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Resources: For Accreditation - FAQs

Documents to Pull

Latest Update: August 8, 2022
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Documents to Pull FAQs

Documents to Pull FAQs

When will my organization receive the list of documents to pull?

Generally, you will receive the list of documents to pull six to eight weeks before the site visit. For sites outside the US, the request for documents to pull will be sent at least six weeks in advance to allow for translation. 

How many years should we go back when pulling documents?

For initial accreditation applications, only pull studies from the last two years counting back from the date of your scheduled site visit.   

For organizations applying for reaccreditation, pull documents from any time in the last accreditation cycle, and provide the most recent study since your last accreditation review that meets the required criteria. For organizations applying for your first reaccreditation, do not go back earlier than your initial accreditation review. For organizations applying for subsequent reaccreditation, do not go back prior to the last reaccreditation review.  

For example: 

  • If you are applying for reaccreditation, and your last study involving prisoners was three years ago, please provide that study.  

  • If you are applying for reaccreditation and the last unanticipated problem or possible noncompliance was reviewed more than two years ago, provide those.


Can one study satisfy multiple criteria?  The table in the Documents to Pull asks for different types of studies (e.g., an industry-sponsored study with an IND, a study involving children).

Yes. For example, you could list the same study under different criteria per IRB/EC (or IRB/EC panel):  

  • A drug study that involves children and pregnant women could be listed under the drugs category, the children category, and the pregnant women category. 

  • A study that underwent expedited review and the IRB granted a waiver of informed consent could be listed under the expedited review category and the waiver of consent category. 


Do we need to provide one study for each of the criteria per IRB/EC (or IRB/EC panel) or is it one study per criterion in total? What if we have multiple IRB(s)/EC(s) or IRB/EC panels?

In general, if you have three or fewer IRBs/ECs (or IRB/EC panels), provide applicable documents for each IRB/EC or IRB/EC panel. For example: 

  • If you have two biomedical IRBs/ECs (or panels), provide documents for each IRB/EC (or panel). 

  • If you have two social/behavioral science IRBs/ECs (or panels), provide documents for each IRB/EC (or panel). 

  • If you have one biomedical IRB/EC (or panel) and one social science IRB/EC (or panel), provide documents for each IRB/EC (or panel).   

  • If you have two biomedical IRBs/ECs (or panels), and one social science IRB/EC (or panel), provide documents for each IRB/EC (or panel). 

In general, if you have more than three IRBs/ECs (or IRB/EC panels), then provide the most recent study or document per IRB/EC (or panel) type. For example: 

  • If you have three IRBs/ECs (or panels) that all review the same types of research, provide one from each. Provide the most recent study, regardless of which IRB/EC (or panel) conducted the review. 

  • If you have different types of IRBs, such as specialized IRBs/ECs (or panels) that review biomedical research and review social/behavioral science research, then provide at least one across IRBs/ECs (or panels) reviewing the same type of research, such as: 

  • If you have three biomedical IRBs/ECs (or panels), and one social/behavioral science IRB/EC (or panel), provide one study per biomedical IRB/EC (or panel) and one from the social/behavioral science IRB/EC (or panel). 

  • If you have two biomedical IRBs/ECs (or panels), and two social science IRB/ECs (or panels), provide one per each biomedical IRB/EC (or panel) and one per each social/behavioral science IRB/EC (or panel).  

  • If you have more than three biomedical IRBs, provide the most recent three examples for biomedical IRBs/ECs (or panels), regardless of which one conducted the review. If you have more than three social/behavioral science IRBs/ECs (or panels), provide the most recent example for social/behavioral science IRBs/ECs (or panels), regardless of which one conducted the review. 

  • If you have IRBs/ECs (or panels) at different campuses with the same leadership and staff, then provide at least one for each IRB/EC (or panel) of the same type (e.g., biomedical IRB/EC or social/behavioral IRB/EC). If you have different campuses, and the IRBs/ECs (or panels) are managed separately, then in general provide documents for each campus.  


Our organization’s IRBs/ECs do not review certain types of research, but AAHRPP asks for documents about research they do not review. What should we do?

If an IRB/EC at your organization does not have a study of a particular type, indicate “not applicable”. For example, if you do not review research involving prisoners, indicate “not applicable”.

Our IRB/EC records are in an electronic system.  Do we have to provide site visitors access to that system to conduct document review?

No. If your organization does not want to or cannot provide site visitors with direct access to the electronic system that contains IRB/EC records, you can provide records in another way (e.g., an online document storage system or platform, such as Dropbox, Box, or Google Drive).

How do I provide documents if some or all are not in the electronic system?

For remote site visits, you will need to make electronic copies of the documents and make them accessible through a cloud-based platform, such as Dropbox, Box, or Google Drive.  

If the site visit is in person, paper copies of the documents can be provided to the reviewers while on site or a combination of paper and electronic records may be provided. 


Can we provide access to records in our electronic IRB/EC system instead of providing records in other formats?

Yes. If your organization needs information from site visitors to create user accounts, please contact sitevisits@aahrpp.org to make arrangements. Please note you should have a backup plan in case there are problems with site visitors accessing the electronic system. Additionally, you will need to provide a tutorial for site visitors regarding how to navigate your electronic system for records review, either during the pre-site visit for remote site visits that are outside the US or at the beginning of the site visit for remote or in-person site visits within the US. For remote site visits, the pre-site visit meeting also includes testing access to records.

What is a “complete protocol”?

See the Evaluation Instrument, Element II.5.A. for a list of the documents included in a complete protocol.

Do you have recommendations about how to organize the studies requested in the documents to pull?

You will receive instructions about best practices to organize records with the request for documents to pull.

My organization is outside the US, what documents do we need to translate?

You will receive instructions about what records must be translated with the request for documents to pull.