Protection of Human Subjects
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 (.doc file or .pdf file) 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
Classroom projects that are exclusively for instructional purposes 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. For additional information, please see University of Tulsa IRB policy on Student Course-Related Research Projects . If in doubt, please contact the Coordinator of Research Compliance for consultation.
The IRB committee is composed of faculty, staff and laymembers (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.
Application Procedure - .doc file or .pdf file
Application Form (.doc file)
Clinical Trials Information
Definition of 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.
Collaborative Institutional Training Initiative (CITI) Training Website*
*Please see the notes below before taking the training:
- In order to get into the training please Click on "New Users Register".
- Under the "Select your institution or organization" page select "The University of Tulsa" in the "Participating Institutions" drop down box.
- Create your own username and password.
- Select the learner group(s) that best fits you.
- If you need assistance contact Carmen Schaar Walden, Coordinator of Research Compliance at (918) 631-3310.
Office of Human Subjects Protection FAQs
Requirements of an Informed Consent Form - .doc file or .pdf file
Sample Informed Consent (.doc file)
Sample Assent Form for Children (.doc file)
Progress/Final Report (.doc file)
Student Course-Related Research Guidelines