HRP Services
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.
How to Prepare for the “Common Rule” Changes
We are happy to help you and your organization as you prepare for the "Common Rule" changes. Download the following electronic copies so that you may pass them along to your institution and/or colleagues: Implementing the Revised Common Rule - 10 Ways to Get Started...
NEWS FLASH: FDA Guidance Effective Immediately
On July 24, 2017 the FDA announced a new guidance, effective immediately, which will have significant impacts on industry, IRBs, and investigators. In short, the guidance is being issued to permit IRBs to waive or alter informed consent for minimal risk clinical...