The IRB-SBS conducts an annual review of all protocols which have been previously 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; instead they complete an annual Protocol Status Update.
- Locate the protocol that you want to continue in the iProtocol Protocol Management page. Select the "create a copy" link below the protocol's title.
- Select the first radio button "I am copying in order to submit a Modification..."
- You will see a “Protocol was successfully updated” message. Click on the “return to protocol management” link to return to the Protocol Management page to find the new copy of the protocol.
- Select "edit" below the new copy of the protocol.
- In the Participant Group section, update the "estimated number of participants" section. If you have more than one Participant Group, update the numbers in each section. For more information, see Participant Groups.
- Review the protocol. Please note that you can edit the protocol if needed but make sure to mark "yes" to the "Modifications" question below the "Continuation" question. Editing the numbers in the "estimated number of participants" section is considered part of the continuation form and not necessarily a modification, but other edits to the protocol or any attached forms is considered a "modification."
- In the "Continuation" section near the end, complete the questions regarding the continuation.
- When you are done making edits, select "submit" at the bottom of the page. In order for the submit button to be revealed, all of the "required" fields must be complete.
Trying to make a copy of the protocol for a continuation but iProtocol won't allow it? iProtocol only allows one "in development" copy of the protocol for the same protocol number. Look for the protocol copy in the Protocol Management page. If you don't see it in your Protocol Management page, check the Trash/Recycle Bin for a copy of the protocol. Once you locate the modification copy, you have two options:
- Revise the copy that you already made for your current continuation needs and submit it.
- Move the copy to the "Trash/Recycle Bin" and select the "permanent delete" button to delete the version (see Trash/Recycle Bin for directions). Once the copy is deleted, you can create a new copy from the most recently approved version of the protocol.
The purpose of this section is to better understand what occurred over the last year in regard 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.
Are you applying for a continuation of your protocol’s approval?
If you are completing the protocol for the first time and it has no previously approved word document version (protocols submitted prior to February 2019), you should mark “no” to this question and continue to the next section. If you are applying for a continued review of a previously approved protocol (either in iProtocol or using the word document form from our previous review process), mark "yes."
Was this projected undertaken?
- (If Yes) Describe what you did during the past year. Provide the Board with a general description of the research activities that occurred. Remember that in the Participant Group section, each participant group has several questions regarding the number of participants enrolled in the study. The pre-reviewer will want to see that you updated this information to reflect new enrollment in the study. Make sure to update this section prior to submitting the protocol.
- (If No) Briefly explain why this project was not undertaken Essentially the Board wants to understand if there are additional considerations that are preventing the study from moving forward, etc.
Are there any additional risks to participants or new information about risk to participants in the study not described in the previously approved protocol?
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.
- Participant withdrawal is reasonable for the study or protocol provides adequate justification/explanation for higher participant withdrawal.
- Risks continue to be minimized and they are reasonable in relation to the benefits.
- Study procedures continue to ensure subject privacy and confidentiality adequately.
- The enrollment rate is reasonable to meet the goals of the study or the protocol provides adequate justification/explanation for slower enrollment rates.
- There any no other factors (new findings, reports, etc) that may alter the Board’s previous determinations for this protocol or the new factors (findings, reports, etc) are dealt with adequately in the protocol.
- Study procedures continue to ensure safeguards for vulnerable subjects are adequate.
Continuation review follows the same process described in Protocol Review "Full Board Review" section. 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 and will follow the expedite review path.
