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Human Subjects Research

The Office of Research will hold two training sessions via Zoom and will be recorded for later viewing if you cannot attend. Zoom Trainings will take place on January 6th & 7th, 2022 at 10am- 12pm (may not take full two hours). If you would like to join either session please send an email to IRBSubmit@tcu.edu with the subject heading Cayuse HE Training RSVP and the date you want to attend. We will forward the invite to you.

What you need to know?

  • The Office of Research requests that all new submissions be placed on hold starting December 17th until the January 10th launch at which point you can create your new study submissions in Cayuse HE. If you need to submit an annual check-in, continuing review, incident report, or a time sensitive amendment you may do so by submitting to IRBSubmit@tcu.edu.
  • All faculty and staff accounts have already been created and you will be able to login starting on January 10th.
  • All students who plan to conduct research as a Co-Investigator, Primary Contact, or as a member of the study team you may request access to Cayuse by completing the Request Access to Cayuse Office of Research staff will create your accounts and you can expect a 24-48-hour turnaround time.
  • For Volunteer Faculty Mentors of the TCU School of Medicine, who are not technically TCU (No TCU ID#) and will serve as Principal Investigator on behalf of a medical student, you may request guest access to Cayuse by completing the Request Access to Cayuse

What about currently approved studies?

All currently approved human subject research studies deemed Exempt before January 10, 2022, will continue to submit modifications and study closures by submitting to IRBSubmit@tcu.edu. These studies will not be migrated into Cayuse HE.

All currently active Full Board and Expedited studies (Legacy studies) will be migrated into Cayuse HE. Your legacy study shells will be created for you and your most recently approved study documents will be uploaded for you and available to download.

Please be reminded our office will be closed during the winter break and we will not process any submissions from December 22nd– January 4th.

TCU is committed to fostering an environment that promotes the adherence to applicable law, ethical principles, and professional standards while pursuing knowledge through research and scholarly activities. The Office of Research Compliance and Training furthers this commitment to compliance by assisting TCU researchers with meeting professional, regulatory, and university requirements.

Investigators must assure that each member of the research team carries out all research procedures in accordance with ethical principles of research. These principles of Justice, Autonomy and Beneficence were set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” known more commonly as the Belmont Report, and codified as regulations in Title 45 Code of Federal Regulations Part 46.

Investigators are strongly encouraged to read these and other relevant documents available at the U.S. Dept. of Health & Human Services Office for Human Research Protections (OHRP) policy guidance and international issues web sites.

As an integral part of ethical conduct of research, federal guidelines require an independent review of protocols involving human subjects before an investigator can begin the study. This independent review process provides an unbiased evaluation of the risks, promotes the safety of research participants and documents that the research, when conducted as approved, will be in accordance with federal regulations. At TCU, the Office of Research Compliance and the Institutional Review Board (IRB) serve this independent review function.

It is the policy of TCU that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University’s Institutional Review Board (IRB).