IRB Administration & Management Flashcards
7 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 IRB Administration & Management flashcards as text
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?
Answer: The institutional official (IO)
The institutional official (IO) signs the FWA and bears ultimate institutional responsibility for compliance with its commitments to OHRP.
Which of the following changes to an approved protocol requires only an administrative review rather than full-board review?
Answer: Updating the PI's contact phone number
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.
Under the Common Rule, research conducted in established or commonly accepted educational settings involving normal educational practices is:
Answer: Exempt under Category 1 regardless of whether data are identifiable
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.
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:
Answer: Obtain a Certificate of Confidentiality to protect identifiable research information from compelled disclosure
A Certificate of Confidentiality (CoC) legally protects identifiable research data from compelled disclosure in legal, administrative, or other proceedings.
During a convened IRB meeting, a member discloses a financial conflict of interest with a study on the agenda. The correct procedure is to:
Answer: Require the member to leave the room for both discussion and vote on that study
IRB members with a conflicting interest must recuse themselves from both deliberation and voting on the affected study, typically by leaving the room.
A sponsor-initiated protocol modification would increase participant burden by adding two extra clinic visits. Before implementing the change, the research team must:
Answer: Submit an amendment for IRB review and receive approval before implementing
Any modification that increases participant burden must be approved by the IRB before implementation, as it may affect participant welfare and consent.
Which element of a HIPAA Authorization is NOT required when research involves protected health information (PHI)?
Answer: The participant's Social Security Number
HIPAA Authorizations do not require a Social Security Number; required elements include description of PHI, authorized persons, expiration, and the individual's right to revoke.