The Common Rule is a set of a federal regulations shared by fifteen Federal departments and agencies that govern all research involving human subjects conducted or supported by the relevant department or agency. With few exceptions, research institutions subject to the Common Rule must secure informed consent from each human subject, receive approval from an Institutional Review Board (IRB), and submit assurance of compliance with the regulation in writing to the appropriate federal department or agency before research can begin. While other federal statutes and regulations have requirements related to research, such as the HIPAA Privacy Rule, the Common Rule is the primary set of requirements applicable to human subjects research.
To learn more about the Common Rule, including a complete overview and a brief summary of the regulations as well information about the relationship between the Common Rule and the HIPAA Privacy Rule, we invite you to access our products below.
Fast Facts: What is the Common Rule?
Myth Buster: HIPAA and the Common Rule regulate research in the same way.
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