top of page
Glossary Term
< Return to Main Navigation

Institutional Review Board (IRB)

Definition

An Institutional Review Board (IRB) is a formally designated committee that reviews, approves, and monitors biomedical and behavioral research involving human subjects. Its primary purpose is to ensure the protection of the rights, safety, and welfare of participants by evaluating research protocols for ethical and regulatory compliance.

Relevance to the MedTech Industry

IRBs are critical for safeguarding participants in clinical trials and research studies involving medical devices. They ensure that studies are ethically conducted, risks to participants are minimized, and that informed consent processes are thorough and appropriate. Approval from an IRB is mandatory for initiating clinical studies required for regulatory submissions.

Additional Information & Related Terms

Key Responsibilities of an IRB

  1. Protocol Review

    • Evaluates study objectives, methodology, and risk-benefit analysis to determine if the study is ethically justified.

  2. Informed Consent

    • Reviews the informed consent documents to ensure participants are provided with clear, accurate, and comprehensive information about the study.

  3. Risk-Benefit Assessment

    • Ensures that potential benefits of the study outweigh the risks to participants.

  4. Participant Protection

    • Monitors the rights, safety, and well-being of participants, especially those from vulnerable populations such as children, pregnant women, or individuals with cognitive impairments.

  5. Ongoing Monitoring

    • Conducts periodic reviews of the study to assess adherence to protocols, manage adverse events, and ensure compliance with ethical standards.


Related Terms

  • Informed Consent: A critical component of IRB review, ensuring participant understanding and autonomy.

  • Ethical Guidelines: Principles that guide the IRB in evaluating studies, such as those outlined in the Declaration of Helsinki or Belmont Report.

  • Good Clinical Practice (GCP): Regulatory guidelines that govern the conduct of clinical trials and align with IRB responsibilities.

  • Post-Market Surveillance (PMS): IRBs often oversee the ethical conduct of PMS studies involving human participants.

bottom of page