res_irbmed_diversity.pptx

1. 1
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U-MIC
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2. DIVERSITY AND
INCLUSIVENESS
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative

3. diversity in research
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Developed by:
U-MIC
FDA guidance on race and ethnicity clinical trials
• participant selection
• data reporting
• Study enrollment has not always reflected disease distribution.
• Assumption-based exclusion hinders drug/device safety data.

4. diversity in research
4
Developed by:
U-MIC
Terminology
• categories standardized by the Office of Management and Budget
• not scientifically or anthropologically based
• intended to reflect current sociocultural constructs and preferences
• Individuals should self-report racial and ethnic identity
• with option to designate multiracial identity
• Race and ethnicity should not be assigned by the study team.

5. diversity in research
5
Developed by:
U-MIC
Race and ethnicity categories
• e.g., “Hispanic or Latino” or “not Hispanic or Latino”
• At minimum, the following racial identity categories:
• American Indian or Alaska Native
• Asian
• Black or African American
• Native Hawaiian or Other Pacific Islander
• White
• “Nonwhite” unacceptable in federal data
• should not be used in research materials/publication
• More specific where conditions are more common in subgroups.

6. diversity in research
6
Developed by:
U-MIC
Study design
strategies for diverse study populations
• study site locations with diverse populations
• neighborhoods where diverse populations receive care
• community clinics
• nursing homes
• pediatric hospitals
• minority healthcare provider groups
• urban hospitals

7. diversity in research
7
Developed by:
U-MIC
Study design
strategies for diverse study populations
• alternative forms of communication
• recruitment
• informed consent
• research-related materials
• community-based organizations/places of worship
• written materials
• multiple languages/appropriate cultural references
• tailored to limited literacy skill
• electronic documents
• social media
• accommodations for the visually/hearing-impaired

8. diversity in research
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Developed by:
U-MIC
Study design
strategies for diverse study populations
• development/revision of eligibility criteria
• frequent recruitment events
• evenings/weekends
• flexibility in study visits
• evenings/weekends
• child/elder care services
• whether to eliminate/modify phase 2 exclusion criteria in phase 3
• reimbursement and/or incentives
Consider cultural competency training for staff involved in screening
and enrollment.

9. diversity in research
9
Developed by:
U-MIC
Diversity and inclusiveness
in human subjects research
Collection of Race and Ethnicity Data in Clinical Trials (October 2016)
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-
data-clinical-trials
Evaluation of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (September 2017)
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-and-reporting-age-
race-and-ethnicity-specific-data-medical-device-clinical-studies
Enhancing the Diversity of Clinical Trial Participants (November 2020)
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-
trial-populations-eligibility-criteria-enrollment-practices-and-trial

10. THANK YOU.
Brian Seabolt
IRBMED
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Developed by:
U-MIC