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Indiana University
Office of Research Compliance Newsletter 12th Edition
July 31, 2014
Kuali Coeus IRB
Phase IV of the KC IRB implementation is live today!

Just as Phase III resulted in the elimination of forms for exempt studies, Phase IV results in the elimination of forms for expedited and full Board studies, as well as amendments, renewals, deferral requests and Humanitarian Use Device (HUD) applications. Here’s what you need to know:

Revised HSO Website

The HSO website has been reorganized to provide more streamlined information for investigators. New features include:

  • Step-by-step design allowing investigators to quickly find information, relevant to where they fall in the research lifecycle
  • New decision-making tool to help investigators determine the appropriate level of review for their studies
  • Streamlined submission information, including tips and tricks
  • Pages with information dedicated specifically to subjects and sponsors
  • Updated guidance page with new content
  • Training page with a list of training opportunities, including current office hours, and how to request training from HSO staff

Visit the HSO homepage.

Questionnaires/Smart Forms

The Questionnaire Tab introduces ‘smart-form’ functionality, allowing investigators to complete IRB applications almost solely within the KC IRB system. As investigators work from the top of the Questionnaire Tab to the bottom, additional questions are displayed based on previous responses, ensuring that only the questions the IRB needs to review in the application are answered. The smart-form functionality should make the IRB application more effective for IRB members and more intuitive for investigators.

The translation of the current IRB forms to the Questionnaire Tab has been a complicated process and has resulted in significant changes to the IRB application questions in many areas. A new tool, called the Crosswalk, for navigating the questionnaires and completing the IRB application is available on the HSO website Policies & Guidance page. You are encouraged to download the Crosswalk document before submitting a new study.

Elimination of HSO Forms

Starting today, investigators submitting new studies will no longer need to download, complete, and upload the forms below. All information contained in these forms has been transferred to the Questionnaire Tab and these forms are no longer available on the HSO website.

  • Summary Safeguard Statement
  • Summary Safeguard Statement for HDEs
  • HIPAA & Recruitment Checklist
  • VA HIPAA & Recruitment Checklist
  • Request Form for VA Research
  • Request Form for Inclusion of Children in Research
  • Request Form for Inclusion of Cognitively Impaired Individuals in Research
  • Request Form for Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research
  • Request Form for Inclusion of Prisoners in Research
  • Request Form – Transnational Research
  • Request to Defer Review
  • NCI Facilitated Review Cover Sheet
  • IU Application for Protocol Review by WIRB
  • Amendment Form
  • Renewal Forms

The following forms will not be replaced by Questionnaires during Phase IV. Study teams will continue to download, complete, and submit them via KC IRB or email:

  • Drug or Biological Products Form
  • Medical Device Form
  • Noncompliance Form
  • Prompt Reporting Form
  • Closeout Form
  • Request Form – IVD with Remnant Samples
  • IU-PU-ND Request for Deferral
  • Application for Non-Human Subjects Research
  • Application for Non-Research Student Projects
New Pre-Review Process

Starting today, HSO staff will no longer send emails detailing pre-review comments. Instead, all pre-review comments and revisions will be communicated via KC IRB.

  1. After the HSO staff member completes pre-review, he/she will add comments, a PDF of any questionnaires with comments, and any documents with tracked changes to KC IRB. The staff member will then take the Return to PI action in KC IRB, and the status of the submission will be updated to Returned to PI.
  2. A notification will be sent to the study team via OneStart directing them to log in to KC IRB to review the staff member’s comments. Questions and/or revisions are found on the Protocol Actions tab under Manage Review Comments and Manage Review Attachments.
  3. The study team should review comments and attachments, make any requested revisions, and upload any updated documents to the Notes & Attachments tab.
  4. When the study team completes revisions, they should take the Submit for Review action on the Protocol Actions tab, notifying HSO staff that response to pre-review is complete.
Considerations for Active Studies

Currently active studies (approved prior to July 31, 2014) will not be required to (and should not) update their currently-approved forms to the new Questionnaires. Currently existing studies will only utilize the Questionnaire functionality for requesting Amendments or for Renewals. Existing study documentation, such as the Summary Safeguard Statement, etc., will remain intact for active studies and these studies will not replace their currently-approved forms with the new Questionnaire.  Please contact HSO if you are adding a vulnerable population to an existing study or opening a study at the VA, as these changes may require that you complete some or all parts of the questionnaire. 

If the status of your new study, amendment, or renewal is pending (Pending– In Progress, Amendment in Progress, Renewal in Progress) as of today, the Phase IV changes apply.

  • For new studies, you are required to complete the full set of KC IRB questionnaires which are replacing the currently-required IRB forms.  The full smart-form application will be required, and the current IRB forms such as the Summary Safeguard Statement, HIPAA and Recruitment Checklist, etc, will not be accepted. 
  • For amendments and renewals, you are required to complete the new amendment and renewal questionnaires in lieu of the Amendment and Renewal Forms.  Amendment and Renewal Forms will not be accepted starting July 31, 2014.
Getting Trained
  • Face to face trainings are being offered now. Visit the KC IRB Training Sessions page to view the schedule and sign up for a training session.
  • If you would like to schedule a session for your department or group, please contact the HSO to schedule a session: email kcirb@iu.edu

For more information about Phase IV, please visit the newly-redesigned HSO website or contact an HSO staff member directly.


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