Responsible Conduct of Research

Treatment of Research Data

Consistent with academic freedom, the investigator/researcher has the authority to make judgments involving the use and dissemination of her or his research data. Each faculty member/research director is ultimately responsible for the maintenance and proper retention of research records. These records should include sufficient detail to permit examination for the purposes of replicating the research, responding to questions that may result from unintentional error or misinterpretation, establishing their authenticity, and confirming the validity of the conclusions. Each research director should maintain a laboratory manual that describes all major procedures. Correspondence with institutional review committees and records of the use of controlled substances and radioactive materials should be maintained as part of the research record in accordance with governmental, regulatory, and University policies. A standardized system of data organization should be adopted and should be communicated to all members of the research group and to the appropriate administrative person.

Where feasible, all original primary data are to be retained by the faculty member or by his or her designee. Accepted practices for retaining data vary among disciplines and depend on the perishability, nature, and logistics of retaining each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility, and validity and to meet the requirements of granting agencies or agreements concerning the retention of data. Primary data should be maintained for a reasonable period of time to ensure that any questions raised by researchers, colleagues, or readers of any published results can be answered. It is recommended that data be retained for at least three years. Potentially patentable data should be signed and dated by the researcher at the time they are entered into notebooks. A witness should also sign these pages. In the event the researcher leaves the University, the researcher and the department chair or dean must together arrange for the researcher's data, notebooks, and other data retention materials (other than clinical research records) to be transferred to the new institution. In such cases an individual written agreement shall be signed which preserves the scholar's right to access and copy (where practical) such data. In cases of multi-institutional studies, the institution of the primary study director is ultimately responsible for guaranteeing appropriate access to, use of, and retention of original data.