Maintaining Accreditation

Annual and Other Notification Reporting

During the intervening years between site visits, AAHRPP requires an accredited Organization to submit annual reports. Failure to submit an annual report within 30 days of the deadline may result in revocation of accreditation.

The purpose of the annual report is to notify AAHRPP of changes related to the Organization’s Human Research Protection Program. An Organization must submit a standard form found on the Web site that includes the following information:
 
Organizational Changes:

• Change in name of the organization.Change in ownership of the organization.
• Change in governance of the organization (e.g., President or Chief Executive Officer).
• Change in the organizational official.Change in the leadership of the Human Research Protection Program (i.e. the individual responsible for the day-to-day operation).
• Change in the application contact.

Changes in Resources:

• Significant change (10% or more) in the balance of resources and active research protocols.
• Significant reduction (10% or more) in resources in the past 12 months and the consequences on the HRPP, such as reduction in FTE and dissolution of an IRB, committee or other function.

Changes in Program Scope:

• Any mergers or acquisitions.
• Addition of new research program (i.e. research not previously conducted or reviewed by the organization such as planned emergency research.Research involving children or gene transfer research).
• Addition of functions, committees or IRBs.

Changes in method of providing services, such as use of external IRBs or use of contracting services of another organization.
 
Catastrophic event that results in an interruption or discontinuance in a component of or the entire Human Research Protection Program.

An Organization must report to AAHRPP within 24 hours that the Organization or Investigator (if the Investigator is notified rather than the Organization) becomes aware of the event:

• Any sanctions taken by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, and FDA Restrictions Placed on IRBs or Investigators.
• Any lawsuits related to human research protection.

If an Organization is in doubt about whether to report a particular item to AAHRPP, it should contact the AAHRPP office for further advice.
 
The Council on Accreditation will review major changes to the Human Research Protection Program and determine whether any action is indicated, such as a request for additional written information or a limited site visit.

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