iProtocol Guide

Board Determinations

The Board carefully considers a protocol when making a determination, and determinations are not made on a whim but rather the process is based on a series of requirements outlined in the federal regulations and ethical guidance. In general, it is the Board’s intention to support researchers and help them to develop compliant protocols that can be approved and statistically only a small percentage of protocols submitted to our office were designated as “not approved.” However, the process for a protocol to reach “approve” may involve additional determinations prior to approval. Though not always, sometimes missing the “approval” designation is the result of not communicating the ideas of your protocol clearly; working with your pre-reviewer and providing good details in your protocol will help you to move your protocol through the review process. For more information about the overall review process, see Review Process.

Expedited/Exempt Review or Full Board Review determination categories
  • Approved: no revisions needed
  • Approved with Conditions: minor revisions that can be verified by the PR
  • Deferred: revisions needed that need to be reviewed by the full board at another convened meeting
Full Board determination categories only
  • Not Approved: protocol cannot be approved even with revisions
  • Suspend: previously approved protocol is reviewed due to an unexpected adverse event or protocol violation and board requires a temporary cessation of research activities
  • Terminate: previously approved protocol is reviewed due to an unexpected adverse event or protocol violation and board requires a final cessation of research activities

Please note that “Not Approved” and “Terminate” are end points for the protocol. The protocols cannot be copied or resubmitted.

You received an email notification that your IRB protocol was reviewed and received an “approval with conditions” protocol. Here are the next steps:

  1. Go to your protocol either on the iProtocol Protocol Management page or use the link provided in the email.
  2. Review the comments in the protocol; the comments are displayed in yellow boxes.
  3. Make the required changes. If the revision involves an uploaded document, you may need to “replace” the document. See “Replacing a Document” for additional directions. **At this time the functionality to reply to comments in iProtocol is not available. If you have questions about the comments, email the PR.
  4. When you are done with the edits, select the “submit” button at the bottom of the page.
  5. iProtocol will notify the PR about your revised submission. The PR can use iProtocol to compare versions so there’s no need to notify the PR about where to look for edits.

You received an email notification that your IRB protocol was reviewed and received an “approval deferred” protocol. Here are the next steps:

  1. Go to your protocol either on the iProtocol Protocol Management page or use the link provided in the email.
  2. Review the comments in the protocol; the comments are displayed in yellow boxes.
  3. Make the required changes. If the revision involves an uploaded document, you may need to “replace” the document. See “Replacing a Document” for additional directions. **At this time the functionality to reply to comments in iProtocol is not available. If you have questions about the comments, email the PR.
  4. When you are done with the edits, select the “submit” button at the bottom of the page.
  5. iProtocol will notify the PR and IRBR about your revised submission. The PR and IRBR can use iProtocol to compare versions so there’s no need to notify the PR and IRBR about where to look for edits.

When a protocol is deferred by the full board, the protocol version reaches an end point. In order to activate the protocol for another round of review, you need to make a copy of the protocol.

  1. Go to your protocol either on the iProtocol Protocol Management page or use the link provided in the email.
  2. Review the comments in the protocol; the comments are displayed in yellow boxes.
  3. Make a copy of the protocol. Indicate that you want to make a copy to resubmit the protocol.
  4. Edit the protocol. When your edits are complete, select “submit” at the bottom of the page.

The Board strives to make recommendations that will ultimately protect participants, but they do not want to compromise the research process either. The protocol process is not always perfect; although the Board is very diligent in trying to understand the study, sometimes details get lost in translation. If you are concerned about a recommendation made by the Board, first, talk to your pre-reviewer. He or she may be able to help you better understand what the Board is asking and help you determine if the Board’s request has any flexibility. Second, if the recommendation for your protocol still needs to be altered, devise alternative solutions to present to the Board. Generally the Board’s underlying concern behind their recommendation is the most important part to satisfy. For example, if the Board recommended that you make a change in your data collection process because they felt like the proposed process would compromise the participant’s confidentiality, but you find that the recommendation actually doesn’t protect participants or makes it impossible for you to collect the data, you should re-evaluate your data collection process and propose a solution that will improve your ability to protect participant confidentiality while maintaining your data collection. In most cases, the Board will be willing to consider alternative solutions if the underlying goal is met. However, if you refuse to consider the concerns of the Board or decide that their recommendations are inconvenient, the Board will be less willing to work with you. Please know that the Board is bound by the federal regulations which determine how the Board makes its decisions; the Board cannot approve measures which violate the regulations that they follow.