- 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
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
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...