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Institutional Review Board (IRB)

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Business Ethics in Biotechnology

Definition

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that ethical standards are maintained throughout the research process. It plays a crucial role in safeguarding the rights and welfare of participants by assessing the risks and benefits of research proposals, and ensuring compliance with regulatory guidelines.

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5 Must Know Facts For Your Next Test

  1. IRBs are required by federal regulations in the United States for any research involving human subjects that is funded by government grants or conducted at institutions that receive federal funding.
  2. The primary function of an IRB is to ensure that research protocols minimize risks to participants while maximizing potential benefits.
  3. IRBs have the authority to approve, modify, or disapprove research proposals based on ethical considerations and regulatory compliance.
  4. There are different types of IRBs, including those that are independent, institution-based, or affiliated with specific organizations or universities.
  5. IRBs also have ongoing responsibilities to monitor approved research studies to ensure continued compliance with ethical standards throughout the research process.

Review Questions

  • How does the Institutional Review Board (IRB) contribute to the ethical conduct of research involving human subjects?
    • The Institutional Review Board (IRB) plays a vital role in maintaining ethical standards in research by thoroughly reviewing study proposals before they begin. By evaluating potential risks and benefits, the IRB ensures that participants' rights and welfare are protected. This oversight fosters trust in the research process and upholds public confidence in scientific inquiry involving human subjects.
  • Discuss the importance of informed consent in relation to the responsibilities of an IRB when approving research proposals.
    • Informed consent is a critical component of ethical research, and it is one of the primary responsibilities of an IRB. Before approving a study, the IRB ensures that researchers adequately inform participants about the nature of the research, potential risks, and their rights. This helps protect participants from exploitation and guarantees that they have voluntarily agreed to participate based on clear understanding.
  • Evaluate the impact of IRB oversight on scientific integrity and responsible conduct in research. How does this oversight shape the future of biomedical research?
    • IRB oversight significantly impacts scientific integrity by enforcing ethical standards that researchers must adhere to during their studies. This oversight helps prevent misconduct such as data manipulation or participant exploitation, promoting transparency and accountability in research practices. As biomedical research continues to evolve with new technologies and methodologies, strong IRB governance will be essential in addressing emerging ethical dilemmas and ensuring responsible conduct in research that ultimately benefits society.
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