Human Research Protections- Standards & Regulations - page 9

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 Institutional Review Boards:
 Institutional Review Boards and the HIPAA Privacy Rule
This is a fact sheet created by the National Institutes of Health. Its contents include the following:
 The role of the Institutional Review Board (IRB) in relation to the HIPAA Privacy Rule
 Details of when and how a ‘Waiver of HIPAA authorization’ can be granted.
 Differences between HHS Human Subjects Protections Regulations, FDA Human Subjects
Protections Regulations, and The HIPAA Privacy Rule
 U.S. Food and Drug Administration (FDA) Regulations for Institutional Review Boards (21
CFR part 56)
These are standards for institutional review boards that review clinical investigations or research
studies that must be regulated by the Food and Drug Administration. It includes information
about requirements for registration with the Food and Drug Administration.
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 Research Misconduct Policy:
 NIH Handling of Research Misconduct
This website provides an overview of NIH policy related to research misconduct and links to actual
policy. It includes definitions for various types of research misconduct and guidelines for the NIH
process for handling findings of research misconduct.