Good Clinical Practice (GCP) Practice Exam

In what year was the "Common Rule" published?

1. 1985

2. 1991

3. 1996

4. 2001

The correct answer is: 1991

The "Common Rule," which is a set of federal regulations that govern the protection of human subjects in research, was first published in 1991. This regulation was established to ensure ethical standards and guidelines are followed in research involving human participants. The Common Rule was created to provide consistency across federal agencies and improve the protections offered to subjects. The 1991 publication established requirements for institutional review boards (IRBs), informed consent, and assurances of compliance, fundamentally shaping how research involving human subjects is conducted in the United States. The rule has undergone revisions to adapt to changes in research practices and ethics, underscoring its significance in the framework of good clinical practice.