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. If your organization has more than 3 internal IRB(s)/EC(s), please contact reporting@aahrpp.org to discuss the number of sets of minutes to provide.

• A list of internal audits or reviews your organization conducted of research teams and/or IRB(s)/EC(s) in the past year. The list should include: the approximate date(s) of the audit, audit focus (e.g., research team informed consent documents, IRB/EC minutes), whether it was a routine or for-cause audit, and the results and/or actions taken. This optional template can be used to capture and provide this information to AAHRPP.

• Any negative action by a government oversight office and follow-up by your organization, such as restrictions placed on IRB(s)/EC(s), researchers, or other compliance actions related to the oversight of human participants research. Include correspondence with relevant regulatory agencies. Negative actions by a government oversight office include, but is not limited to:
  • Compliance actions taken by non-US government authorities related to human research protections 
  • Compliance actions taken by US Federal government authorities related to human research protections, such as:
    • US Office for Human Research Protections (OHRP) Determination Letters
    • US Food and Drug Administration (FDA) Warning Letters
    • FDA 483 Inspection Reports

Do not include government office or agency inspections with no findings or concerns.

For organizations undergoing initial accreditation, these actions should be limited to those that occurred in the last year before submission of the Step 2 application.

For organizations undergoing reaccreditation, these actions include:

• those that occurred since the last Annual Report to AAHRPP,
• any actions that were not resolved as of the last Annual Report to AAHRPP, and
• any actions not previously reported to AAHRPP since the last reaccreditation.

See also Instructions to Apply for Initial Accreditation and Reaccreditation.