Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - Procedures

AAHRPP ACCREDITATION PROCEDURES

Download as PDF
Latest Update: February 27, 2024

Initial Accreditation Procedures

NOTE: This section is for new organizations seeking initial accreditation. Organizations seeking to maintain their existing accreditation, please see Reaccreditation Procedures.

CONDUCT A SELF-ASSESSMENT

The initial step in the accreditation process is for an organization to engage in a thorough self-assessment. The self-assessment is a critical, introspective examination of an HRPP in which the program is evaluated according to each of the AAHRPP Accreditation Standards. This enables the organization to identify and remedy potential program weaknesses. Prior to conducting the self-assessment, the organization should develop a clear concept of the programmatic unit that will seek accreditation.

BUILD AND DEVELOP AN APPLICATION

When the organization has completed its self-assessment and addressed any gaps in its HRPP, the next step is to submit an Application for Accreditation to AAHRPP. An Application for Accreditation is comprised of two parts (Step 1 and Step 2) in which an organization’s written materials are reviewed (Step 1) and then additional documents are later submitted (Step 2) in preparation for a site visit.

EVALUATION OF WRITTEN MATERIALS (APPLICATION FOR ACCREDITATION)

An application reviewer evaluates the Application for Accreditation (Step 1) materials and assesses whether the organization’s policies and procedures are consistent with the Accreditation Standards, or whether revisions are needed. Policies and procedures include any written materials the organization uses to define and communicate its practices, such as standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, job descriptions, memoranda, forms, templates, strategic plans, websites, charters, by-laws, mission statements, or other forms that are used to administer the HRPP. Following review, AAHRPP staff and the application reviewer will communicate any requested changes to the organization in the Application Review report (Step 1 Review) and by email if needed.

The organization’s satisfactory response to any changes to policies and procedures requested in the Application Review report (Step 1 Review) must be completed within one year of the date that the report is sent to the organization. Once the application reviewer determines that the policies and procedures are consistent with the Accreditation Standards, the organization submits additional materials relevant to a site visit (Step 2) and a site visit is scheduled.

EVALUATION OF PRACTICE (IN-PERSON OR REMOTE SITE VISIT)

AAHRPP site visitors review the Application for Accreditation (Step 1 and Step 2), including any requested revisions, and evaluate an organization’s implementation of its policies and procedures by interviewing key personnel and reviewing records during a site visit evaluation. This evaluation may be conducted on-site and/or remotely. 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.

AAHRPP must have sufficient information to adequately evaluate an organization’s HRPP. In general, this requires that site visitors be permitted to interview all key personnel, enter all relevant facilities as applicable, and have access to all relevant records, policies, procedures, minutes, audits, protocols, consent documents, and other materials. AAHRPP will not accredit an organization that cannot be thoroughly evaluated. To perform these tasks, the site visitors must sign confidentiality agreements with AAHRPP prior to the site visit.

The organization’s Application for Accreditation (Step 1 and Step 2) and results of the evaluation of practice site visit forms the basis of a site visit report. AAHRPP provides a Draft Site Visit Report to the organization shortly after (but no later than 30 calendar days after) completion of the site visit. Within 30 calendar days of the date that the Draft Site Visit Report is sent to the organization, the organization has the opportunity to respond to AAHRPP in writing 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 HRPP since the site visit. AAHRPP staff, along with the site visit team leader, reviews the organization’s response to the Draft Site Visit Report and prepares a preliminary version of the final report (known as the Final Site Visit Report) for the AAHRPP Council on Accreditation (Council) to review.

COUNCIL ON ACCREDITATION REVIEW

At its quarterly meeting, the Council reviews the Application for Accreditation, Draft Site Visit Report, the organization’s response, and the evaluation of the response in the preliminary Final Site Visit Report. The Council then makes a determination of accreditation status, and this decision is communicated to the organization in writing in the Final Site Visit Report.

If the Council awards Full Accreditation, the initial accreditation period is three years.