Recent TU Research Community Notices
- Notice of EU GDPR as it applies to research with human subjects (v1.9.2020)
- New Forms and Updates on the TU IRB Webpage (8-8-2019)
- 2018 Common Rule (1-21-2019)
For more details about the changes that went into effect on January 21, 2019, please see 2018 Common Rules and Regulations.
Removal of COVID-19 In-Person Human Subject Restrictions
As a reminder, effective August 2021, The University of Tulsa determined that human subjects research could return to previous in-person procedures. Hence, the revised TU procedures for in-person human subjects research enacted due to COVID-19 are no longer required.
If you modified your protocol (expedited or full board) to incorporate required COVID-19 procedures and want to revert to previous procedures, please contact Debbie Newton at 631-2192 or email@example.com to determine what paperwork may need to be filed (e.g., previous consents may have expired). The IRB goal is to minimize work for PIs but assure compliance.
Please note that while the IRB COVID-19 procedures have been removed, human subjects that visit campus will still have to follow any local or institutional COVID-related policies in effect at the time of their visit.
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
- Monday, February 27, 2023
- Monday, March 27, 2023
- Wednesday, April 26, 2023
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.
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
- The General Data Protections Regulation (GDPR) Frequently Asked Quests (FAQs)
- TU Research Ads – Guideline
- 2018 Common Rule Frequently Asked Questions-FAQs v7-8-2021
- 2018 Common Rule Regulations
- TU IRB Process Chart-2018CR-for PIs 1.9.2020
- 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
- EU GDPR Consent and Notice Requirements v 9.3.2019
- TU General Informed Consent Form
- TU Online Informed Consent Form
- TU Parental-Guardian-LAR Informed Consent Form
- TU Minor Assent Form
- TU Debrief and Second Informed Consent 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. *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, “Students -Classroom Projects”.
To determine if a project meets the QA/QI criteria, please see the guidance materials below.
- TU IRB QA-QI Template
- TU QA-QI – Classroom Project TRN CITI
- QA.QI v. HSR Training PowerPoint
- TU IRB QA-QI Process
- Guidance on HSR v. QA-QI
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
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