IRB (Institutional Review Board) is a group of experts that reviews and approves research studies involving human participants. Think of them as safety guardians who make sure clinical trials and medical research projects protect the rights and well-being of study participants. Every clinical trial or medical study must get IRB approval before it can begin. Sometimes you might see it called an "Ethics Committee" or "Ethics Review Board." IRB review is a crucial step in the clinical research process that ensures studies follow all safety rules and ethical guidelines.
Managed submission of study protocols to IRB for review and approval
Prepared responses to IRB queries and maintained compliance documentation
Coordinated with Ethics Committee to ensure timely study initiation
Successfully submitted 20+ protocols to IRB with 95% first-time approval rate
Typical job title: "Clinical Research Coordinators"
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Q: How would you handle a situation where the IRB has concerns about a study protocol?
Expected Answer: A senior professional should explain the process of receiving IRB feedback, coordinating with study teams to address concerns, making necessary protocol modifications, and maintaining clear documentation of all changes and communications.
Q: What strategies do you use to ensure efficient IRB submissions and quick turnaround times?
Expected Answer: Should discuss organization systems, quality control measures, understanding of common IRB concerns, and methods for preparing comprehensive submission packages that anticipate potential questions.
Q: What are the key components of an IRB submission package?
Expected Answer: Should mention protocol document, informed consent forms, investigator qualifications, recruitment materials, and any supporting documentation required for human subject protection.
Q: How do you track and manage IRB renewal deadlines for multiple studies?
Expected Answer: Should describe systems and tools used for tracking deadlines, ensuring timely submissions, and maintaining compliance with continuing review requirements.
Q: What is the purpose of an IRB?
Expected Answer: Should explain that IRBs protect human research subjects, ensure ethical conduct of research, and review study protocols for safety and compliance with regulations.
Q: What types of changes to a study require IRB review?
Expected Answer: Should identify major protocol changes, informed consent modifications, new safety information, and other significant alterations that need IRB approval.