Data Management

Access to and Retention of Scientific Research Protocols and Data

Both the scholar and the University have responsibilities and rights concerning access to, use of, and maintenance of original research data. Consistent with the precepts of academic freedom and intellectual integrity, the scholar has the primary authority to make judgments involving the use and dissemination of the data. Any disputes regarding access to data should be settled at the lowest possible level, if circumstances permit. Otherwise, each dispute should go before the appropriate University reconciliation committee.

Each scholar is ultimately responsible for the maintenance and proper retention of research records. These records should include sufficient detail to permit examination for the purposes of replicating the research, responding to questions that may result from unintentional error or misinterpretation, establishing their authenticity, and confirming the validity of the conclusions.

Each scholar should maintain a laboratory manual that describes all major procedures. Correspondence with institutional review committees and records of the use of controlled substances and radioactive materials should be maintained as part of the research record in accordance with governmental, regulatory, and University policies.

A system of data organization should be adopted and communicated to all members of a research group and to the appropriate administrative person. The appropriate administrative person should be determined by the college or department.

Where feasible, all original primary data are to be retained by the scholar or by their designee. Accepted practices for retaining data vary among disciplines and depend on the perishability, nature, and logistics of retaining each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility, and validity and to meet the requirements of relevant grants and other agreements concerning the retention of data. Primary data should be reserved for ten (10) years, if there is no requirement in the Award Document, to ensure that any questions raised in published results can be answered. In unusual cases (e.g., data used for a patent application), it may be necessary for original data to be kept at the University. Potentially patentable data should be signed and dated by the researcher when it is entered into notebooks or maintained by other methods of retention.

In the event the scholar leaves the University, an Agreement on Disposition of Research Data may be negotiated by the scholar and the department chair or dean to allow the scholar's data, notebooks, and other data retention materials (other than clinical research records) to be transferred to the new institution. Consistent with the same precepts, and to fulfill its obligations to funding sources and others, the University will ensure in such agreements access to the transferred data for purposes of review. In unusual cases (e.g., data used for a patent application filed by the University) it may be necessary for original data to be kept at the University. In such cases, a separate written agreement shall be signed which preserves the scholar's right to access and copy (where practical) such data. In cases of multi-institutional studies, the institution of the primary study director is ultimately responsible for guaranteeing appropriate access to, use of, and retention of original data.

General Regulation

OMB Uniform Guidance Section 200.333, Retention Requirements for Records, states that "Financial records, supporting documents, statistical records, and all other non-Federal entity records pertinent to a Federal award must be retained for a period of three (3) years from the date of the submission of the final expenditure report, or for Federal awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report, respectively, as reported to the Federal awarding agency or pass-through entity in the case of a subrecipient.

Specific Agencies (for example)

Health and Human Services: 45 CFR**74(D) dictates records must be retained for at least three (3) years from the date of the submission of the final expenditure report.

US Department of Education: 34 CFR**74(A) records must be retained for at least three (3) years from the date of the submission of the final expenditure report.

Records and Reports: Clinical Trial Agreements

The Food and Drug Administration: 21 CFR312.62 requires records be retained at least two (2) years following the date a marketing application is approved for the indication for which the drug is being investigated; or, until two (2) years after the investigation is discontinued and FDA is notified.

The Food and Drug Administration: 21 CFR**56.115 also requires that IRB records shall be retained for at least (3) years after completion of research.

Data Ownership

The policy of the funding agency, as stated in the Award Document, governs ownership of data. It is the responsibility of the principal investigator to read the conditions of the grant or contract. In cases where the funding agency has no stated policy concerning data ownership or in the case of nonsponsored research conducted at a University of Arizona laboratory, The University of Arizona retains ownership of the data.

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