Initiating Your Study

IRB Submissions

IRB—The Institutional Review Board (IRB) is responsible for reviewing research submissions that involve human subjects and assess that it adequately meets the criteria for approval set forth by the federal regulations, state law, and OU policies and procedures. All studies involving human subject research need to be submitted to the IRB for approval. If you are unsure if your study needs IRB approval, please submit a Determination of Human Research Form located in iRIS. Instructions on completion of this form are found here.

You will need several items prior to IRB submission. You will need a list of all personnel that will be working on the study and their duties, information regarding any outside collaborators (Including FWA number for their institution if applicable), your protocol, Informed Consent, HIPAA waivers, any additional study documents, and any other forms which you can review here.

Your Research Study may qualify to be Expedited or Exempt. Review the criteria to determine if your study meets these qualifications. If not, the study will go to the Full Board for review. Verify if these forms are up to date. If you have any question of whether your project is human research and needs to be submitted for IRB review, complete a Determination of Human Research Form found here.

Here is a flow chart for the IRB Submission process. This helps in being prepared for study submission to the IRB.

Human Subject Research Education Requirements

Please review the IRB Education page for additional information regarding requirements here. Any personnel listed on the IRB must complete their CITI Training (uses OUHSC email account) and have completed or be registered to complete the in-house IRB training.

Please also refer to the HIPAA Compliance website to ensure you are diligent in following HIPAA Practices.

Approvals Involving Cancer Research

Other approvals may be required, depending on the type of study you are doing. If your study involves cancer, please complete the forms provided by the Clinical Trials Office on their Protocol Review Page. You will complete the Protocol Notification Form and the Protocol Review Form. You will need to include the protocol, additional grant or budget information, the Informed Consent, HIPAA and any other relevant documents. Once you receive the approval from the SCC you can submit to the IRB. Ensure you attach your approval along with your IRB Application.

Approvals Involving VA Patients

If your study involves recruitment of patients at the VA Medical Center, you will need approval from the VA Research and Development Committee.

Other Regulatory Approvals

You also may require further approvals if your research incudes Radiation Safety, Institutional Biosafety, or if it is an Investigator Initiated study involving drugs or devices (will also need FDA Approval). Ensure that the study goes through the Office of Research Administration, if necessary.

Refer to the SOP on Emergency Use of FDA Regulated Products for instances for using test product on an individual in a life-threatening situation where there is no suitable treatment and no time to obtain IRB approval.

IACUC— The Institutional Animal Care and Use Committee is responsible for overseeing the University’s animal care and use program and reviewing all animal use protocols involving live vertebrate animals, ensuring compliance with federal animal welfare regulations, inspective animal facilities and investigator laboratories, investigating animal concerns, and overseeing training and educational programs.

VA Research

Under development