Research, as defined by the federal regulations, is the systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Systematic investigation – a plan for collecting data consistently and reliably.
- Generalizable – the impact of the research reaches beyond the research population, adds to a body of knowledge; a common test is whether the researcher plans to present or publish the data in a professional platform.
A human subject is defined as a living individual about whom an investigator (whether faculty or student) obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information.
- Note: Studies considering deceased individuals do not usually count as HSR. However, they may if information about a deceased individual can identify a living individual and put the living individual at risk.
The Office for Protection from Research Risks provides decision trees to help explain what constitutes HSR.
If you are unsure that your research qualifies as human subject research, please fill out our HSR determination form. (MS Word)