Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and answers...more
The U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) issued guidance, dated April 8, 2020, on the application of Common Rule requirements to research being conducted during the...more
The spread of the novel coronavirus (COVID-19), and implementation of assorted regulations and guidelines, raise concerns over the impact on clinical testing, data collection for virus tracking and seeking a cure....more