Changes to the Common Rule

Changes to the Common Rule

You may have heard that the federal government is updating the regulations governing human subjects research, as outlined in the “Common Rule” (45 CFR Part 46). These changes touch on critical issues such as informed consent, increased protections for participants, and the expansion of exempt categories of research. While these changes are designed to reduce the administrative burden associated with research, they will come with additional responsibilities that will affect both the university administration and our research community.

What is being done to prepare for these changes?

The University of Miami (UM) is committed to excellence in research. In furtherance of this commitment, a committee comprising representatives of the Office of the Vice Provost for Research, Research Compliance and Quality Assurance, Human Subjects Research Office, Office of Research Administration, Office of Privacy & Data Security, Office of Research IT, and Clinical Research Operations & Regulatory Support is working with key stakeholders to identify areas of policy, draft templates, and guidance documents that will need to change to bring our institution into compliance with the new Common Rule stipulations.

The committee’s goal is to serve as a resource to the research community in navigating the impending rule changes. In the upcoming weeks, further notifications and bulletins will be disseminated to explain changes to UM process, policy, and procedure made in response to the Common Rule revisions.

Timing Question

The majority of rule changes are scheduled to take effect on January 19, 2018. While it is possible that this deadline could be delayed, we are assuming no change so that the university will be fully prepared.