With the pandemic of COVID-19 affecting the way of life across the globe, companies continue to accelerate the clinical development of a vaccine or a therapeutic. The number of Covid-19 clinical trials has been steadily growing because of the increases in incidence...
The Centers for Disease Control and Prevention (CDC) has recommended the implementation of several community actions in an effort to reduce people’s risk of being exposed to COVID-19. These actions slow the spread, reduce the impact of disease (i.e., “flatten the...
The revised Federal Policy for the Protection of Human Subjects (the “Common Rule”) collaborative (multi-site) research provision requires that U.S. institutions engaged in cooperative research conducted or supported by a Common Rule agency must rely on a single IRB...
In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9 technology. He...
On January 18, 2017, the Common Rule (45 CFR 46, Subpart A), which sets forth requirements for the protection of human subjects involved in research conducted or supported by HHS, was updated for the first time since being issued. The main goals of the updates are to...
