Obtaining and Maintaining IRB Approval
The longest duration for approval permitted under the federal regulations for protocols reviewed via the Expedited or Full Board process is one year. In order for research involving human subjects to continue, the IRB must review the research at least annually. In some cases, the IRB may require more frequent reviews depending on the risks of the research or other factors the IRB may take into consideration.
The person listed as Principal Investigator (PI) is responsible for seeking and maintaining all IRB approvals prior to commencing human subject research activities.
Principal Investigators must provide the IRB with all required materials to request continuing review in a timely manner. Therefore, RCS requires requests for continuation be submitted at least 45 days in advance of the IRB approval expiration date. If the PI does not need to continue human subject research activities beyond the IRB approval date, the PI must properly close the study with RCS
Continuing Review Process
At least 45 days in advance of the IRB approval expiration day, a Continuing Review Application must be submitted to Research Compliance Services.
Include your approved Research Plan, current consent documents, and most recent grant progress report (if applicable) with your application.
In order to be in compliance with the regulations, continuations must be reviewed separately from amendments. If you would like to request changes at the time of Continuing Review, you must submit a separate Amendment Application with the changes to the approved materials clearly identifiable by using track changes or highlighting.
At the time of continuing review, the IRB is tasked with reviewing the protocol in relation to the IRB approval criteria set forth in the Federal regulations. There may be necessary revisions or clarifications required as a result of the IRB’s review at the time of continuation. Alterations to a protocol requested by an IRB member during Continuing Review do not require the submission of an Amendment Application.