AAHRPP requires an accredited organization to submit an Annual Report one year after it receives Full Accreditation, Full Reaccreditation, or Qualified Accreditation. Annual Reports are required each year thereafter; however, an Annual Report is not required in the year in which the Application for Reaccreditation is due and the year in which the organization’s Application for Reaccreditation is due for review by the Council on Accreditation (Council). Failure to submit an Annual Report in any year in which it is due may result in an organization being placed into Accreditation-Pending, Reaccreditation-Pending, or Accreditation Revoked.

The purpose of the Annual Report is to keep AAHRPP current on the nature and size of an organization’s HRPP and human research portfolio as well as to notify AAHRPP of changes related to or that might affect the organization’s HRPP, including but not limited to:

• Organizational Changes*, such as:
  • Change in entity type or corporate structure.
  • Change in name of the organization.
  • Change in ownership or control of the organization, including mergers or acquisitions.
  • Change in leadership or governance of the organization (e.g., President or Chief Executive Officer).
  • Change in the organizational official.
  • Change in the leadership of the HRPP (i.e., the individual responsible for the day-to-day operation).
  • Change in the application contact.
• Changes in Resources, such as:
  • 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 impact on the HRPP, such as reduction in full-time equivalent (FTE) or dissolution of an IRB/EC, committee, or other function.
• Changes in Program Scope, such as:
  • Addition of a new research program, including but not limited to a type of research not previously conducted or reviewed by the organization (such as planned emergency research, research involving children, or gene transfer research).
  • Addition, removal, or modification of functions, committees, or IRBs/ECs.

• Changes in method of providing services, such as use of external IRBs/ECs or contracting for services from another organization.
• Catastrophic event that results in an interruption or discontinuance in a part of or the entire HRPP.

*Note that when an accredited organization or its HRPP has a substantive change, including but not limited to a change in corporate structure, a change of ownership or leadership, or a change of name, it should notify the AAHRPP office immediately when the change occurs rather than waiting until providing the Annual Report. The Annual Report serves as a backup mechanism to ensure AAHRPP receives information that could affect an organization’s accreditation. If the organization is unsure whether a change constitutes a substantive change that must be reported to AAHRPP, the organization must request clarification.

OTHER REPORTING

An organization must report to AAHRPP as soon as possible but within 48 hours after the organization or any researcher (if the researcher is notified rather than the organization) becomes aware of:

• Any negative actions by a government oversight office, including, but not limited to:
  • OHRP Determination Letters
  • FDA Warning Letters
  • FDA 483 Inspection Reports with official action indicated
  • FDA Restrictions Placed on IRBs or researchers
  • Compliance actions taken under non-US authorities related to human research protections
  • Any litigation, arbitration, or settlements initiated related to human research protections
  • Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the organization’s HRPP

If it is unclear to the organization whether a particular item is reportable to AAHRPP, the organization must contact AAHRPP for further advice.

When necessary, the Council will review information regarding the HRPP that is provided through the reporting mechanisms described above and will determine whether any action is indicated, such as a request for additional written information or a Limited Site Visit.