Empirical research re
World Health Organization
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/).
NIH (National Institutes of Health)
“According to 45 CFR 46 , a human subject is “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” (NIH, https://grants.nih.gov/policy/humansubjects/research.htm).