Is research that meets the criteria for Exemption 4 considered human subjects research?
Yes. Research that meets the criteria for Exemption 4 is Human Subjects Research. Exemption 4 includes research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Please note: human subjects research that meets the criteria for Exemption 4 is not considered “clinical research” as defined by NIH; therefore, the NIH policies for addressing inclusion of women, minorities and children do not apply to research that is determined to meet the criteria for Exemption 4.
Related Questions
- Who, at my institution, is responsible for determining whether my proposed research involves human subjects but meets the criteria for one or more exemptions (46.101(b)) from regulatory requirements?
- What do I check for human subjects if my application describes research that meets the criteria for an exemption?
- Is research that meets the criteria for Exemption 4 considered human subjects research?
