iProtocol Guide

Continuations

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.

  1. Select the first radio button "I am copying in order to submit a Modification..."
  2. You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to edit the protocol.
  3. In the Participant Group section, update the "estimated number of participants" section. For more information, see Participant Groups.
  4. 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).
  5. In the "Continuation" section near the end, complete the questions regarding the continuation.
  6. 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.

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.

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, you should mark “no” to this question and continue to the next section.

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.