The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are committed to enabling the highest quality health and social care research which can benefit the whole UK population.
We recommend creating an Inclusion and Diversity Plan (Plan) early in the process of study design. The purpose of a Plan is to ensure clinical research is designed to include people who could be impacted by the findings, and that people often under-served by research are not overlooked.
A Plan can be submitted alongside an application for approval.
What is an Inclusion and Diversity Plan?
This section explains the purpose of an Inclusion and Diversity Plan
Developing a Plan will support you, and other members of the research team, to consider how you can do as much as possible to include all those who may be impacted by your research, particularly those from under-served groups.
Involving these groups when designing a study will help to make the research more inclusive.
Inclusion of these populations in clinical trials and clinical investigations helps to:
- improve our understanding of a disease and the medical product / intervention under investigation
- ensure that the data generated reflects the diversity of the population expected to use the medical product / intervention
- potentially identify effects on safety or efficacy outcomes that may be associated with or occur more or less frequently within these populations
A Plan should consider the following:
Q1: Who is affected by the disease or condition being studied?
Q2: Do the aims/design of the research mean that the findings will be generalisable to all identified in question 1? If this is not the case, please explain why
Q3: What are your recruitment goals?
Q4: What is your plan to recruit and retain the proposed study population?
It’s recommended you start developing the Plan at the point of study design, and that it’s continuously revisited and reviewed.
When is a Plan needed?
This section explains when a Plan is needed and who is responsible for completing the Plan
You should develop a Plan if you’re a sponsor or a researcher planning a clinical trial or clinical investigation. This includes:
- a clinical trial of an investigational medicinal product (CTIMPs)
- a clinical investigation or other study of a medical device
- a combined trial of an investigational medicinal product and an investigational medical device
- any other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
Observational studies are out of scope for this guidance.
Single studies, multi-phase studies and development programmes
You can submit a Plan for a single study, or you can submit a Plan for the whole product development programme clearly indicating the information that is relevant to the study.
Early phase trials and Healthy Volunteer trials
Inclusivity should be considered from the very first stage of any product development. 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.
Submission of a Plan is not mandatory, and we do not expect companies delivering phase 1 trials, on behalf of sponsors, to develop their own Plan. 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.
Submitting an Inclusion and Diversity Plan
This section explains how and when to submit a Plan
Submission of a Plan is not mandatory but we encourage you to do so.
How do you submit a Plan for review?
If you’re a sponsor or researcher and are planning a CTIMP, or a combination trial of an investigational medicinal product and a medical device, you can submit a Plan with your combined review service application in the new part of IRAS.
If you’re planning any other type of clinical trial (including a medical device) or clinical investigation, you can submit via the standard part of IRAS and include your Plan as a supporting document.
You can submit relevant information you have provided to other regulators or funding organisations as part of your Plan.
How will the Plan be used?
Research Ethics Committees (RECs) will use the information in the Plan to inform their understanding of the overall application and support discussions in the REC meeting. The REC will review your application as normal, with the discussion focusing on where there may be ethical issues within the application. Should your application provide all necessary information, the Plan may not be raised for discussion within the meeting.
You can also discuss your Plan if it needs scientific input, via scientific advice meetings with the MHRA.
The Plan is not a submission document that will be directly assessed as part of the clinical trial application. Therefore, it is not considered to be a documents which form part of Clinical Trial Approval application, for the purposes of the UK Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) nor the Medical Device Regulations 2002 or EU Medical Device Regulation (EU) 2017/745.
The MHRA GCP inspectors won’t be inspecting how the contents of the Plan were decided, how the Plan was written and approved or adherence to the Plan. However, if aspects of the Plan are covered in other documents included in the CTA such as the protocol, then that aspect may be subject to review on inspection by the MHRA.
Could failure to submit a Plan, or the content included in a Plan and/or cover sheet, result in an application being rejected?
No, failure to submit a Plan will not result in an application being rejected. The REC will use the information provided in the Plan to inform their understanding of the overall application. If what’s contained in the Plan leads to questions about the study design, the REC will ask you about it.
However, an application would not be given an unfavourable opinion based on the information contained in the Plan.
If changes are made after review, do you need to resubmit the Plan?
No, you do not need to resubmit the Plan. However, it’s good practice to document any changes or updates to the Plan and retain records.
Will HRA be collecting information provided in Plans to monitor diversity in clinical trials?
No, information provided in Plans will not be collected for the purpose of monitoring the trial or the overall diversity of participants in clinical trials. However, the HRA may explore this in the future.
Will studies that have already received approval from HRA need to submit a Plan?
No, studies that have already received approval will not need to submit a Plan.
If information relevant to the Plan has already been submitted in IRAS, should it be repeated in the Plan?
It is intended that the Plan will prompt thinking about the research in a way that will draw out information which supports the information already provided in IRAS. However, you can reference relevant sections of the IRAS application if it is relevant to the Plan and avoids duplication.
Developing an Inclusion and Diversity Plan
References
1) Bodicoat DH, Routen AC, Willis A and others (2021) ‘Promoting inclusion in clinical trials-a rapid review of the literature and recommendations for action’ Trials 4(22) (viewed on 28 May 2024)
2) Lauzon-Schnittka J, Audette-Chapdelaine S, Boutin D and others (2022) ‘The experience of patient partners in research: a qualitative systematic review and thematic synthesis’ Research Involvement and Engagement 8(55) (viewed on 28 May 2024)
3) Forsythe LP, Carman KL, Szydlowski V and others (2019) ‘Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute’ Health Affairs 38(3) (viewed on 28 May 2024)
4) Crocker JC, Ricci-Cabello I, Parker A, and others (2018) ‘Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis’ British Medical Journal 363 (viewed on 28 May 2024)