CIP IRB Administration & Management 3

Question 1

An IRB operating under a Federalwide Assurance (FWA) must ensure that all covered research conducted at the institution is reviewed by an IRB. Who is ultimately responsible for the FWA commitments?

Accepted Answer

The institutional official (IO)

Answer

The institutional official (IO) signs the FWA and bears ultimate institutional responsibility for compliance with its commitments to OHRP.

Question 2

Which of the following changes to an approved protocol requires only an administrative review rather than full-board review?

Accepted Answer

Updating the PI's contact phone number

Answer

Changes that are purely administrative (e.g., updating contact information) and do not affect the rights, safety, or welfare of participants do not require full-board review.

Question 3

Under the Common Rule, research conducted in established or commonly accepted educational settings involving normal educational practices is:

Accepted Answer

Exempt under Category 1 regardless of whether data are identifiable

Answer

45 CFR 46.104(d)(1) (Category 1 exemption) covers normal educational practices research in educational settings and does not restrict exemption based on identifiability.

Question 4

A protocol involves a survey about alcohol use among college students. The IRB is concerned about the risk of mandatory reporting if a student discloses illegal underage drinking. The best protective measure is to:

Accepted Answer

Obtain a Certificate of Confidentiality to protect identifiable research information from compelled disclosure

Answer

A Certificate of Confidentiality (CoC) legally protects identifiable research data from compelled disclosure in legal, administrative, or other proceedings.

Question 5

During a convened IRB meeting, a member discloses a financial conflict of interest with a study on the agenda. The correct procedure is to:

Accepted Answer

Require the member to leave the room for both discussion and vote on that study

Answer

IRB members with a conflicting interest must recuse themselves from both deliberation and voting on the affected study, typically by leaving the room.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP IRB Administration & Management 3