The use of human participants in research is extremely important to the development of new knowledge in many areas. However, careful attention must be given to the questions of ethics and human dignity whenever human subjects participate in research.

It is the policy of The University of Tulsa to require that all research activities by faculty, staff and students involving human participants follow the procedures and guidelines established by the Institutional Review Board (IRB) at The University of Tulsa as well as those established by the Department of Health and Human Services Office of Human Research Protections (OHRP). Regardless of the nature or degree of risk anticipated, the applicant must present in writing, and be prepared to defend in person before the IRB, detailed information on the following points:

1. The possible risks to the rights and welfare of human subjects, including the rights of privacy, freedom from undue harassment, and confidentiality of data; a description of the provisions made to minimize these risks must be provided.
2. Methods used to acquire informed consent, with special emphasis on their appropriateness to the particular situation inherent in the study plan.
3. The relative risks and benefits of the project.

The Institutional Review Board is composed of faculty, staff and lay members (both scholars and non-scholars) who are trained in the importance of academic freedom, the protection of the rights and welfare of human research participants, federal regulations about research ethics, and the ethical regulations of various funding agencies.

Student, faculty and staff are encouraged to contact the Coordinator of Research Compliance to receive help with the Human Subjects research issues and the IRB components of their research.

Mandatory IRB Training

TU IRB Policies and Procedures

• Institutional Review Board (IRB) Policies and Procedures
• Institutional Review Board (IRB) Payments to Human Subjects Policy

TU IRB General Application Forms

• TU IRB Application and Instructions
• TU IRB Annual Progress Report
• TU IRB Modification Request Form
• TU IRB Adverse Events/Problems Form
• TU HIPAA Release for Research Form

TU IRB Guidance and Reference Materials

• TU Research Ads – Guideline
• Frequently Asked Questions-FAQs-2018CR v1.22.18
• 2018 Common Rule Regulations
• TU IRB Process Chart-2018CR-for PIs 1.22.18
• List of Exempt Categories-2018CR
• Is This Human Subjects Research? -Checklist
• Classroom Project or Human Subjects Research? -Checklist
• Is this a Prisoner Study? -Checklist

TU IRB Informed Consent Form Options

• TU IRB Informed Consent Form Instructions
• TU General Informed Consent Form
• TU General Informed Consent Form SHORT
• TU Online Informed Consent Form
• TU Online Informed Consent Form SHORT
• TU Parental-Guardian-LAR Informed Consent Form
• TU Parental-Guardian-LAR Informed Consent Form SHORT
• TU Minor Assent Form
• TU IRB Broad Consent

TU IRB Payments to Human Subjects Forms

• Certification of Gift Certificates $25 or less
• Certification of Gift Certificates over $25
• Acknowledgement of Receipt (in excess of $25)

TU Student Course-Related Research Guidelines

Classroom projects that meet ALL the criteria for “Student Course-Related Research Projects”, need not undergo review by the IRB; however, instructors and students are encouraged to follow federal and university regulations when designing and conducting class projects with human participants.

To determine if a project is a “Student Course-Related Research Project” please see The University of Tulsa IRB policy:

• Student Course-Related Research Projects Policy

If in doubt or for additional information, please contact the Coordinator of Research Compliance for consultation.

Other Reference Links

Office of Human Subjects Protections FAQs

Clinical Trials Information

Definition of a clinical trial: a research study designed to test the safety and/or effectiveness of drugs, devices, treatments, or preventive measures in humans

Who is required to register on clinical trials.gov? Registration is required by law, Section 113 of the FDA Modernization Act mandates registration with ClinicalTrials.gov of investigational new drug efficacy trials for serious diseases or conditions and is also required by The International Committee of Medical Journal Editors (ICMJE) as a condition for publication of research results generated by a clinical trial. Other journals may follow these guidelines as well. The National Institutes of Health (NIH) is committed to providing information to increase public awareness and access to clinical trials sponsored federally and by industry foundations.

Contact: Carmen Schaar-Walden, Coordinator of Research Compliance, at 918-631-3310.