Jan 18, 2022, 12:33 PM
Resources: For Accreditation - Procedures
Table of Contents
Initial Accreditation Procedures
The initial step in the accreditation process is for an Organization to engage in a thorough self-assessment. This enables the Organization to identify and remedy program weaknesses. Prior to seeking accreditation, the Organization should develop a clear concept of the programmatic unit that will seek accreditation. 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 Step 1 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 within one year of the date that the Step 1 Review is sent to the Organization. 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 Step 2 application and conduct an onsite 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, protocols, consent documents, and other materials. The length of time of a site visit varies depending upon the size and nature of the research portfolio, and generally ranges from two to four days in length. 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 and adequately evaluated.
The Organization’s Step 2 application and results of the on-site evaluation form the basis of a site visit report. AAHRPP provides a draft report (known as the "Draft Site Visit Report") to the Organization shortly after (but no later than 30 days after) the completion of the site visit. 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 concern 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.