Institutional Review Board (IRB)

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that ethical principles are upheld throughout the research process. The IRB assesses the risks and benefits of research proposals to protect the rights and welfare of participants, ensuring compliance with ethical guidelines such as respect for persons, beneficence, and justice.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in the U.S. to review all research involving human subjects to ensure ethical standards are maintained.
2. An IRB can require modifications to a research proposal or can deny approval if it does not meet ethical criteria.
3. The composition of an IRB typically includes diverse members with varying backgrounds, including scientists, non-scientists, and community representatives.
4. IRBs also monitor ongoing research to ensure compliance with approved protocols and to address any emerging ethical concerns.
5. The core ethical principles guiding IRBs are derived from the Belmont Report, which emphasizes respect for persons, beneficence, and justice.

Review Questions

• How does an Institutional Review Board (IRB) evaluate research proposals to ensure ethical compliance?
  • An IRB evaluates research proposals by carefully assessing the potential risks and benefits to participants, considering factors like informed consent processes and safeguards against harm. They check if the research adheres to ethical principles such as respect for persons, which involves ensuring participants are fully informed about the study. Additionally, they evaluate whether the selection of participants is equitable and if vulnerable populations are adequately protected.
• Discuss the role of informed consent in the IRB review process and why it is critical for ethical research.
  • Informed consent plays a crucial role in the IRB review process as it ensures that participants have a clear understanding of what the research entails before they agree to take part. The IRB scrutinizes the informed consent documents for clarity, comprehensiveness, and transparency regarding risks and benefits. This practice protects participants' autonomy and promotes trust in the research process, making it a foundational aspect of ethical research involving human subjects.
• Evaluate how adherence to ethical guidelines set forth by IRBs influences public trust in healthcare research.
  • Adherence to ethical guidelines established by IRBs significantly enhances public trust in healthcare research by demonstrating a commitment to participant welfare and ethical standards. When individuals see that rigorous oversight is in place to protect their rights and safety, they are more likely to participate in studies. Moreover, transparency about the IRB approval process fosters confidence that research outcomes will be credible and beneficial. This trust is essential for advancing medical knowledge while ensuring community engagement and cooperation in future studies.

Related terms

Informed Consent: A process by which researchers ensure that participants understand the nature, risks, and benefits of a study before agreeing to take part.

Human Subjects Research: Research that involves collecting data from or about living individuals, requiring ethical oversight to protect their rights and well-being.

Ethical Guidelines: Set standards designed to guide researchers in conducting studies responsibly, focusing on the moral implications of their work.