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Developed by:
U-MIC
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VULNERABLE SUBJECT
POPULATIONS
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative
Vulnerable subjects
45 CFR 46, subpart A
Common Rule
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HHS regulations governing human subjects research
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45 CFR 46.111 refers to five vulnerable populations
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may face increased susceptibility to
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Developed by:
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children
prisoners
pregnant women
mentally disabled persons
economically or educationally disadvantaged persons
coercion
undue influence
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Vulnerable subjects
45 CFR 46, subparts B, C, and D
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additional requirements for the protection of three populations
B. pregnant women, fetuses, and neonates
C. prisoners
D. children
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Vulnerable subjects
45 CFR 46, subpart B
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pregnant women, fetuses, and nonviable neonates or neonates
of uncertain viability
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defines these populations
presents IRB approval criteria
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IRB must consider
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risk level
benefit type
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direct
indirect
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Vulnerable subjects
45 CFR 46, subpart C
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prisoners
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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
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Part One: Federal Regulations
Part Two: Certification and IRB Review
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Vulnerable subjects
45 CFR 46, subpart D
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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
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IRB responsibilities
circumstances in which children may participate
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risk/benefit
assent/parental permission
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Vulnerable subjects
FDA regulations (21 CFR 50 and 56)
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also address vulnerable populations
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21 CFR 50, subpart D
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research involving children
differences from 45 CFR 46 (examples)
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FDA does not permit waivers of parental permission.
FDA regulations do not address research involving
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pregnant women, fetuses, and neonates
prisoners
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Vulnerable subjects
UM HRPP Operations Manual
Part 7
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institutional policy governing the IRB review and approval of
research involving
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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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Vulnerable subjects
eResearch
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Researchers must
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consider whether study is designed to include/allow vulnerable populations
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select appropriate vulnerable populations from the following list:
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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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Vulnerable subjects
Common Rule changes
45 CFR 46, subpart A
• effective January 19, 2018
• modifications to
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vulnerable population categories
UM policies/procedures
• Updates forthcoming
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Vulnerable subjects
Vulnerable subject populations
in human subjects research
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THANK YOU.
Brian Seabolt
IRBMED
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