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Indiana University
Office of Research Compliance Newsletter 11th Edition
June 16, 2014
Kuali Coeus IRB
In this issue:
Reflections on KC IRB Phase III

Phase III of the KC IRB implementation went live on April 24, 2014 and included elimination of two HSO forms and several enhancements:

• Exempt Research Checklist (ERC) - Eliminated

No more downloading, completing, and uploading the Exempt Research Checklist (ERC)! All questions for a new Exempt study application are now housed in the KC IRB system on the Questionnaire Tab. Only supporting documents (such as survey questions, Study Information Sheets, Recruitment Materials, etc.) need to be uploaded to the Notes & Attachments Tab.

• Amendment Form for Exempt Studies - Eliminated

Submitting an exempt amendment is now easier than ever since investigators no longer need to download, complete, and upload the Amendment Form. Investigators simply input a short description of the requested changes into the Amendment Summary area when creating the amendment in KC IRB, then update the necessary information in the KC Protocol or upload revised documents to the Notes & Attachments Tab. Investigators are encouraged to review the HSO guidance on Exempt Status Requests (available at the HSO Guidance page) before submitting amendments to ensure that an amendment is required for the change.

• Questionnaire Tab Functional for Exempt Studies

The Questionnaire Tab introduces ‘smart-form’ functionality, allowing investigators to complete IRB applications almost solely within the KC IRB system. As you work from the top of the Questionnaire Tab to the bottom, additional questions are displayed based on responses you select, ensuring that you’re only answering the questions the IRB needs to review your application. Questions have been revised slightly from the old Exempt Research Checklist and investigators are encouraged to contact HSO staff with any questions about how to complete the requested information.

• New options for managing study documents

Phase III included implementation of two major enhancements for helping investigators manage study documents.

One-Click Uploading
Users are now able to upload several attachments with one click. The new functionality utilizes an “Upload Zip” button which uploads all documents from a zip file identified by the user. Once documents are uploaded, users simply update the Attachment Type and Description for each document, and then save. This allows for much faster creation of new submissions; as previously study teams could only upload and provide information about each document individually.

Choosing Documents to Download
The Notes & Attachments Tab has been enhanced with a selection mechanism, which allows study teams to choose specific documents then download them at all once. This new functionality makes managing study documents much easier; since previously study teams could only download one document at a time or download the entire set of documents at once.

• Quick-glance viewing of investigator requirements

The Personnel Tab now allows users to see whether investigators have completed both the Conflict of Interest disclosure and CITI education module requirements at one glance. Names of investigators who have completed both requirements will be highlighted green with a check mark, and names of investigators who still need to complete a requirement will be highlighted red with an X. Study teams can then expand the investigator’s information to see which requirement still needs to be completed.  Investigators without an IU username will display in black text and Human Subjects Office (HSO) staff will check investigator requirements for those individuals upon submission.

What’s Coming in Phase IV on July 31, 2014?

What Phase III did for Exempt Studies, Phase IV will do for Expedited and Full Board Studies!

Just as Phase III resulted in the elimination of forms for Exempt studies, Phase IV will result in the elimination of forms for Expedited and Full Board studies, as well as deferral requests and Humanitarian Use Device (HUD) applications. At the same time, the HSO will roll out a newly-designed website which will integrate KC IRB information with current submission information to better serve investigators.

New HSO website

Phase IV will mark a significant milestone in the implementation of KC IRB. As such, HSO staff decided that it’s time to revise the current HSO website to provide more streamlined information for investigators. New features to watch for:

  • 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
Questionnaire Tab Introduces ‘Smart-Form’ Functionality

As noted above, 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 the application are answered. The smart-form functionality should make the IRB application more effective for IRB members and less redundant 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. HSO staff will be gathering feedback from the research community about the new questions during the month of June before final implementation on July 31st. In addition, HSO will provide a tool to help investigators and IRB members navigate the questionnaires.

Elimination of HSO forms

After July 31st, 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.

  • 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*

* Studies that exist in the KC IRB System prior to July 31st, will not be required to update their forms to the new Questionnaires. However, 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.

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
  • Request Form – IVD with Remnant Samples
  • IU-PU-ND Request for Deferral
  • Application for Non-Human Subjects Research
  • Application for Non-Research Student Projects
Uploading study-specific documents

Some study documents are so study-specific that they cannot be replaced by the Questionnaire. Investigators will still upload these documents to the Notes & Attachments Tab when applicable to the study. Examples include:

  • Informed consent and assent documents;
  • HIPAA Authorization documents;
  • Protocols;
  • Recruitment materials; and
  • Data collection forms
Considerations for active studies

The Questionnaire ‘smart-form’ functionality will go live July 31st. Any new study submitted on or after July 31st will utilize the Questionnaire for its IRB application. Active studies as of July 31st are not required to and should not transfer information from the currently-approved documents to the Questionnaire. Such studies will continue to utilize their active study documents throughout their lifetime.

Training Opportunities

KC IRB training for Phase IV will focus on the questionnaire functionality – specifically, which IU IRB forms have been replaced by an electronic questionnaire, how to navigate the questionnaires, and the logic behind the programming. Training for Phase IV is geared toward users who will be submitting new studies on or after July 31, 2014 and opportunities are available as follows:

  1. New study submission training is available for researchers who anticipate submitting a new Expedited or Full Board study:
    • Face to face trainings will be offered beginning in July. If you are unable to attend and would like to schedule a session for your department or group, 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.
    • In addition to live training sessions, there are multiple training guides available in regards to the new study submission process. You may view them at the eLearning Videos and Training Guides page.
  2. Information in regards to the KC IRB Amendment and Renewal questionnaires and process is captured in the existing training guides. Please make sure to visit eLearning Videos and Training Guides to ensure you’re downloading the most recent versions of the Amend a Protocol and Renew and Amend a Protocol 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 Department-specific 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 at kcirb@iu.edu or via phone at 812-856-4242 (Bloomington) or 317-274-8289 (Indianapolis).

Stay tuned. More to come in future KC IRB Newsletters!
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