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👶developmental psychology review

IRB Regulations

Written by the Fiveable Content Team • Last updated September 2025
Written by the Fiveable Content Team • Last updated September 2025

Definition

IRB regulations refer to the guidelines and policies established to protect human subjects involved in research. These regulations ensure that ethical standards are maintained during research studies, which include obtaining informed consent, minimizing risks, and ensuring confidentiality. They play a crucial role in research methods by safeguarding the rights and welfare of participants, while also promoting responsible conduct in scientific inquiries.

5 Must Know Facts For Your Next Test

  1. IRB regulations are mandated by federal law in the United States for any institution receiving federal funding for research involving human subjects.
  2. There are three primary principles underlying IRB regulations: respect for persons, beneficence, and justice, which guide ethical considerations in research.
  3. IRBs have the authority to approve or disapprove research studies based on their compliance with ethical guidelines and participant protections.
  4. Researchers are required to submit detailed proposals to the IRB, outlining their methods, risks, and how they will obtain informed consent from participants.
  5. Non-compliance with IRB regulations can result in severe penalties for institutions and researchers, including loss of funding and legal repercussions.

Review Questions

  • How do IRB regulations contribute to the ethical conduct of research involving human subjects?
    • IRB regulations contribute to ethical conduct by ensuring that researchers prioritize the rights and welfare of human subjects. By requiring informed consent, minimizing risks, and maintaining confidentiality, IRBs help protect participants from potential harm. The oversight provided by IRBs promotes accountability among researchers and reinforces the importance of conducting studies responsibly.
  • Discuss the process researchers must follow when submitting their proposals to an IRB for review.
    • When submitting proposals to an IRB, researchers must provide detailed information about their study, including objectives, methodology, potential risks, and how they plan to obtain informed consent. The proposal is then reviewed by the IRB, which evaluates whether the research adheres to ethical standards and adequately protects participants' rights. Researchers may need to address any concerns raised by the IRB before receiving approval to begin their study.
  • Evaluate the impact of IRB regulations on the overall landscape of research ethics and participant protection in modern scientific studies.
    • IRB regulations have significantly transformed the landscape of research ethics by establishing a framework that prioritizes participant protection and ethical integrity. These regulations ensure that researchers consider the moral implications of their work and take proactive measures to safeguard human subjects. As a result, IRBs foster greater public trust in research practices while encouraging transparency and accountability within the scientific community.