OHSP has updated Policy 901: Investigator Responsibilities, effective 1/1/2024, as well as the corresponding Exempt, Non-FDA Regulated, and FDA-Regulated Responsibility Summary Sheets.
Updates include clarifications regarding:
- Who can act as the Principal Investigator (PI) on proposals that do not involve human subject research and proposals that involve human subject research but the UR is not engaged in the research (Section 3.1.1);
- Ensuring that only IRB-approved staff conduct research (Section 6.1.2);
- When research can be initiated, when the research involves the transfer of data and/or specimens outside the UR (Section 6.4.5);
- Procedures for transferring PI oversight when the PI is on a leave of absence, short-term disability, or any other circumstance where law prevents the individual from working (Section 6.8);
- Reminder notifications concerning closure reports, for studies that do not require continuing review (Section 8.10);
- Control of investigational products (Section 9.1.1); and
- Additional editorial/administrative revisions.