IRB

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. IRBs are crucial in the research process, as they evaluate the ethical implications of studies and ensure compliance with regulatory requirements before research can proceed.

5 Must Know Facts For Your Next Test

1. IRBs are mandated by federal regulations in the United States, specifically 45 CFR 46, which outlines the ethical principles that guide human subjects research.
2. The composition of an IRB typically includes members with diverse backgrounds, including scientists, non-scientists, and individuals with expertise in ethics and law.
3. IRBs evaluate various aspects of proposed research, including risk assessment, informed consent procedures, and the potential benefits to participants and society.
4. Researchers must submit a detailed protocol to the IRB before initiating their study, including information on participant recruitment, data collection methods, and how they will protect participant confidentiality.
5. IRBs have the authority to approve, require modifications in, or disapprove research proposals based on ethical considerations related to participant welfare.

Review Questions

• How does an IRB ensure that human subjects are protected during research studies?
  • An IRB ensures protection of human subjects by reviewing research proposals to assess ethical considerations such as risk versus benefit, informed consent processes, and participant welfare. By evaluating these factors, the IRB helps safeguard participants from potential harm and ensures that their rights are respected throughout the research process. The board's oversight is essential for maintaining ethical standards in studies involving human subjects.
• Discuss the importance of informed consent in the context of IRB reviews and human subjects research.
  • Informed consent is a key component evaluated by IRBs during the review process. It ensures that participants are fully aware of what the study entails, including potential risks and benefits, allowing them to make an informed decision about participation. The IRB scrutinizes the informed consent documents for clarity and comprehensiveness to guarantee that participants understand their rights and the nature of the research before agreeing to take part.
• Evaluate the role of IRBs in fostering ethical research practices within academic institutions and beyond.
  • IRBs play a critical role in fostering ethical research practices by establishing guidelines that protect human subjects while promoting integrity in scientific inquiry. Their evaluation processes not only ensure compliance with legal regulations but also set a standard for ethical conduct in research across various fields. By holding researchers accountable for their treatment of participants, IRBs contribute significantly to public trust in research outcomes and help maintain the credibility of academic institutions and organizations engaged in human subjects research.

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 participation.

Human Subjects Research: Research that involves collecting data from or about living individuals, which requires ethical considerations and protections for those individuals.

Ethical Review: A systematic evaluation of research proposals by an IRB or similar body to assess the ethical implications and risks involved in conducting the research.