Developing an Inclusion and Diversity Plan

The following sections of this webpage provides advice on what you should include in your Inclusion and Diversity Plan.

Although under-served people and groups are generally considered to be people, communities or groups who are less represented in health research, the communities that constitute these groups may vary depending on the context or study. The NIHR have identified several characteristics common to under-served groups including:

• lower inclusion in research than one would expect from population estimates
• high healthcare burden that is not matched by the volume of research designed for the group
• important differences in how a group responds to or engages with healthcare interventions compared to other groups, with research neglecting to address these factors.

It’s important that the study population reflects the real-world and every effort should be made to include the full range of people who the research is for and about. You should consider:

• how your study population reflects the real-world population
• reaching out to the people and communities who could be impacted by your research
• the effect of your work on minority communities, under-served groups, people who have been identified with health inequalities, people with poor literacy, people from different cultural backgrounds, and people with protected characteristics
• sharing back your findings with under-served groups, to build trust in the effect of their participation in the research process

The HRA and INVOLVE have previously released a briefing explaining the value of public involvement in the design, management, conduct and dissemination of research. Excellent public involvement is essential and has been shown to improve the quality and impact of health and social care research2, 3, 4. Involving people who your research is for and about in the design stage, will help ensure that your research is accessible to everyone. The four principles for meaningful involvement of patients and the public in health and social care also provides guidance on best practice for public involvement.

The following are examples of groups or factors you should consider when developing a Plan (this is not an exhaustive list). The NIHR-INCLUDE project also provides examples of groups that may be under-served. These lists are to support you in considering who may be under-served. You are not expected to make reference to every group listed in your Plan:

• Different ethnic groups
• Sex characteristics
• Sexual orientation
• Language barriers
• Level of education
• Physical or mobility impairments
• People belonging to a faith community or belief group
• Highly mobile communities such as Gypsy, Roma, and Traveller communities, or homelessness
• People living in remote or rural areas
• Carers
• Neurodiversity
• People with a learning disability
• Multiple health conditions
• Pregnancy
• Socioeconomic factors such as employment status, income
• Youngest and oldest age groups such as under 18 and over 75

When considering different people and groups in your Plan, it’s important to consider how different characteristics interact and overlap to create greater disease burden and barriers to inclusion.

Question 1: Who is affected by the disease or condition being studied?

Information you should consider including when you answer this question

Provide a short summary of who is affected by the disease/condition.

Describe the current understanding of any similarities and/or differences in the disease or condition under study across different population groups. Reference any data/evidence you used to provide this description.

Purpose

1. To understand who is affected by the disease or condition and where there are gaps in data.
   
2. To understand what is/isn’t known about how different groups are impacted by the disease/condition.

When considering this question, you should consider under-served groups and how they may potentially be impacted by the disease/condition differently. Under-served groups are generally considered to be groups who are less represented in health research. However, the communities that constitute these groups may vary depending on the context or study. The Plan should show consideration of the under-served groups that are relevant to your study.

Where epidemiological data is available it should be used to support study design (question 2) and recruitment goals (question 3). Where UK specific data is not available, global epidemiological data may be used. The NIHR Life Sciences Industry Hub provides support in navigating the UK's research data.

Question 2: 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?

Information you should consider including when you answer this question

Outline and describe the reasons for choosing the population groups to include in your study.

Where applicable, provide information on:

• study design, study population (including study eligibility criteria), study endpoints, the expected geographic location(s) of the study and how this may help to recruit population groups including under-served groups
• any findings from previous clinical pharmacology studies (PK/PD data, pharmacogenomics) or other investigations that may demonstrate a different effect on different populations where this is available
• any findings that demonstrate a potential difference in perception or acceptability of the intervention in different populations
• if the data will be disaggregated
• how the study will support the product’s safety, performance, effectiveness and, if a drug, dosage in a future marketing or licensing submission or prescribing practice.

Purpose

1. To understand who could be impacted by the product or intervention that’s being developed or investigated.
   
2. To have a clear justification of which population groups identified in point 1 above, including under-served groups, will be included or excluded from the study population.
   
3. To understand how study design including study population, endpoints, and geographical locations will have an effect on generating data relevant for those who could be impacted by the product or intervention.
   
4. To consider how the study design will give adequate (generalisable) evidence on the safety or effectiveness of the product or intervention.

To consider if and when to disaggregate the data.

When answering this question, you should show you’ve considered any differences between the population identified in Question 1 and the study population. You should avoid providing a general overview of the study when answering this question.

You should give the rationale for any inclusion/exclusion criteria (and other aspects of the study) that will, or may, influence inclusion or exclusion of under-served groups. However, it’s important that the inclusion criteria are supported by a positive risk/benefit assessment.

If you don’t have any data about how the product or intervention may perform differently between different population groups, recruitment should reflect the epidemiology of the disease. In other words, the study population should be similar to the disease population.

You should include any plans you have to collect and analyse data that will explore potential differences in safety and effectiveness across population groups, particularly under-served groups you have identified in your response to Question 1.

Demographic data collection

Researchers and sponsors should collect demographic data of participants to support transparency and understanding in relation to the safety and efficacy of the intervention in different groups. This will also support the building of an evidence base. We recognise that how categories are defined can vary according to country or different settings. In the absence of agreed international categories, researchers and sponsors should clearly outline how they have defined demographic categories in their study.

Question 3: What are your recruitment goals?

Information you should consider including when you answer this question

Specify the approximate number of people you are aiming to recruit from the population groups outlined in question 2.

Outline and provide the rationale for planned recruitment of participants based on the information provided in Question 2.

Purpose

1. Consider what goals can be set to recruit the proposed population groups, particularly under-served groups

Decide whether increased recruitment of a population is required for you to identify differences and meet your goals.

For this question you should specify the goals for the recruitment of participants, particularly under-served groups. You should base these on the epidemiology of the disease and/or information that may influence outcomes across under-served populations that you identified in Question 2. You should aim to set informed goals that are realistic and achievable.

If it’s a multinational study your Plan should state the overarching study wide recruitment goals and explain how the UK study will contribute to them.

In some cases, increased (meaning greater than the population percentage) recruitment of certain populations may be needed to reveal potentially important differences.

You’re encouraged to use various data sources (for example published literature and real-world data) to set recruitment goals. In certain situations, it may be challenging to set a recruitment goal based on the epidemiology of the disease due to the limited availability of relevant data regarding the disease and patient characteristics. If this is not possible, it may be appropriate to set the recruitment goals based on the demographic characteristics in the overall population with the disease or condition.

You should outline any potential challenges for the study in recruiting under-served populations. This should support the development of a plan of action to recruit and retain the proposed study population (to be answered in Question 4).

Goals should be taken into consideration when selecting study location(s).

Question 4: What is your plan to recruit and retain the proposed study population?

Information you should consider including when you answer this question

Describe in detail the operational measure(s) that will be implemented to recruit and retain participants, especially those from under-served groups in your study.

Describe specific study recruitment and retention strategies, including but not limited to:

• study location and access
• patient and public involvement, community engagement and/or outreach activities
• reducing burdens on participants through study design/conduct

Describe metrics to ensure that recruitment and retention goals are achieved and specify what you’ll do during the study if planned goals are not met.

Outline how you’ll monitor the success in achieving your recruitment and retention goals.

Purpose

1. To consider how in practice you’ll recruit and retain the proposed population groups, including under-served groups.
   
2. To consider if additional recruitment and retention strategies are required to support inclusion and access.
   
3. To consider what to do if planned recruitment and retention goals are not met.

To ensure ongoing review of the plan, and action is taken when goals are not met.

We recognise the current lack of evidence for effective strategies to recruit and retain under-served groups. However, if you are planning any actions to help earn trust and maintain long term relationships with under-served communities, you should document these in your Plan.

Revisiting and reviewing Plans

A Plan is not intended to be a static document. As your study makes progress, you should monitor the success in achieving your recruitment and retention goals (as you outline in question 4 of the Plan). You may need to try new strategies. It’s good practice to have clear documentation about any changes or updates to a Plan.

We encourage you to share information about what strategies supported you to achieve your goals, those that proved ineffective and any other learnings. This will improve the evidence base relating to effective strategies to recruit and retain different population groups.

Monitoring and reporting

The implementation of Plans will not be monitored. However, we recommend you revisit, review, and update the Plan throughout the study and retain documentation.