The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more
Report on Research Compliance 18, no. 10 (October, 2021) - An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
Report on Research Compliance 17, no. 11 (November 2020) - As the pandemic continues to grip the United States, bringing more illness and death to minorities in particular, and the nation reflects on a summer of unrest over...more
The world has been thrown off its stride by the 2019 novel coronavirus SARS-CoV-2 and the resulting disease, “COVID-19.” At the time of this Alert, the full impact of SARS-CoV-2 and COVID-19 is still unknown. As an example,...more