CCRC - Certified Clinical Research Coordinator IRB Roles and Responsibilities Questions and Answers — Questions and Answers
Question 1: A clinical research study that was initially approved by a full IRB committee is approaching its one-year approval anniversary. What is the primary purpose of the IRB's continuing review for this ongoing study?
- To verify the accuracy of the data collected and ensure it aligns with the study's primary objectives.
- To provide a formal summary of enrollment statistics to the study sponsor and regulatory authorities.
- To renegotiate the site's budget based on the complexity and number of participants enrolled.
- To reassess the risk-benefit ratio and ensure the continued protection of the rights and welfare of research participants. (Correct answer)
Correct answer: To reassess the risk-benefit ratio and ensure the continued protection of the rights and welfare of research participants.
The fundamental purpose of IRB continuing review is to ensure that the study, as it is actually being conducted, continues to meet the ethical standards and regulatory criteria for approval. This involves re-evaluating the risks and benefits based on study progress, any new information, and ensuring that protections for participants remain adequate.
Question 2: A PI submits a protocol for a new minimal-risk study that will involve a one-time blood draw and a quality-of-life survey for healthy adults. This type of research typically does not require review at a convened IRB meeting. This level of review is known as:
- Exempt Determination
- Expedited Review (Correct answer)
- Full Board Review
- Delayed Review
Correct answer: Expedited Review
Research activities that involve no more than minimal risk to subjects and fall into one of the specific categories defined by federal regulations can be reviewed through an expedited process. This review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson, not by the full committee. An exempt determination is for research with even lower or no apparent risk, while full board review is for studies with greater than minimal risk.
Question 3: During the conduct of a trial, the Principal Investigator realizes that a participant's screening lab tests were inadvertently performed one day before the informed consent form was signed and dated. How should the CRC expect this event to be handled with respect to the IRB?
- The event should be documented in the site's internal files but does not need to be reported to the IRB as long as the participant was ultimately eligible.
- The PI should inform the sponsor but wait for sponsor direction before taking any action with the IRB.
- The event must be reported to the IRB as a protocol deviation, as study procedures were conducted prior to obtaining consent. (Correct answer)
- The participant should be asked to re-consent and back-date the form to the day before the lab draw to correct the error.
Correct answer: The event must be reported to the IRB as a protocol deviation, as study procedures were conducted prior to obtaining consent.
Conducting any study-related procedure before obtaining and documenting informed consent is a significant protocol deviation and a violation of fundamental ethical principles and regulations. The site has an obligation to report such deviations to the IRB according to institutional policy, which is typically within a specified timeframe (e.g., 5-10 business days) of discovery.
Question 4: Which of the following is a mandatory membership requirement for an Institutional Review Board (IRB) as specified by federal regulations (45 CFR 46)?
- The IRB must have at least one member who is not affiliated with the institution. (Correct answer)
- The IRB must include at least two members with doctoral degrees in a biomedical science.
- All members of the IRB must be employees of the institution to ensure accountability.
- The IRB chairperson must be a physician with clinical research experience.
Correct answer: The IRB must have at least one member who is not affiliated with the institution.
Federal regulations (45 CFR 46.107) require that each IRB include at least one member who is not otherwise affiliated with the institution (and is not an immediate family member of an affiliated person). This is to ensure that the IRB review includes a community or public perspective, independent of the institution.
Question 5: The sponsor of a global oncology trial issues a protocol amendment. The only change is the addition of a new, non-investigational laboratory test to be drawn at the Week 8 visit to monitor for a rare but known side effect. What must the CRC confirm before implementing this change for any participants?
- That the sponsor has notified the FDA of the change.
- That the site's lab is certified to perform the new test.
- That the Principal Investigator has personally signed off on the scientific merit of the change.
- That the protocol amendment and any revised consent forms have been submitted to and approved by the IRB. (Correct answer)
Correct answer: That the protocol amendment and any revised consent forms have been submitted to and approved by the IRB.
Investigators are prohibited from implementing any changes to a previously approved research plan without first obtaining IRB review and approval. The only exception is when a change is necessary to eliminate an apparent immediate hazard to subjects. Even seemingly minor changes like adding a safety lab test require formal IRB approval of the amendment before they can be implemented.
Question 6: What is the primary and overarching responsibility of an Institutional Review Board (IRB)?
- To ensure the scientific integrity and statistical power of the research design.
- To protect the institution from legal and financial liability arising from research activities.
- To facilitate the efficient and timely completion of clinical trials.
- To protect the rights and welfare of human subjects participating in research. (Correct answer)
Correct answer: To protect the rights and welfare of human subjects participating in research.
The fundamental mission of the IRB, as mandated by federal regulations such as 45 CFR 46 and 21 CFR 56, is to ensure the protection of the rights and welfare of human research participants. While scientific merit is considered in the risk/benefit analysis, the IRB's primary role is ethical oversight and subject protection.
CCRC - Certified Clinical Research Coordinator IRB Roles and Responsibilities Questions and Answers
A clinical research study that was initially approved by a full IRB committee is approaching its one-year approval anniversary.
What is the primary purpose of the IRB's continuing review for this ongoing study?