘good practice’ standards for information governance evidence in IRAS submission for sponsor and sites
We are taking this opportunity to provide a bit more detail about each of these and an update on the work we have done so far to action them.
Making visible the criteria for how information governance is reviewed centrally at study wide review
The UK-wide criteria that we review studies against can be found on the HRA website.
Section 5.1 (‘Compliance with Data Protection law and data security issues assessed’) of the criteria details our expectations on the IG aspects of a research study. The IG study wide review criteria are for use by the HRA staff who review studies and their equivalents in the other nations of the UK, as well as for reference by sponsors designing good IG compliance into studies. We also expect that NHS research offices are familiar with the criteria so that they know what our review covers and do not duplicate it.
As part of our work to make these IG criteria more useful to the research community, our intention is to make the criteria easier to read and understand for people using them by improving the language, format and presentation of the IG criteria.
Our work so far has included:
- simplifying the language
- increasing the use of sub-headings
- increasing the use of bullet points
- introducing a contents page
We hope that this will help research sites to understand the review that has taken place on the IG aspects of a research study and what they can take assurance from when setting up that research study at their organisation.
This work has been supported by people who review research studies in all four nations of the UK. We have also incorporated feedback on the updated criteria from IG specialists, staff at research site organisations, and staff from research sponsor organisations.
Improving training for study wide reviewers and making this visible
We appreciate that IG and research are worlds that are ever-changing and evolving.
Staff who review research studies need to be aware of those changes to ensure they conduct consistent and accurate reviews that can be relied upon by others. The HRA ensures that staff receive detailed, ongoing IG training as part of their job role.
When we spoke to staff at the HRA who received that training, they had some really good ideas about different formats of training to improve its effectiveness for all staff. Those ideas will form part of a long-term update to the training, but in the short-term we intend to update the training provided to our staff, to reflect the refreshed IG study wide review criteria.
We are working with the HRA’s learning and development team to create some interactive, digital learning modules for our staff. This training will also be shared with our equivalents in the other UK nations to support consistency across the UK.
Clarifying ‘good practice’ standards for information governance evidence in IRAS submissions for sponsor and sites
We are developing a checklist-style document that sponsors can use to understand what we consider to be good practice when they submit research studies on IRAS.
We hope this document, particularly when used in conjunction with the updated IG criteria, will provide sponsors with a handy guide to the information we want to see in a study application.
We also hope that sponsors will use this document to tell us and sites about the information provided on IG topics. This will help our staff to easily pick out the key relevant information they need to expedite the review process.
It will also help research sites to feel assured about the information that has been reviewed to avoid unnecessary duplication of work and expedite the review and site set up process.
What next?
Improving IG assurances and reducing the duplication of work that can be done on a once-per-study basis, must reflect the experience and needs of the research community.
The 2022 survey helped shape our priorities and the ongoing feedback we receive will help us implement them.
We will seek support from different groups across the UK to inform our work including:
- research sponsor representatives
- research site representatives
- IG specialists
- Caldicott Guardians
- HRA and devolved nation equivalent staff who review studies
We will continue working on these three priority actions with a view to publishing the updated study wide review criteria and the new good practice document, alongside developing and implementing updated reviewer-facing IG training at the end of Summer 2025.
If you would be interested in getting involved in our work, providing us with feedback or telling us about your experiences of IG in research, please do get in touch with us by emailing Alison.Knight@hra.nhs.uk or Matthew.Sanderson@hra.nhs.uk
To keep updated on this and other work at the HRA you can sign up to our HRA newsletters.
Alternatively, we will regularly update our UKCRD webpage.