KC IRB Reliance Request

Quick Guide: Submitting a reliance request

Applies to: New Studies

Learn How To Create a New Protocol

The KC IRB Protocol is setup using a system of tabs. Within each tab are "folders", which contain bits of information about the research protocol. Expand the sections below to see tab specific instructions.

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: Reliance Request
  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 the Tab key, which will populate the PI Name and Lead Unit; OR
    2. Click the magnifying glass button, 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: (For studies that involve an IDE/IND ) Click ►show
    1. FDA IND or IDE #: Enter IND or IDE #, if applicable; if none, leave blank. If multiple INDs/IDEs, separate with semicolon.
    2. IU or Investigator held IND/IDE? Y/N: If there is an IND/IDE, enter Y or N to identify whether IU or the investigator holds it.
    3. No information should be entered in the remaining fields in this section.
  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: IU-affiliated research personnel.
    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 the "return selected" button. 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 the “add” button. For additional information about how to add funding sources, refer to the Quick Guide: Adding Funding.
  7. Participant Types: You do not need to provide information on this panel.

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. To add additional personnel:
    1. Search for individuals using IU User ID first, even if you think the individual may not have an IU username. Click the magnifying glass icon next to IU User ID Search. This will open a search window.
      1. If known, enter the person’s User Name (this is the fastest search)
      2. If unknown, search by another value, such as Last Name, using an “*” (e.g., Johnson*).
      3. Click search
      4. Click return value next to the appropriate person. This will populate the person’s name in the Add Person section on the Personnel tab.
      5. Select the dropdown menu from the Protocol Role field. Available roles include: Key Personnel; Non-Key, Interacting; Non-Key, Not Interacting, Site Specific PI; Student, Fellow, Resident PI (you should not choose the Principal Investigator option at this time).
      6. Click “add person”
    2. If the person is not found via the IU User ID search, click the magnifying glass icon next to the No IU User ID Search.
      1. Enter the person’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*”.
      2. Click “return value” next to the appropriate person. This will populate the person’s name in the Add Person section on the Personnel tab.
      3. Select the dropdown menu from the Protocol Role field. Available roles include: Key Personnel; Non-Key, Interacting; Non-Key, Not Interacting, Site Specific PI; Student, Fellow, Resident PI (you should not choose the Principal Investigator option at this time).
      4. Click “add person”
    3. If you do not find the person via No IU User ID Search, please refer to the Quick Guide: Address Book to add the person to the KC Address Book.
  3. Click ►show on the person’s folder, then click show on Person Details tab.
    1. Confirm Protocol Role. If an incorrect role was previously selected, choose the appropriate role from the drop-down and click “update view.”
    2. Confirm Affiliation Type.
      1. If the person was added using the IU User ID Search, the Affiliation Type will auto populate to IU. This is the correct Affiliation Type for IU faculty, staff, and students.
      2. If the person is not an IU faculty, staff, or student, but is a member of an affiliated organization, e.g., IU Health, Eskenazi Health, Roudebush VAMC, choose Affiliated.
      3. If the person was added using the No IU User ID Search, choose Non-Affiliated.
    3. Confirm that Investigator Requirements are complete. The Personnel tab allows users to see whether investigators added using the IU User ID Search have completed the required training. All investigators must complete applicable requirements before the submission can be approved.
      1. If an investigator appears in Green then they have completed the training requirements.
      2. If an investigator appears in Red then the investigator is missing a requirement. The system will identify what requirement is missing.
      3. Investigators that appear in Purple have completed requirements and has a documented disclosure with the COI office.
      4. Investigators added using the No IU User ID Search appear in Black and requirements will need to be verified manually.
  4. For investigators identified as a Site Specific PI role and Non-affiliated, there are additional requirements:
    1. Click show on the Attachments section
    2. Select Curriculum Vitae from the Attachment Type dropdown list, upload the CV of the site specific PI and enter a description. Click add.
    3. Select Site Specific Personnel List from the Attachment Type dropdown list, and enter a description. Click add.
  5. Conflict of Interest Questionnaire: Once all personnel have been added and all personnel are green and/or black, the Conflict of Interest Questionnaire should be completed below.

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 Reliance Request panel
    1. Depending on the specific question and your answer, additional questions may appear. For example, checking the box for submission to a qualified independent IRB will open additional questions regarding the specific IRB to be used and any associated requirements to be met. Be sure to select the “Update” button to ensure you get all questions as you answer questions in the questionnaire.
  2. Click ►show on the M-ClinicalTrails.gov panel:
    1. Select all applicable options. Select update.
  3. Click Save and continue.

  1. Click on the Notes & Attachments tab.
  2. Click ►show on the Protocol Attachments folder to attach the required study documents (Refer to the Human Subjects Office website for a list of the required documents for the appropriate deferral type).
    1. Select an Attachment Type from the drop-down list.
    2. Enter a Description that will help you identify the document, e.g. ICS for parents. 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 search.
      • 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. Submission Type: Initial Protocol Application
  4. Submission Review Type: IRB Review not required
  5. Type Qualifier: select (Do Not Complete)
  6. Click submit.

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