Institutional Review Board

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that ethical standards are upheld and participants' rights and welfare are protected. The IRB plays a crucial role in the clinical trials and drug approval process by assessing research proposals to confirm that they comply with ethical guidelines, regulatory requirements, and informed consent protocols.

5 Must Know Facts For Your Next Test

1. IRBs are required by federal regulations for any institution conducting research involving human subjects, ensuring compliance with ethical standards.
2. An IRB's review process includes evaluating the research design, potential risks to participants, and the measures in place to minimize those risks.
3. Members of an IRB typically include scientists, non-scientists, and community members to provide diverse perspectives on ethical considerations.
4. Researchers must submit detailed proposals to the IRB before beginning their studies, and they may need to make modifications based on the board's feedback.
5. The IRB has the authority to approve or disapprove research projects, and they can also suspend or terminate studies if ethical guidelines are not followed.

Review Questions

• How does an Institutional Review Board contribute to the ethical conduct of clinical trials?
  • An Institutional Review Board contributes to the ethical conduct of clinical trials by rigorously reviewing research proposals before they begin. The IRB assesses potential risks to participants, ensures informed consent processes are adequate, and confirms that the study complies with ethical guidelines and regulations. By serving as a safeguard for participant welfare, the IRB plays a vital role in maintaining public trust in clinical research.
• Discuss the responsibilities of an Institutional Review Board in relation to informed consent in clinical trials.
  • An Institutional Review Board is responsible for ensuring that informed consent is properly obtained from all participants in clinical trials. This includes reviewing the consent forms for clarity and comprehensiveness, ensuring that participants understand the study's purpose, procedures, risks, and benefits before agreeing to participate. The IRB’s oversight helps protect participants from potential exploitation and ensures their autonomy is respected throughout the research process.
• Evaluate the impact of Institutional Review Boards on the overall drug approval process and patient safety.
  • Institutional Review Boards significantly impact the drug approval process by enforcing ethical standards that prioritize patient safety during clinical trials. By thoroughly reviewing studies before they start, IRBs help ensure that potential risks are minimized and that participant rights are safeguarded. This oversight not only fosters public confidence in clinical research but also contributes to gathering high-quality data that regulators rely on when making decisions about drug approval. The vigilance of IRBs ultimately enhances the integrity of the entire approval process.

Related terms

Informed Consent: A process by which research participants are educated about the risks and benefits of a study and voluntarily agree to participate.

Clinical Trials: Research studies conducted with human participants to evaluate the safety and effectiveness of new treatments, drugs, or interventions.

Ethics Committee: A group that provides guidance on ethical issues in research, similar to an IRB, but may have a broader focus beyond just clinical trials.