Administrative Records Relating to Research

Retention and Disposition Requirements as of May 2023

Institutional Animal Care and Use Committee (IACUC) Records
Record Retention Period Primary Source Secondary Source

Minutes

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Records of attendance

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Activities of the committee

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Committee deliberations

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Applications

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

 

Proposed activities involving animals (including documentation of IACUC approval / denial, minutes, semi- annual inspections, and research records associated with the protocol.)

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

PHS Policy IV.E.2.

USDA-approved CBRA Guidelines for Record Retention For Protocols Operating Under NIH Grants

CBRA Guidelines for Record Retention Requirements Under the AWA

Proposed activities involving animals (including documentation of IACUC approval / denial)

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Proposed significant changes in activities involving animals (including documentation of IACUC approval / denial)

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Information as specified on any live dog or cat acquired, purchased or otherwise held

Retain records for 3 years after the disposition of the animal.

UC Records Retention Schedule, 0012B4*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Information as specified on any dog or cat sold, euthanized or otherwise disposed of

Retain records for 3 years after the disposition of the animal.

UC Records Retention Schedule, 0012B4*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

Health records associated with an animal needed to convey necessary information to all those involved in the animal’s care, in contemplating utilizing these animals in research, and to share with regulatory agencies responsible for verifying the appropriate provision of veterinary care.

Retain records for 3 years after the protocol has ended.

See ± below

(For NIH-funded research: At least 3 years after completion of the activity. For protocols operating on an NIH grant, all relevant animal records should be maintained as a unit with the associated IACUC protocol and records, and share the same destroy date.)

(Regardless of funding source: For USDA- covered species, throughout an animal’s life and at least one year after the animal’s death or disposition.)

UC Records Retention Schedule, 0012B3*

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

USDA-approved CBRA Guidelines for Record Retention For Protocols Operating Under NIH Grants

CBRA Guidelines for Record Retention Requirements Under the AWA

Semi-Annual IACUC reports and recommendations

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

Animal Welfare Act 9 CFR 2.35(f)

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

 

Any reports and recommendations as forwarded to the institutional official

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

 

Records of accrediting body determinations

Retain records for 3 years after the protocol has ended.

See ± below

UC Records Retention Schedule, 0012B3*

NIH Institutional Animal Care and Use Committee Guidebook — p. 174

 

± For Institutional Animal Care and Use Committee Records, UC will interpret "activity" as protocol which is in accordance with the June 2010 Guidance issued by the California Biomedical Research Association (CBRA). Thus, the retention period is 3 years from the protocol’s end date or termination, whichever later occurs. If the initial protocol approval is followed by a de novo review and approval, this does not change the retention time frame associated with the initial protocol. Specifically, the records from the initial protocol need to be retained for 3 years following the end-date of the initial protocol, as indicated in the approval, regardless of subsequent de novo review and approval.

Conflict of Interest (COI) Records
Record Retention Period Primary Source

For NSF-funded research: Records of all financial disclosures and of all actions taken to resolve conflicts of interest

Retain records for 3 years after the end of the calendar year in which the expiration/termination of the sponsored agreement occurs.

UC Records Retention Schedule, 0012B1*

NSF Proposal & Award Policies & Procedures Guide, Chapter IX, A. 7.++

For FDA-funded research: of Clinical Investigators' financial records - records of all financial disclosures and all actions taken

Retain records for 3 years after the end of the calendar year in which the expiration/termination of the sponsored agreement occurs.

UC Records Retention Schedule, 0012B1*

21 CFR §54.6(b)

For PHS-funded research (includes all NIH awards): Records of all financial disclosures and all actions taken

Retain records for 3 years after the end of the calendar year in which the expiration/termination of the sponsored agreement occurs.

UC Records Retention Schedule, 0012B1*

42 CFR 50.604(i) ++

For research funded by non- governmental sponsors (as covered by the California Political Reform Act §18755): original reports or statements (including 700-U forms)

Retain records for 7 years after the end of the calendar year created. (Record may be retained on microfilm or other space-saving material after a period of 2 years — Government Code 81009(g))

UC Records Retention Schedule, 0012B2*

California Political Reform Act California Government Code 81009(e)

For research funded by non- governmental organizations (as covered by the California Political Reform Act §18755): copies of reports or statements (including 700-U forms)

Retain records until superseded or 5 years after the end of the fiscal year in which the certification was made, unless a longer period is specified in the legal requirements.

Legal requirement is:

Not less than 4 years

Provided that retention of more than one copy is not required (Record may be retained on microfilm or other space-saving material after a period of 2 years — Government Code 81009(g))

UC Records Retention Schedule, 0006C*

California Political Reform Act

California Government Code 81009(f)

++Requirements related to funding from other agencies may vary. In all instances, individual award agreements should be consulted to determine applicability of specific requirements.

Records relating to agreements, awards and contracts
Record Retention Period Primary Source

Financial records pertinent to an award (Federal, State and Private)

Retain records for 6 years after the expiration/termination of the sponsored activities; resolution of any litigation, claim, or audit; or the period stated in the award document - whichever is longer.

UC Records Retention Schedule, 0005A1*

Fiscal Reports, Federal Research

Retain records for 6 years after the expiration/termination of the sponsored activities; resolution of any litigation, claim, or audit; or the period stated in the award document - whichever is longer.

UC Records Retention Schedule, 0005A1*

Statistical records and supporting documents pertinent to an award (Federal, State and Private) for FDA Regulated Sponsored Projects for Investigational New Drugs Applications

Retain records for 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. If no notification of any of these activities occurs, then retain records for 6 years after the expiration/termination of the sponsored agreement; unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A2*

Statistical records and supporting documents pertinent to an award (Federal, State and Private) for FDA Regulated Sponsored Projects for Investigational Devices

Retain records for 2 years after 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 or a notice of completion of a product development protocol - whichever is longer. If no notification of any of these activities occurs, then retain records for 6 years after the expiration/termination of the sponsored agreement, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A3*

Statistical records and supporting documents pertinent to an award (Federal, State and Private) for any projects that include working with radioactive contaminating materials with the Department of Energy and any prior Atomic Energy related entities

Permanent, coordinate the transfer of these records to the University Archives 10 years after termination of the contract or when no longer needed for current operational business.

UC Records Retention Schedule, 0012A4*

Statistical records and supporting documents pertinent to any other awards not listed above (Federal, State and Private) for all other Sponsored Projects

Retain records for 6 years after the expiration/termination of the sponsored agreement, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A5*

Proposals for sponsored contracts, grants, or cooperative agreements that are not accepted/funded/executed

These are considered non-records, and should be retained only until their usefulness has passed.

UC Records Retention Schedule, 0012A1*

FDA Regulated Sponsored Projects Agreements Records for Investigational New Drugs Applications

Retain records for 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. If no notification of any of these activities occurs, then retain records for 6 years after the expiration/termination of the sponsored agreement; unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A2*

21 CFR § 312.62

FDA Regulated Sponsored Projects Agreements Records for Investigational Devices

Retain records for 2 years after 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 or a notice of completion of a product development protocol - whichever is longer. If no notification of any of these activities occurs, then retain records for 6 years after the expiration/termination of the sponsored agreement, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A3*

21 CFR § 812.140

Executed Sponsored Projects Agreements Records for any projects that include working with radioactive contaminating materials with the Department of Energy and any prior Atomic Energy related entities

Permanent, coordinate the transfer of these records to the University Archives 10 years after termination of the contract or when no longer needed for current operational business.

UC Records Retention Schedule, 0012A4*

All Other Executed Contracts, Grants, and Cooperative Agreements Projects Records (funded proposals)

Retain records for 6 years after the expiration/termination of the sponsored agreement, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012A5*

2 CFR §200.334

Proposals for Extramural Support (Rejected or Withdrawn)

These are considered non-records, and should be retained only until their usefulness has passed.

UC Records Retention Schedule, 0012A1*

Contracts and Grants Manual 17-300: “Federal and State of California funding agencies usually require records retention for three years (occasionally four years) measured from "final payment" for contracts and measured from "submission of final expenditures report" for grants. However, it is administratively unreasonably burdensome for Accounting Offices to notify the appropriate Office of Record when final payment or submission of the final expenditures report occurs for every extramural award. Therefore, the retention period for extramural award records is to be measured from expiration/termination of the extramural award (a much easier point in time to assess) forward six years. It is presumed that six years from expiration/termination will more than accommodate the three or four years from final payment or submission of the final expenditures report retention period imposed by extramural sponsors.” [For Federal Guidelines: See 2 CFR 200.500 Audit Requirements/ For State Guidelines: See individual contract terms]

Institutional Review Board (IRB) Records
Record Retention Period Primary Source Secondary Source

Reviewed research proposals

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Scientific evaluations

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Approved sample consent documents

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Progress reports

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Reports of unanticipated problems involving risks to subjects or others

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Minutes of IRB meetings (as specified in 45 CFR 46.115(a)(2) and 21 CFR 56.115(2))

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242 

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Records of continuing review activities

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Copies of all correspondence between IRB and investigators

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

List of IRB members (as specified in 45 CFR 46.115 and 21 CFR 56.115)

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Written IRB procedures

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

Statements of significant new findings provided to subjects

Retain records for 10 years after the end of the calendar year in which the research is completed, unless otherwise specified in the award agreement.

UC Records Retention Schedule, 0012B5*

UC Contract and Grant Manual 18-242

45 CFR 46.115 Protection of Human Subjects**

21 CFR 56.115 IRB Records

IRB records relating to VA research, including the investigator’s research records

Retain records for 6 years after the end of the fiscal year in which the research project was completed.

UC Records Retention Schedule, 0012B6*

Template Memorandum of Understanding between Veterans Health Administration (VHA) Central Office and {Name of Local Veterans Affairs (VA) Facility} and {Name of Local VA Nonprofit Corporation}

Guidance on VA Research Records and the Impact of the Federal Records Act, Office of Research and Development, Veterans Health Administration’s, dated March 8, 2013

These records are considered Federal Records and are found in the Department of Veterans Affairs, Veterans Health Administration’s Records Control Schedule (RCS 10-1) (PDF) - Retain records for 6 years after the end of the fiscal year in which the research project was completed.

** Per UC Policy on the Protection of Human Subjects in Research, “regulations of the Department of Health and Human Services (HHS), set forth in 45 CFR Part 46, are applicable to all research involving human subjects, as defined by these regulations, for which the University is responsible, regardless of the source of funding, or whether the research is funded.” Note: 45 CFR 46 and 21 CFR 56 specify minimum legally-required retention periods; the University has adopted a longer (10-year) retention requirement for all IRB administrative records.   

8/7/2018 Revision History Note: The 10-year retention period for all IRB administrative records reflects the retention period adopted in the current (revised) UC Records Retention Schedule, and replaces guidance contained in previous versions of this RPAC records retention matrix, which had specified that all categories of IRB administrative records were to be kept for 3 years, except for records relating to: 1) children as research subjects (which were to be kept for 7 years after the child reaches the age of maturity), and 2) research pertaining to in vitro studies or pregnant women (which were to be kept for 25 years). Since legal requirements do not mandate longer retention periods for the two categories, this retention matrix was updated to state that the retention period for ALL categories of IRB administrative records should be 10 years. The separate retention periods for research pertaining to children and in vitro/pregnant women were not based on any statutory or regulatory requirement. The University has now replaced those separate retention periods with the current uniform 10-year retention period (which, it should be noted, exceeds the minimum 3-year retention period specified in 45 CFR 46.115 and 21 CFR 56.115).

Investigator Records

Signed consent forms are not considered an IRB administrative record for the purposes of the UC Records Retention Schedule, so the retention period specified in the schedule that requires IRBs to retain sample consent documents does not apply to signed consent forms. However, investigators have a responsibility to retain signed consent forms. Required retention periods may vary depending on the research sponsor; researchers are advised to check with their sponsoring agency to verify the length of time required for record retention.

Retention of Signed Consent Forms by Investigators
Record Retention Period Primary Source

Signed informed consent documents for federally funded research

 Retain for a period of three years from the date of submission of the final expenditure report. 2 CFR 200.334

Signed informed consent documents for FDA-regulated research involving an Investigational New Drug (IND)

 Two 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 two years after the investigation is discontinued and the FDA notified. 21 CFR 312.62

Signed informed consent documents for FDA-regulated research involving an Investigational Device Exemption (IDE)

 Two years after the investigation is completed or terminated or the records are no longer required to support a Pre-Market Approval application or notice of completion of a Product Development Protocol, whichever date is later. 21 CFR 812.140

Signed HIPAA authorizations for HIPAA regulated research for research requiring access to protected health information (PHI)

Signed HIPAA authorizations must be retained for a minimum of 6 years after the completion of the study.

An accounting of all disclosures of Protected Health Information (PHI) (not listed in the consent/authorization) must be retained for 6 years after the disclosure.

 45 CFR 164.530(j)(2)

Signed informed consent documents for Veterans Affairs (VA) research

 Retain records for 6 years after the end of the fiscal year in which the research project was completed. These records are considered Federal Records and are found in the Department of Veterans Affairs, Veterans Health Administration’s Records Control Schedule (RCS 10-1).

Signed consent forms where the research is not subject to the above categories

 Best practice standards are to maintain research records for at least 3 years after completion.
Health Insurance Portability and Accountability Act (HIPAA) Records
Record Retention Period Primary Source

HIPAA-related documents, as specified (policies and procedures, communications etc.)

6 years

(from the date of creation or the date when it last was in effect, whichever is later)

45 CFR 164.530(j)(2)
Research Misconduct Records
Record Retention Period Primary Source

Research misconduct proceedings records, as specified

Retain records for 7 years after the end of the fiscal year in which the specific final report is issued or all specific activity has ended, whichever is longer.

UC Records Retention Schedule, 0006B*

42 CFR 93.317(b)
Food and Drug Administration (FDA) Records
Record Retention Period Primary Source

Investigational New Drug Applications Records of drug disposition (to be retained by investigator)

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(c)

Case histories (to be retained by investigator)

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(c)

Records of receipt, shipment or disposition of an investigational new drug (to be retained by sponsor)

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 312.57(c)

Records showing any financial interest (to be retained by sponsor)

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 312.57(c)