Mar 18, 2020 | Uncategorized
The FDA has released guidance pertaining to the conduct of clinical trials involving medical products during the COVID-19 outbreak. Within this document, you will find information regarding the challenges this outbreak has imposed on studies, as well as how protocols...
Mar 13, 2020 | Hot Topics
Management of Ongoing Human Subjects Research During COVID-19 IRBs and Ethics Committees worldwide are facing operational challenges during the COVID-19 pandemic. HRP has developed this guidance to help organizations and IRBs develop an appropriate approach for the...
Mar 6, 2020 | Common Rule Updates
HRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research. While NIH was previously able to grant exceptions from its own single...
Jan 15, 2020 | Uncategorized
The January 20, 2020 compliance date for the single IRB requirement for cooperative research at §46.114(b) of the revised Common Rule is only a few short days away. While it is HRP’s understanding that OHRP intends to issue guidance about this provision, that...
Dec 4, 2019 | Uncategorized
On November 21st OHRP announced two exceptions from the required use of a single IRB to review cooperative research that is subject to the HHS regulations for the protection of human subjects. The OHRP announcement can be found here:...
