Question

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

A. Determined by research staff Included in the consent process
B. Stated in the human subject protection regulations, but not in the drug or device regulations
C. Determined by the institution in its written policies and procedures

Answer 1

Answer: C. Determined by the institution in its written policies and procedures

Step-by-step explanation:

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are determined by the institution in its written policies and procedures.

The IRB is the constituted body which is formally designated to be in charge of the reviewing and the monitoring of a research that involves human subjects. The IRB is authorized to approve a research, require modifications, or disapprove the research.