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Diversity in Research Best Practice Guidelines
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Audience: Medical device researchers and developers engaging in clinical trials and validation studies
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How to Use: These guidelines 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.
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Collaboration
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Please review our Top 10 Resources page for articles and tools that will provide a foundational knowledge for researchers seeking to diversify their study participation.Diversity Toolkit | OpenOximetry
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Acknowledge and discuss potential power imbalances between study participants and those conducting the study. Community engagement must be conducted in a manner that is respectful of all partners and mindful of their need to benefit from collaboration.Principles of Community Engagement | ATSDR
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Consider establishing a community advisory board to facilitate the planning of your research project or work with an established board.Points to Consider About Recruitment and Retention | NIH
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Maintain transparency – the goals of the research, expected benefits to the community, motivations for engagement, and the allocation of resources should be openly discussed between researchers, community representitives, and study participants early in the partnership development process. Regular updates from the study team should be given on the progress of the study to participating organizations and individuals.Community Engaged Research | Winship Cancer Institute
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Credit contributions from community partners and organizations in published work.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid using overarching variables, such as race, when investigating risk factors and instead consider using genetic markers, biology, social determinants of health or ZIP codeInclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Send notes to thank individuals and communities involved in your research at the conclusion of your project. This goes a long way to maintaining community relationshp and building trust.Points to Consider About Recruitment and Retention | NIH
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Communication & Recruitment Materials
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Invest in accessible and plain-language communications, language interpretation, and translation services for recruitment materials, consents, and other communications provided to participants. Example: MRCT Clinical Research GlossaryHealth Equity in Organized Medicine Survey Report | AMA
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Ensure communication between research team and participants is culturally responsive, accessible, and available. Gateway to Health Communication | CDC
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Ensure that information is available in appropriate formats (for example, audio, video, braille or large print formats, visual/graphic imagery) to maximize inclusivity.Gateway to Health Communication | CDC
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Be clear on the rationale for using race and/or ethnicy in the study.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Clarify whether race and ethnicity were self-reported or observed.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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List race and ethnicity in alphabetical order in study tools or reporting tables.Health Equity in Organized Medicine | AMA
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Use race or ethnicity identifiers as adjectives (e.g., Asian adults or Black women) instead of in noun form (e.g., Blacks, Hispanics, Whites etc.)Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Capitalize the names of race and ethnicity identifiers (e.g Pacific Islander, Alaska Native, etc).Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Capitalize the first word and use lowercase for people when describing persons who are Indigenous or Aboriginal (e.g., Indigenous people, Indigenous peoples of Canada, Aboriginal people)Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid using "other" as a category when possible. If necessary, define the category clearly in the study tools and reports.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid using "minorities" and instead use "minoritized" (e.g., racial and ethnic minoritized groups) Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid using catch-all terminology for races and ethinicity that are not considered White (e.g., people of color, BIPOC, non-White) even when conducting a comparison. It is best to clearly list the various races and ethnicities in reference.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Do not use colors to reference groups like "brown" or "yellow"Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid using the term Caucasian; it had historically been used to indicate the term White, but it should only be used when referring to people from the Caucasus region in Eurasia (i.e. Armenia, Azerbaijan, Georgia, and parts of Southern Russia).Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Do not hyphenate combinations of proper adjectives derived from geographic entities when used as nouns (e.g., African American patient vs African-American). Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid the term "mixed race" as it may carry negative connotation; unless it was specifically used in data collection; in that case, the term should be defined, if possible.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Avoid collective reference to racial and ethnic groups as "non-White". Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Use a two question format for self-reported indentity:
(e.g., Do you consider yourself Hispanic/Latino? If not, which of the following do you identify with?)
Collection of Race and Ethnicity Data in Clinical Trials | FDA
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Equitable Study Design, Funding & Resource Allocation
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Avoid study designs and statistical comparisons of White vs "non-White" groups and should specify racial and ethnic populations included and conduct analyses comparing the specific groups.Inclusive Language for Reporting Demographic and Clinical Characteristics | JAMA
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Provide resources that will allow for participants from lower socioeconomic status to participate in clinical trials, such as offering convenient locations, flexible hours of operation, childcare services, and transportation vouchers.Diversity and Inclusion in Clinical Trials | NIH
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Compensate research participants properly for time that they have contributed to a study. Where applicable it may be necessary to give financial support to participants for travel, missed time at work, etcPoints to Consider About Recruitment and Retention | NIH
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Use caution when aggregating demographic data. Aggregation of demographic data, including race and ethnicity, can also mask important differences in health risks or outcomes for specific subpopulations.Diversity and Inclusion in Clinical Trials | NIH
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Consider that though women’s representation in trials has increased, knowledge gaps remain, especially regarding treatment during pregnancy and while lactating. Where safe and appropriate, consider including these groups.Building Research Equity for Women and Underrepresented Groups | NAP
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Consider that sex, sexual and gender minority (SGM) populations experience significant health disparities compared with their cisgender, heterosexual peers, and support equitable enrollement of these groups.Building Research Equity for Women and Underrepresented Groups | NAP
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Organizational Structure & Hiring Practices
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Ensure that your research mission, research team members, community advisory board members reflect the diversity of the community served by your study initiative or organization.Health Equity in Organized Medicine | AMA
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Collaborate with staff to revise practices and policies guiding hiring, promotion, advancement, compensation, and mediation practices to achieve equitable outcomesHealth Equity in Organized Medicine | AMA
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