CIP Continuing Review & Adverse Event Reporting 1 — Questions and Answers
Question 1: Under 45 CFR 46.109(e), how often must the IRB conduct continuing review of approved research?
- At least once per year regardless of risk level
- At least every six months for all studies
- At intervals appropriate to the degree of risk, but not less than once per year (Correct answer)
- Every two years for minimal risk research
Correct answer: At intervals appropriate to the degree of risk, but not less than once per year
45 CFR 46.109(e) requires continuing review at intervals appropriate to the degree of risk, with the maximum interval being one year.
Question 2: Which of the following best meets the OHRP criteria for a reportable unanticipated problem involving risks to subjects or others?
- An expected adverse event listed in the consent form and protocol
- An unexpected serious adverse event that is related or possibly related to participation (Correct answer)
- A protocol deviation that did not affect subject safety or welfare
- A minor administrative error in consent form documentation
Correct answer: An unexpected serious adverse event that is related or possibly related to participation
OHRP defines an unanticipated problem as unexpected, related or possibly related to participation, and suggesting greater risk than previously known.
Question 3: Under the 2018 revised Common Rule, continuing review is no longer required for which category of research?
- Research involving greater than minimal risk at an early stage
- Minimal risk research approved under expedited review where interventions are complete (Correct answer)
- Research involving prisoners at any risk level
- Multi-site clinical trials with an independent DSMB
Correct answer: Minimal risk research approved under expedited review where interventions are complete
The 2018 Common Rule eliminated mandatory continuing review for minimal risk research previously approved under expedited review once interventions have been completed.
Question 4: What is the primary purpose of IRB continuing review?
- To verify that the research budget is being properly expended
- To ensure ongoing research continues to meet ethical and regulatory standards (Correct answer)
- To update investigators on new IRB membership and procedures
- To collect data for the institution's annual OHRP compliance report
Correct answer: To ensure ongoing research continues to meet ethical and regulatory standards
Continuing review ensures that as a study progresses and new information emerges, it continues to satisfy all criteria for IRB approval.
Question 5: An investigator reports a serious adverse event that occurred at another site in a multi-site study. What should the IRB do first?
- Immediately suspend the local site's involvement in the study
- Determine whether the event is related to the research and whether it affects the local protocol (Correct answer)
- Report the event to FDA and OHRP regardless of local relevance
- Notify all locally enrolled subjects immediately by letter
Correct answer: Determine whether the event is related to the research and whether it affects the local protocol
The IRB must first assess relatedness and local impact before deciding on any action such as suspension, protocol modification, or subject notification.
Question 6: If an IRB's approval period expires before continuing review is completed, what must occur?
- Research may continue for 30 additional days with approval from the IRB chair
- All research activities involving human subjects must stop until renewal is granted (Correct answer)
- Data collection may continue but no interventions may be performed
- The PI may request a 60-day administrative extension without formal IRB action
Correct answer: All research activities involving human subjects must stop until renewal is granted
Lapse of IRB approval means the research is no longer approved; all human subjects activities must cease until the IRB completes its review and grants renewal.
Question 7: Which of the following documents must typically be included in a continuing review submission?
- Investigator's five-year financial disclosure and tax records
- Current enrollment numbers, summary of adverse events, and any protocol changes since last review (Correct answer)
- A new full protocol application identical to the original submission
- Signed letters of support from the funding agency and department chair
Correct answer: Current enrollment numbers, summary of adverse events, and any protocol changes since last review
Continuing review submissions must give the IRB current enrollment data, a summary of adverse events and unanticipated problems, and any changes made since the last approval.
CIP Continuing Review & Adverse Event Reporting 1
Under 45 CFR 46.109(e), how often must the IRB conduct continuing review of approved research?