Introduction
An informal consultation on the draft HRA and Medicines and Healthcare products Regulatory Agency (MHRA) Inclusion and Diversity questions and guidance was launched in October 2024.
The aim of the informal consultation was to provide an opportunity for the wider research community to inform the development of the guidance, inform amendments to the second draft of the guidance, and identify where we could provide more support for researchers and sponsors in developing an Inclusion and Diversity Plan.
The following outlines who responded to the survey and the themes that emerged.
Who we heard from
There were 310 responses received through the survey, with four responses received by email.
The following were the responses to the question ‘In what capacity are you answering this survey?’:
- as an individual – 265
- I am a member of the public – 58
- I apply for funding and approval – 14
- I deliver research – 75
- I develop research proposals / protocols – 41
- I review research application – 66
- other – 55
- as an organisation: 43
Those who indicated ‘Other’ went on to provide various responses to indicate their role. This included ‘I support researchers’, ‘I do all of reviewing applications, developing proposals/protocols, apply for funding and approval and deliver research’, ‘PPIE manager’ and ‘Work in pharma in a quality role but also interested in diversity and health equity’.
What we heard
Draft Inclusion and Diversity questions
The survey asked respondents if the four questions that will form the basis of an Inclusion and Diversity Plan were clear and if the purpose of the questions was clear.
The majority of respondents felt that the questions and their purpose was clear. However, many respondents went on to provide further comments. The following outlines the themes that emerged from these comments and responses to the question ‘What are the potential challenges of answering this question(s)?’.
Challenges and expectations around data
Many responses highlighted potential challenges in finding reliable sources of epidemiological data to answer question 1. It was requested that further guidance is provided on how to answer this question if data is unavailable, this included clarification on whether global data was acceptable.
It was also raised that there can be challenges around how to appropriately collect demographic data within studies. Some respondents felt that guidance around this would be helpful, as well as clarification on minimum expectations for disaggregation of data.
Expectations for setting recruitment goals in Question 3
Many of the comments asked for more specificity on our expectations in relation to goal setting. There was uncertainty on whether the expectation is to provide a target number or the strategies and processes that will be used in the study.
It was also queried whether recruitment goals should refer to recruitment in the UK only or global recruitment goals. Some comments highlighted that it would be more challenging for large multi-national studies to state recruitment strategies or targets.
Early Phase, observational and rare disease studies
Respondents, including many of the organisations, felt that the questions would be difficult for Phase I, healthy volunteer studies or observational studies to answer (or would have little benefit).
It was also highlighted that Question 4 (recruitment and retention) would be difficult to answer for early-phase oncology trials. Similarly, it would be challenging for rare diseases and paediatric studies as they currently have existing challenges for recruitment due to limited patient populations.
Monitoring and reporting
There was a request for clarity around expectations for monitoring and accountability. This included whether goals would be monitored and what the implications would be for failing to meet goals. Comments also highlighted that there was support among a mix of respondents for some kind of monitoring and reporting post submission.
There was also a request from a number of organisations for the HRA to monitor the impact of the Plan on REC behaviours.
Practical challenges of recruitment
The potential challenges of recruitment were raised often in response to the questions on the potential challenges in answering the four questions that will form the basis of an Inclusion and Diversity Plan. This was raised in the form of concerns about how to set achievable goals, challenges when recruiting from unfamiliar population groups, the importance of appropriate funding, and that a Plan can be created but the actual feasibility of delivering on what is set out in the Plan will be challenging.
Further support and signposting to resources
Respondents felt that the guidance would benefit from signposting to further support or training, such as training packages, best practices, strategies, recruitment platforms and translators.
There was a recommendation to signpost to organisations that can support researchers to work effectively with communities to mitigate the risk of overburdening community organisations with requests.
Engaging with study locations
It was highlighted that recruitment challenges may differ across study locations. This could result in the need for a different Plan for each location which would be time consuming and burdensome.
There was also a request to emphasise in the guidance that there should be good dialogue between study locations and sponsors, and that goals should be set in collaboration. It was also suggested that strategies will need to be high level until study locations have been selected.
Greater emphasis on PPI
Some responses highlighted that the guidance would benefit from a greater emphasis on PPI. There was a request to clarify the relationship between the Plan and PPI, for example if PPI is good and informs recruitment approaches, will that be enough to satisfy this requirement.
International alignment
A number of organisations emphasised throughout their responses that the guidance should align with FDA guidance in this area. This was flagged specifically in relation to guidance around setting recruitment goals.
Example Plans and case studies
A large number of respondents felt that example Plans would be helpful and provide guidance on the level of detail required. It was also felt that case studies of best practice diverse and inclusive studies would be helpful.
Overlap between questions
There were a small number of responses that highlighted some overlap between the questions. The most consistently raised was the overlap between Question 3 and Question 4. These respondents generally found Question 4 to be better worded than Question 3. There were also a small number of comments relating to the questions overlapping with the protocol.
Will an Inclusion and Diversity Plan provide an opportunity to include information you would not generally provide or receive in a submission?
The majority of respondents felt that the four questions would provide an opportunity to include information that would not generally be provided or received in a submission. However, it was highlighted that to ensure sponsors are not overburdened with an increase in submission requirements, it was important to align across countries to streamline as much as possible.
A small number of respondents felt that an Inclusion and Diversity Plans would not provide further information as this would also already be provided in a good protocol or simply stated ‘No’ or ‘Not really’ to this question.
Do you think the questions will have a positive impact on the design of studies by helping researchers to develop more inclusive protocols?
Again, the majority of respondents felt that the questions would have a positive impact on the design of studies.
Many of the responses simply stated ‘Yes’ or ‘Hopefully so’, with a small number stipulating that there would need to be some slight changes to the questions to provide more clarity around expectations, a pragmatic approach in the delivery and monitoring of the initiative, signposting to resources, and appropriate funding.
Other respondents were supportive but thought the potential for the questions to have a positive impact was based on certain factors. Some of these factors included the quality of the Plans, whether these Plans are actually implemented or executed, addressing the actual barriers that researchers face and providing supporting tools and resource, the potential extra burden, and the Plan not being mandatory.
There were some respondents who did not think the questions would have a positive impact on the design of studies. The most common reason among these comments were related to a Plan having little benefit for Phase 1 studies, the lack of compulsory language, and it potentially becoming a tick box exercise due to a lack of culture change.
Having read the supporting guidance, I have the information I need to create an Inclusion and Diversity Plan
The majority of respondents felt they had the information needed to create an Inclusion and Diversity Plan. Respondents that answer ‘No’ requested further guidance in areas such as relevant resources, more practical information, effective strategies, and expectations around monitoring or accountability.
Is there anything missing from the guidance or do any sections need more detail?
Some respondents requested clarity on how the guidance applies to multi-phase and global development programmes and early phase and rare disease studies. Signposting to reliable sources of data, case studies and example Inclusion and Diversity Plans were also requested. A number of respondents requested that the HRA monitor the impact of Inclusion and Diversity Plans as part of the approval process.
Amendments to draft version 2 of the Inclusion and Diversity questions and guidance
Early Phase, observational and rare disease studies
- clarification has been provided in the second draft of the guidance that submission of a Plan is not mandatory
- a statement that observational trials would be out of scope for this guidance has also been introduced
- The following statement has been added to further clarify expectations for early phase trials:
"Submission of a Plan is not mandatory, however if you’re planning an early phase trial, including Healthy Volunteer trials, you can briefly describe and justify the trial population for this study as part of your research ethics application, providing assurance that no group has been unnecessarily excluded. Sponsors should consider full justification of any population that would be excluded from early phase trials within the context of the overall product development programme. We do not expect companies delivering Phase 1 trials, on behalf of sponsors, to develop their own inclusion and diversity plans."
Expectations for setting recruitment goals
- clarification that Plans for multinational studies should state the overarching study wide recruitment goals and explain how the UK study will contribute to them
Challenges and expectations around data
- clarification that where UK specific data is not available, global data may be used
- we will explore during the pilot if there are reliable sources of data that can be signposted to in the guidance
Overall clarity of the guidance
- edits to the second draft of the guidance to further emphasise that the under-served groups to be considered will vary depending on the study
- changes to the format of the second draft of the guidance to ensure information is easier to find and the overall guidance is clearer
- small edits to wording to improve clarity of the second draft of the guidance
Ongoing work in response to feedback
Further support and signposting to resources
- we will explore during the pilot how we can signpost to further support or training, such as training packages, best practices, strategies, recruitment platforms and translators - this will sit outside the guidance
Example Plans and case studies
- during the pilot, we will work with researchers and sponsors to explore developing example Inclusion and Diversity Plans and case studies showcasing best practice for inclusive and diverse studies
Further amendments to version 2 of the inclusion and diversity draft questions and guidance
On review of the draft questions and guidance further edits have also been made to the ‘Submitting an Inclusion and Diversity Plan’ section to provide further clarity on how an Inclusion and Diversity Plan will be used when it is submitted as part of an application.
Take part in our pilot
We are now launching a pilot project to ask sponsors and researchers to volunteer to develop the Plan and submit it as part of an application for their trial for review by a Research Ethics Committee.
Our aim for the pilot is to assess the benefits of developing the Plan and we will be asking for further feedback from researchers and RECs on their experience.
The pilot is now open to take part in and will run for approximately 6 months.
If you would like to take part in the pilot, please email engagement.team@hra.nhs.uk