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SOCRA CCRP Exam - Topic 3 Question 11 Discussion
Actual exam question for
SOCRA's
CCRP exam
Question #: 11
Topic #: 3
[All CCRP Questions]
Topic #: 3
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
Suggested Answer:
C
Minimal risk determination is a regulatory function of the IRB/IEC.
45 CFR 46.102(j): Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
45 CFR 46.109(a): The IRB has authority to approve, require modifications, or disapprove research, including assessment of risk level.
Investigators may propose a study as minimal risk, but only the IRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
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