Human Subjects - What is Human Subjects Research?
The IRB reviews human subjects research. The activity has to be considered "research" and has to involve "human subjects" for the IRB to review it.
The DHHS definition of research is "a systematic investigation. . . designed to develop or contribute to generalizable knowledge." Systematic investigations can include:
- surveys and questionnaires;
- interview and focus groups;
- analysis of existing data or biological specimens;
- epidemiological studies;
- evaluations of social or educational programs;
- cognitive and perceptual experiments; and
- medical chart review studies
Please note that research results do not have to be published or presented at a professional meeting to qualify the experiment or data gathering as research. From DHHS' perspective, the contribution to generalizable (widely applicable) knowledge makes an experiment or data collection research, regardless of publication.
In addition, a person cannot circumvent the DHHS regulatory definition of research by claiming that there was no intent to develop or contribute to generalizable knowledge. The IRB evaluates the investigator's proposed actions and behavior, rather than the investigator's intent, to discern the design of the activity.
For more information, please refer to the Human Research Protection Program Plan and the WORKSHEET: Human Research Determination. For example, the Human Research Protection Program Plan provides the FDA definition of "research" and the DHHS and FDA definitions of "human subjects." The Human Research Determination" worksheet can guide you through the analysis of whether an activity is human subjects research.
If you have questions about whether an activity is Human Research, submit a synopsis of the proposed activity to:
The IRB will provide a written determination.
As a reminder, you must not conduct human subjects research without prior IRB review and approval (or an IRB determination that the research is exempt).
