Institutional Review Board

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that their rights and welfare are protected. It serves as a crucial ethical oversight mechanism in the research process, balancing the advancement of knowledge with the need to protect participants from potential harm or exploitation.

5 Must Know Facts For Your Next Test

1. IRBs are required by federal law in the United States for any research involving human subjects that is conducted or supported by federal agencies.
2. The main functions of an IRB include assessing research protocols for ethical concerns, ensuring informed consent processes are in place, and monitoring ongoing research for compliance with ethical standards.
3. IRBs can have multiple members from diverse backgrounds, including medical professionals, ethicists, and community representatives to provide a comprehensive perspective on proposed research.
4. An IRB may approve a study, require modifications before approval, or disapprove it based on ethical considerations related to participant risk and informed consent.
5. Researchers must submit their proposals to the IRB prior to starting their studies, and failure to obtain IRB approval can result in severe consequences for researchers and institutions.

Review Questions

• How does an Institutional Review Board ensure the protection of human subjects in research?
  • An Institutional Review Board ensures the protection of human subjects by thoroughly reviewing research proposals to identify potential ethical issues. The IRB evaluates whether the risks to participants are minimized and whether informed consent processes are adequately described. Additionally, it checks if there are sufficient safeguards in place to protect vulnerable populations involved in the study.
• Discuss the role of informed consent in the review process of an Institutional Review Board and why it is essential.
  • Informed consent is a vital part of the IRB's review process as it ensures that participants are fully aware of the research's purpose, risks, and benefits before agreeing to participate. The IRB evaluates how researchers communicate this information and whether participants have the capacity to understand it. This process is essential because it respects individuals' autonomy and right to make informed choices regarding their involvement in research.
• Evaluate the implications of not having an Institutional Review Board in place for conducting human subjects research.
  • Without an Institutional Review Board, there would be significant ethical risks in human subjects research, including potential harm to participants and exploitation of vulnerable groups. The absence of such oversight could lead to a lack of accountability among researchers, resulting in unethical practices and violations of participants' rights. Furthermore, it could undermine public trust in research endeavors and hinder advancements in medical knowledge by discouraging participation due to ethical concerns.

Related terms

Informed Consent: A process in which researchers provide potential participants with information about a study, including its purpose, risks, and benefits, allowing individuals to make an informed decision about their participation.

Ethical Principles: Fundamental guidelines that govern the conduct of research and clinical practice, such as respect for persons, beneficence, and justice, which are crucial for protecting participants' rights.

Human Subjects Research: Research that involves collecting data from or about living individuals, requiring special ethical considerations and oversight to ensure the safety and rights of those involved.