CIP Protocol Review & Approval Process 5 — Questions and Answers
Question 1: 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?
- The IRB must prioritize all externally funded research over unfunded research
- The IRB should schedule review in a timely manner but is not obligated to alter its review process or standards based on funding deadlines (Correct answer)
- The IRB must approve the protocol within 30 days if federal funding is involved
- Funding deadlines automatically qualify the protocol for expedited review
Correct 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.
Question 2: What is the significance of 'assent' in the context of IRB-approved research involving children?
- Assent is legally equivalent to consent and replaces parental permission for adolescents over age 14
- 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 (Correct answer)
- Assent is required only for studies that involve more than minimal risk
- Assent is a written form that waives the requirement for parental signature
Correct 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.
Question 3: An IRB is reviewing a protocol involving prisoners. Which Subpart of 45 CFR 46 provides additional protections for this population?
- Subpart B
- Subpart C (Correct answer)
- Subpart D
- Subpart E
Correct 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.
Question 4: Which of the following best describes a 'protocol deviation' versus a 'protocol violation' in IRB oversight?
- Deviations are intentional changes; violations are accidental departures from the protocol
- Deviations are unplanned departures that do not affect subject safety; violations are departures that affect subject rights, safety, or data integrity (Correct answer)
- The terms are interchangeable and both require the same IRB reporting response
- Violations involve FDA-regulated products only; deviations apply to all other research
Correct 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.
Question 5: 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?
- Category 2 — survey procedures
- Category 1 — research conducted in established educational settings involving normal educational practices (Correct answer)
- Category 4 — existing data not originally collected for research
- Category 6 — taste and food quality evaluation
Correct 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.
Question 6: What regulatory document must an institution have in place to conduct HHS-funded human subjects research, establishing its commitment to follow the Common Rule?
- A Federal Wide Assurance (FWA) registered with OHRP (Correct answer)
- An Institutional Authorization Agreement (IAA) filed with FDA
- A Cooperative Research and Development Agreement (CRADA)
- A Data Use Agreement (DUA) filed with NIH
Correct 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.
Question 7: 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?
- Placebo controls are never acceptable when any approved treatment exists
- 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 (Correct answer)
- The IRB defers entirely to FDA guidance on placebo acceptability in clinical trials
- Placebo controls are automatically acceptable if the sponsor has FDA approval for the IND
Correct 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.
CIP Protocol Review & Approval Process 5
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?