Forms

Determination Forms

This process is not required unless an Investigator desires an official determination from the IRB stating their project is not human subject research and IRB approval is not required.  It is also available to investigators who are unsure if their project requires IRB approval and wish for the IRB to make a determination prior to the investigator developing a full protocol for submission and review by the IRB.  If you already know that your project is human subject research which requires IRB approval there is no need to submit an HSR determination form.

A request for determination as to whether a project is "research" or involves "human subjects" can be made to the IRB by completing and submitting one of the HSR determination forms. All official IRB determinations regarding whether a project does or does not constitute "human subjects research" must be submitted by the investigator and reviewed by the IRB in this manner.

• Request for Determination of Human Subjects Research
• Request for Determination of Human Subjects Research: Stem Cell Research

Project or Protocol Approval Forms

These forms are used to request IRB approval for projects.  The Exempt form is only used for requesting determination and review of projects that meet the “Exempt” requirements.  The Protocol Review Form is used for projects requiring Full Board or Expedited Review.  In addition to completing the form, most projects will require the attachment of additional documents which vary depending on the project.  The necessary attachments are described in the forms. Please see the Sample Documents section of our website for examples of common attachments.

• Exempt Form As of July 26, 2021, the EXEMPTION application form is a WORD document. Currently the WORD form requires manual application of required signatures.
  
  The Federal Policy for the Protection of Human Subjects, known as the Common Rule, has undergone substantive revisions for the first time since publication in 1991.  The effective date for the revised Common Rule was January 21, 2019.  A request for determination that a project meets “exempt” categories falls under 45 CFR 46.104.  Exempt projects are subject to IRB review in accordance with principles and guidelines for the ethical conduct of human subject research.
   
• Protocol Review Form (Full Board and Expedited Review) Submission to the IRB for Full Board or Expedited reviews of human subject research.

SINGLE IRB Forms

• Ceded Review Application Form (when AU is a study site and will rely on an external IRB)
• Institutional Review Board Authorization Agreement
  
  (Single IRB materials under construction)

Continuing Review Forms

• Request for Renewal: Request for additional time to complete an approved project.
  • Must be submitted prior to the expiration date of IRB approval and with sufficient time for the IRB to review and respond to the submission before the current IRB approval expires.
  • Not required for EXEMPT projects.
     
• Request for Modification: Request for changes to an approved project/protocol.
  • IRB review and approval must be obtained prior to implementation of the change(s).
  • Required for Full Board and Expedited Protocols.
  • Required for Exempt projects.
     
• Final Report: Required to close Full Board and Expedited Protocols.
  • May be filled after all research data has been collected and all identifiers destroyed.
  • Renewals should be filed as long as the researcher maintains identifiable data.  Limited exceptions apply.
  • Not required for Exempt projects.
     
• Personnel Modification:  Request for personnel changes to an approved protocol.
  • IRB approval must be issued prior to any modifications to an approved protocol being implemented.
  • Required for all levels of research.

Reporting Forms

• Non-Compliance Reporting:  For reporting non-compliance or adverse events to the IRB
  • All noncompliance must be reported to the IRB.
  • May be reported by anyone, including the Principal Investigators, members of a research team, or research participants.
  • Noncompliance refers to acts of commission or omission which result in the conduct of human subjects research that is inconsistent with the federal, state, and/or local laws or institutional requirements (including the AU IRB or other IRBs associated with the project)
  • See the Non-Compliance Reporting Form for examples and more information.
• Event Notification: For reporting any event to the IRB other than non-compliance or adverse events
  • May be reported by anyone, including the Principal Investigator, members of a research team, or research participants.
  • See the Event Reporting Form for examples and more information.

Other Forms

• Anonymous Data Collection Assurance:
  • The IRB will determine during review of your protocol if this form is required.
  • It will be required by the IRB and included with your protocol revisions when conducting surveys within SONA that collect data which with electronic data collection are considered greater than minimal risk.  The documentation is required for further protection of participants.
• AU HIPAA Authorization:
  • Use of the AU HIPAA Authorization is ONLY required when HIPAA-covered entities will use or share health information which identifies participants.  If applicable, add the HIPAA Authorization form as the last page of the consent form, including the HIPAA Authorization form in the total number of pages.  Participants must complete the signatures section at the bottom of the form.  Explaining the purpose of the form can occur during the consent process.