A new version of the IRB SOPs (dated 4/24/2014) is posted here and includes the following changes:
- SOP 3.2-Revised to reflect current practices regarding inter-institutional agreements (specifically, reliance on central IRBs).
- SOP 19-Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) reporting revised to require reporting of events that meet all three criteria (previously events that meet criteria 1 & 2 (related and unexpected) were reportable to the IRB)
- SOP 22-Revised to clarify that all events meeting the criteria for an UPIRSOs or cases of alleged serious or continuing non-compliance, will be reviewed by the convened IRB for a final determination.
- SOP 29-Revised HIPAA section to add information regarding “compound authorizations”
- SOP 37– New SOP: Sponsor-initiated holds, suspension and termination of IRB approval (Sections of SOPs 14.3 and 18.1 deleted to eliminate duplication.)
- Revised appendices: F, I, J, K, Q, R, U and Y