Institutional Review Board

Definition

An Institutional Review Board (IRB) is a group that reviews and monitors research involving human subjects to ensure ethical standards are maintained. These boards are essential in the research process as they help protect the rights and welfare of participants by evaluating the potential risks and benefits of studies, ensuring that informed consent is obtained, and confirming compliance with regulations.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in the United States for any institution that conducts research involving human subjects.
2. The primary purpose of an IRB is to assess the risk-to-benefit ratio of research studies to protect participants from harm.
3. IRBs must consist of a diverse group of individuals, including members with scientific expertise, nonscientific members, and individuals who are not affiliated with the institution.
4. Approval from an IRB is necessary before a study can begin, and researchers must adhere to ongoing monitoring and reporting requirements.
5. There are different types of IRB reviews: exempt, expedited, and full board review, depending on the level of risk associated with the research.

Review Questions

• How does an Institutional Review Board contribute to ethical research practices involving human subjects?
  • An Institutional Review Board ensures that ethical standards are upheld in research involving human subjects by evaluating the proposed study for risks and benefits. They review the informed consent process to guarantee that participants understand what they are agreeing to and can make an educated decision about their involvement. By providing oversight, IRBs play a crucial role in protecting the rights and welfare of participants throughout the research process.
• Discuss the different types of IRB reviews and their significance in relation to various levels of research risk.
  • There are three main types of IRB reviews: exempt, expedited, and full board. An exempt review applies to studies that pose minimal risk and meet specific criteria, allowing for a simplified approval process. An expedited review is used for research that involves no more than minimal risk but requires more oversight than exempt studies. A full board review is necessary for studies that present more significant risks to participants. Each type of review is significant as it determines the level of scrutiny required to ensure participant safety based on the nature of the research.
• Evaluate how the role of Institutional Review Boards has evolved in response to historical events in research ethics.
  • The role of Institutional Review Boards has evolved significantly due to historical events like the Tuskegee Syphilis Study and other unethical research practices that highlighted the need for stricter oversight. In response, regulations were established requiring IRBs to oversee human subjects' research to ensure ethical conduct. This evolution reflects a broader societal commitment to protecting participants' rights and welfare, leading to more rigorous ethical standards and accountability in research practices today. As a result, IRBs now play an essential part in fostering trust between researchers and participants while promoting ethical integrity in scientific inquiry.

Related terms

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

Human Subjects Research: Research that involves collecting data from or about individuals, which requires careful ethical consideration to ensure the safety and rights of participants.

Ethics Review: A formal evaluation process that assesses whether a research project meets ethical standards, often conducted by an IRB or similar body.