Human Subjects Research is research that investigates humans–either by observing them or by engaging them in some sort of experimentation.
The World Health Organization defines Human Subjects Research as “any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:
- are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment; or
- become individually identifiable through investigator’s collection, preparation, or use of biological material or medical or other records” (WHO, https://www.who.int/ethics/research/en/).
The NIH (National Institutes of Health) defines human subjects as “. . . a living individual about whom an investigator (whether professional or student)
- 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” (NIH, https://grants.nih.gov/policy/humansubjects/research.htm).
When an investigator aims to go beyond informal research methods and hopes to generate new knowledge and share it with the world via various media and genre, then the investigator must seek approval of an ethics panel–i.e., an Institutional Review Board.
In the United States, investigators who conduct Human Subjects Research must submit their research protocols to IRB (Institutional Review Board) for review and approval before engaging in any research.