AAHRPP Accreditation Frequently Asked Questions

AAHRPP 2026 application and annual fees

AAHRPP sets fees by the number of active protocols in the previous complete year, in US dollars, and the application fee is nonrefundable and pays for the first accreditation review, which includes the site visit. Annual fees begin one year after the organization submits its application (AAHRPP, Application and Annual Fees, page opened October 6, 2026). Verify current fees with AAHRPP.

AAHRPP says it may adjust the schedule and expects fees to rise by 4% to 6% each year. Verify current fees with AAHRPP.

What this is not

• IHS is not AAHRPP. IHS does not grant, deny or influence an accreditation decision.
• IHS drafts, and your organization's named contact submits. IHS does not submit to AAHRPP or correspond with AAHRPP for you.
• This page is not legal advice. Your counsel confirms how federal and state rules apply to your studies.
• An engagement is not a guarantee of accreditation or of any status category.

Frequently asked questions

What is AAHRPP accreditation?

AAHRPP accreditation is a peer-reviewed evaluation of an organization's human research protection program against AAHRPP's published Standards and Elements. AAHRPP, the Association for the Accreditation of Human Research Protection Programs, describes a two-part peer review, first of the written application materials and then of practice at a site visit, followed by a decision from its Council on Accreditation (AAHRPP, Get Accredited Overview, page opened October 6, 2026).

AAHRPP's fee schedule includes a category for organizations that rely entirely on external AAHRPP-accredited IRBs (AAHRPP, Application and Annual Fees, page opened October 6, 2026).

Is AAHRPP accreditation voluntary or required by federal law?

In IHS's reading, AAHRPP accreditation is voluntary and not federally mandated, because the federal rules IHS read for this page do not name it as a condition. 45 CFR 46.114(b)(1) requires an institution in the United States engaged in cooperative research to rely on a single IRB for the United States portion of the research (paragraph (b)(2) lists exceptions), and 21 CFR 56.114 allows institutions in multi-institutional studies to use joint review or reliance on another qualified IRB. Neither text names an accreditor (eCFR, 45 CFR 46.114 and 21 CFR 56.114, page opened October 6, 2026). A sponsor or relying institution may still ask for it, so ask each one what it expects. Your counsel confirms how the rules apply to your studies.

Who is AAHRPP accreditation for, and who is it not for?

It is for an organization that runs a human research protection program and wants an external peer evaluation of it, such as a university, academic medical center, hospital, research institute or independent IRB. It is not for an organization with little research activity whose sponsors and relying institutions do not ask for accreditation, and an organization that relies entirely on external IRBs that AAHRPP has accredited falls in AAHRPP's lowest fee category, Level 0 (AAHRPP, Application and Annual Fees, page opened October 6, 2026). It is also not for an organization that wants IHS to deal with AAHRPP for it or to influence the outcome, because IHS does neither.

What are the three AAHRPP Domains?

The three Domains are the Organization, the IRB or Ethics Committee, and Researchers and Research Staff. Each Domain holds Standards, each Standard holds Elements, and AAHRPP states that an organization must meet all Standards and Elements to be accredited (AAHRPP, Evaluation Instrument for Accreditation, page opened October 6, 2026). An IHS gap assessment reads the program against each Domain: leadership, resources, policies, quality assessment and conflict of interest management for the Organization, study files and meeting minutes for the IRB, and daily practice in consent and study personnel records for researchers and staff.

How does the AAHRPP accreditation process work?

AAHRPP lays the process out in six parts: self-assessment, building the application, evaluation of written materials, evaluation of practice at a site visit, Council on Accreditation review and response to the Council (AAHRPP, Get Accredited Overview, page opened October 6, 2026). The application has two steps. Step 1 is the application form, a program overview of no more than seven pages, the policies and an index, and AAHRPP states it typically gives feedback on Step 1 materials within about 60 calendar days (AAHRPP, Build and Develop an Application, page opened October 6, 2026).

How long does AAHRPP accreditation take?

IHS plans for 12 to 18 months from the start of an engagement to the Council determination, and that is IHS's own planning estimate because AAHRPP sets its own schedule. AAHRPP states that after Step 1 is approved and Step 2 is complete, it normally schedules the site visit within two to three months (AAHRPP, Build and Develop an Application, page opened October 6, 2026). An organization with a strong existing compliance program may need less time, and one with large policy gaps may need more.

What does AAHRPP accreditation cost?

AAHRPP sets an application fee and an annual fee by program size. On its 2026 schedule, Level 1 (1-100 active protocols) is $13,352 to apply and $5,960 a year, and Level 2 (101-500 active protocols) is $20,183 and $8,170 (AAHRPP, Application and Annual Fees, page opened October 6, 2026). The table above lists every level. Verify current fees with AAHRPP. IHS sets a fixed fee for each engagement after a free discovery session, because scope, number of sites and gap severity change the work.

How is AAHRPP accreditation different from IRB registration?

Registration is a federal filing and accreditation is a peer evaluation by AAHRPP. 45 CFR 46.501 requires registration with HHS for an IRB designated under an OHRP-approved assurance that reviews research conducted or supported by HHS, and 21 CFR 56.106 requires registration for IRBs in the United States that review FDA-regulated clinical investigations or investigations meant to support FDA research or marketing permits (eCFR, 45 CFR 46.501 and 21 CFR 56.106, page opened October 6, 2026). Registration and accreditation are separate processes.

What is a single IRB and how does it relate to AAHRPP?

A single IRB is one IRB that reviews cooperative research on behalf of the participating United States sites. NIH states that its single IRB policy applies to multi-site non-exempt human subjects research under the same protocol, for applications and solicitations on or after January 25, 2018, and that the revised Common Rule provision at 45 CFR 46.114(b) has applied since January 20, 2020 (NIH, Single IRB Policy for Multi-site Research, page opened October 6, 2026). Those texts do not name AAHRPP, so whether a relying institution asks for accreditation from a single IRB is that institution's own decision.

What happens at the AAHRPP site visit and after it?

AAHRPP schedules the site visit, which can be on-site or virtual, and about six weeks ahead it asks the organization to prepare records such as IRB meeting minutes, rosters, study files and copies of notification letters to federal agencies about noncompliance. The visit includes confidential interviews, record review and a closing session, and its length depends on the size and scope of the organization (AAHRPP, Evaluation of Practice, page opened October 6, 2026). The Council on Accreditation then decides based on the site visit report, your written response and its evaluation of that response, and a new applicant receives Full Accreditation, Qualified Accreditation, Accreditation Pending or Accreditation Withheld (AAHRPP, Council on Accreditation Review, page opened October 6, 2026). IHS prepares your team for the interviews and records and drafts your response, and your named contact submits it.

How does AAHRPP reaccreditation work?

Accredited organizations renew three years after initial accreditation and every five years after that. AAHRPP states there is no new application fee for reaccreditation and that annual fees cover its cost (AAHRPP, Applying for Reaccreditation, page opened October 6, 2026).

How can I see which institutions are AAHRPP accredited?

AAHRPP publishes a directory of accredited organizations with each one's type, accreditation category and date of initial accreditation (AAHRPP, Find an Accredited Organization, page opened October 6, 2026). It lists only organizations in good standing. Applicants and organizations in the Accreditation Pending, probation, revoked or withheld categories are not listed, so a missing name does not show where an organization stands.

What does IHS do for an AAHRPP engagement?

IHS drafts the policies, procedures and application materials for your Institutional Official, IRB chair and HRPP staff to review and approve. The work runs from a gap assessment against the Evaluation Instrument, through policy drafting, an index that maps each document to the Standard and Element it supports, and a mock site visit with interviews and record review, to a draft response to the Council. Your organization's named contact submits to AAHRPP, and IHS does not correspond with AAHRPP for you.

Ready to prepare for AAHRPP accreditation?

An engagement starts with a gap assessment against the current Evaluation Instrument, so you see where the program stands before you commit to the full process. See the AAHRPP accreditation consulting overview for the service in full.

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