AAHRPP Accreditation Frequently Asked Questions

What is AAHRPP accreditation?

AAHRPP — the Association for the Accreditation of Human Research Protection Programs — is the premier accrediting body for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs). AAHRPP accreditation is a voluntary, peer-driven credential demonstrating that an institution's research protection systems meet the highest ethical and operational standards in human subjects research.

As of April 2025, 245 parent organizations hold AAHRPP accreditation — 205 in the United States and 40 internationally — representing more than 600 distinct research entities globally when counting sub-agencies, hospital sites, and clinical network affiliates. 85% or more of top NIH-funded academic medical centers are accredited or in process. 70% of US medical colleges hold the credential.

Who needs AAHRPP accreditation?

AAHRPP accreditation is not federally mandated, but it is effectively required in several contexts:

• Independent IRBs seeking commercial pharmaceutical and medical device sponsor relationships — virtually all sponsors require AAHRPP accreditation as a site selection prerequisite. All 13 major US independent IRBs are AAHRPP accredited.
• Institutions seeking to serve as sIRB of record for multi-site NIH-funded cooperative research — AAHRPP is a practical prerequisite because relying institutions require it before ceding review authority.
• Academic medical centers and universities competing for NIH funding where 85%+ of top-funded institutions are already accredited — the absence of accreditation is increasingly a competitive liability.
• Community hospitals seeking to attract oncology, cardiovascular, and other clinical trial activity from commercial sponsors.
• Mid-tier universities building research portfolios and seeking to establish relationships with pharmaceutical and biotech sponsors.

Organizations that conduct only minimal research with no commercial sponsor involvement and no interest in sIRB status may not require AAHRPP accreditation. IHS can help organizations assess whether the credential is warranted given their research portfolio and strategic objectives.

What are the three AAHRPP domains?

AAHRPP evaluates organizations against a hierarchical architecture of Domains, Standards, and Elements. The three domains reflect the full organizational ecosystem of human research protection:

• Domain I — The Organization: Evaluates the institution's HRPP at the systemic level — leadership commitment, resource allocation, policy infrastructure, quality improvement mechanisms, conflict of interest management, and community engagement. Domain I Standards assess whether the organization has created the conditions under which ethical research can occur.
• Domain II — The IRB or Ethics Committee: Evaluates IRB operational practices — membership composition, documentation quality, review procedures, and management of unanticipated problems involving risks to subjects (UPIRSOs) and serious adverse events (SAEs).
• Domain III — The Researchers and Research Staff: Evaluates whether investigators and their staff understand and apply HRPP policies in daily practice — not just whether they know the policies exist, but whether they actually follow them during research activities, consent processes, and study file management.

What is the most common AAHRPP deficiency?

The single most commonly cited AAHRPP deficiency is failure to adhere to own written policies (Standard I-5). Organizations purchase off-the-shelf SOP templates but fail to culturally integrate them — creating a mismatch between what the policy manual says and what staff actually do in practice. AAHRPP peer reviewers are themselves research professionals who conduct random record reviews and staff interviews specifically designed to expose this gap. A well-written policy that no one follows is a deficiency, not a credit.

Other frequent deficiencies include:

• Missing IRB documentation in study files — absent approval letters, missing signatures, or meeting minutes that lack documented risk-benefit rationale (Domain II)
• Unauthorized methods or materials used by investigators — recruitment ads or procedural variations never approved by the IRB (Domain III)
• Incorrect consent form versions — signed ICDs not matching the most recently approved version (Domain III)
• Inadequate quality assessment metrics — relying exclusively on turnaround-time metrics rather than substantive deliberative quality measures (Standard I-5)
• Conflict of interest management failures — inadequate financial disclosure documentation or failure to enforce COI management plans (Standard I-6)
• Unauthorized study personnel — individuals accessing PHI or interacting with subjects not listed on delegation of authority logs (Domain III)

What is the AAHRPP application fee?

AAHRPP 2026 application fees are tiered by active protocol volume in the preceding 12 months:

Organizations that prepay the application fee become "clients" of AAHRPP, locking in the current fee structure through the end of the following year and gaining unlimited AAHRPP staff consultation during preparation. Reaccreditation is covered by ongoing annual maintenance fees — no separate application fee is required at the 3-year or 5-year renewal cycles.

How long does AAHRPP accreditation take?

Initial AAHRPP accreditation typically takes 12–18 months from consulting engagement through final Council determination. The timeline breaks into distinct phases:

• Months 1–3: Gap analysis and program evaluation
• Months 4–9: Policy development and SOP overhaul (heaviest lift)
• Month 10: Step 1 application submission
• Months 11–13: Written evaluation response
• Month 14: Mock survey and site visit preparation
• Month 15: AAHRPP site visit
• Months 16–18: Draft report response and Council review

Organizations with strong existing compliance infrastructure can compress this timeline. Reaccreditation preparation for organizations maintaining good compliance posture typically requires 6 months.

What is the difference between AAHRPP accreditation and IRB registration with OHRP?

IRB registration with OHRP (Office for Human Research Protections) is a federal requirement for any IRB reviewing federally funded research or research subject to FDA regulations. It is an administrative baseline — essentially confirming that an IRB exists and has designated membership. Registration is not a quality evaluation.

AAHRPP accreditation is a voluntary quality credential that goes substantially beyond registration. It evaluates the full HRPP ecosystem across three domains — organization, IRB, and researchers — through peer review, document review, and site visits. An institution can be OHRP-registered and fail an AAHRPP evaluation on multiple dimensions. The two processes are entirely separate and serve different purposes.

What is a Single IRB (sIRB) and why does AAHRPP matter for it?

Under NIH policy and the revised Common Rule, multi-site cooperative research must rely on a Single IRB (sIRB) of record — one centralized IRB that reviews and oversees the research on behalf of all participating sites. Before the sIRB mandate, each participating site in a multi-site study had its own IRB review the same protocol — creating redundant, time-consuming reviews without improving participant protection.

AAHRPP accreditation is a practical prerequisite for serving as sIRB because relying institutions require it before ceding review authority. An institution without AAHRPP accreditation will find that research-intensive relying sites — particularly those with their own IRBs — decline to enter reliance agreements. This effectively excludes unaccredited institutions from the most valuable multi-site research networks.

How did the FDA's May 2024 regulatory changes affect AAHRPP compliance?

FDA updates to 21 CFR 50 and 56, released May 2024, harmonized FDA human subjects regulations with the revised Common Rule. For AAHRPP-accredited or accreditation-seeking organizations, the key compliance implications are:

• "Key information" summaries: All informed consent documents must now begin with a concise summary of the most important information a participant needs — before the detailed consent language. Organizations must update their entire ICD library to comply.
• Cooperative research governance: Updated requirements for multi-site cooperative research governance affect reliance agreement content and the operational responsibilities of sIRBs.

Organizations that were accredited before May 2024 and have not updated their consent form templates and reliance agreement procedures since then carry documentation risk at their next survey.

What changed with research participant compensation reporting in 2026?

Effective January 1, 2026, the IRS increased the mandatory reporting threshold for research participant compensation from $600 to $2,000 per calendar year. This seemingly administrative change has meaningful compliance implications for HRPPs:

• Financial disclosure SOPs must be updated to reflect the new threshold throughout policy documentation.
• Internal accounting procedures for tracking and reporting participant compensation must be revised.
• Informed consent templates that reference specific dollar thresholds must be updated — outdated consent language with the $600 threshold is a documentation deficiency.

What is the AAHRPP reaccreditation cycle?

Initial AAHRPP accreditation is followed by a first renewal 3 years later, then reaccreditation every 5 years thereafter. Reaccreditation carries no separate application fee — it is covered by ongoing annual maintenance fees.

One important ongoing obligation: organizations must formally report any 10% or greater reduction in HRPP FTE resources directly to AAHRPP. This makes sustained staffing adequacy a condition of maintaining accreditation between surveys, not just a metric evaluated at survey time. Organizations that quietly reduce HRPP staffing after accreditation without notifying AAHRPP are technically in violation of accreditation conditions.

What does an AAHRPP site visit involve?

An AAHRPP site visit is a 2-to-3 day intensive evaluation conducted by AAHRPP peer reviewers — experienced professionals from accredited research institutions. Site visitors conduct:

• Executive interviews with the Institutional Official and senior leadership on organizational commitment and resource allocation
• IRB Chair and member interviews assessing deliberation practices, meeting conduct, and documentation standards
• Investigator and research staff interviews probing Domain III compliance — consent processes, protocol adherence, study file maintenance
• Extensive random record reviews of active and closed study files, verifying that practices match written policies

Site visitors are specifically looking for the gap between Domain I written commitments and Domain III actual investigator behavior. Organizations that pass the written evaluation but have not integrated new policies into daily practice frequently receive Domain III findings at the site visit that they did not anticipate.

What happens after the AAHRPP site visit?

After the site visit, AAHRPP generates a draft site visit report summarizing findings across all three domains. The institution develops and submits a formal corrective action plan (CAP) addressing each finding. The AAHRPP Council on Accreditation reviews the draft report and institutional CAP, then makes one of several determinations:

• Full accreditation: All requirements met; accreditation awarded.
• Accreditation with requirements: Accreditation awarded, with specific issues that must be resolved and documented within a defined period (typically 6–12 months).
• Deferral: Accreditation deferred pending additional corrective action and a follow-up evaluation.

Most organizations that invest in thorough preparation receive accreditation with requirements rather than deferral. IHS supports the corrective action plan development regardless of the determination outcome.

How much does AAHRPP accreditation consulting cost?

Comprehensive end-to-end AAHRPP accreditation consulting typically ranges from $50,000 to $150,000, depending on the size and complexity of the organization's research program and current compliance posture. Hourly rates for ad-hoc work are $350 or higher. Ongoing reaccreditation maintenance retainers are available for organizations that have achieved initial accreditation and want to maintain continuous survey readiness.

IHS scopes engagements based on current posture, protocol volume, and number of research sites. Targeted gap remediation and mock survey preparation are available at lower cost for organizations that are closer to readiness but need specific expert support for the site visit preparation phase.

What is the IHS approach to AAHRPP preparation?

IHS takes a three-domain integrated approach. Most consultants focus primarily on Domain II documentation — the traditional IRB records and approval letter compliance — because that is what paper audits expose. IHS addresses all three domains simultaneously, with particular emphasis on the cultural integration work that determines Domain III outcomes: whether investigators and research staff actually follow policies in daily practice.

The most common reason organizations fail to achieve accreditation on the first attempt is not inadequate documentation — it is inadequate integration. Written policies are necessary but not sufficient. IHS builds compliance systems that staff follow, not just policies that look correct on paper.

Dr. Goddard brings 25+ years of healthcare accreditation consulting experience to each AAHRPP engagement — the same depth of accreditation expertise that IHS applies to URAC, ACHC, and other credentialing programs.