CIP IRB Administration & Management 5

Question 1

An IRB receives a report that a PI conducted research activities before receiving IRB approval. Under most institutional policies, the most appropriate first response is to:

Accepted Answer

Halt the unapproved research activities and conduct a protocol deviation review

Answer

Research conducted without IRB approval must be stopped and reviewed as a serious protocol deviation, regardless of perceived minimal risk, because prospective review is a regulatory requirement.

Question 2

Under the 2018 revised Common Rule, broad consent may be obtained for the storage, maintenance, and secondary research use of identifiable private information. Which statement about broad consent is accurate?

Accepted Answer

Broad consent must include a description of the types of research that may be conducted

Answer

Broad consent under 45 CFR 46.116(d) must describe the types of research, including foreseeable uses, for which identifiable information may be used in the future.

Question 3

A researcher proposes to use existing de-identified biospecimens from a biobank. Under the 2018 Common Rule, this research:

Accepted Answer

Is not research involving human subjects if the specimens cannot be re-identified

Answer

Under the 2018 Common Rule, research using de-identified biospecimens that cannot be linked to individuals does not meet the definition of 'research involving human subjects.'

Question 4

Which scenario requires submission of a continuing review report to the IRB for studies approved under the 2018 Common Rule?

Accepted Answer

A study involving greater than minimal risk that has not yet closed to enrollment

Answer

Under the 2018 Common Rule, continuing review is no longer required for most minimal-risk studies, but remains required for studies that have not yet closed to enrollment and involve greater than minimal risk.

Question 5

An IRB administrator is training a new IRB member. Which statement about the role of the primary reviewer in a full-board meeting is CORRECT?

Accepted Answer

The primary reviewer presents the protocol to the board but all members vote equally

Answer

The primary reviewer leads the discussion and presents the protocol summary, but all board members deliberate and vote with equal weight.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP IRB Administration & Management 5