Institutional Research Ethics Review Board (IRB)

An Institutional Research Ethics Review Board (IRB) is a committee that is legally responsible for reviewing clinical research methods and ensuring they are ethical.

• AKA: Independent Ethics Committee (IEC), Research Ethics Board (REB).
• Context:
  • They can reviews the Clinical Study Patient Experience.
  • ...
• Example(s):
  • United States Food and Drug Administration (FDA),
  • European Medicines Agency (EMA),
  • …
• Counter-Example(s):
  • Clinical Trial Sponsor,
  • European Space Agency (ESA),
  • National Aeronautics and Space Administration (NASA),
  • World Health Organization (WHO).
• See: IRB Approval, Clinical Trial, Good Clinical Practice, Risk-Benefit Analysis, Quality of Life. Research Ethics, Methodology, Research, Ethics, Biomedical, Behavioral, Human.

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References

2022a

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Institutional_review_board Retrieved:2022-1-22.
  • An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assuNational Aeronautics and Space Administrationre that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.

2022b

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-1-22.
  • QUOTE: Independent Ethics Committee
    • An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guidance. (ICH E6)

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