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 standards are met and protecting the rights and welfare of participants. The IRB plays a critical role in maintaining ethical integrity in research and clinical practice by assessing potential risks, benefits, and the informed consent process. This oversight helps ensure that research complies with legal regulations and ethical norms.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in many countries to review research proposals that involve human subjects before they can begin.
2. The primary goal of an IRB is to protect the rights and welfare of participants while ensuring that the research design has scientific validity.
3. IRBs assess factors such as risk-to-benefit ratios, informed consent processes, and the recruitment methods used to enroll participants in studies.
4. There are different types of IRBs, including full board review, expedited review, and exempt review, based on the level of risk involved in the research.
5. Researchers are required to obtain IRB approval before starting their studies, and ongoing oversight is often required to ensure compliance with ethical standards throughout the research process.

Review Questions

• How does an Institutional Review Board (IRB) contribute to ethical practices in research involving human subjects?
  • An IRB contributes to ethical practices by evaluating research proposals to ensure that they comply with established ethical guidelines. This includes assessing the risks involved, ensuring informed consent is properly obtained, and making sure that participants' rights and welfare are prioritized. By serving as a check on researchers, IRBs help maintain public trust in the research process and protect vulnerable populations from exploitation.
• Discuss the importance of informed consent in the context of IRB reviews and how it impacts participant safety in clinical trials.
  • Informed consent is crucial during IRB reviews because it ensures that participants fully understand what they are agreeing to when participating in a study. An IRB evaluates whether researchers provide clear information about the study’s purpose, procedures, potential risks, and benefits. This process directly impacts participant safety by empowering individuals to make informed choices about their involvement and ensuring they can withdraw from a study at any time without penalty.
• Evaluate the implications of IRB oversight on research innovation and how it balances ethical considerations with scientific advancement.
  • IRB oversight plays a vital role in balancing ethical considerations with scientific advancement by providing necessary scrutiny of research designs while allowing innovation to flourish within ethical boundaries. While some may argue that IRB processes can slow down research initiatives or stifle creativity, effective oversight ensures that studies are conducted responsibly. This balance is crucial for fostering public confidence in research outcomes while encouraging advancements that could lead to significant medical breakthroughs.

Related terms

Informed Consent: A process by which a participant voluntarily confirms their willingness to participate in a study, having been informed of all relevant aspects, including potential risks and benefits.

Ethical Principles: Foundational guidelines that govern the conduct of research involving human subjects, typically including respect for persons, beneficence, and justice.

Human Subjects Research: Research that involves collecting data through intervention or interaction with individuals, or obtaining identifiable private information about individuals.