NEW! More Flexibilities for Human Subjects Research that is Determined to be Exempt
The TU IRB is working hard to lessen investigator and administrative burdens with minimum risk studies that meet one or more of the IRB Exempt Categories. On September 20, 2023, the TU IRB voted on additional flexibilities in the Common Rule for Exempt research.
Summary of TU IRB New Flexibilities for Exempt Protocols:
- “Exempt Research Checklist for PIs” to make preliminary determinations;
- Peer Review not required for Exempt protocols;
- Informed Consent Forms/Assent Forms and recruitment materials no longer need to be submitted;
- Flexibility in using oral or written consent and limiting the required information; and
- Exempt protocols only require a completed and signed TU Exempt Modification Request Form for changes (no longer requiring the revised IRB documents).
Frequently Asked Questions – FAQS
How will the Exempt Protocol Review Process Work?
Investigators who believe their proposed research may fit the Exempt criteria would complete the Exempt Checklist for PIs.→
The investigator preliminarily determines their study is Exempt.→
The PI completes the Exempt Application Form and follows the instructions, attaches the completed and signed Exempt Checklist, the completed and signed TU IRB Application form and a copy of the survey/interview questions/measures/research activities list to the TU IRB Office (without a Peer Review).→
The TU IRB Office conducts review (without a Peer Review or Consent/Assent Forms) and makes the final determination for Exempt Status.→
If determined Exempt, the TU IRB Office will send out the TU IRB Exempt Determination Letter
If determined Expedited or Full Board, the TU IRB Office will contact the investigator for additional documents to submit.
See the TU IRB Exempt Process Flow Chart.
What is the TU IRB training course requirement for Exempt research?
The TU IRB training requirement is the same for all human subjects research projects:
- Social & Behavioral Research –Basic or Refresher Course or
- Biomedical Research – Basic or Refresher Course
See Institutional Review Board Training.
Is there a different TU IRB Application Form for Exempt protocols?
Yes. The TU IRB Exempt Application Form with different instructions is on the TU IRB website. Once you complete the checklist and determine your study is Exempt, use the TU IRB Application for Exempt Research and follow those submission instructions.
Is there a different TU IRB Modification Request Form for Exempt Protocols?
Yes. The TU IRB Exempt Modification Request Form can be found on the TU IRB website. You will not need to submit the revised/new IRB documents with your highlighted/tracked changes with the completed/signed form. You will be reminded to revise your forms once your requested changes have been reviewed/approved, but the TU IRB Office will not need to see those revisions.
ALL EXEMPT RESEARCH FORMS ARE IN A NEW SECTION IN THE TU IRB WEBSITE BELOW!
If you have further questions please contact the Research Compliance Coordinator at email@example.com or 918-631-3310.
TU Human Subjects Research
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:
- 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.
- Methods used to acquire informed consent, with special emphasis on their appropriateness to the particular situation inherent in the study plan.
- 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.
Upcoming TU IRB Meeting Dates
- Thursday, January 25, 2024 (10:00 AM)
- Thursday, February 22, 2024 (10:00 AM)
- Thursday, March 28, 2024 (10:00 AM)
- Thursday, April 25, 2024 (10:00 AM)
- Thursday, May 23, 2024 (10:00 AM)
- Thursday, June 20, 2024 (10:00 AM)
Although the TU IRB posts the meeting dates for each current semester, meeting dates/times are subject to change. If you would like to confirm a meeting date/time, please contact firstname.lastname@example.org, 918-631-3310.
Mandatory IRB Training
NEW Exempt Research Forms and Information
TU IRB Policies and Procedures
TU IRB General Application Forms
TU IRB Guidance and Reference Materials
TU IRB Informed Consent Form Options
TU IRB Payments to Human Subjects Forms
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. *Students and their Faculty Mentors are encouraged to complete the CITI Training course, “Students – Classroom Projects.”
To determine if a project is a “Student Course-Related Research Project” please see The University of Tulsa IRB policy:
Quality Assurance/Quality Improvement (QA/QI) Project Guidelines
Projects that meet the criteria of Quality Assurance/ Quality Improvement (QA/QI), need to submit the completed TU QA/QI Form to the TU IRB Office for review and confirm that no IRB review is needed.
*Students and their Faculty Mentor conducting a QA/QI project are required to complete the CITI Training course, “Conducting Classroom Projects or Quality Assurance/Quality Improvement (QA/QI) Projects”.
To determine if a project meets the QA/QI criteria, please see the guidance materials below.
If in doubt or for additional information, please contact the email@example.com or 918-631-3310 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: firstname.lastname@example.org, 918-631-3310