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:...
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...
Jan 18, 2019 | Common Rule Updates
On 1/18/19 OHRP issued a FAQ recommending that IRBs continue to conduct continuing review of research that is eligible for expedited review under the current categories 8(b) or 9 of the OHRP Federal Register list even though continuing review is not required for such...
Jan 14, 2019 | Common Rule Updates, Regulatory Updates
On January 2nd, the National Institute of Justice (NIJ) updated their guidance regarding Human Subjects Protections to remind organizations that: “Because the Department of Justice (DOJ) is not a signatory of the Revised Common Rule, the DOJ regulations regarding...
Jan 11, 2019 | Common Rule Updates, Regulatory Updates
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).” While the guidance is draft, it provides insight into OHRP’s...
