It is usual that the IRB will make its determinations based on information from the principal investigator. However, the IRB may determine that a study shall require enhanced monitoring from sources (to be defined by the IRB) other than the investigator [45 CFR 46.103(b)(4), 21 CFR 56.108(a)].
Criteria that the IRB may use as a basis for requiring enhanced monitoring may include but are not limited to:
1) Randomly selected studies
2) Complex studies involving unusual levels or types of risks to subject
3) Studies conducted by investigators who previously failed to comply with applicable regulations or institutional or IRB requirements
4) Studies where other concerns have been raised by subjects, a DSMB, study or HSRO staff, IRB members or others about possible material changes occurring without IRB approval.