Does your research project involve studying people? If so, there may be some additional steps you need to take before you get started. When human subjects are involved in a research study there is a set of federal regulations and guiding ethical principles that need to be observed. Before getting started here are a couple of important definitions that will guide the decision process.
Research
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(l))
Human Subject
A living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e)(1))
If the work you are planning meets these two definitions, then you may be required to conduct your work in accordance with 45 CFR 46, more commonly known as the “Common Rule.” Such research must be approved by the Committee on the Use of Human Subjects in Research (CUHSR), Missouri Western’s Institutional Review Board (IRB). The process for submitting a research protocol to the IRB is described on the CUHSR website.