As Approved by the Academic Council May 5, 1994
Revised by Research Policy Committee January 2007
The preparation, sharing and retention of appropriate records are essential components of any research endeavor at the University. The University, its faculty and its trainees have a common interest and a shared responsibility to assure that research is appropriately recorded, shared and retained. Original records may be required to protect the University’s intellectual property rights, to answer ongoing questions regarding management of a research program, to address possible questions that may arise regarding the propriety of research conduct and to comply with the data sharing requirements of many sponsors. Most importantly, it is essential that original research records be mutually available to all the collaborators on a research project.
Definition of Research Records
Research records include, by way of example but not limitation, material contained in research notes, laboratory notebooks and in other media such as computer disks and instrument printouts. Significant research materials or products generated by any research are also part of the record and should be retained and available.
Sharing of Research Records
Research records must always be available to collaborators (co -investigators, supervisors and their trainees). In collaborative projects, all investigators should know the status of all contributing research records and have access to them consistent with confidentiality restrictions. Investigators also should be aware if their research records are subject to specific data sharing requirements of a sponsor.
Retention of Research Records
Faculty, or the responsible investigators, have the obligation to ensure that, for all aspects of their research program, sufficient records are kept to document the experimental methods and accuracy of data collection as well as the methods and accuracy of data interpretation. This policy does not create an obligation to retain the research records of an unfunded project unless it results in publication or involves the use of animals or human subjects. Research records should be archived for a minimum of five years after final reporting or publication of a project (or longer if required by an external sponsor, law, rule or regulation). The archived records should be the originals. In addition, the records should be kept for as long as may be required to protect any patents resulting from the work. If any questions regarding the research are raised during the required retention period, the records should be kept until such questions are fully resolved. In the event an investigator leaves the University for any reason, the original research records must be retained at the University and the investigator’s department and collaborators notified as to their location.
Ownership of Research Records
The primary owner of research records is the University. The University has the right of access to the supporting records for all research carried out through the University with the understanding that information or data that would violate the confidentiality of sources or subjects involved in the research should not be disclosed. In addition, extramural sponsors providing support for research at Duke University may have the right to review any data and records resulting from that extramural support.