The AAHRPP Accreditation Program is a voluntary, peer driven, educationally-based model of accreditation. It seeks to recognize high-quality Human Research Protection Programs (HRPP) of organizations that conduct or review research.

Accreditation uses a set of objective Standards to evaluate the quality and level of protection that an organization provides research participants. AAHRPP's Accreditation Standards meet or exceed U.S. federal regulatory requirements and the International Council for Harmonisation — Good Clinical Practice (E6) guideline for protection, and are reasonable, attainable, and representative of current best practices. 

AAHRPP promotes research excellence by offering accreditation to organizations that commit to high standards for research ethics and safety. Through accreditation, an organization can demonstrate the overall excellence of its research program by providing the most comprehensive protections for research participants.

AAHRPP will accredit the HRPP of any eligible organization that seeks accreditation (as below).

Common organizations that seek accreditation include, but are not limited to:

Academic institutions: A single, free-standing university, college, medical school, or other professional school under a single chief executive officer is an accreditable organization. The academic institution applies for accreditation as a whole unit regardless of the number of institutional review boards/ethics committees (IRBs/ECs) or separate schools within the university. In rare exceptions, smaller units within a university may be accepted as an accreditable organization if the university can demonstrate that each smaller unit has its own organizationally separate HRPP, e.g., a separate Federalwide Assurance. However, AAHRPP's policy is to accredit academic institutions at the "campus" level rather than to accredit IRBs/ECs of the academic institution.

In large university systems, individual campuses that are functionally distinct with a chief executive officer (e.g., Chancellor) may apply for accreditation as individual entities. Each institution (typically, an individual campus) applies for accreditation as a whole unit regardless of the number of IRBs/ECs or separate schools within the entity. On the other hand, if a university system as a whole wishes to apply for accreditation, AAHRPP will consider such requests on a case-by-case basis.

Academic medical centers: A free-standing medical school or other professional school with an affiliated teaching hospital or health system under a single chief executive officer is an accreditable organization.

Contract research organizations: A contract research organization under a single chief executive officer is an accreditable organization. The contract research organization applies for accreditation as a whole unit regardless of the number of IRBs/ECs or separate departments within the organization. In large contract research organizations, individual units that are functionally separate and have an executive officer may apply individually.

Government agencies: An agency within a department that has its own director, commissioner, or administrator is an accreditable organization. The agency applies for accreditation as a whole unit regardless of the number of IRBs/ECs or separate units within the agency. In rare exceptions, smaller units within an agency may be accepted as an accreditable organization if the agency can demonstrate that each smaller unit has its own organizationally separate HRPP.

Health systems: A hospital/health system is a group of healthcare organizations (e.g., physician practices, hospitals, skilled nursing facilities) that are jointly owned or managed under a single chief executive officer. The health system applies for accreditation as a whole unit regardless of the number of hospitals or healthcare organizations or number of IRBs/ECs.

Hospitals: A hospital under a single chief executive officer or director is an accreditable organization. The hospital applies for accreditation as a whole unit regardless of the number of IRBs/ECs or separate departments, centers, or similar subunits within the hospital. In large hospital systems, individual hospitals that are functionally separate and have chief executive officers or directors may apply individually.

Independent Review Boards or independent IRBs/ECs: An independent IRB/EC is not part of an organization that conducts research and is not owned or operated by the research organization for which it provides review services. These organizations are sometimes referred to as commercial IRBs/ECs. IRBs/ECs embedded within the organization that may conduct research (such as academic organizations, hospitals, or health systems) are not considered independent IRBs or ECs. The independent IRB/EC applies for accreditation as a whole unit. Independent IRBs/ECs that apply for accreditation must be able to meet the Accreditation Standards in all three domains, as applicable.

Private entities: A corporation or other incorporated entity, either non-profit or for-profit, under a single chief executive officer, is an accreditable organization. The entity applies for accreditation as a whole unit regardless of the number of IRBs/ECs or separate departments within the entity. In large entities, individual divisions, plants, facilities, or other parts that are functionally separate and have an executive officer may apply individually.

Dedicated research sites: A dedicated research site under a single chief executive officer is an accreditable organization. The research site applies for accreditation as a whole unit regardless of the number of facilities that it has engaged to conduct research. Research sites that apply for accreditation must be able to meet the Accreditation Standards in all three domains, as applicable.

NOTE: This section is for new organizations seeking initial accreditation. Organizations seeking to maintain their existing accreditation, please see Reaccreditation Procedures.

CONDUCT A SELF-ASSESSMENT

The initial step in the accreditation process is for an organization to engage in a thorough self-assessment. The self-assessment is a critical, introspective examination of an HRPP in which the program is evaluated according to each of the AAHRPP Accreditation Standards. This enables the organization to identify and remedy potential program weaknesses. Prior to conducting the self-assessment, the organization should develop a clear concept of the programmatic unit that will seek accreditation.

BUILD AND DEVELOP AN APPLICATION

When the organization has completed its self-assessment and addressed any gaps in its HRPP, the next step is to submit an Application for Accreditation to AAHRPP. An Application for Accreditation is comprised of two parts (Step 1 and Step 2) in which an organization’s written materials are reviewed (Step 1) and then additional documents are later submitted (Step 2) in preparation for a site visit.

EVALUATION OF WRITTEN MATERIALS (APPLICATION FOR ACCREDITATION)

An application reviewer evaluates the Application for Accreditation (Step 1) materials and assesses whether the organization’s policies and procedures are consistent with the Accreditation Standards, or whether revisions are needed. Policies and procedures include any written materials the organization uses to define and communicate its practices, such as standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, job descriptions, memoranda, forms, templates, strategic plans, websites, charters, by-laws, mission statements, or other forms that are used to administer the HRPP. Following review, AAHRPP staff and the application reviewer will communicate any requested changes to the organization in the Application Review report (Step 1 Review) and by email if needed.

The organization’s satisfactory response to any changes to policies and procedures requested in the Application Review report (Step 1 Review) must be completed within one year of the date that the report is sent to the organization. Once the application reviewer determines that the policies and procedures are consistent with the Accreditation Standards, the organization submits additional materials relevant to a site visit (Step 2) and a site visit is scheduled.

EVALUATION OF PRACTICE (IN-PERSON OR REMOTE SITE VISIT)

AAHRPP site visitors review the Application for Accreditation (Step 1 and Step 2), including any requested revisions, and evaluate an organization’s implementation of its policies and procedures by interviewing key personnel and reviewing records during a site visit evaluation. This evaluation may be conducted on-site and/or remotely. The length of time of a site visit varies depending upon the size and nature of the research portfolio, and generally ranges from two to four days in length.

AAHRPP must have sufficient information to adequately evaluate an organization’s HRPP. In general, this requires that site visitors be permitted to interview all key personnel, enter all relevant facilities as applicable, and have access to all relevant records, policies, procedures, minutes, audits, protocols, consent documents, and other materials. AAHRPP will not accredit an organization that cannot be thoroughly evaluated. To perform these tasks, the site visitors must sign confidentiality agreements with AAHRPP prior to the site visit.

The organization’s Application for Accreditation (Step 1 and Step 2) and results of the evaluation of practice site visit forms the basis of a site visit report. AAHRPP provides a Draft Site Visit Report to the organization in approximately 30 calendar days after completion of the site visit. Within 30 calendar days of the date that the Draft Site Visit Report is sent to the organization, the organization has the opportunity to respond to AAHRPP in writing to identify any errors of fact, to describe any corrective actions it has taken in response to Areas of Concern identified by the site visitors, and to report any other changes it has made to its HRPP since the site visit. AAHRPP staff, along with the site visit team leader, reviews the organization’s response to the Draft Site Visit Report and prepares a preliminary version of the final report (known as the Final Site Visit Report) for the AAHRPP Council on Accreditation (Council) to review.

COUNCIL ON ACCREDITATION REVIEW

At its quarterly meeting, the Council reviews the Application for Accreditation, Draft Site Visit Report, the organization’s response, and the evaluation of the response in the preliminary Final Site Visit Report. The Council then makes a determination of accreditation status, and this decision is communicated to the organization in writing in the Final Site Visit Report.

If the Council awards Full Accreditation, the initial accreditation period is three years.

CONDUCT A SELF-ASSESSMENT

An organization that is renewing its accreditation conducts a self-assessment. The purpose of a self-assessment for reaccreditation is to identify any relevant changes, updates, or improvements to the organization’s HRPP that may have occurred since the last accreditation period.

BUILD AND DEVELOP AN APPLICATION

When the organization has completed its self-assessment and addressed any gaps in its HRPP, the next step is to submit an Application for Reaccreditation to AAHRPP. An Application for Reaccreditation is comprised of two parts (Step 1 and Step 2) in which an organization’s written materials are reviewed (Step 1) and then additional documents are later submitted (Step 2) in preparation for a site visit.

Organizations must submit their Application for Reaccreditation (Step 1) no later than 12 months prior to their assigned Council on Accreditation (Council) review date. The Council review date is determined by the date (month and year) initial accreditation was awarded.

An organization that cannot submit their Application for Reaccreditation (Step 1) by the renewal application due date must promptly notify AAHRPP in writing. Organizations that submit an Application for Reaccreditation (Step 1) after the renewal application due date, or fail to complete the Application for Reaccreditation (Step 1 and Step 2) in time to complete the reaccreditation process before the Council meeting at which the organization is assigned to be reviewed, may be placed into Reaccreditation-Pending, on Probation, or may lose accreditation status.

EVALUATION OF WRITTEN MATERIALS (APPLICATION FOR REACCREDITATION)

An application reviewer evaluates the Application for Reaccreditation (Step 1) materials and assesses whether the organization’s policies and procedures are consistent with the Accreditation Standards, or whether revisions are needed. Policies and procedures include any written materials that the organization uses to define and communicate its practices, such as standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, job descriptions, memoranda, forms, templates, strategic plans, websites, charters, by-laws, mission statements, or other forms that are used to administer the HRPP. Following review, AAHRPP staff and the application reviewer will communicate requested changes to the organization in the Application Review report (Step 1 Review) and by email if needed.

Once the application reviewer determines that the policies and procedures are consistent with the Accreditation Standards, the organization may be asked to submit additional materials relevant to a site visit (Step 2) and a site visit is scheduled.

The Application for Reaccreditation process, i.e., the organization’s satisfactory response to the Application Review report (Step 1 Review), must be completed according to the time schedule provided by AAHRPP to ensure that the Application for Reaccreditation is reviewed at the organization’s assigned meeting of the Council. If this deadline is not met, the Council may place the organization into Reaccreditation-Pending.

EVALUATION OF PRACTICE (IN-PERSON OR REMOTE SITE VISIT)

AAHRPP site visitors review the Application for Reaccreditation (Step 1 and Step 2), including any requested revisions, and evaluate an organization’s implementation of its policies and procedures by interviewing key personnel and reviewing records during a site visit evaluation. This evaluation may be conducted on-site and/or remotely. The length of time of a site visit varies depending upon the size and nature of the research portfolio, and generally ranges from two to four days in length.

AAHRPP must have sufficient information to adequately evaluate an organization’s HRPP. In general, this requires that site visitors be permitted to interview all key personnel, enter all relevant facilities as applicable, and have access to all relevant records, policies, procedures, minutes, audits, sample protocols, consent documents, and other materials. AAHRPP will not accredit an organization that cannot be thoroughly evaluated. To perform these tasks, the site visitors must sign confidentiality agreements with AAHRPP prior to the site visit.

The organization’s Application for Reaccreditation (Step 1 and Step 2) and results of the evaluation of practice site visit forms the basis of a site visit report. AAHRPP provides a Draft Site Visit Report to the organization in approximately 30 calendar days after completion of the site visit. Within 30 calendar days of the date that the Draft Site Visit Report is sent to the organization, the organization has the opportunity to respond to AAHRPP in writing to identify any errors of fact, to describe any corrective actions it has taken in response to Areas of Concern identified by the site visitors, and to report any other changes it has made to its HRPP since the site visit. AAHRPP staff, along with the site visit team leader, reviews the organization’s response to the Draft Site Visit Report and prepares a preliminary version of the final report (known as the Final Site Visit Report) for the Council to review.

COUNCIL ON ACCREDITATION REVIEW

At its quarterly meeting, the Council reviews the Application for Reaccreditation, Draft Site Visit Report, the organization’s response, and the evaluation of the response in the preliminary Final Site Visit Report. The Council then makes a determination regarding accreditation, and this decision is communicated to the organization in writing in the Final Site Visit Report.

If an organization has not completed all the steps required to be reviewed at a Council meeting or the organization causes delays in its accreditation timeline, the Council may take one of the actions outlined in the Categories for Reaccreditation.

If the Council awards Full Reaccreditation, the reaccreditation period is five years from the Council meeting date to which the organization was assigned. 

The Board of Directors delegates to the Council on Accreditation (Council) the role, responsibilities, and authorities to facilitate the efficient operation of the accreditation program. The Council, comprised of experienced site visitors, reviews all relevant organizational documents, applications, and reports and makes a determination regarding accreditation status. The Council meets no less than four times annually.

The Council may place an organization seeking initial accreditation into one of four categories:

Full Accreditation:

An organization placed in this category meets all the Accreditation Standards. AAHRPP awards Full Accreditation to new applicants for three years, which commences on the date (month and year) AAHRPP makes the award.

Qualified Accreditation:

An organization placed in this category meets almost all the Accreditation Standards. Issues requiring corrective action are minor and non-regulatory in nature. AAHRPP awards Qualified Accreditation for three years, which commences on the date (month and year) AAHRPP makes the award. However, if the issues requiring corrective action are resolved before the next triennial site visit, the Council, upon acceptance of the corrective actions, may award Full Accreditation for the remainder of the accreditation period. Qualified Accreditation is only available to new applicants.

Accreditation-Pending:

The Council places an organization in the Accreditation-Pending category until it decides whether to award Full or Qualified Accreditation or to withhold accreditation. The Council may place an organization in the Accreditation-Pending category when the organization does not meet the criteria for Full or Qualified Accreditation, and the Council determines the organization is able and willing to commit to taking corrective actions to meet the criteria for accreditation within a reasonable time period.

An organization that is placed in the Accreditation-Pending category must submit an Improvement Plan within the timeframe specified by the Council. Based on the Improvement Plan and any requested progress reports (i.e., Status Reports), the Council may defer their decision and extend the length of time until the accreditation determination will be made. At its discretion, the Council also decides whether a Limited Site Visit or other actions are required before making a final accreditation determination.

Accreditation Withheld:

Before the end of its then-current accreditation period, an organization must reapply (i.e., submit an Application for Reaccreditation) and have a site visit. Following the site visit, the Council makes a decision about the renewing applicant based on the Application for Reaccreditation, Draft Site Visit Report, the organization’s response, and the evaluation of the applicant's response in the preliminary Final Site Visit Report.

The Council may place an organization seeking reaccreditation into one of four categories:

Full Reaccreditation:

An organization placed in this category continues to meet all the Accreditation Standards, or in the case of an organization awarded Qualified Accreditation at the time of its initial review, meets all Standards at the time of reaccreditation. Regardless of whether an organization is awarded Full Accreditation or Qualified Accreditation at time of initial review, at the time of reaccreditation, AAHRPP awards Full Reaccreditation for five years. The accreditation period for organizations placed into Reaccreditation-Pending status (see below) or on Probation (see below) is five years minus the time the organization was in Reaccreditation-Pending status or on Probation.

Reaccreditation-Pending:

The Council may place an organization in the Reaccreditation-Pending category when all of the steps necessary for the application process for reaccreditation have not occurred or the organization’s Application for Reaccreditation does not meet the criteria for Full Reaccreditation. For organizations placed into Reaccreditation-Pending, the Council determines the organization is able to successfully complete the reaccreditation process or is willing to commit to taking corrective actions to meet the criteria for reaccreditation within a reasonable time period.

Based on a review of the organization’s response to any requested corrective actions, the Council decides whether to grant Full Reaccreditation, place the organization on Probation, or to revoke accreditation. The accreditation period for organizations placed into Reaccreditation-Pending status is five years minus the time the organization was in Reaccreditation-Pending. An organization that is placed in the Reaccreditation-Pending category remains on AAHRPP’s published list of accredited organizations.

Probation:

The Council places an organization on Probation when the organization does not meet the criteria for Full Reaccreditation and cannot make changes within a reasonable time period. Probation is also considered when the Council does not feel the organization is taking appropriate corrective actions as proposed in the Improvement Plan or a request for a Status Report (as described below).

An organization placed in the Probation category will be removed from AAHRPP’s published list of accredited organizations and must submit an Improvement Plan within the timeframe specified by Council. Based on a review of the organization’s response to any requested corrective actions in the Improvement Plan and the continued commitment of the organization, the Council may award Full Reaccreditation, keep an organization on Probation and request additional follow-up, or revoke accreditation. At its discretion, the Council may require a Limited Site Visit or other actions before making a final accreditation determination.

Accreditation Revoked:

The Council may revoke accreditation at any time. The Council may revoke accreditation when an organization does not meet the criteria for Full Reaccreditation, and the Council believes the organization has demonstrated an inability or unwillingness to take effective corrective action. An organization placed in the Accreditation Revoked category will be removed from AAHRPP’s published list of accredited organizations.

In general, an organization in this category would have been placed initially on Probation and did not make the requested corrective actions to meet the timeline described in its Improvement Plan. Accreditation may also be revoked by AAHRPP for failure to comply with AAHRPP requirements, including those related to the payment of fees, as described here.

• If an organization fails to submit payment of its annual fee within 90 days of the date on its invoice, it will be placed on Financial Hold. Financial Hold means that until an organization pays its fees, AAHRPP will not process any submissions related to its accreditation (including but not limited to, Annual Reports or Applications for Reaccreditation). If an organization does not pay its fees within 6 months of receiving its annual fee invoice, its accreditation will be revoked.
• If an organization fails to submit accreditation/reaccreditation materials by their respective due dates, the organization will be notified of its failure to submit by AAHRPP. The organization will be provided with one extension to its submission deadline, if appropriate. If the organization fails to meet its extension deadline, the organization will be presented to the Council for its consideration and determination of the organization’s accreditation status.

Resolve Areas of Concern to Achieve or Maintain Accreditation

For an organization that is in the Accreditation-Pending or Reaccreditation-Pending categories or is on Probation, the Council attempts to resolve corrective actions through written communication. However, if the corrective actions are of such magnitude that a site visit (remote or in-person) is required to complete the evaluation and/or confirm the correction of deficiencies, then the Council may require a Limited Site Visit.

Limited Site Visits are also conducted when the Council deems it necessary to verify compliance with the Accreditation Standards or other requirements, or in response to information reported in an Annual Report or Status Report. Generally, AAHRPP notifies the organization of the need for a Limited Site Visit at the time it is placed in the Accreditation-Pending or Reaccreditation-Pending categories, is placed on Probation, or following the Council’s review of a Status Report or Annual Report.  In these situations, the costs of the Limited Site visit are the responsibility of the organization unless AAHRPP determines otherwise.

Inability to Conduct or Complete the Initial Site Visit

For an organization seeking Accreditation or Reaccreditation, AAHRPP may require a Limited Site Visit in situations when the initial site visit was compromised and not able to be completed. In situations where the inability to conduct or complete the initial site visit was beyond the organization’s control (e.g., a site visitor was unable to travel or became ill during the visit and could not complete the site visit activities), AAHRPP will bear the cost of the Limited Site Visit. Conversely, in situations where the site visit could not be completed due to the organization’s failure to meet AAHRPP’s stipulated requirements related to site visit preparation (e.g., the organization’s failure to produce the required documents), the organization will bear the cost of the Limited Site Visit.

Other Reasons for a Limited Site Visit

There are other situations in which AAHRPP may require a Limited Site Visit, including but not limited to, the following examples:

• For an organization that is awarded Full Accreditation or Qualified Accreditation, the Council may require a Limited Site Visit to occur during the accreditation period to assess major changes in an HRPP or otherwise to ensure that compliance with the Accreditation Standards is maintained. In this situation, AAHRPP will bear the cost of the Limited Site Visit.
• A Limited Site Visit may also be scheduled as part of AAHRPP's response to an organization that receives certain types of sanctions (e.g., governmental regulatory) or when an organization appears to have acted in willful disregard of AAHRPP Accreditation Standards or policies, or otherwise at the discretion of the Council. In these cases, the organization will bear the cost of the Limited Site Visit.

The Council may request a Status Report to confirm that one or more Accreditation Standards continues to be met at any time, both for organizations applying for initial accreditation and organizations applying for reaccreditation. Failure to submit a Status Report within 30 calendar days of its due date may result in an organization being placed into Accreditation-Pending, Reaccreditation-Pending, or on Probation.

The purpose of the Status Report is to document for the Council any activities performed to achieve compliance with an Accreditation Standard for which the Council has a specific Area of Concern. A Status Report may also be requested for the organization to report on progress of any areas or activities in transition to confirm the organization continues to meet AAHRPP Accreditation Standards. Examples include activities such as implementation of policies or forms or completion of an education or training program.

If an organization does not meet one or more Accreditation Standards or is unable to adequately address any Areas of Concern to meet the Standards, the Council may request that the organization provide an Improvement Plan. The purpose of an Improvement Plan is to document for the Council any corrective actions an organization has taken or will take to satisfy any unmet Accreditation Standards.

When the Council makes a decision to withhold or revoke accreditation, AAHRPP notifies the organization in writing of the decision and the factual findings and reasons supporting the decision. Such notice is sent to the organization’s application contact and organizational official electronically via email and/or by using a delivery mechanism that permits package tracking and confirmation of delivery. Within 30 calendar days after receipt of such notice, the organization may offer written evidence or argument tending to refute or overcome the factual findings and decision of AAHRPP, or may appeal the decision by submitting a written request to the President and CEO for an oral hearing before the Council.

If the organization requests a hearing within the 30-calendar-day period, the Council holds a hearing at its next scheduled meeting following receipt of such request. The organization is given an opportunity at the hearing to present evidence or argument tending to refute or overcome the factual findings and decision of the Council. Counsel may represent the organization at the hearing, which shall be conducted by the Council in its reasonable discretion and shall not be required to follow any rules of evidence or civil procedure. Within 30 calendar days after its Council meeting, AAHRPP renders its decision after considering the information before it, and sends written notification of its decision to the organization electronically via email and/or by using a delivery mechanism that permits package tracking and confirmation of delivery.

If, following the hearing, the decision of the Council is to continue to withhold or revoke accreditation, the organization may appeal the decision within 30 calendar days after receipt of notice of the decision by submitting a written request to the President and CEO for an appeal to the Board of Directors (Board). If the organization does not request an appeal within the 30-calendar-day period, the Council forwards its decision to the Board for review. The decisions of the Council are final in all but those rare instances when a Council decision is appealed to the Board.

The Council on Accreditation (Council) is comprised of individuals elected by the Board of Directors. Council members are experienced AAHRPP representatives who often have served in many different roles for AAHRPP (e.g., peer reviewers, application reviewers, team leaders, and site visitors). In selecting Council members, AAHRPP's goal is to seek representation from the human research protection, researcher, and organizational perspectives:

• Members representing the human research protection perspective are individuals who are or have been responsible for an organization’s HRPP. These members are likely to be HRPP program managers, senior HRPP administrators, IRB/EC chairs, or compliance officers.

• Members representing the researcher perspective are individuals who have years of recognized experience in their respective field of expertise in the conduct and/or review of human participant research. These members are likely to be physicians, registered nurses, professors, or senior scientists.

• Members representing the organizational official perspective are those who have authority over an organization’s HRPP or a significant aspect of that enterprise, particularly ensuring the protection of human research participants. Organizational officials usually include Provosts, Vice Presidents for Research, Deans, Directors, or Chief Executive Officers.

After submission and review of the Application for Accreditation/Reaccreditation, a team of experienced AAHRPP site visitors conducts a site visit to assess the HRPP's performance with respect to each Accreditation Standard. At its discretion, AAHRPP may use one or more site visitors for Limited Site Visits after the initial site visit has been concluded if there are outstanding issues to be addressed to meet the Standards. AAHRPP will not accredit an organization without a site visit.

Site visitors are selected based on their experience, expertise, and perspective. Site visit team leaders are experienced site visitors and/or members of AAHRPP's Council on Accreditation. The number of site visitors assigned to a team depends upon the size and complexity of the organization’s HRPP.

AAHRPP issues a Certificate of Accreditation to each organization that receives Full Accreditation, Full Reaccreditation, or Qualified Accreditation. If an organization has its accreditation revoked, the Certificate of Accreditation must be removed from display by the organization or returned to AAHRPP, and all references to AAHRPP accreditation and any use of the AAHRPP accreditation seal must be removed from all organization materials, including websites and emails. The organization may no longer represent itself (or permit others to identify it) as accredited by AAHRPP. Organizations that are placed in Accreditation-Pending are not entitled to receive Certificates of Accreditation until Full Accreditation or Full Reaccreditation are awarded.

Subject to the limits specified below, AAHRPP publishes the name of the organization, the type of organization, its category of accreditation, and the date (month and year) it was initially accredited. In addition, AAHRPP encourages the accredited organization to publicize its AAHRPP accreditation status. When an organization publicizes its accreditation status, it must do so accurately and not in a manner that could be misleading.

AAHRPP does not publish the name of or release information about an organization that is in the process of seeking accreditation or that has been placed in the Accreditation-Pending or Accreditation Withheld categories.

AAHRPP does not release information about an organization that is in the process of renewing its accreditation or that has been placed in the Reaccreditation-Pending category. An organization that is placed in the Reaccreditation-Pending category remains on the published list of accredited organizations.

An organization will be removed from the published list if it is placed on Probation or has its accreditation revoked.

AAHRPP requires an accredited organization to submit an Annual Report one year after it receives Full Accreditation, Full Reaccreditation, or Qualified Accreditation. Annual Reports are required each year thereafter; however, an Annual Report is not required in the year in which the Application for Reaccreditation is due and the year in which the organization’s Application for Reaccreditation is due for review by the Council on Accreditation (Council). Failure to submit an Annual Report in any year in which it is due may result in an organization being placed into Accreditation-Pending, Reaccreditation-Pending, or Accreditation Revoked.

The purpose of the Annual Report is to keep AAHRPP current on the nature and size of an organization’s HRPP and human research portfolio as well as to notify AAHRPP of changes related to or that might affect the organization’s HRPP, including but not limited to:

• Organizational Changes*, such as:
  • Change in entity type or corporate structure.
  • Change in name of the organization.
  • Change in ownership or control of the organization, including mergers or acquisitions.
  • Change in leadership or governance of the organization (e.g., President or Chief Executive Officer).
  • Change in the organizational official.
  • Change in the leadership of the HRPP (i.e., the individual responsible for the day-to-day operation).
  • Change in the application contact.
• Changes in Resources, such as:
  • Significant change (10% or more) in the balance of resources and active research protocols.
  • Significant reduction (10% or more) in resources in the past 12 months and the impact on the HRPP, such as reduction in full-time equivalent (FTE) or dissolution of an IRB/EC, committee, or other function.
• Changes in Program Scope, such as:
  • Addition of a new research program, including but not limited to a type of research not previously conducted or reviewed by the organization (such as planned emergency research, research involving children, or gene transfer research).
  • Addition, removal, or modification of functions, committees, or IRBs/ECs.

• Changes in method of providing services, such as use of external IRBs/ECs or contracting for services from another organization.
• Catastrophic event that results in an interruption or discontinuance in a part of or the entire HRPP.

*Note that 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 should notify the AAHRPP office immediately when the change occurs rather than waiting until providing the Annual Report. The Annual Report serves as a backup mechanism to ensure AAHRPP receives information that could affect an organization’s accreditation. If the organization is unsure whether a change constitutes a substantive change that must be reported to AAHRPP, the organization must request clarification.

OTHER REPORTING

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 researchers
  • 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 HRPP

If it is unclear to the organization whether a particular item is reportable to AAHRPP, the organization must contact AAHRPP for further advice.

When necessary, the Council will review information regarding the HRPP that is provided through the reporting mechanisms described above and will determine whether any action is indicated, such as a request for additional written information or a Limited Site Visit.

Organizations seeking accreditation must submit a nonrefundable application fee. The application fee covers the costs of the initial accreditation evaluation, including the site visit. The application fee is due when the organization applies as an applicant. Fees are based on the size and complexity of the HRPP and the fee schedule takes into account the most common HRPPs' structures.

APPLICATION FEE

AAHRPP encourages organizations to make a formal commitment by prepaying their application fee and becoming clients. AAHRPP offers an incentive to prepaying by guaranteeing the fee through the end of the following year. If an organization does not submit an application by the end of the following year, there is no penalty, the organization simply pays any difference in the fee between the year in which it submits an application and the year through which the fee is guaranteed. AAHRPP offers this option because it helps organizations make accreditation a priority. In addition, AAHRPP provides unlimited consultation to its clients.

ANNUAL FEES

Annual fees commence one year after the organization submits an application. An organization granted Full Accreditation, Qualified Accreditation, or Accreditation-Pending pays an annual fee. Because annual fees are linked to the date of application submission (and not to the date of accreditation), the annual fees would be due regardless of whether an Application for Accreditation or Application for Reaccreditation has been reviewed by the Council on Accreditation.

Information about specific AAHRPP clients (and the third parties with whom they do business or from whom they receive information) is confidential. This applies to an organization that participates at any level of the accreditation process, including potential clients that have only indicated their intent to apply for accreditation. The only information that may be released by an AAHRPP representative about the accreditation status of a participating organization is whether the organization is or is not accredited. AAHRPP client confidential information includes (but is not limited to) all information regarding the client's business, personnel, facilities, management, technical and scientific information, and deliberations or comments originating from the accreditation process, as well as all information regarding third parties with whom the organization does business or from whom the organization receives information.

All AAHRPP client confidential information made available by an organization to AAHRPP or its representatives is kept confidential to the extent required by law. No representative (e.g., staff, application reviewer, site visitor) may remove or retain copies of any organization’s confidential documents without the permission of the organization. AAHRPP site visitors do not retain copies of any organization’s confidential documents beyond the duration of the accreditation/reaccreditation process. No AAHRPP representative may disclose any of their findings to any person or agency except AAHRPP, except to the extent required by applicable law. AAHRPP representatives who fail to adhere to this policy may be discharged. In addition, AAHRPP may pursue legal action against them.

An AAHRPP representative will not participate in the review of an applicant, including, but not limited to, review of an Application for Accreditation/Reaccreditation, attendance at a site visit, or participation in any other matters related to an organization’s accreditation status, including discussions during AAHRPP meetings or in any vote regarding the applicant. This includes any of the following organizations for which an AAHRPP representative may have a conflict of interest:

• An organization with which the AAHRPP representative or an immediate family member* is currently, or within the last two years, has been connected as a student, employee, staff member, or agent.
  
• An organization with which the AAHRPP representative or an immediate family member*, currently have or have had within the last two years a cooperative or contractual arrangement with the organization.
• An organization with which the AAHRPP representative or an immediate family member*, serve or have acted as a consultant within the last two years for the organization.
• An organization with which the AAHRPP representative or an immediate family member*, have or have had within the last two years a financial, political, professional, or other interest that might conflict with the interests of AAHRPP or the organization.
• An organization that is located geographically within 150 miles of the address of the AAHRPP representative’s current (or former, if retired) employer.
• An independent IRB, when the AAHRPP Representative has any affiliation (including but not limited to, as employee, staff, agent, or volunteer) with another independent IRB.

 *An immediate family member is a spouse or life partner of an AAHRPP representative or a child, parent, or sibling of an AAHRPP representative when the AAHRPP representative has information about the family member's interest.

 An AAHRPP representative (except as described below**) may act as an external consultant on human research protection or accreditation matters as circumscribed above and within this paragraph. An AAHRPP representative who acts as an external consultant may not, under any circumstances, pursuant to these activities: hold themselves out as an agent of AAHRPP in regard to these activities, including reference to their AAHRPP affiliation in any marketing or public pronouncements or materials; or, use or share with any organization proprietary AAHRPP materials (including but not limited to, forms, templates, and evaluation tools) to which the AAHRPP representative has access by virtue of their affiliation with AAHRPP.

AAHRPP representatives are not considered to have a conflict of interest with an applicant organization if the only relationship between the AAHRPP representative and the organization is that the AAHRPP representative’s organization is providing IRB review services under a single IRB review arrangement for multi-site studies with the applicant organization.

**The definition of AAHRPP representative does not include AAHRPP staff, Board members, or members of the Council on Accreditation, all of whom are expressly and without exception prohibited from engaging in external consulting on or related to accreditation matters during the entirety of their tenure as AAHRPP staff, Board member, or member of the Council on Accreditation.

Applications, reports, and other documents from site visits resulting in accreditation and all documents following and relating to that accreditation are kept for 10 years from the date of that accreditation.

All records will be retained in accordance with the law.