Monitoring and Review of Reportable Events

Question 1

What are the three major reportable event categories?

Answer 1

• Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)
• Noncompliance
• Research Misconduct

Question 2

Define an Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)

Answer 2

An event that is:

• Not expected
• Related/possibly related to participation
• Suggests greater risk to subjects then previously known

Example: A serious adverse event not listed in the protocol or consent form

Question 3

Define Noncompliance

Answer 3

Failure to follow federal regulations, IRB policies, or approved protocol.

Example: Enrolling subjects without consent = serious noncompliance

Question 4

Serious Noncompliance vs Continuing Noncompliance

Answer 4

Serious = increases risk or compromises data integrity or subject rights

Continuing = recurring or unaddressed over time

Question 5

Define Research Misconduct

Answer 5

Fabrication, falsification, or plagiarism in proposing, conducting, or reporting research. Must be:

• A significant departure from accepted practices
• Committed intentionally, knowingly, or recklessly

Question 6

Who typically handles Research Misconduct?

Answer 6

The institution’s research integrity office or some other appropriate entity outside the IRB, but the IRB may respond to findings.

Question 7

What must an IRB report to OHRP or FDA?

Answer 7

Serious or continuing noncompliance, suspensions or terminations, and unanticipated problems involving risk.