Protocol Review & Approval Process 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 Protocol Review & Approval Process flashcards as text
A protocol is submitted for IRB review mid-year with a funding expiration deadline in 3 months. Which aspect of the timeline is the IRB obligated to consider when scheduling review?
Answer: The IRB should schedule review in a timely manner but is not obligated to alter its review process or standards based on funding deadlines
While IRBs should conduct reviews in a timely manner, funding deadlines do not change the applicable review standards or obligate the IRB to compromise its process.
What is the significance of 'assent' in the context of IRB-approved research involving children?
Answer: Assent is the child's affirmative agreement to participate, which is required in addition to parental permission when the child is capable of providing it
Assent reflects respect for the developing autonomy of children; the IRB must determine when assent is required and whether any child's dissent should be respected even if parents consent.
An IRB is reviewing a protocol involving prisoners. Which Subpart of 45 CFR 46 provides additional protections for this population?
Answer: Subpart C
Subpart C of 45 CFR 46 (46.301–46.306) provides additional protections for prisoners as research subjects, including requirements for the composition of the IRB and permissible categories of research.
Which of the following best describes a 'protocol deviation' versus a 'protocol violation' in IRB oversight?
Answer: Deviations are unplanned departures that do not affect subject safety; violations are departures that affect subject rights, safety, or data integrity
While terminology varies by institution, deviations typically refer to minor unplanned departures without safety impact, while violations involve departures that may compromise participant safety, rights, or data integrity.
An investigator wants to conduct a study entirely within a single classroom using an educational intervention on normal school curriculum. Under 45 CFR 46, which exemption category is most applicable?
Answer: Category 1 — research conducted in established educational settings involving normal educational practices
Category 1 exemption applies to research involving normal educational practices in established educational settings, such as comparing instructional methods or curricula.
What regulatory document must an institution have in place to conduct HHS-funded human subjects research, establishing its commitment to follow the Common Rule?
Answer: A Federal Wide Assurance (FWA) registered with OHRP
A Federal Wide Assurance (FWA), filed with OHRP, is the institutional commitment required to conduct HHS-regulated human subjects research and establishes the institution's ethical framework.
When reviewing a placebo-controlled trial for a serious condition, how should the IRB evaluate the ethical acceptability of withholding active treatment from the control group?
Answer: The IRB must assess whether placebo use is scientifically necessary, whether participants can safely be without active treatment, and whether rescue medications or stopping rules are in place
The IRB must evaluate the ethical justification for placebo use holistically, including scientific necessity, participant safety without active treatment, and protections such as rescue medication availability and stopping rules.