Human Subjects Research Records Retention Schedule

 

Notice:
The retention information contained on this schedule is the minimum State-required retention for the specified categories. This does NOT authorize disposal action. State approval is expressly required prior to each disposal of records, regardless of format or volume, unless the documents are specifically categorized as non-records. Contact the RIMS office to initiate a records disposal or for the State-approved retention period of any items not listed below.

Upon completion of the retention period for human subjects research records they will either be deleted, destroyed, or transferred to the University Archives. Before the retention period expires, please follow the records storage guidelines. For questions or more clarification about the correct process for these actions, please contact the RIMS office.

The Notes column includes pertinent information about the documents, if known, such as the Office of Record and System of Record. If you have a document that does not appear below or if you have further information about the Office of Record or System of Record, please contact RIMS.

A PDF version of this retention schedule is available. Download

The categories of Human Subjects Research records are:

Institutional Review Board (IRB) Protocol Files

Responsibilities for managing research involving human subjects on each campus are shared between the offices of the Vice Chancellor for Research and the Principal Investigators. The Vice Chancellor for Research is responsible for creating an Institutional Review Board charged with assuring the protection of the rights and welfare of human subjects participating in the research. Principal Investigators are responsible for following requirements spelled out in the Protocol Files. Pursuant to the National Research Act (P.L. 93-348) and 45 C.F.R. 46.103, the University of Illinois maintains an Institutional Review Board. The IRB is required to review all research involving human subjects prior to the conduction of any research. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Descriptions of research using human subjects 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial of the research project, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Consent forms 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial of the research project, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Recruitment material 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial of the research project, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Documentation of the review 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial of the research project, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Determination that approval criteria have been met 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial of the research project, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Institutional Review Board (IRB) Full Board Review Minutes

These records include documentation of discussion during meetings of the IRB Full Board. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Meeting discussion documentation 5 years past the year in which the review took place in office, then transfer to University archives

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Report of Expedited Reviews

The IRB expedited review process involves research that falls into specific federally-defined categories where collection of samples and data are conducted in a manner that is not anonymous and that involves no more than minimal risk to subjects such as analyses of voice recordings, studies of blood samples from healthy volunteers, or studies involving collection of hair, saliva, or dental plaque samples. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Descriptions of protocols reviewed and approved through IRB expedited review process 10 years past the close of the review process in office, then transfer to University archives

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Federal Rosters Log Files

These records include a listing of current and past IRB Review Board Members. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Listing of members 5 fiscal years in office, then transfer to University archives

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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IRB Committee Member Files

These documents contain information about each current member of the IRB Committee. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Member curriculum vitae 3 years past the end of term for each committee member, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Confidentiality forms 3 years past the end of term for each committee member, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

Documentation of training related to performing their duties as an IRB Committee Member 3 years past the end of term for each committee member, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Authorization Agreement Files

These files contain documentation of terms of agreement between two institutions engaged in the same research project using the same IRB protocol, regarding responsibilities for managing the protocol allowing both institutions to conduct research under the same protocol with clearly defined administrative and research responsibilities. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Documentation of terms of agreement 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial, then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Memoranda of Understanding Files

These files contain specific agreements between universities and outside entities including medical clinics such as Mayo Clinic in Rochester, Minnesota; Carle Clinic in Urbana, Illinois; and Johns Hopkins Medical Center in Baltimore, Maryland related to how research projects requiring IRB protocols will be conducted and what responsibilities each entity has throughout the research project. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Agreements 10 years past the date of expiration of each agreement then transfer to University archives

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Data Use Agreements Files

These files contain documents that specify the terms of sharing data created or received in the course of conducting the research associated with IRB protocols. Retain departmental/unit duplicate copies until there is no longer a business need (e.g., 1-3 years).

DocumentsSorted Ascending press space to sort Descending Retention Press space to sort Notes Press space to sort
Agreements 3 years past the date of closure of the protocol (after completion of the research) or past the date of denial then obtain State approval to dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Withdrawn Protocols

These are important University documents, categorized as non-records, which do not need State approval prior to disposal.

DocumentsSorted Ascending press space to sort Descending Recommended Retention Press space to sort Notes Press space to sort
Withdrawn protocols 1 year after submission then securely dispose

UIS office of record: Office of Grants, Contracts, & Research Administration

UIS system of record: U of I Box

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Primary Audience

This Schedule will specifically help staff who support research using human subjects such as staff from the following areas:

  • IRB offices
  • Research assistants

Contributors

Our many thanks to the following contributors who worked with us to create this schedule through discussion, collaboration, input, and consensus:

  • UIC OVCR, Office for the Protection of Research Subjects – Associate Director, Cynthia Tom-Klebba
  • UIC OVCR, Office for the Protection of Research Subjects – Director, James Fischer
  • UIS Grant, Contracts & Research Administration – Assistant Director of Research Administration, Kathleen Furr
  • UIUC OVCR – Executive Associate Vice Chancellor, Melanie Loots
  • UIUC Protection of Research Subjects, Institutional Review Board – Director, Anita Balgopal
  • University Counsel – Senior Associate University Counsel, Laura Clower
  • UIC University Archives – University Archivist, Scott Pitol
  • UIS University Archives – University Archivist, Tom Wood
  • UIUC University Archives – University Archivist, Bill Maher