In accordance with the CFR, which body must determine that a study meets the criteria...

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 ofrisk level.

Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.

This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.