KUMC Research Record Management, Disposition and Retention Policy
To set forth the requirements for the management, retention and disposition of Research Records.
All University of Kansas Medical Center faculty, staff, postdoctoral fellows, students, trainees, and any other persons at KUMC or KUMC Research Institute involved in the design, conduct, or reporting of research at KUMC, including all research projects on which those individuals work, regardless of funding source for the project.
The retention of original Research Records shall be the responsibility of the Principal Investigator (PI) on behalf of KUMC, but at all times shall remain the property of KUMC, unless otherwise specified by law, regulation or agreement.
This KUMC policy assures that Research Records are appropriately archived and retained, and available for review under the appropriate circumstances. The PI is responsible for the maintenance and retention of Research Records in accordance with this policy and this policy exists so KUMC and the PI can:
- verify compliance with federal, state, and local laws, and supporting regulations;
- ensure the protection of intellectual property;
- ensure open and timely access to research records;
- fulfill contractual obligations and sponsored project agreement requirements;
- support issues of scientific integrity;
- support issues of human subject and animal use;
- assure appropriate use of recombinant DNA, etiologic agents, radioactive materials, etc., and;
- avoid disputes among researchers and protect the rights of all those participating in the research, including postdoctoral fellows, students, and staff.
Ownership and Access
- KUMC’s responsibilities include, but are not limited to: (a) complying with sponsored project agreements; (b) ensuring the appropriate use of animals, recombinant DNA, etiological agents, radioactive materials, and the like and protection of human subjects; (c) protecting the rights of students, postdoctoral scholars, and staff, including, but not limited to, their rights to have access to research record results from research or sponsored projects in which they participated; (d) securing intellectual property; and (e) facilitating the investigation of charges, such as scientific misconduct or conflict of interest.
- Both the PI and KUMC have responsibilities and rights concerning access to, use of, and maintenance of original Research Records. KUMC can be held accountable for the integrity of the Research Records even after the PI(s) has left KUMC. Although the primary Research Records should remain with KUMC, consistent with the precepts of academic freedom and intellectual integrity, the PI may be allowed to retain copies of the Research Records and materials created by him/her.
- Where necessary to assure needed and appropriate access, KUMC has the option to take custody of the Research Records in a manner specified by the Associate Vice Chancellor for Research Administration. When a collaborative research team is dissolved, KUMC will allow each member of the team to have reasonable access to the Research Records and materials with which he/she had been working, unless some other agreement was established at the outset. The unique materials prepared in the course of the research or sponsored project should be available/accessible under negotiated terms of a transfer agreement.
Retention of Research Records:
- The PI is responsible for the collection, management, storage and retention of Research Records.
- PIs should adopt an organized system of Research Records collection and record retention, including the use and retention of laboratory notebooks as appropriate, and ensure compliance with the system by all research team members.
- Research Records will be maintained in the department or division in which they were produced. Electronic Research Records must be stored in authorized KUMC network locations, with access limited to authorized personnel, during the life of the project.
- Research records must be retained on the University campus or campus affiliate (including KUMC- approved long term storage facilities) during the course of the study, unless specific permission to do otherwise has been given by the Vice Chancellor for Research.
- If the research is funded by contract, the terms of the contract shall supersede this policy, if more conservative. Adequate funding must be available to pay for storage prior to agreeing to a contract that specifies how long Research Records are to be maintained.
- If the research involves Protected Health Information (PHI), the PI must retain the permission to use the PHI for 7 years beyond the expiration date of the authorization (i.e. the consent form or authorization).
|Record Type||Retention Period||Primary Policy Source|
|Financial records, supporting documents, statistical records, and all other records pertinent to an award [Grant files]||7 years after Final Financial Report filed||NIH Grants Policy Statement; 45CFR74.53, 2CRF215.53; 2CFR200|
|Research Misconduct: records or documents involved in proceedings related to an allegation of research misconduct.||7 years after the final resolution date of the case||NIH; Office of Research Integrity; 42CFR93.317|
|Studies involving Adults||At least 7 years after completion of the research.||FDA-regulated: 21CFR312.57, 21CFR312.62 and 21 CFR812.140. Federally Funded: 45CFR46.115|
|Studies involving Minors||At least age 21 or 7 years after completion of the research, whichever date is later.||FDA-regulated: 21CFR312.57, 21CFR312.62 and 21 CFR812.140. Federally Funded: 45CFR46.115|
|Investigational Drug Records||7 yrs following the date a marketing application is approved; or, 7 yrs after the investigation is discontinued & FDA notified. Written confirmation should be received from the sponsor and/or FDA granting permission to destroy the records.||21 CFR 312.62|
|Investigational Device Records||7 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 or a notice of completion of a product development protocol.||21 CFR 812.140|
|Research involving Pregnant Women, Human Fetuses and Neonates||25 years after close of study||45 CFR 46 subpart B|
|Regulatory Documents, Case histories, Binder Documents, Source Documents, Original Source Documents, Paper Medical Records, Other Study Materials||7 years following the date of completion of the research study||FDA-regulated: 21CFR312.57, 21CFR312.62 and 21 CFR812.140. Federally Funded: 45CFR46.115|
|Contract provisions may be more stringent and will therefore supersede this policy.|
|KUMCRI Controller's Office|
|Vendor Invoices, Journal Entries, Deposit Slips, Purchase Orders||7 years after the end of the fiscal year||Internal Revenue Service; NIH Grants Policy Statement, 2CFR200 Uniform Guidance|
Sharing of Research Records
- Internal: Research Records created by KUMC PIs may be shared for research or scholarly purposes with other KUMC personnel when such sharing is not limited by written agreement, policy, or regulation. PIs shall make every effort to protect intellectual property rights.
- External: Certain external sponsors (e.g., U.S. Public Health Service) require that research records gathered in the course of research supported with their funds be shared in a timely manner with qualified individuals in the scientific community after the associated research results have been published or provided to the sponsor. When research records sharing is not governed otherwise by another written agreement or an applicable policy or regulation, research records created by KUMC PIs may be shared with a broad scientific or educational audience. Tangible Research Materials shall be shared with persons or entities outside KUMC (or vice-versa) only by specific written agreement. Such specific agreements may include but are not limited to Material Transfer Agreements, grants, and contracts and must be processed through the KUMC Research Institute or KU Innovation and Collaboration, as appropriate.
Transfer of Research Records
- KUMC must retain all original Research Records. Any patient/subject records will require appropriate patient/subject authorization for use and disclosure to another entity.
- If a grant is being transferred to another university or institution along with the PI, then the PI is responsible for leaving all of the original Research Records with KUMC.
- The PI may take copies of Research Records not involving human subjects, upon written approval of the Vice Chancellor for Research.
- Before transferring the grant and a copy of the Research Records, the PI must also ensure that any special conditions stated in the grant, contract, or cooperative agreement are met.
- The PI’s KUMC department is responsible for archiving the Research Records for seven (7) years following the transfer of the PI or the term of the grant or agreement, whichever is longer.
- Prior to allowing the removal of any Tangible Research Product from KUMC, the recipient/university must execute a Material Transfer Agreement with KUMC.
Storage of Research Records
- The Uniform Administrative Requirements, Cost Principals, and Audit Requirements for Federal Awards; Final Rule provides an opportunity to shift from paper to electronic methods of storage. It encourages federal agencies and universities to use electronic formats rather than paper whenever practicable. When original records are electronic and non-alterable, there is no need to create and retain paper copies; for Federal Awards subject to this Final Rule, when original records are paper (e.g. receipts), electronic versions (e.g. pdf scans) may be substituted provided they remain readable, are subject to periodic quality control reviews, are reasonably safeguarded against alteration, 2 CFR § 200.335.
- Information regarding document imaging resources is available through KUMC Information Resources.
- Off-site Paper or hard copy storage must be in a KUMC-approved storage facility. Information regarding approved facilities is available from KUMC Purchasing.
- Storage of research records on jump drives, CDs, in homes, vehicles, etc, is not appropriate.
Access to Research Records
- Where necessary, KUMC has the right to access all Research Records and to take custody thereof, in a manner specified by the Executive Vice Chancellor or his/her designee.
- The Research Records shall be available to representatives of external sponsors of the research or designated governmental officials, when such access is appropriate.
- Any disputes regarding requests for original Research Records, copies, or transfer of Research Records will be resolved by the Executive Vice Chancellor or his/her designee.
Destruction of Research Records
- Research Records cannot be destroyed until the KUMC requirements for Research Records destruction are met. This policy shall not be construed to authorize or condone destruction of any document in contemplation of or in anticipation of, or during, any litigation or investigation. This prohibition of destruction is applicable regardless of whether the document is otherwise eligible for or past the point at which it may be destroyed. Questions regarding this requirement should be directed to the Office of the General Counsel.
- When the applicable retention period has passed for specific Research Records, the department will securely dispose of the documents in a manner consistent with the terms for secure disposal in the sponsored research agreement, if any. The following must be recorded and maintained by the department: PI name; protocol identifiers such as funding source or sponsor (when applicable), protocol number (when applicable), IRB, IACUC or committee identifier; date shredded; person shredding the documents; and a summary of documents shredded.
Faculty, staff and student employees who violate this Policy may be subject to disciplinary action for misconduct and/or performance based on the administrative process appropriate to their employment or other status.
Associate Vice Chancellor for Research Administration
Updates required due to changes in applicable requirements.
IRB: Institutional Review Board (Human Subjects Committee).
Human Subject: As defined by the Code of Federal Regulations Title 45 Part 46.102, means a living individual about whom an investigator (whether professional or student) conducting research obtains 1) Research records through intervention or interaction with the individual, or 2) Identifiable private information.
IACUC: Institutional Animal Care and Use Committee
Material Transfer Agreement: A contract for governing the exchange of tangible research materials between academic, government, and commercial organizations. The types of materials typically transferred under MTAs include cell lines, cultures, plasmids, nucleotides, proteins, bacteria, transgenic animals, pharmaceuticals, chemicals, and other proprietary physical materials.
Research (research): A systematic, intensive study intended to increase knowledge or understanding of the subject studied, a systematic study specifically directed toward applying new knowledge to meet a recognized need, or a systematic application of knowledge to the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.
Research Records: The record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any other information needed for the purpose of a research study, regardless of form or the media on which it may be recorded. Research Records may include technical research records, computer software, laboratory worksheets, memoranda, notes or exact copies thereof that are the result of original observation and activities of a study, and any records that are necessary for the reconstruction and evaluation of reported results of the research and the events and processes leading to those results. Furthermore the term includes software (computer programs, computer databases and documentation thereof), and records of scientific or technical nature. In practice scientific research records include both intangible (statistics, findings, conclusions, etc.) and Tangible Research Records. Items which constitute Research Records under this policy also include, but are not limited to: de-identified data, laboratory notebooks, samples of chemicals and materials synthesized during research, specimens, vouchers, computer files or other electronic research records, video tapes and audio tapes.
Sponsor: Individual, company, KUMC or organization taking responsibility for initiation, management and financing of study.
Tangible Research Records: Tangible research records include but are not limited to notebooks, printouts, computer disks, photographs, slides, negatives, films, scans, images, videotapes, autoradiograms, electrophysiological recordings, gels, blots, spectra, samples, specimens, IRB consent forms, research reports, analytical results, analysis, research records contained in theses and dissertations and all other materials that are relevant to the research or sponsored project.
Tangible Research Product: A wide range of tangible property resulting from the conduct of research, as distinct from copyrightable expressions and patentable inventions. Tangible Research Products include but are not limited to items and products that may confer a public benefit through commercial licensing and may include biological materials, such as cell line and plasmids; chemical compounds; electrical schematic diagrams; mechanical design drawings; and more abstract products such as detailed descriptions or compilations of laboratory procedures, analytical methods, or other such “know-how”.
08/30/2004: Original issue date.