540. Closing a Research Project Involving Human Participants

Updated July 1, 2019

Federal regulations and University of Nevada, Reno (the University) policy require continuing review and re-approval of non-exempt research involving human participants.

As defined by the DHHS at 45 CFR 46.201, item (f), a human subject (i.e., participant) is a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. data through intervention or interaction with the individual, or
  2. identifiable private information (or 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 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

  1. submitting of a Closure form at any time (preferred), or
  2. selecting the Final Report option and submitting a Continuing Review form at the time of continuing review.

Either form constitutes a final report for the project.