Application for Accreditation or Reaccreditation: Section F Minutes, Audits, and Government Correspondence

Resources: For Accreditation - Additional Resources

Section F consists of a single PDF file that contains the following:

A recent set of minutes for each IRB/EC, if your organization has an internal IRB(s)/EC(s) or is an independent IRB/EC.
Correspondence with government offices, including, but not limited to in the US:
- Department of Veterans Affairs (VA) Office of Research Oversight (ORO)
- US Office for Human Research Protections (OHRP) Determination Letters
- US Food and Drug Administration (FDA) Warning Letters
- FDA Restrictions Placed on IRBs or Investigators from the last year.
A summary of internal audits or reviews in the past year your 0rganization conducted of research teams or IRB/EC records.