Institutional Review Board (IRB)

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects to ensure that their rights and welfare are protected. The IRB assesses the ethical implications of research proposals, ensuring compliance with regulatory standards and protecting participants from potential risks associated with the study.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in the United States to review all research involving human subjects funded by federal agencies.
2. An IRB must include members with diverse backgrounds, including scientific and non-scientific individuals, to ensure comprehensive review from various perspectives.
3. IRBs have the authority to approve or disapprove research studies based on ethical considerations and can require modifications before granting approval.
4. The primary purpose of an IRB is to safeguard participants by ensuring that risks are minimized and informed consent is obtained.
5. Research studies that do not receive IRB approval cannot legally begin until they meet the ethical guidelines set forth by the board.

Review Questions

• How does an Institutional Review Board (IRB) influence the research process involving human subjects?
  • An Institutional Review Board (IRB) plays a crucial role in influencing the research process by reviewing research proposals to ensure they adhere to ethical standards. By evaluating factors such as risk, informed consent, and participant welfare, the IRB ensures that the rights and safety of human subjects are prioritized. This oversight helps to maintain public trust in research practices and ensures that researchers follow established ethical guidelines.
• Discuss the responsibilities of an IRB in relation to informed consent and participant protection.
  • The IRB is responsible for ensuring that informed consent is properly obtained from participants before they engage in research. This includes reviewing consent forms for clarity and completeness, making sure that participants understand the nature of the study, its risks, benefits, and their right to withdraw at any time. Additionally, the IRB monitors ongoing research to ensure that participant protections are continuously upheld throughout the study duration.
• Evaluate the impact of IRB decisions on the ethical conduct of biomedical research involving human subjects.
  • IRB decisions significantly impact the ethical conduct of biomedical research by enforcing strict compliance with ethical standards aimed at protecting human subjects. When an IRB approves a study, it indicates that researchers have adequately addressed potential risks and have implemented measures to safeguard participant rights. Conversely, disapproval can prompt researchers to rethink their methodologies or enhance their ethical considerations, ultimately leading to more responsible research practices. This oversight fosters accountability and helps maintain public confidence in scientific inquiry.

Related terms

Informed Consent: A process by which researchers provide potential participants with information about a study, allowing them to make an informed decision about their participation.

Ethics Review: An evaluation process conducted by an IRB to assess the ethical considerations of a research proposal before it can be approved for execution.

Human Subject Research: Research that involves collecting data from or about living individuals, requiring ethical oversight to protect participants' rights and welfare.