East Carolina University Faculty Manual
VII. Policy on the Custody, Retention, Transfer and Access to Research Data and Records
The preparation and retention, of accurate and appropriate records are essential components of a credible research endeavor. East Carolina University, its faculty, its staff, and its students have a common interest and a shared responsibility to assure that research data and records are recorded appropriately, archived for a reasonable length of time, and available for review by scholars and others under appropriate circumstances. Original research records are also essential to protect intellectual property rights, to answer ongoing questions regarding the management of a research program, and to address questions that may arise regarding the propriety of research conduct and methods. This policy defines the nature of research data and its associated records. It also describes the importance of good data and record keeping for obtaining and defending intellectual property rights, and the procedures to be used for the custody, retention, access, and transfer of research data and records.
This policy shall apply to all faculty, staff, and students of East Carolina University who are involved in the design, conduct, and/or reporting of research at or under the auspices of East Carolina University, regardless of source of funding.
DEFINITION OF RESEARCH DATA AND RECORDS
Research data and records refers to recorded information, regardless of its form or the media on which it may be recorded, which is necessary for the reconstruction and evaluation of the reported results of a research project. Research data and records include more than just primary data (e.g., raw numbers generated by a measuring instrument; audiotapes or transcripts of survey interviews). They also include documentation or citation of a) the experimental methods for data collection, and b) the methods used for data processing and interpretation. In practice, they include, but are not limited to, the material contained in laboratory notebooks or other media such as computer disks and machine printouts. The term does not include the intellectual property generated by a research project; administrative information, such as financial data; or the tangible products of research, e.g., tissue banks, specialized tools or chemicals produced by the project. (Ownership and disposition of intellectual property or the tangible products of research are covered by other ECU policies.)
INTELLECTUAL PROPERTY ISSUES INVOLVING RESEARCH DATA AND RECORDS
Retention of maximum intellectual property rights places additional importance on the preparation and retention of research data and records. Documented research records are important in determining priority of research data, such as identifying who first conceived an invention or in defending against patent infringement. In order to protect the rights of investigators and the University to the intellectual property generated by their research programs, university technology transfer managers recommend specific record keeping and retention practices such as the use of bound laboratory notebooks. Maintaining good data records is recommended for all university laboratories, but is essential for any patentable or licensable research activity. Responsible faculty should be aware of and follow, as closely as possible, the record-keeping recommendations described in Addendum B. Section II of the OPERATIONAL PROCEDURES FOR IMPLEMENTATION OF FACULTY MANUAL PART VII, SECTION II http://www.research2.ecu.edu/ott/operating.html.
The data management approaches above will also help defend an investigator and his/her work if there is an allegation of misconduct regarding this research
CUSTODY OF RESEARCH DATA AND RECORDS
By tradition, and for practical reasons, custody of original research data and records shall be with the senior investigator of a project, usually a faculty member. This senior investigator (the responsible investigator) shall insure the integrity, preservation and security of the original research data and records. Expenses of data and record preservation and security are allowable costs to sponsored programs. As an aid to scholars and other appropriate individuals who may wish to review the research data and records, they should be appropriately organized and labeled to allow the identification of specific information within the records by someone who was not involved with the original project.
In situations where the Vice Chancellor for Research, Economic Development and Community Engagement (the designated ECU Integrity Officer) has received an allegation of research misconduct pursuant to the ECU policy (Faculty Manual Part VII Section VI) or when patent litigation is imminent, the University may take immediate and preemptory custody of the original research data and records relating to the allegation or the patent. In this circumstance the University shall provide needed copies of data and records to the investigator that will allow active research projects to continue.
In multi-institutional studies, contractual agreements often stipulate that the home institution of the primary study director shall have custody of original primary data from all participating institutions. In situations where ECU is not the site of the home institution and will need to transfer the original data to the institution of the study director, ECU shall retain a true copy of all data and records generated for the multi-institutional study.
Senior members of research teams have obligations to discuss the responsibilities of data management and retention with other members of the research team and to directly oversee the data and record management of the technicians, post-doctoral fellow, students, and others working under their direct supervision.
ACCESS TO RESEARCH DATA AND RECORDS
The University has the right of access to and to make copies of the data and records for all research performed at the University or under University auspices provided such access to the records shall be for reasonable cause, at reasonable times and after reasonable notice (except in cases of misconduct allegations, see below). For example, the University Medical Center Institutional Review Board and the Brody School of Medicine Compliance Office acting for the University may review records and study data of projects that use human subjects to assure compliance with human subjects protection regulations. In cases involving an allegation of research misconduct, the University through the Vice Chancellor for Research, Economic Development, and Community Engagement may request immediate, preemptory access and custody of original research records. When such records contain confidential information about human participants in research, the Vice Chancellor shall institute appropriate procedures to assure that participant confidentiality is maintained while the research records are in his custody.
Extramural sponsors providing support for East Carolina University or appropriate governmental officials also have the right to review the data and records resulting from that extramural support. In addition, investigators, co-investigators, students, visiting researchers, and students who are or were an integral part of a research project team have the right to review all records and data which are part of that project, or which support publications for which they are named authors. Similarly, investigators, co-investigators, students, visiting researchers, and students have a right to a copy of data that they personally generated or substantially analyzed unless prohibited by law, regulation, or contractual agreements. The responsible investigator in addition has the right to distribute to other scholars or individuals copies of any part the research records in his custody per the general practices of his/her field of study unless prohibited by law, regulation, or contractual agreements.
RETENTION OF RESEARCH DATA AND RECORDS
Research data and records, including the primary experimental results, should be retained for a sufficient period to allow evaluation and repetition by others of published results emanating from those data. In general, three years from the first publication date of the research results is specified as the minimum period of retention for research published in peer-reviewed journals. For sponsored research that is not published, the minimum retention period is three years from the date of the issuance of the final report to the research sponsor, unless the sponsor specifies a longer retention period. However, if an investigation, legal action or an official inquiry concerning a research project is underway, all data and records related to the project must be retained and made accessible until all issues are resolved. In addition, the records should be kept for as long as may be required to protect any patents or other intellectual property resulting from this work. If a research project is not funded with external or designated internal funds (e.g., an internal university grant), the above retention policy shall apply to these research data and records only when the project results in a publication; its data is used to support a grant or contract application; or it involves the use of animal or human subjects.
TRANSFER OF RESEARCH DATA AND RECORDS THAT SUPPORT UNIVERSITY PATENTS OR WERE FUNDED BY FEDERAL GRANTS & CONTRACTS
Pursuant to federal regulations (OMB Circular A-110, section 53) and the need of the University to protect its patent rights, original research data and records that support university patents or were funded by federal grants and contracts must remain in the custody of the University for the required retention period as discussed above. In the event the responsible investigator transfers to another institution or leaves the University for any reason, the responsible investigator shall transfer custody of these original research data and records to the University. Exceptions to this policy are discussed at the end of this section. The responsible investigator, however, may make a copy of the data and research records at University expense for his/her personal use at a new institution unless prohibited by law, regulations or contractual agreements. Before his/her departure, the responsible investigator shall transfer custody of the original research data and records to his/her department chair or supervisor as required by this policy. These records shall be retained in the University Archives of Joyner Library pursuant to the retention paragraph above. These data and records shall be organized in a format to permit reasonable identification of specific experiments and data by individuals not involved with the original research.
These research data and records shall be used by the University only for patent litigation, misconduct inquires and investigations, or for other purposes required by federal regulations for US government funded research.
1) Currently Active Federal Grants and Contracts: If the responsible federal agency allows the transfer of an active grant or con tract to the new institution of the principle investigator, and the new institution accepts the administrative responsibility for the federal award, the original research data and records may be transferred to the new institution upon the request of that institution. The University, however, shall retain a true copy, made at University expense, of all research records produced while the research project was active and under ECU jurisdiction.
2) Faculty Request for Transfer of Original Records: Per OMB Circular A-110 section 53c, a faculty member may request authorization from the responsible federal agency to substitute true copies of the research data and records in the University Archives in place of the originals. If so authorized, the investigator may then transfer his/her original data and records to the new institution.
3) Multi-Institutional Federal Grants and Contracts: If such federal awards designate a specific institution as the depository of original data and records for a multi-institutional project, the University shall comply with this requirement. However, the University shall retain a true copy of the original records produced at University expense.
TRANSFER OF OTHER RESEARCH DATA AND RECORDS
In the event the responsible investigator transfers to another institution or leaves the University for any reason, the responsible investigator shall provide a true copy at University expense of his/her research data and records that have been retained less than three years in the investigator’s possession per the retention paragraph above. Before his/her departure, the responsible investigator shall provide these true copies of the research data and records to his/her department chair or supervisor. These data and records shall be organized in a format to permit reasonable identification of specific experiments by individuals not involved with the original research. These research data and records shall be used by the University only for misconduct inquires and investigations,
RESOLUTION OF DISPUTES Involving RESEARCH DATA AND RECORDS
The Vice Chancellor for Research, Economic Development, and Community Engagement or his designee shall arbitrate all disputes involving research data ownership, retention, and access. Whenever possible, the Vice Chancellor or his designee shall first attempt to mediate a resolution to the dispute acceptable to all parties. When the dispute involves faculty from the School of Medicine or the College of Arts and Sciences, the Vice Chancellor or his designee shall consult with the designated Associate Deans for Research in those units.