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Resources: For Accreditation - Procedures

AAHRPP ACCREDITATION PROCEDURES

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Latest Update: July 9, 2019

Accreditable Organizations

AAHRPP will accredit any eligible Organization that seeks accreditation. Most organizations that conduct human research are also involved in other activities that are not directly related to their research activities: universities are involved in teaching and service, hospitals are involved in patient care and community outreach, and companies are involved in marketing and distribution activities. AAHRPP accredits only an Organization’s Human Research Protection Program.

The Organization seeking accreditation must be functionally distinct and have a single chief executive officer (who may be referred to by a different title). Its Human Research Protection Program may be comprised of either units within the Organization, external arrangements that make up the program, or both. For example, some Organizations arrange for functionally separate units to fulfill critical roles in their research protection programs, such as a contractual arrangement for ethics review (institutional review board (IRB) or ethics committee review) by another independent organization. Organizations may also share resources to form a single comprehensive Human Research Protection Program. AAHRPP's policy is to accredit whole programs and not individual components of Human Research Protection Programs (e.g., IRBs or ECs, or investigators). AAHRPP's policy is not to accredit subunits within a functionally separate unit.

As examples, this definition of an accreditable Organization is interpreted as follows:

Academic institutions: A single, free-standing university, college, medical school, or other professional school under a single chief executive officer and typically in a single geographical location is an accreditable Organization. The academic institution applies for accreditation as a whole unit regardless of the number of IRBs 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 Human Research Protection Program, e.g., a separate federal wide assurance. However, AAHRPP's policy is to accredit academic institutions at the "campus" level. AAHRPP's policy is not to accredit IRBs or ECs of the academic institution.

In large university systems, individual universities that are functionally distinct with a chief executive officer (e.g., Chancellor) may apply for accreditation as individual universities. Each university applies for accreditation as a whole unit regardless of the number of IRBs 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 Human Research Protection Program. On the other hand, if the university system as a whole wishes to apply for accreditation, AAHRPP considers such requests on a case-by-case basis.

Clinical research organizationsA 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 or separate departments within the company. In large contract research organizations, individual units that are functionally separate and have an executive officer may apply individually.

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 or separate departments within the company. 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 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 Human Research Protection Program.

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 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: An independent review board under a single chief executive officer is an accreditable Organization. The independent review board applies for accreditation as a whole unit. Independent review boards that apply for accreditation must be able to meet the 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 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 sitesA 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 the facilities that it has engaged to conduct research. Research sites that apply for accreditation must be able to meet the Standards in all three domains, as applicable.

Other types of Organizations that have a Human Research Protection Program might be eligible to apply for accreditation. Such Organizations should contact the AAHRPP office to discuss eligibility.


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