Institutional Review Board (IRB)

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that their rights, welfare, and safety are protected. IRBs are crucial in overseeing ethical standards in research by evaluating study protocols, informed consent processes, and potential risks to participants, thus helping to balance the pursuit of knowledge with the obligation to protect vulnerable populations.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations for any research involving human subjects conducted in the U.S. or funded by federal agencies.
2. The composition of an IRB must include at least five members with diverse backgrounds to ensure a comprehensive review of research proposals.
3. IRBs assess studies based on ethical principles such as respect for persons, beneficence, and justice, aligning with the Belmont Report's guidelines.
4. Researchers must submit their proposals for IRB approval before starting any study involving human participants to ensure ethical compliance.
5. IRBs have the authority to approve, require modifications, or disapprove research studies based on their assessments of ethical risks and protections for participants.

Review Questions

• How does the role of an Institutional Review Board (IRB) contribute to the ethical conduct of research involving human subjects?
  • An Institutional Review Board (IRB) plays a vital role in ensuring ethical conduct in research by reviewing proposals to protect human subjects from potential harm. By evaluating the study design, informed consent procedures, and overall risk-benefit ratio, the IRB ensures that researchers prioritize participants' rights and welfare. This oversight helps maintain public trust in the research process and promotes adherence to ethical standards.
• Discuss the criteria that an IRB uses to evaluate research proposals involving human subjects.
  • When evaluating research proposals, an IRB considers several criteria including the minimization of risks to participants, equitable selection of subjects, informed consent processes, and monitoring of data privacy. They also assess whether potential benefits outweigh risks and ensure that vulnerable populations are adequately protected. This rigorous evaluation process aims to uphold ethical standards while facilitating valuable research.
• Evaluate the implications of not having an Institutional Review Board (IRB) in place for research involving human subjects.
  • Without an Institutional Review Board (IRB), there would be significant risks associated with conducting research involving human subjects, including potential violations of ethical standards and participant rights. The absence of an IRB could lead to exploitation of vulnerable populations, inadequate informed consent, and lack of accountability for researchers. This could result in harmful consequences for participants and diminish public trust in scientific research overall, undermining the integrity and validity of findings.

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.

Ethics Review: The process by which an IRB examines the ethical considerations of a proposed study to ensure compliance with ethical standards and regulations.

Human Subjects Research: Research that involves direct interaction with individuals or data obtained from individuals, where the rights and well-being of those subjects are of primary concern.