Research records and data must abide by any and all applicable federal, state, and organizational statutes and policies. The Institutional Review Board and the Office of Research have additional procedures you should also be familiar with.
Principal Investigator Leaving UF
Per UF’s Intellectual Property Policy: “In accordance with recognized scientific research procedures, University Personnel are required to record all research data and information accurately and clearly and to keep all such data in a permanent and retrievable form. In addition, with regard to a patentable Invention, original laboratory data must be kept for the life of the patent. University Personnel must also securely store tangible property (such as, biological materials, chemical compounds, and computer discs) related to an Invention or Work to which the University has asserted or may assert its ownership rights. Personnel who leave the University may be permitted to copy their laboratory notebooks and other research data and take the copies with them, and take samples of tangible property with them, although they are required to maintain the confidentiality of the data contained within the notebooks and the tangible property pursuant to this Intellectual Property Policy. The original notebooks and other research data will remain at the University.”
Prior to transferring to another institution, departing PI’s will need to determine where and with whom research records and data will reside at the University of Florida. It is recommended that PI’s work with their department to ensure the necessary records and/or data are retained appropriately. This process may also involve Information Technology staff and any other applicable personnel. PI’s will also be advised to submit a Records Disposition Request to the University Records Manager to document that any and all applicable records will remain at the University of Florida, who is taking custodianship over the records and/or data, and where the records and/or data will physically reside.
Required Reading
Investigator Requirements for Retaining Research Data
Releasing Data to Other Parties
Data/Record Storage and Security
Use and Disclosure of PHI in Research
Retention of Signed Informed Consent Forms
Office of Research Compliance Resources
VA Research Data Requirements
Research Data Management
You may be required to retain research data for an extended period of time or you may be required to make your research publicly available. You can find more information on how to prepare a data management plan, suggestions for data repository storage, and much more on the Research Data Management site.
Disposing of Grant Records and Data
In addition to record retention schedules set by the State of Florida, the Office for Human Research Protections also outlines federal requirements under 45 CFR part 46. In addition to these requirements, some federal agencies also have their own requirements for record retention. Please be aware of any terms set out in the grant agreement that may affect record retention, and always read any related administrative codes completely to ensure you are abiding by all aspects of the law. For more on this, please see the Office of Research’s Federal Agency Grant & Contract website. In order to receive destruction approval, you will need to provide proof that the grant or project has officially been closed out by an applicable agency, office or review board. Grant records should never be destroyed until all granting agency requirements have been met. Retention requirements may vary based on several different factors, and the retention periods listed below may not be appropriate for your grant or project. Grant records and data must be retained per the longest applicable retention period as described below or by contract or law.
| Type of Grant | Retention Schedule | Description of Records | Retention Period | Applicable Laws & Notes |
|---|---|---|---|---|
| Grant Files | GS1-SL, Item #422 | This record series documents the activities and administration of grant funded programs, including the application process and expenditure of grant funds. The series may include, but is not limited to, grant applications; notifications to applicants of award or denial of grant funds; contracts; agreements; grant status, narrative and financial reports submitted by recipient agencies; and supporting documentation. For grantor agencies, grant cycle completion has not occurred until all reporting requirements are satisfied and final payments have been received for that grant cycle. For grant recipients, project completion has not occurred until all reporting requirements are satisfied and final payments have been made or received. See also “PROJECT FILES: FEDERAL” and “PROJECT FILES: NON-CAPITAL IMPROVEMENT.” These records may have archival value. | 5 fiscal years after completion of grant cycle or project | Chapter 1B-24.003 *In order to receive destruction approval, you will need to provide proof that the grant or project has officially been closed out by an applicable agency or review board. **This schedule is superseded by Clinical Study Records (GS4, Item #137) where applicable. |
| Project Files: Federal | GS1-SL, Item #137 | This record series consists of original approved federal project contracts, agreements, awards, line item budgets, budget amendments, cash requests, correspondence, and audit reports. NOTE: Check with applicable federal agency and the Code of Federal Regulations (CFR) for any additional requirements. See also “GRANT FILES,” “PROJECT FILES: CAPITAL IMPROVEMENT,” “PROJECT FILES: NON-CAPITAL IMPROVEMENT,” and “VOUCHERS: FEDERAL PROJECTS PAID.” | 5 fiscal years after completion or termination of project | Chapter 1B-24.003 |
| Clinical Study Records | GS4, Item #137 | This record series consists of records of clinical studies to develop new and better methods to diagnose, treat and prevent disease by recruiting volunteers for trials using new medicines or treatments. Clinical studies answer specific questions regarding vaccines, new therapies or new ways of using current treatments. The series may include, but is not limited to, reports; narrative descriptions; informed consents and authorizations; physical examination records; laboratory results; diagnostic test reports; progress notes; medication records; physician order forms; and participant's confidential medical information including medical history, physical examination and tests results. This includes clinical studies using grant and federal funds. See also General Records Schedule GS1-SL for State and Local Governmental Agencies, item #422 “GRANT FILES” and item #137, “PROJECT FILES: FEDERAL.” | 10 anniversary years after completion of study. | Chapter 1B-24.003 *In order to receive destruction approval, you will need to provide proof that the grant or project has officially been closed out by an applicable agency or review board. **This includes the retention of HIPAA Waivers associated with the grant or study (45 CFR 164.530). |
| FDA – Investigational New Drug | Cite 21 CFR 312.62 (Please note this on your request.) | 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. | 21 CFR 312.62 | |
| FDA – Investigational Device Exemptions | Cite 21 CFR 812.140 (Please note this on your request.) | 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification of submission, or a request for a De Novo classification. | 21 CFR 812.140 | |
| FDA – Nonclinical Laboratory Studies | Cite 21 CFR 58.195 (Please note this on your request.) | 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the FDA; OR 5 years following the date on which the results of the nonclinical laboratory study are submitted to the FDA in support of an application for a research or marketing permit, whichever is shortest. *Do not use this retention for investigational new drug applications or applications for investigational device exemptions.* | 21 CFR 58.195 | |
| Patents through UF (Records & Data) | UF’s Intellectual Property Policy | Records and original laboratory data (including tangible property) must be kept for the life of the patent. | UF's Intellectual Property Policy |