Research Data and Responsible Publishing | Research Data Management and Sharing: Stewardship, Retention, and Repositories
In January, an introduction to research data and ownership was discussed. This month, the Spotlight explores research data management – stewardship, retention, data transfer, and storage. When something is determined to be research data, what happens with the management and sharing of that data? Also, what is the National Institutes of Health (NIH) asking research institutions to do with research data and sharing?
Data stewardship usually falls to the Principal Investigator (PI), but the ultimate responsibility, rights, and principles for handling the data belong to the university or organization. Unpublished data and databases generated by research should have restricted access and follow a chain of command for use.. The PI should be contacted directly for access. For published data, stewardship also includes data use agreements. These agreements should be in place before providing any research data to a third party. In return, researchers must obtain a data use agreement with an organization when requesting to use data for their own research.
Data retention should be considered when completing research. The length of time to retain data typically varies by organization. In our case, it is a requirement that data created from research should be retained for a minimum of ten years. The state of Louisiana Revised Statute 44:402 states that “any material regardless of physical form or characteristic, generated or received under law or in connection with the transaction of official business, or preserved by an agency or political subdivision because of other informational or legal value” should be retained.
Records should be retained where produced. The PI should keep copies of consents and authorizations and make them accessible for review by the Institutional Review Board (IRB) when requested. Data must always be retained for an adequate period of time to respond to inquiries about accuracy, authenticity, primacy, and compliance. An adequate amount of time could be extended for several reasons. Time needed to protect intellectual property is a critical one. Also, if charges arise from the data, the information must be retained until issues are resolved. Student research data must be kept until a degree is awarded or it is clear that the work has been abandoned. Even after the minimum retention period has passed, destruction of the data is left to the discretion of the organization and PI.
What happens in the case where the PI or other faculty member is leaving the institution and wants to take their work to the new employer? Two things must occur: 1) The person must have evidence of participating in the design, conduct, or reporting of the associated project with the university, and 2) appropriate permission is received. All original data should be retained by the original organization; the person requesting the transfer is only allowed to take copies of the data. The transfer should be approved by the Vice Chancellor for Research or other appropriate person at the institution. The organization receiving the transfer must provide a written agreement to accept the custodial responsibilities for the data and provide access to the transferring organization when necessary.
There has been much discussion about data sharing resulting from the January 2023 NIH Policy for Data Management and Sharing (NOT-OD-21-013). Under the policy, organizations should: 1) plan and budget for the managing and sharing of data; 2) submit a data management and sharing plan for review when applying for funding; and 3) upon funding comply with the approved plan. Organizations can budget within proposals to comply with this policy. Allowable costs include curating data, de-identifying data, and preserving and sharing data through established repositories, among others. The NIH has provided resources on suggestions for writing a data management and sharing plan.
The NIH also has an established list of repositories currently supported by individual institutes, centers, or offices. A Registry of Research Data Repositories is available if the NIH list does not meet an organization’s needs. Data should be shared and made accessible as soon as possible, and no later than the time of an associated publication or end of a performance period (NIH, 2022). Sharing data for human participants has additional regulations that are discussed here. It is important to address data management with all potential human subject study participants during the informed consent process to ensure potential participants understand how their data will be shared (NIH, 2022).
Publication of research data also has implications for PIs and organizations. Next month, the Catalyst will highlight the Center for Publication Ethics (COPE) background and standards, as well as the NIH guidelines for credible journals. Compliance implications for publishing and publication open access requirements will be considered as well.
As we continue to discuss Research Data in our Spotlight series this month, take a moment to answer our Spotlight Poll regarding repositories.
https://www.surveymonkey.com/r/H9KNLZX
Authored by Carly Pigg, CRA, Coordinator of Grants and Development
Louisiana State University Health Sciences Center
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