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.

Definitions

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, 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

Submit the “Proposed Human Subjects Research Assessment” form

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.

Contact untirb@unt.edu with any questions.