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...
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:...
Nov 21, 2019 | Uncategorized
The Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health of the Department of Health and Human Services (HHS) has announced its determination of exception for two categories of research from the required use of a single...
Mar 17, 2019 | Common Rule Updates, Uncategorized
News Flash: IRBs must continue to determine that research within the expedited categories is minimal risk OHRP released 8 new FAQs regarding the revised Common Rule on March 15th. Importantly, among these is the following clarification that because the Federal...
Jun 21, 2016 | Uncategorized
The NIH has released its final policy on the use of central IRBs for multi-site research. Starting May 2017, in multi-site studies in the United States involving non-exempt human subjects research funded by the National Institutes of Health (NIH), research...
