Getting Information & Help

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.

HHS Office for Human Research Protections

Regulation decision charts that are useful in making decisions regarding your study.

Regulations and Policy Pages

Compliance and Reporting

Education and Outreach

Certificates of Confidentiality are documents issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. Certificates of Confidentiality allow investigators and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates can be used for biomedical, behavioral, clinical or other types of research that is sensitive and could adversely affect or damage a subjects' financial standing, employability, insurability, or reputation. Certificates of Confidentiality may be issued to any research study on a sensitive health-related topic that collects names or other identifying information even if the research is not funded by NIH. You can also reference the NIH site for Certificates of Confidentiality.

United States Food and Drug Administration

OUHSC Policies/SOP on the FDA—Refer to the University guide for the SOP on the FDA to ensure regulations are being followed appropriately.

Clinical trials guidance and information

FDA responses to questions on Good Clinical Practices. The areas are sorted by section the question pertains to, and then sorted by year.

Electronic FDA Submission guidance. This page offers guidance and additional links as well as answers to Frequently Asked Questions.

Drugs must have an approved marketing application prior to transfer or distribution across state lines. For trial drugs, they must obtain exemption from this law. This is done through the IND application. This page also discussed the types of IN and the IND Categories. If your product is a device you will have to go through the process for the IDE. Please also see the IDE Policies and Procedures.

The FDA guide to IND or IDE exemption. IND/IDE authorization or exemption must be obtained prior to drug or device being administered (and is not the subject of an approved New Drug application or License Application).

The FDA required a Form 1572 be completed for Sponsored Trials. Instructions for filling out this document are here. This form, along with other FDA forms can be located at the FDA site, here.

Patients may also have questions regarding research or treatment. They can refer to the FDA to learn about Expanded Access and Other Treatment Options.

Clinical trials must follow FDA Regulations. A listing of the Regulations is provided by the FDA on the FDA website.

Clinicaltrials.gov

Research studies may be required to be registered on clinicaltrials.gov. Their website has a helpful guide to help you determine if your trial should be registered. The International Committee of Medical Journal Editors (ICMJE) also provides additional answers to questions about clinical trial registration.

In order to register your trial you must first apply for an account at clinicaltrials.gov. Then you can follow the instructions on How to Register Your Study.

Other Federal Agencies

Other federal agencies have their own rules or regulations in addition to the Common Rule. These requirements have to be met when reviewing, approving and conducting research when supported by these agencies. Please review the SOP on Other Federal Agencies for specific regulations each of these other agencies may follow to ensure that your project meets all requirements.

Hold for GCA

Under development