The purpose of an IRB is to review research conducted using human subjects. For the purposes of UNT’s IRB, human subjects research is defined as:
- Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to create generalizable knowledge. Generalizable knowledge means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature. (45CFR46.102(l))
- 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))
Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that meet the definitions of Human Subject and Research must be submitted for review and approval by the IRB.
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. Determinations must be made by Research Integrity and Compliance staff and not individual researchers. Student Researchers and Principal Investigators must reach out to the firstname.lastname@example.org to assist with these determinations. This process ensures that the requirement of obtaining IRB review and approval for applicable projects is satisfied as required by federal regulations.
Students should expect the IRB process to take at least one month. However, review times vary based on complexity of the research. Graduate students are encouraged to begin their discussions with their faculty advisor about the nature of their intended research and its potential IRB review as soon as possible.
Please reach out to email@example.com with any questions.