The TUN Institutional Review Board (IRB) exists to provide protection for human subjects who participate in research. The main focus of the IRB is to review applications to identify the risks which may exist for potential research participants.
All studies that involve human subjects must apply for IRB approval or Exempt determination. Questions about the IRB application process or human subject research at TUN should be directed to TUN.IRB@tun.touro.edu or (702) 777-4784.
A Research Registration Form must be submitted for every research project affiliated with TUN, even if IRB approval is not required.
IRB Forms and Documents:
TUN IRB ManualFull/Expedited IRB Application FormExemption Determination FormConflict of Interest FormContinuing Review FormAmendment Request FormReporting Deviations FormAdverse Event FormCloseout Report FormAddendaIRB Basics PowerPoint PresentationExamples of Consent FormsInstructions for CITI training
TUN IRB Manual – Institutional Review Board manual.
Full/Expedited IRB Application Form – Application for IRB approval.
IRB Exemption Determination Form – Complete this form to determine if your study is EXEMPT from full IRB review. If you are unsure if your study requires full IRB review, please use the checklist on this form to help you decide.
IRB Conflict of Interest Form – You are required to complete this form and attach to your IRB application.
IRB Continuing Review Form – Complete this form at least 1 month prior to the expiration of your IRB approval if you wish to renew your IRB approval. This is typically warranted if you have made no changes to your study procedures, are still collecting data, or are still recruiting participants.
IRB Amendment Request Form – Complete this form to request an amendment to your already approved study protocol. Do not change your procedures until the amendment has been approved by IRB.
IRB Reporting Deviations Form – Complete this form if any part of your study procedures deviated from the approved protocol. You must report the deviation as soon as you are aware of the change. If the deviation was an adverse event you must complete the IRB Adverse Event form.
IRB Adverse Event Form – Complete this form if an adverse event occurs during any part of your study procedures. You MUST report any and all adverse events to IRB as soon as you are aware of the occurrence. In some situations it is advisable to personally contact the Chair of IRB as soon as the adverse event occurs.
IRB Closeout Report Form – Complete this form at least one month prior to the completion of your study and before the expiration of IRB approval.
- Addendum 1 – Expedited Categories and Determinations
- Addendum 2 – Research with Children
- Addendum 3 – Research with Prisoners
- Addendum 3A – Research with Prisoner Data Sets Collected for Purposes Other than Research
- Addendum 4 – Alteration or Omission of Elements from Informed Consent Process
- Addendum 5 – Waiver of Documentation of Informed Consent Process
- Addendum 6 – Waiver of Informed Consent Process
- Addendum 7 – HIPAA Authorization Form and Appendix A
- Addendum 8 – Investigational Drugs, Other Drugs, and Devices
- Addendum 9 – Blood, Tissue, Bodily Fluids, or Other Biological Specimens
- Addendum 10 – Confidentiality Agreement
IRB Basics PowerPoint Presentation – This presentation was created to answer basic questions about the TUN IRB. Please refer to the TUN IRB Manual for a comprehensive explanation of IRB policies and procedures.
Examples of Consent Forms – Guidelines for constructing various types of consent forms.
Instructions for CITI training – How to log in, register, and load the appropriate training for different types of research.
IRB Meeting Schedule:
The TUN IRB meets on the second Wednesday of each month at 9:00 am.