Guidance for Adding External Investigators

Purpose The purpose of this guidance is to provide general considerations for adding external study staff to human subjects research reviewed and approved by the Charles River Campus IRB. Defined Terms Federalwide Assurance (FWA): Institutions that are engaged in non-exempt human subjects research must hold a FWA. Through the FWA, an institution commits to the […]

NIH – Enhanced Checks for Compliance with Clinical Trial Registration and Reporting in RPPR

Enhanced checks on non-compliance with clinical trial registration and reporting came into effect in eRA’s Human Subjects System on October 1 that could delay your RPPR submission if you are late on either front (see details in eRA news item). Remember that all NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, […]

Native American Graves Protection and Repatriation Act (NAGPRA) Procedures

I. Purpose Pursuant to the NAGPRA Policy (the “Policy”), the University has developed the following procedures to comply with the Native American Graves Protection and Repatriation Act and its implementing regulations (collectively, and as they may be amended from time to time, “NAGPRA”). These procedures will be applied whenever the University becomes aware of human […]

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