Preparing the Application

Tip Sheets

The application submission process for initial and renewing applicants involves two steps:
  • Step 1. Submit the application form, the program overview (no more than seven pages), copies of your policies and procedures (supporting documents), and an index for these documents.  AAHRPP will review the application materials and request revision or additional documentation, if needed. AAHRPP typically provides feedback on application materials within 45 days for new applications and within 45 days for renewing applications.
  • Step 2. Once the written documents are complete, AAHRPP staff will schedule your site visit. Normally, site visits are scheduled within three months after the written documents are determined to be complete.

Conduct a self-assessment

Applying for accreditation primarily involves conducting a self-assessment. The self-assessment is a critical, introspective examination of a Human Research Protection Program in which the program is evaluated according to each element of the AAHRPP Accreditation Standards. During the self-assessment Organizations create a list of supporting documents that becomes Section C of the application, and submit copies of those documents as Section D (Figure 1). An Organization's success in achieving accreditation depends on the depth of the self-assessment, and on the actions taken to improve the Human Research Protection Program. Completion of the application involves the addition of the application form and a description (seven page maximum) of your Human Research Protection Program.

Make a List of Supporting Documents

For each Element, collect the policies and procedures that describe the practices your Organization follows to meet the Element, or indicate that the Element is not applicable to your Organization. When available, collect documents that verify that your Organization follows those practices. Most Elements can be supported by one to five documents, and some Elements may not have any supporting documents. In general, no more than 10 documents are necessary.

“Policies and procedures” refers to any written document that your Organization uses to define and communicate its practices, such as policies, procedures, standard operating procedures, checklists, guidelines, job descriptions, memoranda, forms, templates, strategic plans, websites, charters, by-laws, mission statements.

Construct an Element-by-Element Index to the Supporting Documents

List the supporting document for each Element. Reference the document’s number and provide a brief explanation. Use page numbers, paragraph numbers, line numbers, item numbers, chapter titles, and section headings to pinpoint the supporting information. For example, if you wish to point out information in your investigator’s manual that addresses conflicting interests, provide the page numbers, section numbers, and section titles as appropriate. For example:

 


Element I.1.C: The Organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in its role in protecting human participants.

  • Board of Directors Policy “Research Involving Humans” (Document 10, Section V on page 3) grants the IRB its authority as required by the regulations, and outline the IRBs independence.
  • Job Description for Senior Vice President for Research. (Document 14, 4th bullet on page 2) identifies the Senior Vice President for Research as the Institutional Official, and delegates to the Institutional Official the responsibility to protect the IRB from undue influence or coercion.
  • IRB Policies and Procedures (Document 15, page 10, Item XI, “Undue Influence of IRB members”) describe what IRB members should do if they believe they are being coerced or unduly influenced.
  • Letter from Institutional Official to an investigator (Document 16) who attempted to unduly influence IRB members.

This becomes Section C of your application.

Make a copy of each document authored by your Organization and cited in the list of supporting documents. Include copies of Web sites, educational materials, and slide presentations. If cited for more than one element, include just one copy. Do not make copies of documents not authored by your Organization. Assign a reference number to each document. This becomes Section D of your application.

Save time for formatting. The application for accreditation is submitted as a PDF, with links to supporting documents. Allow one to two weeks to convert your application from word-processing format to PDF. Prepare for your site visit. Reaccreditation involves the same comprehensive, on-site evaluation that is required for accreditation. See Preparing for Your Site Visit for more information.

Please contact AAHRPP staff with questions about conducting your self-assessment.