Accreditation: Maintain Accreditation - Required Reports
Reports Between Accreditation Cycles
AAHRPP expects Organizations to provide periodic updates after Full Accreditation is achieved. There are two key types of reports that they should provide AAHRPP: an Annual Report and Event Reports.
In order to maintain accreditation, an Organization completes a report and files it with AAHRPP annually until an Application for Reaccreditation is submitted.
An Annual Report includes the following information:
- Organizational Changes, including but not limited to:
- Change in entity type or corporate structure.
- Change in name of the Organization.
- Change in ownership or control of the Organization.
- Any 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 Human Research Protection Program (i.e. the individual responsible for the day-to-day operation).
- Change in the application contact.
- Changes in Resources, including but not limited to:
- 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 Human Research Protection Program, such as reduction in FTE or dissolution of an IRB, committee or other function.
- Changes in Program Scope, including:
- Addition of 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.
- Changes in method of providing services, such as use of external IRBs or contracting for services from another organization.
- Catastrophic event that results in an interruption or discontinuance in a part of or the entire Human Research Protection Program.
Guidance on Completing the Annual Report Form
Issues Requiring Prompt 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 Investigators, and corresponding 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 Human Research Protection Program
When an accredited Organization or its Human Research Protection Program 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 must notify the AAHRPP office when the change occurs within 30 days. If the Organization is unsure whether a change constitutes a substantive change that must be reported to AAHRPP, the Organization must request clarification from AAHRPP.
The Council on Accreditation will review information regarding the Human Research Protection Program 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.If it is unclear whether a particular item is reportable to AAHRPP, the Organization must contact the AAHRPP office for further advice.
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