KC IRB Not Human Subject Research

In order to move to any of the other tabs, you must complete information on the Protocol tab first. Once you have completed all required fields, you can save the information and move to the next tab.

Required Fields for Saving Document

  1. Protocol Type: Not Human Subject Research
  2. Title: Enter the title of your study.
  3. Principal Investigator: Identify the Principal Investigator (PI) by:
    1. Enter the user Id in the box and press tab, which will populate the PI Name and Lead Unit; OR
    2. Click the magnifying glass, which will bring up a search window:  Enter the PI’s Last Name in the appropriate field and click search.  Helpful Tip, using the “*” before or after a person’s name is helpful in ensuring the correct person is found.  For example, “Johnson*”.  
    3. Click return value next to the appropriate person. This will populate the PI Name and Lead Unit on the Protocol tab.
  4. Additional Information: N/A
  5. Organizations: Add IU affiliated organizations (locations) that are engaged in the project, i.e., any organization where records will be accessed, or where project interactions and/or interventions occur. For more information on IU affiliated organizations please see IU-affiliated research personnel.
    1. Select the magnifying glass, which will bring up an organization lookup screen listing of frequently used organizations. From the list, check the box or boxes for the organization(s) engaged in the project.
    2. If the organization you are searching for isn’t listed, change the value in the Organization Type field to "select" and click search to return all organizations included in the KC Organizations database.
      1. To narrow your search, enter part of the organization’s name in the Organization Name text box (e.g., *health*).
    3. Check the box or boxes for the organization(s) engaged in the project.
    4. Click return selected. All organizations checked will populate onto the Organizations panel on the Protocol tab.
  6. Funding Sources: All projects must have some kind of funding source listed.  If your project is not funded, select unfunded from the dropdown and click add.
  7. Participant Types: N/A

For additional information about how to add funding sources, refer to the Quick Guide: Adding Funding.

Once all required information has been entered on the Protocol tab, click save and navigate to the next tab.

  1. The Principal Investigator identified on the Protocol tab will display in the first folder in the Personnel tab.
  2. For additional information on how to add Personnel, refer to the Quick Guide: Adding or Removing Personnel.
  3. Conflict of Interest Questionnaire: Once all personnel have been added, the Conflict of Interest Questionnaire should be completed.
  4. Click save and navigate to the next tab.

Study personnel are automatically assigned certain permissions based on the protocol role assigned to them on the Personnel tab. The Permissions tab is where additional persons who need access to the KC IRB Protocol, but aren’t directly engaged in the research. e.g., an administrator whose only role is to submit items to the IRB, are added.  For additional information about how to add persons to the Permissions tab, refer to the Quick Guide:  Permissions.

  1. Click ►show on the Research Not Subject to Human Subjects Regulations panel
    1. Complete all questions that appear.  Depending on the specific question and your response, additional questions may appear. Be sure to select update to ensure that all required questions appear.
  2. Click save and navigate to the next tab.

There are no specific document requirements for research not subject to human subjects regulations.  However, if you need to upload a document for review:

  1. Click ►show on the Protocol Attachments panel to attach any required study documents.
    1. Select an Attachment Type from the drop-down list.
    2. Enter a Description that will help you identify the document, e.g. “Protocol.”
    3. To add an attachment, click Browse for File Name.
      1. Locate the file and click open to attach. Note: all commonly used file types should be compatible except for “.msg” (Outlook messages).
    4. When file returns, click add.
    5. Repeat as many times as necessary to add all necessary documents.
  2. When all documents have been added, select save and navigate to the next tab.

When the item is ready for review, it must be submitted in the KC system via the Protocol Actions tab.

  1. Click ►show on the Request an Action panel.
  2. Click ►show next to Submit for Review.
  3. Click submit.
  4. If you do not receive a confirmation notification, then you have not submitted your study.
    1. Additionally your submission’s status will change from “pending/in progress” to “Submitted to IRB.”

Contact the IU Human Research Protection Program

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 856-4242