The past two years have revealed the ugly truth about diversity in research: it’s not been a priority. But with all of the media coverage, federal and NIH mandates, and even FDA guidelines now available, many researchers struggle with how to take real steps to reduce health disparities and achieve diversity, equity and inclusion in health research.
In order to achieve a diverse participant population for your research, you must clearly define what that means. Without understanding what a truly equitable participant population looks like, you will struggle to understand if you’ve successfully achieved your goal.
In working with organizations like the All of Us Research Program, we’ve found that there are things you can do to succeed in recruiting and retaining a diverse set of participants in your research.
This goes beyond listing desired ethnic, gender, socioeconomic, and other groups, and requires that you seek inputs into what obstacles they face, and what needs they have.
To be effective, begin by clearly defining your participant population.
Define the Research Participants You Need to Reach
The simplest way to begin this task is to ask, “Who are the desired participants to include in a research study?”
However, after doing this, you must reflect and also ask, “Is anyone being unintentionally excluded?”
There are many considerations to include. For example:
- Race
- Ethnicity
- Age
- Ability
- Culture
- Education/literacy
- Gender identity
- Geography/location
- Income/socioeconomic status
- Language
- Religious beliefs
- Sexual orientation
- Technology knowledge/skill/comfort level
Depending on your particular research area, you may not need to include all of these considerations. However, to meet FDA mandates, you should explore each of these areas.
Then, seek input from colleagues or collaborators from some of these demographic areas, and ask them the same question: “Is anyone being unintentionally excluded?”
Seeking that input is a critical step, because without doing so, you risk creating your own ideas about under-represented groups. In research, you seek accuracy, so you should seek the same level of validation as you design your research protocol.
Supporting Your Participant Populations’ Needs
When it comes to preparing the tools and materials we need to promote and launch a research study, most researchers are focused on “speed to market.” In other words, with the sheer volume of effort to begin the study, preparing materials can become no more than a task to complete, rather than an exercise in understanding your participants.
However, there are baseline considerations you can explore. We’ll cover them here to help you begin.
Plan to Support Languages Based on Your Research Study and Community
Language is an obvious consideration, and you may need to support more than one. It’s also one that requires real planning and effort to ensure accessibility to non-native English speakers.
Develop a plan to document your assessment of the community, key policy decisions, standard operating procedures for implementation, documentation, and resources.
You’ve already defined the participant universe. Based on who you need to reach, ensure you understand the primary languages spoken by the population in your community. Evaluate language preferences from system EHRs, community organizations, and census data.
Do you need to stay in touch with your research participants? The answer to that question should determine how much effort you expend in translation. Some research has retention as a key goal, and other research studies return results to participants.
When either of these additional steps are a part of your protocol, you’ll need to go beyond just translation at the start of the study. You must consider the long-term implications of translation and your commitment to those participants.
And there are best practices to ensure your materials do the job of clearly communicating the value and purpose of your study.
- Do not rely on AI solutions for translation, especially online translations. Nuance and humanity exist in phrasing and semantics. Ensure that the translation speaks to your specific communities.
- Strive for contextual translation rather than direct translation.
- Consider translating in parallel – translation developed in tandem with the original language. This ensures intent is captured in both languages.
- Test with intended audiences to ensure readability and comprehension.
- Federal, state, institutional review boards, and organizational/institutional laws can and do govern the approach to translation of materials. Check with all governing entities to ensure that you do not run afoul of any legal regulations.
Because ensuring successful language support for other languages requires planning and resources, don’t expand further than is necessary for your enrollment targets. Prioritize translation for the highest frequency language(s).
For the rest of your community, focus on improving readability.
Readability
Readability is how easy it is for a person to understand a piece of writing. Because medical terminology can stretch even highly educated participants, it is imperative that you include wording that is easy to understand. A commonly used standard is at grade level 7 (or below).
The CDC Health Literacy website has tremendous resources to ensure that complicated health and medical terms are communicated in an understandable manner.
You don’t have to translate into every spoken language to offer a more accessible set of study materials. However, you do need to ensure that materials are designed for easy consumption for non-native English speakers.
In addition to the CDC’s resources, here are some guidelines we use to ensure readability.
Adhere to plain language.
- Use common terminology and avoid colloquial expressions.
- Write short sentences of 15 words or fewer.
- Limit paragraphs to 5 sentences or fewer.
- Address points directly and use words with fewer syllables.
- If your materials will have a speech component, ensure you plan for those who speak with an accent or use a dialect.
Seek resources to help you.
- For writing, try the www.plainlanguage.gov website.
- Use readability testing tools like a Fry Graph Readability Tool or Flesch Automatic Readability Checker (Flesch Kincaid scale).
Craft a plan for facilitated consent. Document your answers to these questions.
- Will you accept if a family member offers to translate for someone who does not speak the provided languages?
- How will you document that someone facilitated the consent?
- Check with governing regulations for requirements. Are you certain that you comply with those?
If working with a health system for clinical interactions, be aware of their service level.
- Do local health clinics offer translation or language support?
- Will you use those services in all situations? In some situations?
- How will you document the use of that service?
- There may be costs associated with those services. How can you ensure your study participants can get the support they need to make informed decisions for you – and themselves?
Ensure Your Research Study Materials Reflect a Diverse Participant Population
People from Specific Racial or Ethnic Groups
If you earnestly seek to increase the diversity in your participant population, start with your study materials.
Ensure the imagery you use is diverse across racial and ethnic groups. This includes anything your community will see, like:
- Email campaign images
- Brochures
- Written materials
- Mobile apps
- In-office and clinic materials
Here are some important best practices in image selection that will help you succeed.
Strive to use images of diverse people in your own community, instead of relying on traditional or cultural dress images.
Avoid using images that promote inequity with status (e.g., participant is a person of color being treated by a White clinician).
Use artifacts, products, or other cultural assets only when they are relevant to the message you are trying to communicate.
Remember that successfully recruiting members of each racial and ethnic group in your community means considering them at each touchpoint. And ask for help from community groups to audit your images and materials.
Gender and Sexual Orientation
In addition to race and ethnicity of your imagery, consider the gender presentation of the people in the images used in communications. Avoid stereotypes and ensure equity with status.
Here are some important best practices that will help you be inclusive in your communications.
If your study materials use wording that specifies gender pronouns, ensure you include non‐binary options (such as “they”). Alternatively, explore if you can remove references to gender altogether.
Ensure diversity in gender representation. For example, balance parenting across genders, and clinical and professional roles across genders.
For every image, ensure that your alternative text (alt text) is inclusively written, especially regarding pronouns and racial or cultural descriptors.
Socio-Economic and Cultural Inclusivity
If you fail to consider the socio-economic status and culture differences across your community, you will risk losing credibility. To succeed in building the relationships you need to diversify your participant population, you must audit your materials and your protocol.
Consider these important questions:
- How might the study have limited availability and access for some people? How can we mitigate that challenge?
- How might the technologies, infrastructure, or policies exclude some people?
- How do we support those who are not closely located to physical facilities?
- Does the study ensure access to people with slow internet service?
- Is the study equally available to lower income people?
- When compensating participants, does the study offer multiple options (including non-digital compensation)?
Accessibility
Consider the Americans with Disabilities Act (ADA) requirements and guidelines. Information should be made available in accessible formats, and here are a few guidelines to review to support accessibility.
For digital tools and resources, ask:
- Do your digital touchpoints support multiple input modes (speech, keyboard, mouse, touch screen)?
- Is the interface accessible to users with visual impairments?
- Have you confirmed that your documents are compliant with Section 508?
- Is there sufficient contrast of text, iconography, and focus against the background?
- Are any instructions or other text easily readable and understandable?
- Are your digital interfaces easy to navigate using a screen reader?
For imagery and study materials, ask:
- Have you added appropriate and inclusive alt text to accurately describe the avatars or images of people to screen reader users?
- Have you included persons with visible disabilities in any materials besides just those focused on ability status?
Succeed in Creating a Diverse Participant Population for Your Study
Achieving equity in research requires researchers to consider the many characteristics that define our diverse communities. It demands that we apply the same rigor to building an inclusive research protocol that we do to the data we seek in that research
