Section 3361:10-43-18 - Records: responsibilities and rights concerning ownership, access to and maintenance of original scientific records(A) This policy shall apply to all university of Cincinnati (UC) employees and to all research conducted on the premises of UC, utilizing UC resources or infrastructure, or utilizing funding provided by or through UC, regardless of the source of funding for the project.(B) As used herein, "scientific record" shall mean all original research data and materials, and includes raw data and all other records describing or embodying research activities, such as laboratory notebooks, electronic records, reports, notes of observations, images, instrumental printouts, and the like, as well as any other information or materials which are reasonably 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 including computer software. The scientific record shall not include any records to which federal or state law restricts access, for example, patient medical records.
(C) An accurate and complete scientific record is an essential component of any research project. Both UC and the "principal investigator" (PI) have responsibilities and rights concerning access to, use of, and maintenance of the original scientific record. UC has an obligation to protect the university, employees, and members of the general public from loss or misuse of the scientific record. UC is ultimately responsible for producing original records in a variety of circumstances, irrespective of the source of support for the research project. UC's ownership rights and obligations concerning the scientific record include, but are not limited to:
(1) Compliance with the terms of sponsored project agreements and other contractual undertakings by the university;(2) Ensuring the appropriate treatment of animals and human subjects, and handling of hazardous and potentially hazardous materials;(3) Protection of the lawful rights of students, faculty and the general public, including, but not limited to, their rights to access the scientific record for research in which they participated;(4) Protection of intellectual property rights;(5) Facilitation of the investigation and resolution of disputes arising from research; and(6) Provision of a record sufficient to demonstrate compliance by the university with applicable laws and regulations. UC must retain the scientific record in sufficient detail to accomplish these goals for a period of not less than five years beyond the completion of the research unless statute or regulation requires a longer retention period.
(D) Except as provided herein, title to the scientific record shall be vested in UC. Title to the scientific record may be transferred to a third party only in accordance with applicable law and the contracting rules of the university. In any such transfer of title, the university shall reserve such rights as shall be reasonably necessary to accomplish the goals set forth herein.
(E) Insofar as possible, the scientific record should be retained in the laboratory or work area in which the scientific record was originally generated. Any physical relocation of the scientific record must be fully documented in such a fashion as to expedite the prompt location of the materials if required. Except as specifically authorized by contract or by the office of the vice president for research, the scientific record may not be removed from the premises of the university. In case of removal, suitable provision shall be made to assure access to the removed scientific record by the university and those persons who created it.
(F) A research agreement may provide for confidential treatment of bona fide proprietary, competitive, or trade-secret information and data received from a private sponsor, provided that such materials can be readily identified and conditions for the confidential treatment and retention of such materials are reasonable in scope and duration. A research agreement may provide that information in the scientific record that is generated during the course of research may be afforded confidential treatment for a period not to exceed ninety days except as specifically authorized by the office of the vice president for research for the purposes of seeking protection under intellectual property laws.
(G) The PI is responsible for the collection, management and retention of the scientific record as directed by appropriate college and departmental officials. The PI must adopt an orderly system for management of the scientific record and should communicate the chosen system to all members of a research group and appropriate administrative personnel, where applicable.
The scientific record must be archived for a minimum of five years after the termination date specified in the contract, grant, or award pertaining to that project or for such longer period as may be specified therein, with original scientific records retained wherever possible. In addition, any of the following circumstances may justify longer periods of retention:
(1) The scientific record must be kept for as long as may be necessary to protect any intellectual property resulting from the work as directed by the university patent officer;(2) If the PI becomes aware of disputes regarding the research, the scientific record must be retained until alternate arrangements are authorized by appropriate university officials; and(3) If the scientific record has been generated as a part of a student's academic requirement, the scientific record must be retained at least until the degree is awarded or it is clear that the student has abandoned the work as evidenced by no student activity over a three year period.(H) Beyond the period of retention specified here, the destruction of the scientific record is to be only in accordance with disposition instructions issued by the university.(I) The PI shall provide access to the scientific record to authorized representatives of the university in a manner specified by the office of the vice president for research as may be reasonably necessary to accomplish the goals set forth herein.(J) If a PI leaves UC, and a research project is to be moved to another institution, custody of the scientific record may be transferred with the approval of the vice president for research and in accordance with procedures specified by that office. No request for the transfer of custody of the scientific record shall be approved unless accompanied by written agreement from the PI's new institution that guarantees: (1) Its acceptance of custodial responsibilities for the scientific record;(2) UC's access to the scientific record, should that become necessary; and(3) Retention of a copy by UC for use by graduate students still working on the project. Replaces: 3361:10-43-18
Ohio Admin. Code 3361:10-43-18
Effective: 3/21/2005
Promulgated Under: 111.15
Statutory Authority: 3361
Rule Amplifies: 3361
Prior Effective Dates: 4/24/2003