No human research protection program is immune from an OHRP Determination Letter or FDA 483 or Warning Letter. The best HRPPs realize it is how they respond to findings from federal agencies that will ensure that their organization is protected from additional sanctions and that the credibility of their HRPP remains intact.
With over 50 years of combined experience working as OHRP regulators, research administrators, and IRB managers, we’ve been on both sides of the regulatory oversight process. We can use this experience to help you address audit findings so that you can be confident that one bad audit does not lead to additional compliance problems for your organization.
For more information about how we can help you respond to federal agencies, please contact us at (347) 862-9321 or by email at services@thehrpconsultinggroup.com.