The retention of accurately recorded and retrievable results is of utmost importance for the progress of research inquiry. LLU policy and government regulations place great value in protecting the integrity of research data.
See General Guidance
- Faculty, fellows, other research personnel and students who conduct research in LLU or affiliated entities, have the primary responsibility for the collection, recording, preservation and publication of the research data and findings. However, the data and supporting documentation are the legal property of LLU, LLUMC or their affiliated entities, unless ownership is assigned under the terms of a grant or contract. Custody of the primary data must be retained by the unit in which they are generated. An investigator may make copies of the primary records for personal use.
- The investigator should organize and maintain research records in a manner that will facilitate prompt recovery of the primary data. For example, if there is an allegation of scientific misconduct, the original raw data from which any figure or statistic included in a manuscript or grant application was derived, must be located and made available within one working day (see section 3.4.11(c)(2) of the Faculty Handbook) . Original experimental results should be recorded, when possible, in bound notebooks with numbered pages. Machine printouts should be affixed to, or referenced from, the notebook. Research results may also be recorded on charts, tapes, computer disks, or other digital media. In all cases an index should be maintained to facilitate access to data.
- To facilitate access to research data in the event of allegations of misconduct, investigators’ annual faculty reports should include the locations of all research data records and indexes (see (2) above) which support each listed grant application or manuscript.
- Primary data should remain in the research facility at all times and should be preserved as long as there is a reasonable need to refer to them. The chief of each research unit must decide whether to preserve such data for a specified number of years or indefinitely. In no instance, however, should primary data be destroyed while investigators, colleagues, or readers of published results may raise questions answerable only by reference to such data.
- With the permission of the director of the research facility, department chair or dean of the school, copies of research data and supporting documentation may be made and utilized at another institution. Original data may not be removed from the University without the prior approval of the director of the research facility, department chair, dean of the school and the vice president for research affairs; a copy of such data must be retained by the research facility or department in which the data was obtained. Investigators who transfer research data and supporting documentation from another institution for use in connection with research supported or sponsored through LLU, LLUMC, or their affiliated entities must advise the director of the research facility, department chair, dean, or LLUMC unit director of the location (see (3) above) of these copies within 60 days after the transfer is made.
Research records must be prepared and maintained, and kept, stored, and accessed as allowed by federal regulation and approved by institutional policy. See LLUAHSC policy (H-42): Research Records, Documentation, Retention, Storage, and Access For Human Subject Research.
A procedure will be developed to address each of the areas pertaining to research records. Currently, we have developed a procedure (see LLUAHSC procedure (H-42A): Clinical Research Records Documentation) that identifies specific requirements that must be followed in setting up and maintaining research records when they have the potential to impact current or future care of the patient. Three charts have been attached that outline which research records belong in the Medical Record, Investigational File for Clinical Research, and in the Investigator’s Research files (administrative). Subsequent procedures will also be developed in the future to address retention, storage, and access.