Having trouble reading this email? View it in your browser
Indiana University
Office of Research Compliance Newsletter 10th Edition
March 24, 2014
Kuali Coeus IRB
In this issue:
 
 
KC IRB Phase III is coming April 24

Phase III of the KC IRB implementation involves two main components: an enhanced exemption process as well as improvements to overall KC IRB functionality.

 
 
What’s New for You in Phase III:
The Exempt submission process has been improved
Elimination of an IRB form
  • No more downloading, completing, and uploading the Exempt Research Checklist (ERC)!
  • All questions for a new Exempt study (Initial Protocol Application) will be housed in the KC IRB system on the Questionnaire Tab. As you work from the top of the Questionnaire Tab to the bottom, additional questions or questionnaire folders will be displayed based on responses you select. Each folder will update when you save showing that a questionnaire is Complete.
  • Only supporting documents (such as survey questions, Study Information Sheets, Recruitment Materials, etc) will need to be added to the Notes & Attachments Tab.
Use of more system fields
  • Information you once entered into the Exempt Research Checklist is now captured directly within the KC IRB system.
  • For example, you will need to enter a Participant Total and Count, as well as any of the other Participant Types that will be involved in the research. This enables the “smart form” to correctly display questions related to your research.
Elimination of Amendment form for Exempt protocols
  • Some, but not all, changes to Exempt Protocols require an amendment so the Human Subjects Office can confirm the research is still Exempt.
  • You are still required to submit those changes via an Amendment in KC IRB but, as of Phase III, you will not need to complete and upload an Amendment form.
  • For Protocols submitted before Phase III, you will also have the option to complete the new Exempt Questionnaires and eliminate your Exempt Research Checklist OR you may still revise your Exempt Research Checklist and replace it within the Notes & Attachments Tab.
 
 
KC IRB Enhanced Functionality…coming with Phase III

Function

Enhancement

Identifying studiesThe Principal Investigator’s name will be included in the header information for each protocol.
Uploading study documents to the Notes & Attachments tabUsers will be able to upload several attachments with one click. The new functionality will include an “Upload Zip” button which will upload all documents from a zip file identified by the user. Once documents are uploaded, users simply need to update the Attachment Type and Description for each document, and then save. Previously, study teams had to upload and provide information about each document individually.
Downloading study documents to the Notes & Attachments tabThe Notes & Attachments Tab will be enhanced with a selection mechanism, which allows study teams to choose specific documents then download them at all once. Previously, study teams had to download each document individually or download the entire set of documents at once.
Viewing investigator requirementsThe Personnel tab will be enhanced to allow users to see whether investigators have completed the COI and CITI requirements at one glance, with no clicks. Investigators who have completed both requirements will be highlighted green with a check mark, and investigators who still need to complete a requirement will be highlighted red with an X. Investigators without an IU username will display in black text and HSO staff will check investigator requirements for those individuals upon submission.
 
 
Training Opportunities

KC IRB training continues in Phase III with both new and enhanced training opportunities:

  1. Exempt submission process training is available for researchers who frequently submit exempt research or who anticipate submitting for exempt review:
    • Face to face trainings: sessions will be offered in Indianapolis and Bloomington. Come sit with an experienced staff member and trainer to walk through the new exempt submission process. You can register for KC IRB training sessions at the KC IRB Training Sessions page. Be sure to choose a session entitled, ‘KC IRB Training – Exempt study submission process changes.’
    • In addition to live training sessions, there are two training guides available in regards to the exempt submission process. You may view them at the eLearning Videos and Training Guides page.
  2. Information in regards to the KC IRB enhanced functionality is captured in the existing training guides and videos. Please make sure to visit the eLearning Videos and Training Guides page to ensure you’re downloading the most recent version of the training guides, which have been updated with the enhanced functionality.
  3. Do you have ongoing KC IRB training needs or new staff who requires training on KC IRB? Please contact the HSO to schedule a session and we’ll be happy to come to you or to host a session: email kcirb@iu.edu.

If you have any suggestions, questions, or need assistance registering for KC Training contact us at kcirb@iu.edu.

 
 
Requests for special reports

KC IRB has several search options that can be effectively utilized for finding a limited number of protocols and content per search. If you have a reporting need that extends beyond the capabilities of these search options, you will need the assistance of Research Compliance staff. General reporting inquiries and specific requests should be sent to Casandra Greene, Office of Research Compliance, at cjgreene@iu.edu or (317) 274-2123. For other concerns regarding search options within KC IRB, continue to contact HSO by email: kcirb@iu.edu or phone: 812-856-4242 (Bloomington) or 317-274-8289 (Indianapolis).

 
 
Stay tuned. More to come in future KC IRB Newsletters!
 
Copyright © 2014, The Trustees of Indiana University