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Diversity Toolkit for Medical Device Researchers

This toolkit is intended to empower medical device researchers to design and implement studies with diverse participants that can advance medical science and improved health equity.

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How to use this toolkit?

Use this toolkit by leveraging the resources to learn, identify targets for improvement, and applying a health equity lens to your work.

1

Learn

Browse the Resources, FAQs, and Key Terms to learn about health equity & diversity in medical device research.

2

Reflect

Identify targets for improvement in your initiative's work to advance health equity.

3

Apply

Use our Resources and Best Practices Checklist (coming soon) to create an action plan that improves diversity and equity your research.

Top 10 Resources

This section will provide the basic foundation for diversifying study participation through guidance on the historical context, importance and benefits, outlining barriers and providing tangible steps for improvement.

icon-course-z59r0g Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials Vanderbilt University 01
icon-protocols-2e95w6 A new way to talk about the social determinants of health Robert Wood Johnson Foundation 02
icon-protocols-2e95w6 Health Equity Guiding Principles for Inclusive Communication Centers for Disease Control & Prevention 03
icon-protocols-2e95w6 Strategies Addressing Barriers to Clinical Trial Enrollment of Underrepresented Populations C. Heller et al 04
icon-video-wzn6y3 Unconscious Bias Training University of California, San Francisco 05
icon-protocols-2e95w6 Points to Consider about Recruitment and Retention While Preparing a Clinical Research Trial NIH 06
icon-protocols-2e95w6 Diversity and Inclusion in Clinical Trials NIH 07
icon-protocols-2e95w6 A Resource Guide for Researchers and Community-Based Organizations NCI & Emory WCI 08
icon-protocols-2e95w6 Community-Engaged Research with Community-Based Organizations UCSF CTSI 09
icon-protocols-2e95w6 Explaining Health Inequities — The Enduring Legacy of Historical Biases NEJM 10

Frequently Asked Questions

We've collected some common questions and answers from health equity literature and our resource library

What are the benefits of diversity to my research? icon-faq-article
What are the top 10 ways to ensure adequate diversity in my research? icon-faq-article
Do I need to have a focus group of research participants? icon-faq-article
Do I need Community Advisory Board? icon-faq-article
How do I address compensation for participants? icon-faq-article
How do I engage minoritized populations when planning a study? icon-faq-article
What are considered ‘at-risk’ communities? icon-faq-article
What considerations should be made before engaging with different communities? icon-faq-article
What are effective strategies for community engagement? icon-faq-article
How do I know when I have enough diversity? icon-faq-article
What race and ethnicity categories should I use for a study? icon-faq-article
When should I use race vs skin color in research? icon-faq-article
What are common terms to avoid using? icon-faq-article
What is the best way to characterize skin color for research? icon-faq-article

Key Terms

This section defines commonly encountered terms for those in the clinical research and medical device development space aiming to learn more about diversity, recruitment, and retention

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Ableism

Discrimination and social prejudice against people with disabilities and people who are perceived as being disabled.

Ableism is not an equitable practice as it classifies disabled people as inferior to non-disabled people.

Accessibility

Measurement of how successfully a person with a disability can locate, get to, and understand the wanted or needed information as a result of the elmination of associated barriers both physical and intangible.

Accessibility should not be an afterthought, but built into the design of a research study.

Ageism

Stereotypes, prejudice, and discrimination against others based on their age, which can lead to poorer economic and health outcomes.

Coming soon

Antiracism

The active process of identifying and eliminating racism by changing systems, organizational structures, policies and practices and attitudes, so that power is
redistributed and shared equitably.

Antiracism is not the responsibility of a few persons or organizations. Dismantling racism is everyone’s work.

At Risk Populations

Individuals who are at greater risk of poor physical and social health status. May also be called 'vulnerable populations'. In general most institutional review boards list minors, pregnant women, fetuses, neonates or human in vitro fertilization, prisoners, and people with cognitive impairments.

This definition is not all encompassing and may not address all populations that could be considered 'at risk' when participating in research.

Bias

Bias occurs when a person allows a preconceived opinion or judgement to affect their view of information, people, situations, etc. Bias can be both positive or negative and conscious or unconscious.

Bias cannot be offset passively. Combating bias requires intentional and often systemic changes, and combating information bias in research often requires careful study design including randomization and blinding techniques.

Colorism

Discrimination based on skin color or within-group and between-group prejudice in favor of lighter skin color.

Colorism is not specific to a certain racial or ethnic group.

Community Advisory Board (CAB)

A group typically composed of community clinicians, advocates, and organizations that help advise researchers on the community they are collaborating with. Often, they serve as liaisons between the community and the trial researchers. Creating a community advisory board is a key component of best practices for ensuring equitable and inclusive research practices.

CABs do not meet just at the beginning of a study. They should meet on a regular basis throughout the life of a study to discuss progress and give feedback.

Community Based Participatory Research (CBPR)

A collaborative research approach that is designed to ensure and establish structures for collaboration by communities affected by the issue being studied, representatives of organizations, and researchers in all aspects of the research process to improve health and well-being through taking action, including social change.

This type of research is not a one-way gate into a community and its resources. This research approach requires an open exchange of information and resources to and from community partner and researchers.

Community Engagement

The process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people. Community engagement is important to promoting DEI in research because it promotes the flow of information between researchers and the communities they wish to recruit participants from. This in turn increases participation and trust from the community and helps researchers to conduct studies that are safer and more culturally informed.

Community engagement should not be a static process, but instead a dynamic, collaborative, and positive relationship between researchers, participants, and stakeholders within the community.

Skin Color Quantification Protocols

Ensuring diversity of skin pigments in a medical device study has become recognized as increasingly important yet challenging.

Lack of a standardized approach to skin color quantification is problematic.

According to FDA regulations, manufacturers of pulse oximeters should validate device performance on “a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.”

While ‘darkly pigmented’ is not formally defined, it is routinely defined by testing labs as Fitzpatrick skin phototype groups V-VI. The Fitzpatrick scale is a widely used method for classifying skin pigment, from I (pale white) to VI (darkest brown). However, it was originally developed for skin photosensitivity typing, which is not the same as skin color, and should not be conflated with race or ethnicity

Studies have shown inaccuracies in self-reported values, especially in darker skin types. There are other similar visual skin color classification systems, but as with the Fitzpatrick scale, they are all subjective.

Full Protocol

If you would like to know more about Skin Color Protocols click on the button below.

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Research Diversity Best Practices

We have compiled a checklist of best practices to improve diversity in research cohorts.

Audience: Medical device researchers and developers engaging in clinical trials and validation studies

How to Use: These best practices can be consulted at any time during the development of a research study, but ideally during the early phases, and should be used to aid the planning, implementation and write-up of research by helping avoid inappropriate use of terminology, communication and engagement practices with diverse populations.

The checklist includes best practices for collaboration, communications, recruitment, study design, funding, resource allocation, and organizational structure and hiring practices.

Checklist

If you would like to view the checklist, click on the button below.

View Checklist

Acknowledgements

This page is a collaborative effort from many individuals across many institutions including: Olubunmi Okunlola, Fekir Negussie, Ashlee Osborne, Casey Norlin, Odinakachukwu Ehie, Jana Lyn Fernandez, Michael Lipnick, Maryn Kanter, Gregory Leeb, Lily Ortiz, Galen Joseph, Consuelo Wilkins and team at Vanderbilt, Brianna Carreno, Caroline Hughes, Leonid Shmuylovich, Jenna Lester, and Ellis Monk. This project was made possible through funding from the Robert Wood Johnson Foundation.