University of Illinois System
Last item for navigation

Human Subjects Research Records Retention Schedule


The information contained on this schedule is the minimum State-required retention period for each specific category. 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.


No record should be held for more than one (1) year beyond its listed mandatory minimum retention period. If further retention is needed and there is a documented business need, please contact RIMS for a variance. However, if your records are subject to a legal hold or pending legal action, you will need to follow the retention recommended by legal counsel. RIMS should be notified of any decisions to keep records past their minimum retention.

Upon completion of the retention period for human subjects research records they will either be deleteddestroyed, 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 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 for 3 years past the date of the completion of the research, or past the date of denial for the research project, then obtain state approval to dispose:

  • Consent forms
  • Descriptions of research using human subjects
  • Determination that approval criteria have been met
  • Documentation of the review
  • Recruitment material.

Institutional Review Board (IRB) Full Board Review Minutes

Institutional Review Board (IRB) Full Board Review Minutes include documentation of discussion during meetings of the IRB Full Board.

Retain for 5 years past the year the review took place, then transfer to the University Archives:

  • All meeting minutes discussion documentation and records.

Report of Expedited Reviews

Report of Expedited Reviews 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.

Examples of Report of Expedited Reviews include, but are not limited to: analyses of voice recordings, studies of blood samples from healthy volunteers, or studies involving collection of hair, saliva, or dental plaque samples.

Retain for 10 years past the close of the review process, then transfer to the University Archives:

  • All expedited review reports.

Federal Rosters Log Files

Federal Rosters Log Files include a listing of current and past IRB Review Board Members.

Retain for 5 fiscal years in office, then transfer to the University Archives:

  • All Member Listings for IRB Review Board Members.

IRB Committee Member Files

IRB Committee Member Files contain information about each current member of the IRB Committee.

Retain for 3 years past the end of term for each committee member, then obtain state approval to dispose:

  • Confidentiality forms
  • Documentation of training related to performance of duties as an IRB Committee Member
  • Curriculum Vitae for Members.

Authorization Agreement Files

Authorization Agreement 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 for 3 years past the completion of the research or the date of denial, then obtain state approval to dispose:

  • Documentation for the terms of agreement between institutions.

Memoranda of Understanding Files

Memoranda of Understanding 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 for 10 years past the date of expiration of each agreement, then transfer to the University Archives:

  • Agreements between universities and outside entities.

Data Use Agreements Files

Data Use Agreements 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 for 3 years past the completion of the research or the date of denial, then obtain state approval to dispose:

  • Agreements on data sharing.

Withdrawn Protocols

Withdrawn Protocols important University documents, categorized as non-records, which do not need State approval prior to disposal:

Retain for 1 year past submission before being securely disposed of.

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