IRB Protocol Submission
*Please note: UNT is experiencing some system-wide issues with the Cayuse Human Ethics system. These have been reported to the Cayuse organization. You may experience some error messages and outages while using the Cayuse system. The IRB team has been notified that a system fix is set for 3/16/2021. Please reach out to email@example.com with any questions.
Plan in Advance
Please plan ahead to allow a sufficient amount of time for submission, review, and approval of your study. The current review timeline is posted in a message in the Cayuse system and will depend on the volume of submissions received by the IRB office. The turnaround time for IRB protocol approvals can be impacted by many variables and will vary throughout the year. Protocols are reviewed on a rolling basis, in the order that they are received. Protocols of greater complexity or risk will take more time to review. Please reach out to the office if you have questions regarding the posted review timeline. If the current review timeline will place undue burden on your research, please contact our team at firstname.lastname@example.org immediately to discuss the situation.
Protocols that are incomplete or lack details will be returned to the Principal Investigator (PI), further delaying the review and approval processes. Please review all of the IRB Resources for Researchers to assess the readiness of your study documents for review.
To request permission to proceed with in-person human subjects research during the COVID-19 University reopening, please follow this guidance.
Accessing Cayuse Human Ethics (formerly Cayuse IRB)
IRB Protocol Submission requires access to Cayuse Human Ethics (formerly Cayuse IRB), UNT’s electronic IRB submission portal. If you are new, please start at Step 1 to Request Cayuse Access. Current researchers who have previously logged into Cayuse successfully, please skip to Step 4 to Log into Cayuse Human Ethics.
Guidance for Submissions
Once you have successfully accessed Cayuse Human Ethics (formerly Cayuse IRB), please follow the guidance provided below to help you navigate the submission process. If you have any additional questions regarding the contents of your application or requirements for submission, please contact email@example.com
- Proposed Human Subjects Research Determinations
Research projects involving human subjects require review and approval by an Institutional Review Board. The IRB is responsible for assuring that the rights and welfare of human subjects in research are adequately protected. The UNT IRB is responsible for reviewing and overseeing human subjects research conducted by UNT faculty, staff, or students.
The first question an investigator should consider with respect to IRB review is whether the research project fits the federal definition of human subjects research.
- Research is defined as “a systematic investigation, including development, testing, and evaluation designed to develop or contribute to generalizable knowledge.” (45CFR46.102(l))
- “Generalizable knowledge” is information where the intended use of the research findings can be applied to populations or situations beyond that which was studied.
- The Belmont Report defines research as “an activity designed to test a hypothesis or answer a research question and permit conclusions to be drawn. Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.” (Belmont Report)
- Human Subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.” (45CFR46.102(e))
- “Intervention” includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- “Interaction” includes communication or interpersonal contact between investigator and subject.
- “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- “Identifiable private information” is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- “An identifiable biospecimen” is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Investigators are responsible for obtaining IRB approval before beginning any human subjects research that meets the definitions above. The Office of Human Research Protections (OHRP) recommends that institutions ensure knowledgeable individuals assist investigators in making the appropriate decision about the status of their project and ensure that an IRB reviews all studies that are determined to be human subjects research. Investigator must err on the side of caution and submit a “Proposed Human Subjects Research Assessment” form to determine if the study meets the federal definition of human subjects research. This process ensures that the requirement of obtaining IRB review and approval for applicable projects is satisfied as required by federal regulations. These decisions should be made by Research Integrity and Compliance staff and not individual investigators.
- Once the form is submitted, the Research Integrity and Compliance staff will determine whether your project meets this federal definition as outlined in the federal regulations, noted above. The staff will issue a formal response for your records and state if further action needs to be taken. These forms must be submitted, reviewed, and determinations issued prior to beginning research activity.
Contact firstname.lastname@example.org with any questions.
- Complete Training and Education
- New Study Submission
- IRB Review and Approval
- Submitting a Modification
- Closing a Research Study
If you have any questions regarding the content of the protocol submission, please contact the UNT IRB at email@example.com.
If you have any technical/access questions or technical issues, please contact CayuseAccess@unt.edu.