Determinations for Research on Human Subjects
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.
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, in this case Research Integrity and Compliance staff and the IRB members, 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 a study meets the federal definition of human subjects research and requires IRB approval. 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.
Quality Improvement Activities
Quality improvement (QI) activities are an important part of the University of North Texas operations. QI activities are data-driven, often involve human participants, and can overlap with research practices common to human subjects research. It is important to assess QI activities to see if the federal regulations that protect human research participants may apply.
It is always vital that, regardless if your activity is deemed to be a QI or research activity, that it is performed in an ethical and respectful manner that protects the rights and welfare of the human participants. If you believe you have a Quality Improvement (QI) or Quality Assurance (QA) activity, please complete the assessment form below to identify if IRB submission and approval will be required. It is important to receive an assessment form review from the IRB prior to beginning your QI or QA activity to ensure you are following all regulations with respect to human subjects.
Making a Determination
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. Investigators are responsible for obtaining IRB assessment and/or approval prior to beginning any research activities.
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