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.

Information about eligibility is on our website at https://aahrpp.org/accreditation/why-accreditation-matters/eligibility. In addition, AAHRPP's Accreditation Procedures define eligible organizations.

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

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 https://www.aahrpp.org/education-news-and-events/webinars. If you have additional questions, please contact AAHRPP staff or submit a question to be addressed during the Ask AAHRPP webinars.

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.

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

The AAHRPP website describes the value of accreditation: https://aahrpp.org/accreditation/why-accreditation-matters/overview. You can also hear from accredited organizations about what they see as the value of accreditation at https://aahrpp.org/about/testimonials.

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

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 https://www.aahrpp.org/resources/for-accreditation/procedure/procedure-doc-1/initial-accreditation-procedures 

For more information about reaccreditation procedures go to https://www.aahrpp.org/resources/for-accreditation/procedure/procedure-doc-1/reaccreditation-procedures

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 https://aahrpp.org/accreditation/get-accredited/application-and-annual-fees. 

Please contact AAHRPP staff with cost questions. 

Generally AAHRPP releases updates to the Evaluation Instrument in January. A list of changes is included in the Evaluation Instrument; changes are listed here: https://www.aahrpp.org/resources/for-accreditation/instruments/evaluation-instrument-for-accreditation/introduction/summary-of-revisions

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

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.

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.

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:

• Get Accredited - Part 1: Conduct a Self-Assessment
  
• Tips for Planning Accreditation
• Information about Application Fees
• Tips for Conducting a Self-Assessment

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:

• Tips for Putting Together an Application for Reaccreditation
• Tips for Conducting a Self-Assessment
• Instructions to Apply for Initial Accreditation or Reaccreditation
• Build and Develop an Application

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. 

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.

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 reporting@aahrpp.org if you have questions related to submitting an Application for Accreditation or Reaccreditation.

Learn more here:

• Tips for Conducting a Self-Assessment
• Build and Develop an Application
• Instructions to Apply for Initial Accreditation or Reaccreditation
• Advance Newsletter - Fall 2022: Tips for Smooth Application Review

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

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:

• Instructions to Apply for Initial Accreditation or Reaccreditation
• Instructions for Submitting Materials in Support of Accreditation or Reaccreditation
• Instructions for Responding to the Draft Site Visit Report
• Instructions for Preparing a Status Report
• Instructions for Preparing an Improvement Plan

Learn more here:

• Conduct a Self-Assessment
• Build and Develop an Application
• Advance Newsletter - Fall 2022: Tips for Smooth Application Review

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

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 (reporting@aahrpp.org). AAHRPP staff stands ready to assist you.

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:

Please find additional information at Applying for Reaccreditation.

You can expect to receive feedback from your Step 1 Application submission approximately 60 days after submission. Once you receive the Application (Step 1) Review you will have approximately 30 days to work with the application reviewer to update your policies and procedures so that all of the Standards and Elements are satisfactorily addressed.

In general, site visits for applications for reaccreditation are conducted remotely, while site visits for organizations applying for initial accreditation in the United States are generally conducted in-person. However, organizations can request that AAHRPP conduct an in-person or remote site visit.

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.

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.

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.

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:

• Council may determine your organization meets a Standard but wants to confirm your organization continues to implement the change in practice. In this case, Council may request a Status Report which are typically due in approximately four months following the Council meeting at which it was assigned. See the Instructions for Submitting a Status Report: https://www.aahrpp.org/resources/for-accreditation/additional-resource/instructions-for-preparing-a-status-report
  

• One or more Standards are not met. 
  • If one or more Standards are not met, Council will request an Improvement Plan. When an organization does not meet one or more Standards, Council defers making a decision on accreditation and the organization is placed in Accreditation-Pending or Reaccreditation-Pending status. This deferred status is confidential and is not reflected on AAHRPP's website. See instructions for submitting an Improvement Plan: https://www.aahrpp.org/resources/for-accreditation/additional-resource/instructions-for-preparing-an-improvement-plan

AAHRPP defines categories of accreditation in the Accreditation Procedures:

• Categories of Accreditation for new applicants 
• Categories of Accreditation for organizations applying for reaccreditation

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.

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. 

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:

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:

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

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

• Response to Council Requests Form
• Supporting documents, if applicable

AAHRPP requires Annual Reports and certain Event Reports. 

For more information about Annual reports, see:

• Annual and Other Notification Reporting
• Annual Report Guidance

For more information about Event Reports, see:

• Required Reports
  
• Reportable Events Form

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 reporting@aahrpp.org.

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.

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.

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?

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

AAHRPP publishes metrics. The 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

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