Closing a Protocol
A Closure Application is required for all human research studies. The closure report is a final opportunity to update the IRB on the conduct and outcome of the research. The PI does not need to wait for the expiration of the study to submit a Study Closure Application.
A research protocol may be closed once the researcher is no longer interacting with participants and/or identifiable participant data (any code keys linking the data to the participants is destroyed and the data is completely de-identified).
- Identifiable participant data is data that by itself, or in combination with other information, could be used by the researchers or another party to identify a participant in the research and/or the participant’s contributions during the research process. For example, legal names, email addresses, and even screen or Avatar names can be used to identify individuals. Similarly, personal information that is disclosed during research about a person’s identity and/or experiences (e.g. their narrative of a particular event) could also be considered identifiable information.
Research records must be retained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulations or requirements (e.g. study sponsor) may apply to the retention of records, for a longer period of time.
Documentation of IRB approval documents, the approved research plan, and informed consent of subjects (without a link to data), are records related to the conduct of research that are typically held, unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.