The IRB-SBS conducts an annual review of all protocols that are reviewed and approved at a full board meeting. Protocols that are deemed "expedited" or "exempt" and reviewed administratively in our office are not required to apply for an annual review; in addition, protocols that are no longer actively collecting data and/or in the "data analysis" phase of the study qualify for the "expedited" category even if the original review took place in a full board meeting. Please note that expedited and exempt protocols reviewed under the pre-2018 federal regulations are still required to apply for continuation approval. If your protocol is on a Word document than it was reviewed under the pre-2018 federal regulations; all protocols in iProtocol are reviewed under the 2018 regulations. Protocols approved under the pre-2018 regulations will transition to iProtocol and the new regulations when they apply for a continuation approval. For more information see "Transitioning a previously approved protocol to iProtocol."
Locate the protocol that you want to continue in iProtocol Protocol Management and Document Storage page. Select the "create a copy" link below the protocol's title.
Overall the purpose of this section is to better understand what occurred over the last year in regards to the study activities, etc. The Board will want to know if the study went forward and if there were any issues or new information that they need to consider.
If you are completing the protocol for the first time and it has no previously approved word document version, you should mark “no” to this question and continue to the next section.
If the answer to this question is yes, you need to modify the “risks” section of the protocol to reflect the new information. Please note that the reviewers will be able to see the changes made as our program highlights any text changes from previous versions of the protocol. There’s no need to provide additional comments regarding changes made unless you feel something needs additional explanation. If you need to alter the protocol for any reason, make sure to mark “yes” to the modification question and complete that section as well.