CIP Protocol Review & Approval Process 4

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?

Accepted Answer

Accommodate the request only if the protocol qualifies for expedited review under 45 CFR 46.110 categories

Answer

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?

Accepted Answer

Apply both sets of requirements, as the research must comply with both HHS (45 CFR 46) and FDA (21 CFR 50/56) regulations

Answer

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?

Accepted Answer

The protocol is set aside for later consideration, typically because more information is needed before a final vote

Answer

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?

Accepted 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

Answer

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?

Accepted Answer

When the degree of risk justifies more frequent review, or when required by the IRB as a condition of approval

Answer

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.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Protocol Review & Approval Process 4