 Look out for your chance to feedback on our diversity plan
We’ve been working with the MHRA on guidance to help researchers to design studies that include people who could be impacted by the findings, and ensure that the people often underserved by research are not overlooked.
We now have a first draft, developed in collaboration with a group of researchers, public contributors, people from industry, research funding organisations and Research Ethics Committees.
The draft includes a set of questions which will form the basis of an inclusion and diversity plan. The plan will help researchers to consider how they can best support participation in the design of their research.
We’re getting ready to share it for your feedback.
Our informal consultation will ask for your help to refine the questions asked as part of the plan and to make sure the guidance is easy to understand.
We’re also keen to understand thoughts or concerns you might have with the plan, including how this relates to the new requirements of research inclusion from other organisations such as the U.S. Food and Drug Administration.
Look out for more information coming soon!
 Public involvement guidance for clinical trials
The diversity plan is just one area in which we’re working on new guidance.
We’ll be publishing updated public involvement guidance for clinical trials, including specific guidance to support public involvement in Phase 1 clinical trials.
We hope the updated guidance will make it easier to understand our expectations when it comes to public involvement in designing, conducting and sharing the results of clinical trials.
Good public involvement can lead to the development of higher quality research and make it easier to recruit and retain participants.
With that in mind the new guidance will include examples of best practice to help highlight the difference properly involving members of the public in research can make.
 An update on Research Ethics Committees
Over the past few weeks we’ve been asking doctors and pharmacists across England to step forward to help review proposals for new life-changing research.
Now, as part of new clinical trials legislation, we are considering whether we can align the constitution of our Research Ethics Committees with the scientific guideline on good clinical practice (ICH-GCP-E6).
This would mean that all RECs would need to have:
-
a minimum of five members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial
-
one member appointed as a chair person and one person who is a lay person
A lay person is defined as someone who does not have a formal qualification or professional experience in the field of clinical research or healthcare. We’ll update you on plans for the make up of committees in the coming months.
 Simplified means of seeking consent in lower risk trials
As part of the update of the Clinical Trials Legislation, we are looking at ways to make it easier to seek and record informed consent from large groups of participants, rather than individuals, in a way that people can trust.
We asked for views on this in the 2022 consultation on future clinical trial legislation and now we’re nailing down the detail.
Our work is focusing on trials that are considered to have lower risk as they involve medicines that are already authorised for use in the UK.
For example, cluster trials are a type of large trial that compares the effectiveness of different treatments. Instead of assigning treatments to individuals, entire groups are given the same treatment. This could mean that one hospital's patients might all receive one treatment, while another hospital's patients get a different one. This helps researchers see which treatment works better.
In the next few months we will be coming out to ask your thoughts on simplified means of seeking consent.
We will then develop new guidance informed by this feedback. We want to develop a simplified means of seeking consent that maintains people’s trust whilst supporting high quality research in the NHS.
Planning for new research transparency requirements
When the Clinical Trials Legislation is updated, we are planning to introduce new transparency requirements for sponsors.
We’ve been working with the MHRA on a draft version of the legislative text that will make it a mandatory requirement to:
-
register a clinical trial on a public registry before the recruitment of the first participant, or within 90 days of approval, whichever is the sooner
-
publish a summary of the results within 12 months of the end of the trial
-
share an easy to understand summary of the results (where appropriate) with participants, those who may have provided consent on behalf of the participant or other relevant people
The new legislation will also outline a new process for deferring the above requirements for a certain period of time, and in rare cases exemptions for national security reasons.
Once the legislation is published, we will be able to set out our timeline to develop clear guidance to support researchers to meet these new requirements.
We will be asking for your feedback to ensure that this works in practice.
Tell us what you think
To help us make sure we’re sharing the right information in these updates, please complete our short two question survey.
|
