OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
FDA Announces ClinicalTrials.Gov Enforcement Action
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Institutional Review Board: Management and Function
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...
Cheryl Savini Appointed to Serve on the SACHRP Subcommittee on Harmonization
We’re pleased to announce that Cheryl Savini, SVP, has been appointed to the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Subcommittee on Harmonization. The Harmonization Subcommittee is charged with identifying, prioritizing, and developing...
HRP Continues to Monitor the COVID-19 Situation
HRP Consulting Group continues to monitor the local, national and worldwide incidence of the coronavirus and the illness it causes, as well as any federal and/or state guidance. As such, please continue to visit our dedicated COVID-19 page as we will be updating our...
Exception Process for Revised Common Rule Single IRB Requirement
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...