Protocols - Ancillary Review

Overview

Institutions often need external reviewers to signoff on research protocols before they can be approved.  Reasons for this range from approving space changes required to perform certain research, to gathering Biosafety approval of an IACUC or IRB protocol utilizing recombinant DNA. Kuali Protocols allows institutions to record these approvals within the system in parallel with or before committee review.

Creating An Ancillary Review Group

Navigate to the IRB or IACUC Configuration screen and scroll to the bottom of the screen. To add a new Ancillary Review Group press +Reviewer

Enter the following information for your Ancillary Review Group

• Reviewer: This is the name that will display in the Ancillary Review Dropdown in your Protocol documents.
• Abbreviation: Enter a short name for the Ancillary Review. This is the code used in the database to identify the Ancillary Review Type.
• Contacts: This is a Typeahead search of your user list. You can add as many users as you need in this field by searching multiple times.  All of these users will be able to see protocols with this Ancillary Review type on their Protocols Assigned to Me screen.
• Status: This indicates if this Ancillary Review should be active for a given Protocol Type.  When you add a new Ancillary Review it is added to all Protocol Types, but defaults to Inactive unless you explicitly activate it in each Protocol Type.

Press the checkmark at the end of your Ancillary  Review entry to save your changes.

Once you've added several Ancillary Review types to your protocol you can search for them by name.

Adding Ancillary Review to a Protocol

Ancillary Review can be added to a Protocol by the compliance administrator at any time during it's life cycle. Once an Ancillary Review entry is added to a protocol all Admins will be able to see and update the Review entry. Members of that Ancillary Review Type will also be able to view and update the entry and review the entire protocol. Ancillary Review members will not be able to view or change other Ancillary Reviews added to the same protocol or add Action Items to the protocol.

To add an Ancillary Review click on the Ancillary Review tab at the top of the Protocol form and click +Ancillary Review

Next select the type of Ancillary Review you want to add to the protocol and click Create.  All Ancillary Review groups that are active for your Protocol Type will display.

Next expand your Ancillary Review entry to see your details.  The status will be Pending.

Once the review is added all members of this Ancillary Review group can see it on their Protocols Assigned to Me page. You can now add comments to provide any additional details to your Ancillary Reviewers by pressing Add Comment. Once you've entered your comment press Post.

Each comment will record the user who made the comment along with the date and time the comment was added to the Ancillary Review. Whenever the status is changed on an Ancillary Review a comment will be added by the System documenting the date and time the status was changed. The Ancillary Reviewers can also add comments to the review. Over time this will collect a full log of all activity related to this review type on the protocol.

The Admin or Ancillary Reviewers can also add attachments to an Ancillary Review to serve as documentation of their review process.

If you need to delete an ancillary review assignment, click on the menu at the far right side of the listing. For audit purposes, the delete option is only available before any reviewers have posted comments or added attachments. Once there are comments or attachments, the delete option will be greyed out.

The Ancillary Review Tab will display the color associated with the highest level Ancillary Review status. Approved is the lowest level and is marked in green, Pending is the next lowest level and is marked in orange, and Not Yet Approved is the highest level and is marked in red. This allows a compliance Administrator to quickly identify if the there are any Ancillary reviews on a protocol and if any of them are outstanding.

    

Ancillary Review is connected to an overall protocol, so when a new submission is submitted Admins can quickly reference the Ancillary Review history. If they need Ancillary Reviewers to look at a new submission, an existing Approved review can be put back into Pending or Not Yet Approved status to collect additional details about an Amendment or Renewal.

Automatic Assignment of Ancillary Review

If you have questions on your protocol form that can be used to automatically identity the need for an Ancillary Review you can add the Ancillary Review Auto Assignment gadget to your protocol template. If the Progressive Disclosure rules defined on the Ancillary Review Auto Assignment gadget are true when the protocol is submitted for review the Ancillary Review will be added automatically. This automatic assignment will not happen when an amendment or renewal is submitted.  It will also not happen on resubmission of a protocol.  More information on the 'Assign Ancillary Review' gadget can be found in the Compliance - Form Gadgets article.