CIP Continuing Review & Adverse Event Reporting 3

Question 1

An IRB may use expedited review procedures for continuing review of approved research when:

Accepted Answer

The research involves no more than minimal risk and the work falls within defined expedited categories

Answer

The study involves greater than minimal risk but enrollment is nearly complete

Answer

All enrolled subjects have completed all study visits

Answer

The principal investigator requests expedited review and provides a written justification

Question 2

When reviewing a continuing review submission, which factor is most important for the IRB to reassess?

Accepted Answer

Whether the risk/benefit ratio remains acceptable in light of any new information

Answer

Whether the investigator has published papers from the study data

Answer

Whether the research funder has approved expenditures to date

Answer

Whether all IRB members have completed annual conflict-of-interest training

Question 3

Which of the following actions requires prospective IRB review and approval rather than merely a notification report?

Accepted Answer

Making a protocol amendment that increases risk or burden to subjects

Answer

Submitting the annual continuing review application

Answer

Reporting an unanticipated adverse event that has already occurred

Answer

Enrolling a new subject who meets all eligibility criteria under the current protocol

Question 4

What did the 'one-year rule' require under the pre-2018 Common Rule?

Accepted Answer

Continuing review of approved research was required at least once per year for all studies

Answer

All IRB members must be recertified in human subjects protections every year

Answer

Investigators must reapply for federal funding annually to maintain IRB approval

Answer

IRBs must submit annual compliance reports to OHRP within one year of FWA issuance

Question 5

When an investigator discovers a serious unanticipated adverse event, what is the correct sequence of actions?

Accepted Answer

Take immediate action to protect subjects → notify the IRB → cooperate with the IRB's evaluation

Answer

Notify OHRP immediately → modify the consent form → then notify the IRB

Answer

Suspend the entire study → notify FDA → then report to the IRB

Answer

Notify all subjects by letter → notify the IRB → continue the study pending review

Question 6

An IRB determines that noncompliance was serious. Which of the following entities must be notified promptly in writing?

Accepted Answer

OHRP and, where applicable, the relevant federal department or agency head supporting or regulating the research

Answer

The National Institutes of Health and the principal investigator's department chair

Answer

The American Association of IRBs and the institutional legal counsel only

Answer

The funding sponsor and the journal where results will be published

Question 7

Which statement best describes the IRB's authority when continuing review results in a finding of significant new risk to subjects?

Accepted Answer

The IRB has authority to suspend or terminate approval of the research to protect subjects

Answer

The IRB may only recommend corrective action but cannot suspend the study without a federal order

Answer

The IRB must wait for the next convened meeting before taking any protective action

Answer

The IRB may issue a warning letter but must allow the study to continue pending sponsor review