Accreditation: Get Accredited - Part 2: Build and Develop an Application
Once you have completed your Self-Assessment, it is time to start putting together a formal Application for Accreditation.
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 approximately 60 calendar days.
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 Step 2 application for accreditation or reaccreditation is submitted and determined to be complete.
STEP 1 & 2 SUBMISSION
Section A: Application form
Section D: Supporting Documents
Section E: IRB/EC Roster(s)
STEP 2 Submission ONLY
Section F: Minutes and correspondence
Section G: List of Active Studies
Section H: Key Personnel
Tips for Building Your Application:
Tips for Building Your Application:
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.
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 conflicts of interest, provide the page numbers, section numbers, and section titles as appropriate.
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 outlines the IRB's 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.
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.
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