Regulatory Reporting Obligations

Question 1

The IRB must report the following to ____ , and the institution must report to ____ :

• Unanticipated problems involving risks to subjects or others (UPIRSOs)
• Serious or continuing noncompliance
• Suspension or termination of IRB approval

Answer 1

the Institutional Official (IO);
OHRP;

Question 2

In terms of reporting requirements what Must Be Included in the Report to OHRP and FDA?

Answer 2

• Description of the event/issue
• Basis for IRB’s determination (e.g., how noncompliance was assessed)
• Corrective actions or follow-up plans
• Date of IRB action and when the event occurred

Question 3

What other entities might need to be informed when reporting to OHRP and the FDA?

Answer 3

• NIH or funding agency (e.g., in a grant progress report)
• Data Safety Monitoring Board (DSMB)
• Sponsor or coordinating center
• FDA for IND/IDE studies (especially serious adverse events)

Question 4

What is OHRP’s timeline for reporting?

Answer 4

“Promptly” — no specific deadline, but interpreted as within a few weeks at most

Question 5

What is the FDA’s timeline for reporting?

Answer 5

Within 5 working days for emergency use notifications, but for other issues, it’s typically interpreted as 30 calendar days

Question 6

Who Sends Reports to OHRP and the FDA?

Answer 6

Usually the Institutional Official (IO) or HRPP Director on behalf of the institution. The IRB typically documents the finding and recommends reporting, but does not directly contact agencies.

Question 7

What three events must be reported to OHRP or FDA?

Answer 7

• Unanticipated problems involving risk
• Serious or continuing noncompliance
• Suspension or termination of IRB approval

Question 8

When must emergency use of an investigational product be reported to the IRB?

Answer 8

Within 5 working days (per 21 CFR 56.104(c))