Penn State uses the Collaborative Institutional Training Initiative (CITI) program to offer content that fulfills that human subjects research training requirement for IRB approval. The CITI human subjects training includes a required module on HIPAA privacy and security that fulfills HIPAA training for investigators human subjects research. Click here to begin training in CITI.
Some studies defined as "clinical research" or a "clinical trial" have special compliance requirements. For compliance purposes, there are three definitions of clinical trials depending on the funding or regulatory oversight. Studies with NIH funding follow the Common Rule definition, which is a similar definition used by other federal funding agencies. FDA-regulated research defines a clinical trial as research meeting the criteria of an "applicable clinical trials" (ACT).
Penn State has a number of policies relevant to clinical research. Research protections policies include: