SOCRA 2024 Annual Conference Program Book - Flipbook - Page 62
The Office for Human Research Protections (OHRP):
Partnering to Protect Participants in Human
Subjects Research
Julie Kaneshiro, Acting Director
Office for Human Research Protections (OHRP)
Department of Health and Human Services (HHS)
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OHRP Organizational Chart
Office of the
Director
Division of
Education and
Development
Division of
Compliance
Oversight
Division of
Policy and
Assurances
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Department of Health and Human Services (HHS):
Regulatory Framework
What is “Common” About the Common Rule?
CR Departments & Agencies
• Regulations at 45 CFR 46
• CR is followed by 20 US federal departments
and agencies through various mechanisms
for human subjects research that they
conduct or support.
• Each CR department or agency is
responsible for oversight of the research that
it conducts or supports.
(https://www.hhs.gov/ohrp/sites/default/files/revised-common-rule-reg-textunofficial-2018-requirements.pdf)
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Subpart A — Basic policy for the protection of
living individuals who participate in research
Subpart B — Additional protections for
pregnant individuals, fetuses, and neonates
Subpart C — Additional protections for
incarcerated individuals
Subpart D — Additional protections for
children
Subpart E — Administrative requirements for
registration of IRBs (i.e., ethics committees)
A.k.a., The Common Rule
• Followed by 20 Federal
Departments and Agencies
through various mechanisms
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