Regulatory Affairs is about much more than simply following the U.S. Code of Federal Regulations or working with the Institutional Review Board and various committees. The Institute’s Regulatory Affairs team provides in depth training and education on why rules are important when conducting research. We provide education about the Institutional Review Board (IRB), the Food and Drug Administration (FDA), and the U.S. Department of Health and Human Services (DHHS). We explain why it is important for studies to be independently reviewed, and we provide education about the events that resulted in the Nuremburg Code, Declaration of Helsinki, and Belmont Report. Informed consent is the cornerstone of Good Clinical Practice (GCP). We provide detailed training on what truly constitutes informed consent and the best practices for conducting consent.
The benefits of in person training include:
- Engagement with global UNC teams to discuss specific ethical issues that have come up at their sites, and
- Understanding regulations in a very practical way while working with vulnerable and marginalized populations, children/adolescents, or prisoners.
Regulatory Affairs currently offers scheduled training sessions and support including:
- Specific active modules in Good Clinical Practice and Human Subjects Protections,
- IGHID SOPs, including essential documents, informed consent, safety reporting, privacy, and
- Monthly calls to each UNC global site to provide study oversight.
We schedule special group training sessions upon request. Send us an email: firstname.lastname@example.org