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Institutional Review Board(IRB) for the Protection of Human Subjects

 
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ETHICAL AND HISTORICAL DOCUMENTS

  • The Nuremberg Code - Ten principles developed in 1947 during the trial of USA vs. Karl Brandt et al. The doctors on trial were accused of wartime medical experiments on human beings.
  • The World Medical Association Declaration of Helsinki - A statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
  • The Belmont Report - Attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research during the course of its deliberations in 1976.

FEDERAL DOCUMENTS AND GUIDES

  • Title 45 CFR 46 - Code of Federal Regulations: Title 45 Public Welfare, Part 46 Protection of Human Subjects is a federal policy that guides the conduct of research involving human subjects.
  • Office for Human Research Protections (OHRP) - The federal office responsible for regulating IRBs.
  • IRB Guidebook - A document created by OHRP that outlines basic information about the IRB system.
  • Office of Research Integrity (ORI) - Monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.
  • Food and Drug Administration Regulations - A must read for those interested in conducting research involving new drugs or devices regulated by the FDA (see 21CFR50, 21CFR56).
  • NIH Bioethics on the Web - Contains numerous links to bioethical information on the web.

 
 
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