Research Data Access and Retention
This policy establishes the University's responsibility in ensuring that research data is appropriately recorded, archived for a reasonable period of time, and available for review under the appropriate circumstances.
B. Revision history
Originally issued: March 2000
C. Persons affected
All Northwestern Health Sciences University faculty, staff, students and any other persons at the University involved in the design, conduct or reporting of research at or under the auspices of Northwestern Health Sciences University regardless of the source of funding for the project.
D. Related research policy documents
Accurate and appropriate research records are an essential component of any research study. Both the University and the Principal Investigator (PI) have responsibilities and rights concerning access to, use of, and maintenance of original research data. Research data includes all records that are necessary for the reconstruction and evaluation of reported results of research and the events and processes leading to those results, regardless of the form or the media on which they may be recorded.
Except where precluded by the specific terms of sponsorship or other agreements, tangible research property, including the scientific data and other records of research conducted under the auspices of Northwestern Health Sciences University, belongs to the University. The PI is responsible for the maintenance and retention of research data in accord with this policy.
Northwestern Health Sciences University must retain research data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy and compliance with laws and regulations governing the conduct of the research. It is the responsibility of the PI to determine what needs to be retained under this policy. Where research is funded by a contract with Northwestern Health Sciences University that includes specific provision(s) regarding ownership, retention of and access to technical data, the provision(s) of that agreement will supersede this policy.
The University's ownership and stewardship of the scientific records for projects conducted at the University, under the auspices of the University, or with University resources are based on both Federal regulation (Office of Management and Budget Circular A-110, Sec. 53) and sound management principles. Northwestern Health Sciences University's responsibilities in this regard include, but are not limited to:
- Complying with the terms of sponsored project agreements
- Ensuring the appropriate use of human subjects
- Protecting the rights of students and staff including, but not limited to, their rights to access to data from research in which they participated
- Securing intellectual property rights
- Facilitating the investigation of charges, such as scientific misconduct or conflict of interest
Collection and retention
The PI is responsible for the collection, management and retention of research data. PIs should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel, where applicable. Particularly for long-term research projects, PIs should establish and maintain procedures for the protection of essential records in the event of a natural disaster or other emergency. Research data must be archived for a minimum of three years after the final project close-out, with original data retained wherever possible. In accordance with state regulations, x-rays must be archived for a minimum of seven years.
In addition, any of the following circumstances may justify longer periods of retention:
- Data must be kept for as long as may be necessary to protect any intellectual property resulting from the work.
- If any charges regarding the research arise, such as allegations of scientific misconduct or conflict of interest, data must be retained until such charges are fully resolved.
- If a student is involved, data must be retained at least until the degree is awarded or it is clear that the student has abandoned the work.
Beyond the period of retention specified here, the destruction of the research record is at the discretion of the PI and his or her department. Records will normally be retained in the department where they are produced. Research records must be retained on the University campus, or in facilities under the auspices of Northwestern Health Sciences University, unless specific permission to do otherwise is granted by the Vice President and Provost.
When individuals involved in research projects at Northwestern Health Sciences University leave the University, they may take copies of research data for projects on which they have worked. Original data, however, must be retained at Northwestern Health Sciences University by the PI. If a PI leaves Northwestern Health Sciences University, and a project is to be moved to another institution, ownership of the data may be transferred with the approval of the Vice President and Provost, and with written agreement from the PI's new institution that guarantees:
- Its acceptance of custodial responsibilities for the data
- Northwestern Health Sciences University's access to the data should that become necessary