540. Closing a Research Project Involving Human Participants
Updated August 23, 2021
Federal regulations and University policy require continuing review and re-approval of human research approved by Full Committee Review and, in limited circumstances, by Expedited Review. As defined by the Department of Health and Human Services (DHHS) at 45 CFR 46.102 item (e)(1), a human subject (i.e., participant) is a living individual about whom an investigator (whether professional or student) conducting research obtains information or biological specimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biological specimens.
NOTE: Data and specimens are considered identifiable when the identity of an individual research participant can be readily ascertained by the investigator or is associated with the information/specimens (e.g., via a master code sheet).
When a Project May Be Closed
A research project may be closed when it no longer involves human participants; specifically, when the investigators are no longer:
- obtaining information or biological specimens through interaction or intervention with participants, or
- obtaining or using identifiable private information about a participant or identifiable biological specimens from a participant.
Master code sheets or other mechanisms that could be used to link data to an individual participant must be destroyed.
For funded research, financial transactions related to the involvement of human participants must be completed (e.g., processing claims for incentives or payment to participants). Investigators planning to close a funded project are advised to contact the Sponsored Projects (SP) to confirm the status of remaining transactions and to notify SP of the planned closure of the human research project.
Closing a Project
Investigators should notify the IRB of a project closure prior to the expiration date by either:
- submitting of a Closure form at any time (preferred), or
- selecting the Final Report option and submitting a Continuing Review/Progress Report Form at the time of continuing review.
Either form constitutes a final report for the project.