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

Expedited review for continuing review is appropriate when the research involves no more than minimal risk and the activities fit within the federally designated expedited review categories.

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

A core function of continuing review is to evaluate whether the risk/benefit ratio remains acceptable as new data, adverse events, or other information have emerged since initial approval.

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

Protocol amendments that increase risk or burden to subjects must receive prospective IRB approval before implementation; retrospective events require reporting but not pre-approval.

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

Under the pre-2018 Common Rule, all approved research required continuing review at intervals no greater than one year, applying to minimal risk and greater-than-minimal-risk studies alike.

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

The investigator's first obligation is to protect subjects from immediate harm, followed by prompt IRB notification so the IRB can evaluate the event and determine required actions.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Continuing Review & Adverse Event Reporting 3