AAHRPP Accreditation Consulting for Research Programs and IRBs

What is AAHRPP accreditation?

AAHRPP accreditation is a peer-reviewed evaluation of an organization's human research protection program against a published set of Standards and Elements. AAHRPP 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).

The Evaluation Instrument is organized into three Domains: the Organization, the IRB or Ethics Committee, and Researchers and Research Staff. Each Domain holds Standards, and each Standard holds Elements. AAHRPP's page says an organization must meet all Standards and Elements to be accredited (AAHRPP, Evaluation Instrument for Accreditation, page opened October 6, 2026).

IHS offers this service to community hospitals building research programs, universities building HRPP infrastructure, academic medical centers, health systems and independent IRBs.

Does a federal rule require AAHRPP accreditation?

The federal rules IHS read for this page do not make AAHRPP accreditation a condition. They set other duties: 45 CFR 46.114(b) requires a United States institution engaged in cooperative research to rely on a single IRB for the United States portion of the research (paragraph (b)(2) lists exceptions), and the reviewing IRB is identified by the supporting agency or proposed by the lead institution and accepted by the agency (eCFR, 45 CFR 46.114, page opened October 6, 2026). That text does not name an accreditor. Whether a relying institution or a sponsor asks for AAHRPP accreditation is that party's own decision, so ask each one what it expects before you budget for the process.

Which federal rules sit next to AAHRPP accreditation?

How does the single IRB requirement work?

For NIH-funded multi-site research, NIH states that its single IRB policy applies to non-exempt human subjects research conducted under the same protocol at more than one site, 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). Your counsel confirms how these rules apply to a given study.

What changed in the PHS research misconduct rule?

HHS published the final rule revising the Public Health Service Policies on Research Misconduct at 89 FR 76280 on September 17, 2024, effective January 1, 2025 (Federal Register, Public Health Service Policies on Research Misconduct, page opened October 6, 2026). An HRPP's research integrity policies are worth reading against the revised 42 CFR part 93, and your counsel confirms whether the rule applies to your organization.

What does an AAHRPP gap assessment look for?

An IHS gap assessment compares the program against each Domain of the Evaluation Instrument and ranks what it finds.

Domain I, the Organization

IHS looks at leadership commitment, resources, the policy set, quality assessment, conflict of interest management and community engagement. IHS checks whether written policies match daily practice and whether conflict of interest plans are enforced as written.

Domain II, the IRB or Ethics Committee

IHS reads study files and meeting minutes as a reviewer would. IHS checks for approval letters, minutes that record the risk and benefit reasoning, and consent documents that match the protocol.

Domain III, Researchers and Research Staff

IHS checks whether investigators and staff apply the policies. IHS checks that materials used have IRB approval, that signed consent forms are the approved version, and that everyone working on a protocol is listed as approved study personnel.

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. Step 2 follows once a peer reviewer clears the written materials. 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).

AAHRPP schedules the site visit, which can be on-site or virtual, and sends a list of records to have ready about six weeks ahead. The Council on Accreditation then decides based on the draft site visit report and the organization's response. For new applicants the status categories are Full Accreditation, Qualified Accreditation, Accreditation Pending and Accreditation Withheld (AAHRPP, Evaluation of Practice and Council on Accreditation Review, page opened October 6, 2026). Accredited organizations renew three years after initial accreditation and every five years after that (AAHRPP, Applying for Reaccreditation, page opened October 6, 2026).

What does IHS do at each stage?

IHS drafts the policies, procedures and application materials for your Institutional Official, IRB chair and HRPP staff to review and approve. IHS plans an initial engagement at 12 to 18 months from start to Council determination. That is IHS's planning estimate, and AAHRPP sets its own schedule.

Months 1-3: program evaluation and gap assessment

IHS reviews your policies, interviews the Institutional Official and IRB chair, and observes a convened IRB meeting. The output is a ranked remediation plan across the three Domains.

Months 4-9: policy development and procedure rewrite

IHS drafts new or revised policies and procedures so that the written program matches how your staff work, and replaces generic templates that were never put into practice.

Month 10: Step 1 application package

IHS prepares the program overview, the policy set and the index that maps each document to the Standard and Element it supports, and checks the package for completeness. Your organization's named contact submits it.

Months 11-13: response to the written evaluation

IHS drafts revisions and written justifications for each item the peer reviewer identifies, for your team to approve and submit.

Month 14: mock site visit

IHS runs mock interviews with investigators, IRB staff and executives so that each person can describe how the policies work in daily practice. IHS also reviews the record sets AAHRPP asks you to have ready.

Month 15: AAHRPP site visit

IHS prepares your team for the interviews and record review AAHRPP describes for the site visit, using the agenda and record list AAHRPP sends.

Months 16-18: response and Council review

IHS drafts your organization's response to the draft site visit report and to any status report the Council requests, for your named contact to submit.

How much does AAHRPP accreditation cost?

The cost has four parts, and a different party sets each one. AAHRPP sets the application fee and the annual fee. Your organization sets the internal staff time it commits. IHS sets its consulting fee. Your own counsel or finance team sets any outside legal or research administration cost.

The application fee is nonrefundable and pays for the first accreditation review, which includes the site visit. Annual fees start one year after the application is submitted. AAHRPP assigns the fee level from the number of active protocols in the previous complete year, and its fee page defines which studies count toward that number. AAHRPP also lets an organization prepay the application fee, and AAHRPP guarantees that fee through the end of the following year (AAHRPP, Application and Annual Fees, page opened October 6, 2026).

The table lists every level of AAHRPP's 2026 schedule in US dollars, as read on October 6, 2026 (AAHRPP, Application and Annual Fees, page opened October 6, 2026). AAHRPP says it may adjust the schedule and expects fees to rise by 4% to 6% each year. Verify current fees with AAHRPP. Renewal needs no new application fee, and annual fees cover the cost of reaccreditation (AAHRPP, Applying for Reaccreditation, page opened October 6, 2026).

IHS sets a fixed fee for each engagement after a free discovery session, because scope, number of sites and gap severity change the work.

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

Is AAHRPP accreditation required?

No federal rule IHS read for this page names AAHRPP accreditation as a condition. 45 CFR 46.114 requires single IRB review for the United States portion of cooperative research, with exceptions listed in paragraph (b)(2), and 21 CFR 56.114 allows reliance on another qualified IRB. Neither names an accreditor (eCFR, 45 CFR 46.114 and 21 CFR 56.114, page opened October 6, 2026). A relying institution or sponsor may still ask for it, so ask each one.

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 HHS-conducted or HHS-supported research, and 21 CFR 56.106 requires registration for United States IRBs that review FDA-regulated clinical investigations (eCFR, 45 CFR 46.501 and 21 CFR 56.106, page opened October 6, 2026). Registration and accreditation are separate processes.

How long does AAHRPP accreditation take?

IHS plans for 12 to 18 months from the start of an engagement to the Council determination. 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).

What does AAHRPP accreditation cost?

AAHRPP sets the 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) is $20,183 and $8,170 (AAHRPP, Application and Annual Fees, page opened October 6, 2026). The full table above lists every level. Verify current fees with AAHRPP. IHS sets a fixed fee for each engagement after a free discovery session.

What happens after the AAHRPP site visit?

The Council on Accreditation decides based on the draft site visit report, your response and its evaluation of that response. For a new applicant the status categories are Full Accreditation, Qualified Accreditation, Accreditation Pending and Accreditation Withheld, and the Council may ask for status reports (AAHRPP, Council on Accreditation Review, page opened October 6, 2026). IHS drafts your response and any report, and your named contact submits it.

How can I see which institutions are AAHRPP accredited?

AAHRPP publishes a directory that lists accredited organizations with the organization 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 tell you where an organization stands.

When did AAHRPP accredit the NCI Central IRB?

AAHRPP's directory lists the National Cancer Institute Central Institutional Review Board with Full Accreditation and a December 2012 date of initial accreditation (AAHRPP, Find an Accredited Organization, page opened October 6, 2026). The NCI CIRB history page also records AAHRPP accreditation in 2012, a move to an independent model in 2013 and a reaccreditation in 2015 (NCI CIRB, Our History, page opened October 6, 2026).

Who is this not for?

This service is not for an organization with little research activity whose relying institutions and sponsors do not ask for accreditation. It is also not for an organization that wants IHS to handle contact with AAHRPP or to influence the outcome, because IHS does neither. If you are unsure, ask your relying institutions and sponsors what they expect, then book a discovery session.

Ready to start an AAHRPP gap assessment?

IHS provides AAHRPP accreditation consulting for universities, academic medical centers, health systems, independent IRBs and community hospitals building research programs. 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. If you are also pursuing URAC, ACHC or another accreditation, IHS can plan the policy drafting so shared policies are written once.

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