- HHS Office for Human Research Protections (OHRP)
- U.S. Food & Drug Administration (FDA)
- Office of Research Integrity (ORI)
- National Institutes of Health (NIH):
- Centers for Disease Control (CDC) Human Research Protections
- National Institute of Justice (NIJ) Human Subjects Protection
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...