Jan 18, 2022, 12:33 PM
Resources: For Accreditation - Procedures
Table of Contents
Annual and Other Notification Reporting
During each of the intervening years between site visits, AAHRPP requires an accredited Organization to submit Annual Reports based on its accreditation date. Failure to submit an Annual Report within 30 days of the due date may result in revocation of accreditation.
The purpose of the Annual Report is to notify AAHRPP of changes related to or that might affect the Organization’s Human Research Protection Program. An Organization must submit its Annual Report on a standard form found on the website that 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.
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
If it is unclear whether a particular item is reportable to AAHRPP, the Organization must contact the AAHRPP office for further advice.
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.
AAHRPP staff 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. In some circumstances, the Council on Accreditation will be advised of the situation and requested to determine whether further action is needed, such as further reporting or a Limited Site Visit.