Common Rule

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Common Rule

Common Rule (pronounced: /ˈkɒmən ruːl/) is a rule that was established in the United States to protect the rights and welfare of human subjects involved in research activities. The Common Rule was first published in 1991 and has been revised several times since then.

Etymology

The term "Common Rule" is derived from the fact that it is a rule that is commonly applied across multiple federal agencies in the United States. The term was first used in this context in the early 1990s.

Definition

The Common Rule is a federal policy in the United States that provides regulations for the protection of human subjects in research activities. It is applicable to all research involving human subjects that is conducted, supported, or otherwise subject to regulation by any federal department or agency.

Key Elements

The Common Rule includes several key elements, including requirements for Informed Consent, Institutional Review Boards (IRBs), and assurances of compliance.

  • Informed Consent is the process by which a subject voluntarily confirms his or her willingness to participate in a particular research, after having been informed of all aspects of the research that are relevant to the subject's decision to participate.
  • Institutional Review Boards (IRBs) are committees that review and approve research involving human subjects. They are responsible for ensuring that the rights and welfare of human subjects are protected.
  • Assurances of compliance are written documents submitted by an institution in which the institution commits to comply with the requirements of the Common Rule.

Related Terms

External links

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