Jan 18, 2022, 12:33 PM
Resources: For Accreditation - Procedures
Table of Contents
The initial accreditation period is three years. Thereafter, the accreditation period is five years. An Organization that is renewing its accreditation conducts a self-assessment. The results of the internal review are submitted to AAHRPP in the form of a Step 1 application. Next, AAHRPP staff assigns a Step 1 Reviewer who evaluates the application and determines whether the written documents meet the Accreditation Standards. Staff will communicate required changes to the Organization. The Step 1 application process, i.e., the Organization’s satisfactory response to the Step 1 Review of Materials, must be completed according to the time schedule provided by AAHRPP to ensure that the Organization’s renewing application for accreditation is reviewed at the assigned meeting of the Council on Accreditation. Once the Step 1 Reviewer determines that the written documents are satisfactory, the Organization submits a Step 2 application and a site visit is scheduled. AAHRPP site visitors review the application and conduct an on-site evaluation. AAHRPP must have sufficient information to evaluate adequately an Organization’s program. In general, this requires that site visitors be permitted to enter all facilities and have access to all relevant records, policies, procedures, minutes, audits, sample protocols, consent documents, and other materials. The length of time of a first reaccreditation site visit varies depending upon the size and nature of the research portfolio, in the same manner as an initial accreditation, as well as whether the Organization is a "Legacy Organization" (see Streamlined Reaccreditation Procedures for Legacy Organizations below). To perform these tasks, the site visitors must sign confidentiality agreements with AAHRPP prior to the visit. AAHRPP will not accredit an Organization that cannot be thoroughly evaluated.
The Organization’s application and results of the on-site evaluation form the basis of a site visit report. AAHRPP provides a Draft Site Visit Report to the Organization shortly after the site visit and no later than 30 days after the completion of the site visit unless the site visitors make no observations that warrant a response from the Organization. Within 30 days of the date that the Draft Site Visit Report is sent to the Organization, the Organization has the opportunity to respond in writing to AAHRPP to identify any errors of fact, to describe any corrective actions it has taken in response to areas of concerns identified by the site visitors, and to report any other changes it has made to its Human Research Protection Program since the site visit. The site visit team leader then reviews the Organization’s response and writes an evaluation of the response. The Council on Accreditation reviews the application, Draft Site Visit Report, the Organization’s response, and the evaluation of the response. At its quarterly meeting, the Council then makes a determination regarding accreditation. The decision of the Council is communicated to the Organization in writing.
Each Organization is assigned to one of the Council on Accreditation quarterly meeting dates. The assignment is based on the Organization’s most recent accreditation date. Organizations must submit their Step 1 applications 12 months in advance of the Council meeting to which they are assigned.
Failure to submit renewal applications by the deadline could result in a loss of accreditation status. An Organization that cannot submit by the deadline must notify the AAHRPP office in writing at least 30 days in advance. Extensions will be granted by the President and CEO only under unusual or exceptional circumstances.
Organizations that submit renewal applications after the deadline date, or fail to complete the Step 1 application in time to complete the accreditation process before the Council meeting at which the Organization is to be reviewed, will be placed in Reaccreditation-Pending, on Probation, or lose accreditation status. Organizations must provide justification to the Council on Accreditation to avoid being placed on Probation or losing accreditation status. Organizations that are placed in Reaccreditation-Pending or on Probation and eventually earn reaccreditation will have a reaccreditation period equal to five years minus the time spent in Reaccreditation-Pending or on Probation.