HRPP Policy - Kuali Protocols

System Access

Kuali Protocols is a cloud-based system protected by Central Authentication Service (CAS) and can be accessed only with an IU computing account (username and passphrase). Anyone with an IU computing account can access Kuali Protocols; however, only certain individuals (or groups) can access individual studies, called “IRB Protocols”, in Kuali Protocols.

Audit Trail

A history of actions taken on each IRB Protocol is maintained in the Activity Log. It contains the following in regard to the altered record:

• Description of action
• Username of person performing action
• Time/date of action 

Changes to IRB Protocol submissions can be made by individuals with Full Access permissions to the IRB Protocol and by individuals with the IRB Admin Role when the IRB Protocol is in the following statuses:

• Amendment in Progress
• Close Request in Progress
• In Progress
• In Progress (Withdrawn)
• Renewal in Progress
• Returned to Researcher
• Revisions in Progress
• Revisions Required
• Withdrawn 

All changes made to the IRB Protocol while in an editable status are tracked in the system and a history of the changes can be viewed via the Compare Versions function in Kuali Protocols. 

Additionally, designated individuals with the IRB Admin Role have the ability to edit the approval date information associated with an IRB Protocol submission via the Approval Update action. This action is used to correct an error made in assigning an incorrect approval date, continuing review date, or expiration date during the approval process in Kuali Protocols.

IRB Protocols are created in Kuali Protocols by users taking the New IRB Protocol action.  Information required by the IRB or HRPP to review the IRB Protocol submission is collected in an online smart form maintained in Kuali Protocols and in attachments uploaded into the system. 

Detailed information about the form logic and specific questions are included in the Kuali Protocols Form Guides located on the HRPP Forms & Templates webpage. 

All actions related to each IRB Protocol, including information entered, documents attached, post-approval submissions and actions, correspondence generated, HRPP and IRB notes, and history and status are stored together electronically within the Kuali Protocols record for each research protocol.

Expedited and Full Board studies and Reliance Requests that were active (approved) in KC IRB were migrated to Kuali Protocols in January 2021. Additionally, Exempt studies and Not Human Subjects Research submissions approved in 2020 were migrated to Kuali Protocols.

Exempt and Not Human Subjects Research approved prior to 2020 and studies that were closed in KC IRB can still be viewed in KC IRB with read-only access for researchers.  Read-only access to KC IRB will be maintained for at least three years from January 2021.

Kuali Protocols accommodates various types of IRB Protocol submissions, including:

• New Protocol Applications:
  • Emergency Use
  • Exempt
  • Expedited/Full Board
  • Humanitarian Use Device (HUD)
  • Not Human Subjects Research
  • Request to Rely on a non-IU IRB
• Amendment
• Renewal
• Reportable Event
• Request to Close 

IRB and/or HRPP review of each IRB Protocol submission is conducted in Kuali Protocols.  Upon completion of review, the IRB or HRPP’s decisions and determinations are recorded for each IRB Protocol Submission in Kuali Protocols. System actions taken and documentation produced include the following:

• Not Human Subjects Research
  • Qualified HRPP staff member takes the NHSR action, indicating they have reviewed the submission and determined the submission does not meet the definition of human subjects research and therefore does not require further review.
  • A notification of the determination is generated by Kuali Protocols and sent to individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab.
• Request to Rely on a non-IU IRB
  • Qualified HRPP staff member takes the Approve External Reliance action, indicating they have reviewed the submission and determined the research is appropriate for reliance on a non-IU IRB.
  • An Approval Letter is generated by Kuali Protocols and individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab receive notification of the approval.
• Exempt Research
  • Qualified HRPP staff member takes the Approve action, indicating they have reviewed the submission and determined that the study meets the requirements of the IU HRPP Policy on Exempt Research and any applicable regulations.
  • An Approval Letter is generated by Kuali Protocols and individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab receive notification of the approval.
• Expedited and Full Board Research
  • An IRB Chair, IRB member, or designee, takes the Approval action, indicating the IRB member, or the convened IRB, has reviewed the submission and determined the study meets the requirements of the IU HRPP Policy on IRB Review Process and any applicable regulations.
  • An Approval Letter is generated by Kuali Protocols and individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab receive notification of approval.
• Humanitarian Use Device (HUD)
  • An IRB Chair, IRB member, or designee, takes the Approval action, indicating the IRB member, or the convened IRB, has reviewed the submission and determined the study meets the requirements of the IU HRPP Policy on Humanitarian Use Devices and any applicable regulations.
  • An Approval Letter is generated by Kuali Protocols and individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab receive notification of approval.
• Emergency Use
  • Qualified HRPP staff member takes the NHSR action, indicating they have reviewed the submission and determined the use complied with FDA requirements and the requirements of the IU HRPP Policy on Emergency Use of Investigational Test Articles.
  • A notification of the determination is generated by Kuali Protocols and sent to individuals appearing in the Personnel list with Full Access and all individuals listed in the Permissions tab.