Protocol Type

This is the level of review the protocol likely will require; however, the final determination is made by the IRB prior to review. Select one of the following options:

• Deferral (for independent IRB review and other requests to defer);

• Emergency Use;

• Exempt;

• Expedited;

• Full Board;

• Humanitarian Use Device (HUD); or

• Not Human Subject Research (for Non-Human Subjects Research and Non-Research Student Projects)

When you create the KC Protocol, the system defaults to Protocol Type = Exempt. Click on the drop-down menu arrow to display the list, then select a value in the list for the applicable type.

Title

Click within the text box to type or paste the study title. Click the add note  icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. 

It is best to type the Title in manually. Special characters, such as copyright symbols, do not copy and paste well in KC IRB.

Principal Investigator

If you know the username of the PI, you can type the username into the field. Otherwise, click the lookup icon to search for and return the value to populate the Principal Investigator. The display of this selection becomes read-only after saving.

• The person designated as the PI must have an IU User ID. If the PI you wish to designate does not have an IU User ID, please refer to Accessing KC IRB at: https://research.iu.edu/compliance/human-subjects/submissions/kc-irb.html to obtain one.

Lead Unit

This defaults to  the primary home unit of the PI, as defined in the KC Person table. It is automatically populated after selection of the Principal Investigator. If a different unit should be listed as the lead unit, either type the unit value in the box and click the direct inquiry icon or click the lookup icon to search for and return the value to populate the box. This value becomes read-only after saving.