IRB

Term from Clinical Trials industry explained for recruiters

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.

Examples in Resumes

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"

Also try searching for:

Clinical Research Associate IRB Coordinator Regulatory Specialist Clinical Trial Manager Research Compliance Specialist Clinical Operations Manager

Example Interview Questions

Senior Level Questions

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.

Mid Level 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.

Junior Level Questions

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.

Experience Level Indicators

Junior (0-2 years)

  • Basic understanding of IRB submission process
  • Ability to prepare simple IRB documentation
  • Knowledge of research ethics principles
  • Document organization and tracking

Mid (2-5 years)

  • Managing complete IRB submission packages
  • Handling IRB correspondence and follow-up
  • Understanding of regulatory requirements
  • Protocol review and analysis

Senior (5+ years)

  • Strategic planning of IRB submissions
  • Managing complex multi-site studies
  • Training and mentoring junior staff
  • Resolving complex regulatory issues

Red Flags to Watch For

  • No knowledge of human subject protection regulations
  • Unfamiliarity with informed consent requirements
  • Poor attention to detail in documentation
  • Lack of experience with regulatory submissions