Interactions with Federal Agencies
Any program can find itself struggling with a regulatory interpretation or needing to report or respond to a federal agency. The best administrators realize that proactively addressing questions, managing mandated reporting responsibilities, and providing complete and on-target responses to findings or observations from federal agencies will minimize organizational risk and ensure that the credibility of their program remains intact.
With over 100 years of combined experience in the field, including experience within FDA, OHRP, and other agencies, our consultants and associates understand agency processes and expectations and can help your organization with anything from asking a question anonymously to responding to agency concerns and findings.
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...
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