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2. Vulnerable subject populations
in human subjects research
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University of Michigan IRB Collaborative

3. 45 CFR 46, subpart A Vulnerable subjects Common Rule
HHS regulations governing human subjects research
45 CFR refers to five vulnerable populations
children
prisoners
pregnant women
mentally disabled persons
economically or educationally disadvantaged persons
may face increased susceptibility to
coercion
undue influence
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4. 45 CFR 46, subparts B, C, and D Vulnerable subjects
additional requirements for the protection of three populations
pregnant women, fetuses, and neonates
prisoners
children
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5. 45 CFR 46, subpart B Vulnerable subjects
pregnant women, fetuses, and nonviable neonates or neonates of uncertain viability
defines these populations
presents IRB approval criteria
IRB must consider
risk level
benefit type
direct
indirect
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6. 45 CFR 46, subpart C Vulnerable subjects prisoners
IRB membership requirements for the review and approval of research involving prisoners
additional IRB duties
circumstances in which prisoners may participate
U-MIC: Prisoners as Research Subjects
Part One: Federal Regulations
Part Two: Certification and IRB Review
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7. 45 CFR 46, subpart D Vulnerable subjects children
persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted
IRB responsibilities
circumstances in which children may participate
risk/benefit
assent/parental permission
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8. FDA regulations (21 CFR 50 and 56)
Vulnerable subjects
FDA regulations (21 CFR 50 and 56)
also address vulnerable populations
21 CFR 50, subpart D
research involving children
differences from 45 CFR 46 (examples)
FDA does not permit waivers of parental permission.
FDA regulations do not address research involving
pregnant women, fetuses, and neonates
prisoners
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9. UM HRPP Operations Manual
Vulnerable subjects
UM HRPP Operations Manual
Part 7
institutional policy governing the IRB review and approval of research involving
pregnant women, fetuses, and nonviable neonates or neonates of uncertain viability
prisoners
children
adults with cognitive impairment or otherwise impaired decision-making capacity
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10. eResearch Vulnerable subjects Researchers must
consider whether study is designed to include/allow vulnerable populations
select appropriate vulnerable populations from the following list:
children (including viable neonates)
neonates of uncertain viability and/or nonviable neonates
individuals and/or products involving human in vitro fertilization,
pregnant women and/or fetuses
lactating women
women of childbearing potential
prisoners
cognitively impaired adults
college students
economically or educationally disadvantaged persons
patients of the study team
employees, students or trainees of the study team
family members of the study team
Based on populations selected, IRB applies appropriate federal regulations, institutional policies, and special considerations in its review.
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11. Common Rule changes Vulnerable subjects 45 CFR 46, subpart A
effective January 19, 2018
modifications to
vulnerable population categories
UM policies/procedures
Updates forthcoming
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12. Vulnerable subject populations in human subjects research
Vulnerable subjects
Vulnerable subject populations in human subjects research
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13. Thank you.
Brian Seabolt
IRBMED
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