Institutional Review Board Procedures Flashcards

Which of the following best describes the 'minimal risk' standard used by IRBs?

Answer: Risk not greater than ordinarily encountered in daily life or routine examinations

Minimal risk means the probability and magnitude of harm anticipated in research is not greater than those encountered in daily life or routine physical or psychological examinations.

A researcher receives a report that a participant experienced an unexpected serious adverse event possibly related to the study drug. Within what timeframe must this typically be reported to the IRB?

Answer: Within 7 calendar days

Serious unexpected adverse events that may be related to the research are typically required to be reported to the IRB within 5–7 calendar days per institutional policy.

Which document establishes the IRB's authority, membership requirements, and review procedures at an institution?

Answer: The IRB written procedures and charter

IRBs must maintain written procedures (SOPs) and a charter that describe membership, authority, quorum, and review processes.

What quorum is required for an IRB to conduct full board review and make binding decisions?

Answer: A simple majority of all members, including a nonscientist member

A quorum requires a majority of IRB members to be present, and a nonscientist member must be included for the quorum to be valid.

Under Subpart D of 45 CFR Part 46, research involving children may only be approved if it offers the prospect of direct benefit when it presents:

Answer: Greater than minimal risk with direct benefit to subjects

Under Subpart D, research presenting greater than minimal risk is approvable only if it offers direct benefit to individual child subjects and the benefit/risk ratio is at least as favorable as alternatives.

Which office within the U.S. Department of Health and Human Services (HHS) has primary oversight authority for human research protections compliance?

Answer: Office for Human Research Protections (OHRP)

OHRP oversees compliance with 45 CFR Part 46, investigates compliance concerns, and provides guidance on human research protections.

When can an IRB chairperson approve a study without convening a full board meeting?

Answer: For expedited review categories designated by DHHS

The expedited review procedure allows the chairperson or designated reviewer to approve studies falling within DHHS-designated categories of minimal-risk research.