Association for the Accreditation
of Human Research Protection Programs, Inc. ®

Resources: For Accreditation - FAQs

Frequently Asked Questions

Latest Update: June 17, 2024

Considering Accreditation and Getting Started

We are interested in accreditation. How do we get started?

Contact AAHRPP staff, who will work with you to define the organizational unit seeking accreditation. We will discuss what types of research you conduct and what regulations you must follow as this will help determine if some parts of the Evaluation Instrument may not be relevant to your organization. Should this be the case, you would not need to have policies or be evaluated for certain Standards and Elements. For example, if you do not conduct research involving investigational drugs, you may not need to meet Standard I-7. Similarly, if you do not conduct single IRB review for other organizations, or rely on other organizations for IRB review, then you may not need to address Standard I-9.

More information on getting started is available at

What are the benefits of accreditation?

The benefits of accreditation are described on AAHRPP's website at

Is our organization eligible for accreditation?

Information about eligibility is on our website at In addition, AAHRPP's Accreditation Procedures define eligible organizations.

We encourage you to contact AAHRPP staff for questions about eligibility.

Does AAHRPP provide education about how to apply for accreditation?

AAHRPP provides several different educational events to help organizations learn about the accreditation process:

  • Accreditation Workshop: Organizations can sign up for this day-long workshop, which is available the day before the AAHRPP Annual Conference. This workshop provides information about how to apply for accreditation.
  • Ask AAHRPP: A free webinar series that focuses on questions from participants which AAHRPP staff and representatives answer to provide practical advice on all stages of the accreditation process.
  • HRPP Innovations: An opportunity for organization to learn some of the current best practices from our accredited organizations.
  • AAHRPP Website: The AAHRPP website provides detailed information about the accreditation process and should help answer your questions.

Learn more about our educational opportunities for accreditation at If you have additional questions, please contact AAHRPP staff or submit a question to be addressed during the Ask AAHRPP webinars.

Does AAHRPP assist help organizations achieve accreditation?

While AAHRPP does not provide standalone consulting services, organizations that pay the AAHRPP application fee in advance are eligible to receive expert staff assistance as they prepare to apply for accreditation. This can include review of some policies, access to webinars demonstrating how to get started, receiving priority answers to questions, and the option to schedule meetings or video conferences.

Can we apply for accreditation if we are not located in the United States?

Yes. AAHRPP is a global organization. As of 2023, about 20% of accredited organizations are located in countries outside the US. AAHRPP accredits organizations based on the laws, regulations, and guidance of the organization’s country, and any relevant laws, regulations, or guidance from other countries (for example, requirements based on US National Institutes of Health funding). The list of accredited organizations, which can be sorted by country, is at

If we are outside the United States, does AAHRPP require that we follow US regulations to obtain accreditation?

AAHRPP accredits organizations using the Evaluation Instrument for Accreditation and the laws of their country. Unless organizations are required to follow US laws, regulations, and guidance, organizations are not required to follow US regulations to obtain accreditation and can apply equivalent protections. For example:

  • If your organization is not covered by US law, regulations, and guidance (for example, because you do not receive funding from a US government agency such as the US National Institutes of Health) AAHRPP will evaluate your organization based on the Evaluation Instrument for Accreditation and the laws of your country.
    • If your organization is not required to follow US laws, then you do not need to have a FederalWide Assurance (FWA) from the US Office of Human Research Protections.
  • If your organization is required to follow US regulations (for example, because you receive funding from a US government agency such as the US National Institutes of Health) then AAHRPP will evaluate your organization based on the Evaluation Instrument for Accreditation, the laws, regulations, and guidance of your country, and applicable US laws.
Even if you do have to follow US regulations for some research funded by US government agencies such as the US National Institutes of Health, you do not need to apply these regulations to all your research. You can create separate policies for compliance with US government agency requirements and only use those when applicable to a particular study. 

What if we want to accredit part of our organization, not the entire organization?

Organizations may apply to accredit only part of their organization and are encouraged to discuss any such plans with AAHRPP whose staff will help you develop a clear concept of the programmatic unit that will seek accreditation. For example:

  • a university may apply for accreditation of the main campus and not include the medical school or affiliated hospitals
  • a university may apply for accreditation and not apply for accreditation of all campuses, such as campuses located outside the country or international campuses
  • a university may apply for accreditation of a medical school or medical campus and not apply for accreditation of the entire university
  • a university may apply for accreditation of a medical school without accreditation of the affiliated hospital(s)
  • a hospital system may apply for accreditation of one hospital or several hospitals in the system

If we apply for accreditation of a part of our organization, are we required to obtain accreditation of the entire organization later?

No. Organizations can choose to accredit only part of their organization.

Do we have to use an electronic system or purchase an IRB/EC management system to obtain accreditation?

No. Organizations have obtained accreditation using paper records, word processor documents and/or PDF documents, and using easy-to-use databases, such as a spreadsheet that tracks studies and submissions.

How do we make the case for accreditation and obtain leadership support and funding to apply for accreditation?

The AAHRPP website describes the value of accreditation: You can also hear from accredited organizations about what they see as the value of accreditation at

Contact AAHRPP for information that you can share with decision-makers within your organization.

How long are organizations accredited? To maintain accreditation, do organizations have to apply for reaccreditation?

Initial accreditation is awarded for three years, after which time organizations must reapply if they wish to maintain AAHRPP accreditation. These subsequent reaccreditations are for five years. For example, if an organization is initially accredited in June 2023, to maintain accreditation it must be reviewed by the Council on Accreditation in June 2026. If an organization obtains Full Reaccreditation in June 2026, to maintain accreditation it must be reviewed again in June 2031. Applications for reaccreditation are due one year prior to when Council is scheduled to review the application.

For more information about the initial accreditation procedures go to 

For more information about reaccreditation procedures go to

Are the fees for reaccreditation the same as the initial application fee?

No. An organization pays an initial application fee and thereafter annual fees. 

How much does AAHRPP accreditation cost?

AAHRPP's fees are based on the number of open studies involving human participants. Please see the AAHRPP Tip Sheet on Counting the Number of Studies for guidance. More details on Application and Annual Fees are at

Please contact AAHRPP staff with cost questions. 

Is the accreditation process confidential? Does AAHRPP release information that my organization is considering applying for accreditation?

All communication with AAHRPP is confidential. The only information AAHRPP releases is the names of accredited organizations published on our website. All agents of AAHRPP (including staff, site visitors, and members of Council) are bound by a confidentiality agreement. AAHRPP does not release information about whether you may be considering accreditation. After organizations apply, AAHRPP does not release names of peer reviewers, dates of site visits, or other information about the accreditation process. AAHRPP's confidentiality policy may be found in the Accreditation Procedures.

When does AAHRPP update its requirements? Does AAHRPP modify the Evaluation Instrument?

Generally AAHRPP releases updates to the Evaluation Instrument in January. A list of changes is included in the Evaluation Instrument; changes are listed here:

AAHRPP emails all accredited organizations, along with organizations that have subscribed to our mailing lists when we update the Evaluation Instrument.

We are a new IRB/EC and just starting out. Can we apply for initial accreditation if we have not started reviewing studies yet?

Organizations applying for accreditation need to demonstrate that written materials meet AAHRPP Standards and that they can implement AAHRPP Standards in practice. Evidence that organizations meet AAHRPP Standards in practice is normally provided by a) showing examples of actual study reviews as well as convened meeting minutes and other records, and b) that relevant persons in the HRPP are knowledgeable through interviews with AAHRPP site visitors. 

Ideally, organizations should be able to demonstrate review of at least one

  • study by a convened IRB/EC
  • study by an expedited procedure, and
  • exemption determination, if the organization makes exemption determinations.

However, in some circumstances, organizations may be eligible to apply for accreditation with a limited number of actual study reviews, provided they can demonstrate the HRPP meets AAHRPP requirements in other ways. Organizations should always discuss any unique circumstances with AAHRPP.

However, in some circumstances, organizations may be eligible to apply for accreditation without actual study reviews, provided they can demonstrate the HRPP meets AAHRPP requirements in other ways. For example, organizations may be able to demonstrate they meet AAHRPP Standards by providing examples of "mock" studies, where the information reviewed represents a complete study file, where the IRB/EC actually reviews the mock study, and where minutes and other records demonstrate the IRB/EC has reviewed and made determinations for mock studies. Organizations should always discuss any unique circumstances with AAHRPP.

Conducting a Self-Assessment

Does AAHRPP provide any resources to help start the accreditation process and conducting the organization's self-assessment?

First, read AAHRPP's Accreditation Procedures. This will provide your organization with an overview of the accreditation requirements and process.

Evaluate your program using AAHRPP's Evaluation Instrument for Accreditation. The Evaluation Instrument for Accreditation contains all the information you need to evaluate your program. AAHRPP uses the Evaluation Instrument for Accreditation to review your policies and to confirm that your organization follows those policies in practice when we conduct site visits.

Your program must meet all Standards in the Evaluation Instrument to obtain accreditation. For example, your IRB or EC membership must meet AAHRPP Element II.1.A., which includes regulatory requirements and additional AAHRPP requirements. You should check your policies against all Essential Requirements and additional requirements in the Evaluation Instrument, and ensure your policies, applications, reviewer comment forms, and other written materials contain all required information.

How do I plan for AAHRPP accreditation? When can I begin the process?

Applying for accreditation starts with a self-assessment of all your written materials. The self-assessment is a critical, introspective examination of a Human Research Protection Program (HRPP) in which the program is evaluated according to each element of the AAHRPP Accreditation Standards. Once you complete this part you can begin preparing and assembling your application.

You must have at least one active research study before submitting your application. Learn more at:

Building and Developing an Application

What is the process to apply for initial accreditation?

The accreditation process is described at

How long does the accreditation process typically take?

The accreditation process starts with a self-assessment of your HRPP’s policies and procedures using AAHRPP’s Evaluation Instrument for Accreditation. Most organizations complete this process in approximately six months to one year. The next step is to assemble your Application for Accreditation (Step 1) and submit it to AAHRPP for review. Once AAHRPP receives a complete application, it takes about 12 months to go through the process of reviewing your written materials, schedule and conduct a site visit, and prepare the application for review by the Council on Accreditation.

How do I get ready for reaccreditation and when should I begin preparing?

Reaccreditation applications are due 12 months prior to the Council on Accreditation meeting at which your organization is scheduled for review. If you are not sure when your scheduled Council on Accreditation meeting is, please contact us.

At least six months before your application submission deadline, start the same detailed self-assessment that you conducted for your original accreditation. One way to stay organized is to create and maintain a detailed list or filing system for all written materials you will use for your AAHRPP application. Each time a change in your practices, policies, or procedures is approved at your organization, update the list and files immediately. Treat the list of policies and procedures as a “live document,” and you will always have a current and accurate record of your organization’s efforts to safeguard research participants.

Learn more here:

What materials does AAHRPP review?

As part of the evaluation of your organization’s policies and procedures, AAHRPP reviews all written materials used to operate your HRPP. This includes standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, strategic plans, charters, by-laws, mission statements, IRB/EC applications and review forms, conflict of interest disclosure forms, websites, position descriptions, IRB/EC rosters, and all other written materials your program uses to operate its HRPP.

A site visit is conducted to confirm your organization follows your HRPP’s policies and other written materials in practice. During a site visit, AAHRPP site visitors conduct interviews with key personnel and review records, including but not limited to IRB/EC minutes, protocols and IRB/EC application forms, IRB/EC reviewer comment forms, correspondence with any regulatory agencies regarding serious and continuing noncompliance, unanticipated problems, and suspensions of IRB/EC approval.  AAHRPP site visitors must have access to all materials used to operate your HRPP, and must be permitted to interview all key personnel.

Organizations that conduct classified research should contact AAHRPP well in advance of sending an application for accreditation for assistance with how AAHRPP can evaluate your organization. Classified information is material that a government body deems to be sensitive information that must be protected. 

Are there any best practices that make applying for reaccreditation easier? 

The best way to apply for reaccreditation is to keep your policies and other written materials up to date between accreditation cycles and update a spreadsheet containing a list of current versions of policies and approval dates by conducting periodic (e.g., annual) reviews of policies and other written materials, and maintain a list of current materials. For example, if you revise a policy, instead of waiting for the next reaccreditation cycle to update your list of approved policies, update that list when you revise the policy, recording the new version and date, and saving the new policy in a "current policies" folder.

In addition, AAHRPP requires organizations to conduct periodic evaluations of HRPP resources. Conducting these periodic evaluations helps organizations make sure policies are up to date and ensure organizations meet AAHRPP requirements to conduct evaluations.  

 Organizations also should conduct these reviews and maintain records that document the review occurred. We expect evaluations to occur more than once every accreditation cycle. Conducting periodic evaluations helps organizations make the case for additional resources or program changes. For example, conducting an evaluation of resources, and comparing these to AAHRPP's metrics can help organizations justify additional budget requests, so it makes sense to conduct these evaluations every year prior to your organization's budgeting process.

What is the best way to compile and format the application materials for submission to AAHRPP?

Please refer to the Instructions for Submitting Materials in Support of Accreditation webpage for information on the assembly and submission of an Application for Accreditation or Reaccreditation.

Contact AAHRPP staff at if you have questions related to submitting an Application for Accreditation or Reaccreditation.

Learn more here:

Does AAHRPP require hyperlinks in the application?

No, hyperlinks are not required. Because hyperlinks must be created manually by the organization, and generally must be manually updated when generating the Step 2 application, AAHRPP does not require hyperlinks. AAHRPP requires bookmarks (which are created automatically by Adobe Acrobat when generating the PDF application, and which are updated automatically when generating both the Step 1 and Step 2 applications).

AAHRPP instructions say organizations should not make changes to policies and procedures, applications, and other written materials between the Step 1 review and the site visit. Are any changes acceptable?

In general, once an organization has revised written materials and been cleared through Step 1, written materials should not be changed prior to the site visit. During site visits, organizations are evaluated based on written materials submitted in the Step 2 application to confirm that an organization’s practices are consistent with its policies and meets AAHRPP Standards. Minor changes - meaning those that do not change a process - are acceptable (examples include minor spelling corrections). However, substantive changes - meaning those that change a process - require prior review and approval by AAHRPP. Examples of substantive changes that may result in AAHRPP requiring an organization to re-start the Step 1 process include, but are not limited to:

  • Implementing electronic IRB/EC management systems or changing electronic IRB/EC management systems
  • Making changes to workflows, applications, forms, procedures, staff responsibilities; or implementing a new set of policies
  • Adding new types of research (such as an organization that indicates it does not conduct biomedical research starting to conduct biomedical research)
  • Mergers or acquisitions involving the organization

Substantive changes require review and may require revision to meet AAHRPP Standards. As a result, substantive changes may require postponing the site visit or starting the application process over, and may result in adverse action against the organization, including being placed into Accreditation-Pending or Reaccreditation-Pending. If an organization anticipates there may be a need for substantive changes to the program after submission of the Step 1 Application, the organization should contact AAHRPP immediately.

In terms of your application, once your Step 1 Application is submitted, AAHRPP staff and an application (Step 1) reviewer will evaluate your written materials according to the Accreditation Standards and request revision or additional documentation, if needed.

You will work with the AAHRPP application (Step 1) reviewer to update your written materials so that all Standards and Elements are satisfactorily addressed. Once this occurs, AAHRPP staff will clear you to submit additional materials in preparation for a site visit (your Step 2 Application for Accreditation or Reaccreditation) and provide instructions and guidance.

Please do not change your written materials between the submission of your Step 2 Application and the site visit. Ideally, policy changes would not occur until after the Council on Accreditation makes a determination regarding your accreditation status. If changes to policies and procedures are unavoidable, please contact AAHRPP staff.

Learn more here:

Instructions to Apply for Initial Accreditation or Reaccreditation

How can my organization avoid some of the common problems that delay accreditation or reaccreditation?

Here are some steps you can take to help avoid delays in the application process:

Conduct a thorough self-assessment.

The Evaluation Instrument for Accreditation takes you through each of the Accreditation Standards and Elements and shows you how to provide the written materials needed to meet each of them. Once you’ve submitted your application, AAHRPP staff and an application (Step 1) reviewer will evaluate your written materials. If revisions or additional documentation are needed, you will work with the AAHRPP application (Step 1) reviewer to update your written materials until all Standards and Elements are satisfactorily addressed. Responding in a timely manner to any questions or requests for information will help reduce any potential delays.

Complete the application materials fully and accurately.

For example, in the Section A: Application form, ensure that the list of entities for your organization and the list of regulations your organization follows are correct. Inconsistencies between the information you provide in Sections A & B and your written policies and procedures can cause delays.

Double check formatting requirements for each submission.

AAHRPP provides instructions to help you format documents correctly. We also provide extensive accreditation resources, including all the templates you need to build your application.

The most common problems are due to not following the instructions to apply for accreditation or reaccreditation. The instructions can be found at:

Learn more here:

What are best practices for ensuring current approved versions of policies and written materials are used? How do we make sure we include updated policies and other written materials in the Step 2 application once they have been cleared by the AAHRPP application reviewer? 

Organizations should have a process to manage updates to policies and other written materials. While AAHRPP does not list specific requirements in the Evaluation Instrument, having a plan for managing and tracking changes to policies and other materials helps organizations maintain a current list of all written materials used to operate their HRPP. Examples of things the process could describe may include:

  • who is responsible for managing and maintaining a list of current policies and other written materials
  • a spreadsheet or list that includes columns or headers including but not limited to:
    • names of all documents used to operate the HRPP
    • approval dates of current policies and other written materials
    • version number of the approved policies and other written materials
    • contact information for the person or office responsible for maintaining the document
  • the location of current versions (such as a folder called "current HRPP policies")
  • the location of prior versions (such as folders called "retired policies 2022", retired policies 2021, etc.); organizing by date helps track when policies were changed
  • planned changes and location of written materials in process of revision (such as "draft updated policies 2025")
  • a location of updated or revised policies that are in the process of obtaining approval (such as a folder called "pending approval")
  • plans for education about changes in policies, including:
    • who needs to be educated
    • the person or office responsible for conducting education about new policies
    • dates when education will occur
The process should describe when policies are periodically evaluated to see if updates are needed or if updates have been made, particularly when other departments are responsible for maintaining policies. For example, scheduling a review of current versions of policies and other materials before the AAHRPP Annual Report is due will help you answer questions in the Annual Report about changes to the HRPP in the previous year.

Who can I contact if I have questions during the application process?

AAHRPP is available as a resource throughout the accreditation process. If you have questions or need help, just ask.

Contact us via our website or by sending an email to AAHRPP Reporting ( AAHRPP staff stands ready to assist you.


How long does the accreditation process typically take?

The accreditation process is a milestone-based process. It typically takes approximately 12 months to prepare your accreditation package to be reviewed by the Council on Accreditation. 

When will I need to renew my accreditation?

Accredited Organizations renew their accreditations three years after the initial accreditation and every five years thereafter, by performing the same self-assessment required for the initial accreditation application. You do not need to pay a new application fee to renew your accreditation; annual fees cover the costs of reaccreditation. Once your organization achieves accreditation you are tethered and assigned to a particular Council meeting in March, June, September, or December. Please see example below:


Date of AccreditationInitial organization or Reaccredited organizationAccreditation Period  Step 1 Application Due DateNext Review of Accreditation Package
March 2024 Initial 3 years   March 2026 March 2027
March 2024 Reaccreditation 5 years   March 2028 March 2029


Please find additional information at Applying for Reaccreditation.

When should an organization begin working on the reaccreditation application?

You can expect to receive a reminder email approximately 6 months prior to your application due date. You can begin working on your application at that time. For more information see Part 2: Build and Develop an application.

When should I expect to receive feedback after my Step 1 Application?

You can expect to receive feedback from your Step 1 Application submission 60 – 90 days after submission. Once you receive the Application (Step 1) Review you will have approximately 6-8 weeks to work with the application reviewer to update your policies and procedures so that all of the Standards and Elements are satisfactorily addressed.

You can find more information about next steps at Part 3: Evaluation of Written Materials.

Evaluation of Practice (Site Visits)

Are site visits conducted in person or remotely?

As of 2023, the site visit for an organization applying for initial accreditation in the United States is generally conducted in-person. However, international organizations or if an organization does not have a physical location within the US, site visits for these organizations applying for initial accreditation may be conducted remotely. In general, site visits for applications for reaccreditation are conducted remotely but organizations can request that AAHRPP conduct an in-person site visit.

What does it mean when site visitors identify an Area of Concern?

An Area of Concern means that site visitors have identified an area where an organization does not appear to meet all of the requirements for a Standard or Element in practice. This is based on both the site visitors’ review of the organization’s documentation and written materials, and on the interviews of key personnel during the site visit .

How do we respond to an Area of Concern?

Organizations should describe program improvements to ensure the organization meets the Element or Standard in practice. This generally includes education for relevant staff and/or researchers about what is required, and monitoring or checking to confirm that changes have been implemented. Sometimes improvements may include revisions to processes and changes or clarifications to policies or other written materials. AAHRPP's form for responding to Areas of Concern is available at

What if we think site visitors did not understand our organization or disagree about an Area of Concern?

If you think site visitors were mistaken about an Element or Standard, you can provide documentation with your Response to the Draft Site Visit Report showing your program meets an Element or Standard.

Who can we contact after the site visit if we have questions about an Area of Concern?

Contact AAHRPP with questions after a site visit. Do not contact the team leader or other site visitors following the site visit.

How can we prepare for site visit interviews?

AAHRPP interviews key personnel provided by your organization using the Section H Key Personnel and Research Team List form. You know who will be interviewed based on the people you list in the Key Personnel form. Those selected for interviews are also named on the final site visit agenda.

Interview questions are based on the roles and functions of people in the HRPP. Some examples:

  • We ask IRB/EC members about the materials they review, how they ensure the criteria for approval by the IRB/EC are met, and how they review other materials such as researcher and research staff management plans and reports of serious and/or continuing noncompliance and unanticipated problems.
  • When we interview personnel involved in negotiating contracts and sponsor agreements, we only ask questions about how they ensure human participant protections are included in contracts and grants.
  • When we interview personnel responsible for oversight of investigational drugs (often a pharmacist) we only ask about their role in oversight of investigational drugs.

Because you know the people who will be interviewed, and the Standards and Elements that may be specific to the interview session, you can conduct education prior to the site visit. AAHRPP site visits are "open book" conversations. While people being interviewed can bring relevant policies, site visitors will not ask specific questions about details in policies or questions designed to trick people. We ask questions about processes and are interested in how people fulfill their responsibilities. This means that sometimes an acceptable answer will be that the person knows there is a policy or worksheet or checklist and knows to consult that during their review or during their work.

Council on Accreditation Review

What is the Council on Accreditation?

The Council on Accreditation is composed of peers from accredited organizations.  Council reviews applications and makes decisions about whether an organization meets all accreditation Standards and may be granted Full Accreditation, Qualified Accreditation, Full Reaccreditation, or whether organizations need additional time to meet all AAHRPP Standards.

When will my application for accreditation or reaccreditation be reviewed by the Council on Accreditation?

The Council on Accreditation meets no less than four times per year. If this is your organization’s initial application for accreditation, your organization may be assigned to ANY quarterly Council meeting (March, June, September, or December). Organizations that have already achieved accreditation are tethered to a particular Council month, typically the month in which they were initially accredited. Your organization’s application will be reviewed three years after your initial accreditation, and then every five years after all subsequent reaccreditations.

What determinations does the Council on Accreditation make?

The Council on Accreditation reviews all site visit reports and makes a determination regarding accreditation status.

  • For new applicants, the categories of accreditation status are Full Accreditation, Qualified Accreditation, Accreditation Pending and Accreditation Withheld.
  • For renewing applicants, the categories of accreditation status are Full Accreditation, Probation, Accreditation Revoked and Reaccreditation-Pending.

The Council on Accreditation also reviews Status Reports and Improvement Plans, which may be requested by the Council when they review an organization’s site visit report.

For more information see AAHRPP Accreditation Procedures.

What if my organization does not receive Full Accreditation or Full Reaccreditation?

The AAHRPP Council on Accreditation may make the following determinations:

  • All Standards are met, and no additional actions are required.
  • All Standards are met, but request additional information to confirm a Standard is met:

AAHRPP defines categories of accreditation in the Accreditation Procedures:

Please see Part 6: Response to Council Review for additional information about these requests.

Has Council ever revoked an organization's accreditation?

AAHRPP's approach is educational, collegial, and respectful, and is designed to help organizations improve their programs. If Council believes your organization is able and willing to commit to taking corrective actions to meet all AAHRPP Standards within a reasonable time period, accreditation can be maintained. In extremely rare circumstances, Council has revoked accreditation.

By when should my organization expect to receive the Council’s decision?

The exact dates of the Council meetings vary annually within the assigned months; however, AAHRPP sends the Council’s decision to organizations in writing in approximately 30 days from the Council meeting. If you have questions or believe that you should have received notification from AAHRPP, please contact

How may my organization publicize our accreditation status?

AAHRPP encourages the accredited organization to publicize its accreditation with AAHRPP. AAHRPP publishes the name of an organization, a short description of the organization, its category of accreditation, and the date it was accredited. All currently accredited organizations can be found at Find an Accredited Organization.

AAHRPP also issues a Certificate of Accreditation to each Organization that receives Full Accreditation or Qualified Accreditation.

Response to Council Review

When should my organization begin working on our response to the Council Request?

It is essential that your organization begin working on its response immediately. Requested changes, education, and monitoring often require time to complete. 

How will I know if the Council on Accreditation has requested a Status Report or Improvement Plan?

Any Council requests, along with corresponding due dates, will be found within the Final Site Visit Report that you will receive upon Council’s review of your organization’s application. Please read the report carefully to ensure that you have addressed all requests. 

Additional Status Reports or Improvement Plans may be requested when further information is needed.

When is my Response to the Council Request due?

AAHRPP will provide the due date for your report(s) at the time when it is requested. Generally, the following timelines are observed:

Status Reports are reviewed two Council meetings (approximately six months) after they are assigned, and they are due from your organization on the first day of the month before the Status Report is due to be reviewed by Council. For example:

Status Report AssignedDue DateReviewed by Council
March 2024 August 1, 2024 September 2024
June 2024 November 1, 2024 December 2024
September 2024 February 1, 2025 March 2025
December 2024 May 1, 2025 June 2025


Improvement Plans are reviewed at the next Council meeting (approximately three months) after they are assigned. Improvement Plans are due from your organization on the first day of the month before the report is due to be reviewed by Council. For example:

Improvement Plan AssignedDue DateReviewed by Council
March 2024 May 1, 2024 June 2024
June 2024 August 1, 2024 September 2024
September 2024 November 1, 2025 December 2024
December 2024 February 1, 2025 March 2025

How can I find instructions to prepare my Response to the Council request?

Please read through the Council’s request, and then review the instructions and examples at Response to Council Requests. 

Required Reporting and Maintaining Accreditation

What forms of reporting may AAHRPP request in addition to Applications for Accreditation and Reaccreditation?

Please follow AAHRPP’s formatting guidance when compiling your Status Report or Improvement Plan. The report should be submitted as a PDF document that is bookmarked, paginated, and searchable, with the following sections:

Annual Reports

Does AAHRPP require Annual Reports?

Yes, organizations must provide an annual report except in the eear they are applying for reaccreditation. 

My organization has a Step 1 Application due this year. Do I also need to submit an Annual Report?

Annual Reports are due on the 15th of the anniversary month of your organization’s accreditation. However, Annual Reports are not due in the year when your organization submits an Application for Reaccreditation or in the year when your organization is scheduled for review by the Council on Accreditation. 

How do I submit my Annual Report?

You will receive a reminder containing instructions to submit your Annual Report approximately 60 calendar days before your Annual Report is due. To ensure that this reminder is received, please notify AAHRPP of any new Application Contact by submitting a PDF of Section I (first two pages) of the Section A Application to

Currently, the AAHRPP Annual Report is submitted via an online form, and you should receive the link for this form at the same time that you receive the above reminder and instructions.

If you have any questions or believe that you may have missed the form or reminder, please contact

Where can I find guidance on completing my Annual Report?

Guidance for each question of the Annual Report is available on our website at Annual Report Guidance.

How do I know if my Annual Report has been accepted, or whether AAHRPP requests additional information?

You will receive an email notifying you once your Annual Report has been found to be complete. Sometimes AAHRPP may request additional information upon receipt of your Annual Report to resolve any questions or potential issues.

Events Requiring Prompt Reporting

Are organizations required to notify AAHRPP of any changes that impact the HRPP?

When does AAHRPP require notification of Reportable Events?

An organization must report to AAHRPP as soon as possible but within 48 hours after the organization or any researcher (if the researcher is notified rather than the organization) becomes aware of:

  • Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions Placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human research protections
  • Any litigation, arbitration, or settlements initiated related to human research protections
  • Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the organization’s Human Research Protection Program

Additionally, when an accredited organization or its HRPP has a substantive change, including but not limited to a change in corporate structure, a change of ownership or leadership, or a change of name, it must notify the AAHRPP office within 30 days of when the change occurs.

If it is unclear whether a particular item is reportable to AAHRPP, or if you are unsure whether a change constitutes a substantive change, the organization must contact for further advice. 

How do I submit information about one of the above Reportable Events?

Please use our Reportable Events Form to report to AAHRPP either events that require prompt reporting or substantive changes to an organization’s HRPP. Please follow the instructions in the form, and also reference AAHRPP’s formatting guidance. 

How does AAHRPP respond to Reportable Events?

AAHRPP staff will review information regarding the event that is provided and will determine whether any action is indicated, or if additional information is needed. In some circumstances, the Council on Accreditation will be advised of the situation and requested to determine whether further action is needed, such as further reporting or a Limited Site Visit.

Our organization is merging with another organization. What should we do to maintain our accreditation?

Contact AAHRPP for guidance on maintaining accreditation when merging with other organizations. If two accredited organizations are merging, very little is required. If an accredited organization is acquiring a non-accredited organization, AAHRPP will seek information about the process for integrating the HRPPs. If an accredited organization is being acquired by a non-accredited organization, AAHRPP will request a plan for integration of HRPPs and information on how the new organization will meet AAHRPP Standards. Information AAHRPP may request includes, but is not limited to:

  • What is the timeline for integrating policies and other written materials?
  • Will there be staffing changes? What is the timeline for staffing changes?
  • Will there be any changes to IRBs/ECs? For example, will IRBs/ECs be closed or reorganized?
  • Will there be a change in the type of research conducted by the accredited organization? For example, if an accredited organization acquires a non-accredited hospital or biomedical research program, how will the accredited organization meet AAHRPP Standards for biomedical research?
  • If an accredited organization is acquiring a non-accredited organization, will the accredited organization’s policies and application systems be applied to the non-accredited organization?
  • If a non-accredited organization acquires an accredited organization, will the accredited organization's policies and IRB/EC application systems be replaced by those of the non-accredited organization?

Metrics and Data About Accredited Organizations

Does AAHRPP provide information about accredited organizations or metrics about accredited organizations?

Yes. AAHRPP provides data to help research organizations, researchers, sponsors, government agencies, and participants identify and support high-performing practices for HRPPs.

AAHRPP publishes metricsThe metrics include data about:

  • the types of organizations accredited
  • what regulations and guidelines organizations apply
  • the number of active studies organizations have
  • types of funding that support research organizations conduct, review, or manage
  • how many IRBs or ECs organizations support
  • IRB/EC review times
  • IRB staffing and budgets
  • audits of researchers and IRBs/ECs
  • unresolved complaints and determinations of serious or continuing noncompliance and unanticipated problems

Questions about specific Standards and Elements

Does AAHRPP provide guidance on how to meet specific Standards and Elements?

Yes. Please see AAHRPP’s library of Tip Sheets.