Author Archives: Jeanne Lovmo

It can be challenging to navigate the Department of Health and Human Services (HHS) regulations for the protection of human subjects (“The Common Rule”) in a rapidly changing landscape of biomedical and health-related research. The UNC Chapel Hill required CITI Human Subjects Protection (HSP) Training and CITI HSP supplemental training...

It can be challenging to decide if a project represents Quality Assurance (QA)/Quality Improvement (QI) or qualifies as Human Subjects Research (HSR). To mitigate this challenge, we have developed a QA/QI frequently asked questions document and a screening checklist.

As clinical researchers, a large part of what we do involves working together through collaboration, mentoring, and direct support. However, it can be challenging to identify the right person for a specific activity. The School of Medicine (SOM) CRAU Directory mitigates this challenge by enabling you to identify personnel with...

On September 26, 2022, the U.S. Food and Drug Administration (FDA) announced in the Federal Registry the newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The goal of this guidance is to provide FDA’s perspective on the ethical considerations for including children in...

As part of its obligations under the 21st Century Cures Act, the U.S. Food and Drug Administration (FDA) announced, on September 28, 2022, two proposed rules aimed at harmonizing, to the “extent practicable and consistent with statutory provisions,” certain sections of the agency’s regulations on human subject protections and Institutional...

On April 8, 2022, the U.S. Food and Drug Administration (FDA) adopted and issued the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) General Considerations for Clinical Studies. ICH E8 guidelines sets out general scientific principles for the conduct, performance, and control of clinical...