KC IRB Humanitarian Use Device

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: Humanitarian Use Device
  2. Title: Enter the title of your study.
  3. Principal Investigator: Identify the Principal Investigator (PI) by:
    1. Entering the user Id in the box and pressing tab, which will populate the PI Name and Lead Unit; OR
    2. Click the magnifying glass icon, 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 research, i.e., any organization where subject records will be accessed, or where research related interactions and/or interventions occur. For more information on IU affiliated organizations, go to: https://research.iu.edu/compliance/human-subjects/guidance/affiliated-institutions.html
    1. Select the magnifying glass icon to take you to an organization lookup for a list of frequently used organizations. From the list, check the box or boxes for the organization(s) engaged in the research.
    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 research.
    4. Click return selected. All organizations checked will populate onto the Organizations panel on the Protocol tab.
  6. Funding Sources: All studies must have some kind of funding source listed.  If your study is not funded, select unfunded from the dropdown and click add. For additional information about how to add funding sources, refer to the Adding Funding Sources Instructional Guide.
  7. Participant Types: N/A as this is not a required field for HUDs.

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.

Study personnel are automatically assigned certain permissions based on the protocol role assigned to them on the Personnel tab. For more information about automatic permissions, please see the Quick Guide: Permissions.

If individuals who are not a part of the study team need to view protocol information, make submissions or request IRB actions, or receive protocol notifications, they must be designated as a Study Manager/Correspondent on the Permissions tab.

    1. Click ►show on the Humanitarian Use Device panel.
      1. Question ID #23396: Must be answered “No.” If you need to answer “Yes,” this study does not qualify as a Humanitarian Use Device.
      2. Depending on the specific question and your answer, additional questions may appear. Be sure to select update to ensure that you get all questions as you answer questions in the questionnaire.
    2. Click save and continue.

Specific documents are needed to receive approval for the use of a HUD, to see the list of these documents, please visit New Studies.

  1. Navigate to the Notes & Attachments tab.
  2. Click ►show on the Protocol Attachments folder 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.” Other fields that can be completed if needed, though not required for saving, are Contact Name, Email, Phone, and Comments.
    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 required documents.
  3. When all documents have been added, select save.

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