Closure and Retention
Approved human subject research projects should be closed at the time all data have been collected and identifying information is no longer needed. De-identified data for which no identifying key exists can be kept for further analysis and do not require continuing review and approval by an IRB.
A project closure report should be submitted to the IRB once data are no longer identifiable.
Compliance with 45 CFR 46.115(b) requires that all records relating to IRB-approved research be retained for three years after the closure of the project.
Records to be maintained include: copies of all research proposals reviewed, scientific evaluations (if any), consent documents, progress reports, reports of injuries to subjects and other unanticipated problems. Electronic copies of correspondence between the IRB and the investigator(s) is preserved and stored in the IRBNet system and any other electronic records of a research project in hard copy, electronic or other media form, must be preserved and accessible for audit purposes. Records for the completed project should be stored in secure locations on campus with the same care used when the project was active.
If a researcher (faculty, staff or student) leaves DU, a copy of the research records must remain on campus. Students should coordinate the storage of research records with their faculty sponsor and/or department/college. In the event that the faculty sponsor or department/college are unable to retain the records, they should be sent for secure storage in the University Archives. Records sent to archives will be recalled only in the event of an audit requirement and will be destroyed at the end of the three-year retention period.
Destruction of Records
Destruction of human subjects research records should be performed in a fashion that protects the confidentiality of the research subjects. It is recommended that paper records be shredded, that physical tapes (audio and video) be erased and physically destroyed, and that electronic media used to store data be scrubbed after the fields are deleted.
Researchers may retain de-identified data for future analysis in the context of the project for which the data were collected. Data are considered to be completely de-identified when ALL links between individual identity and the data are destroyed. Research data are not considered de-identified simply because names have been removed if they still contain information that might identify the participants such as date of birth, address, etc.
Contact Us
For further guidance, please contact the Office of Research Integrity & Education at 303-871-2121 or through IRBAdmin@du.edu.
