CIP Protocol Review & Approval Process 4 — Questions and Answers
Question 1: A study sponsor requests that an IRB expedite review of a protocol to meet a drug development deadline. What is the appropriate IRB response?
- Expedite review if the sponsor covers additional administrative fees
- Accommodate the request only if the protocol qualifies for expedited review under 45 CFR 46.110 categories (Correct answer)
- Approve the protocol provisionally and conduct full review afterward
- Grant a 30-day extension to allow sponsor to revise the protocol
Correct answer: Accommodate the request only if the protocol qualifies for expedited review under 45 CFR 46.110 categories
The type of review is determined by the nature and risk level of the research, not by sponsor timelines; expedited review is only available for protocols meeting specific regulatory criteria.
Question 2: In reviewing a protocol that involves both FDA-regulated research and HHS funding, how should the IRB approach the regulatory requirements?
- Apply only the stricter of the two regulatory frameworks
- Apply both sets of requirements, as the research must comply with both HHS (45 CFR 46) and FDA (21 CFR 50/56) regulations (Correct answer)
- Apply only FDA regulations since they take precedence over HHS
- Request a waiver from one agency to avoid dual compliance
Correct answer: Apply both sets of requirements, as the research must comply with both HHS (45 CFR 46) and FDA (21 CFR 50/56) regulations
When research is subject to both FDA and HHS regulations, the IRB must ensure compliance with both regulatory frameworks simultaneously.
Question 3: What does it mean when an IRB votes to 'table' a protocol?
- The protocol is permanently rejected
- The protocol is set aside for later consideration, typically because more information is needed before a final vote (Correct answer)
- The protocol is approved with conditions
- The IRB chair is given authority to approve the protocol unilaterally
Correct answer: The protocol is set aside for later consideration, typically because more information is needed before a final vote
Tabling a protocol means postponing the vote to a future meeting, usually because the IRB needs additional information, clarification, or modifications before making a final determination.
Question 4: An investigator proposes to conduct research using a novel implantable device not yet approved by the FDA. Under what conditions may the IRB approve such research?
- The IRB cannot approve any research involving unapproved devices
- The IRB may approve the research if it meets standard approval criteria and an IDE (Investigational Device Exemption) has been obtained from FDA when required (Correct answer)
- Approval requires a waiver from both FDA and the institution's legal counsel
- The research may proceed under expedited review since it is a device rather than a drug
Correct answer: The IRB may approve the research if it meets standard approval criteria and an IDE (Investigational Device Exemption) has been obtained from FDA when required
Research with significant-risk unapproved devices requires an FDA-approved IDE in addition to IRB approval before the study may begin.
Question 5: When must an IRB require that research be reviewed more frequently than annually during the approval period?
- When the study involves more than 100 participants
- When the degree of risk justifies more frequent review, or when required by the IRB as a condition of approval (Correct answer)
- Whenever FDA-regulated products are involved
- When the principal investigator has had a prior protocol violation
Correct answer: When the degree of risk justifies more frequent review, or when required by the IRB as a condition of approval
45 CFR 46.109(e) allows the IRB to specify a review interval shorter than one year when the risk level or other factors warrant more frequent oversight.
Question 6: Which of the following scenarios would most likely require an amendment to an already-approved protocol?
- A change in the contact telephone number for the principal investigator
- Adding a new co-investigator who will perform study procedures on participants (Correct answer)
- The IRB office changing its submission portal software
- A minor correction to an internal data coding manual not seen by participants
Correct answer: Adding a new co-investigator who will perform study procedures on participants
Adding personnel who will conduct study procedures that affect participants represents a change in research activities that requires IRB review and approval via an amendment.
Question 7: Under what circumstance may an IRB waive the requirement for signed written documentation of informed consent?
- When the PI has more than 10 years of research experience
- When the principal risk is a breach of confidentiality and the consent form itself would link the participant to the research (Correct answer)
- When the study involves more than minimal risk but offers direct benefit
- When the sponsor has obtained a waiver from the FDA
Correct answer: When the principal risk is a breach of confidentiality and the consent form itself would link the participant to the research
45 CFR 46.117(c)(1) allows waiver of the requirement for a signed consent form when the only record linking the subject to the research is the consent document and the principal risk is breach of confidentiality.
CIP Protocol Review & Approval Process 4
A study sponsor requests that an IRB expedite review of a protocol to meet a drug development deadline.
What is the appropriate IRB response?