The Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46 defines a human subject as: 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.
Your research may fall under the umbrella of human subjects research even if your research doesn’t involve direct interactions with humans. Federal requirements to protect human subjects may apply to research on human specimens (such as cells, blood, and urine), residual diagnostic specimens, and medical information. Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are identifiable is considered “research involving human subjects.” Some research may qualify for an exemption from federal regulatory requirements but is still considered to be human subjects research.
Am I Doing Human Subjects Research?
The NIH Office of Extramural Research (OER) has developed a quick decision tool that can assist investigators with determining whether research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research.
If you have questions about whether your application involves human subjects, consult with your NIH Program Official or ask your institutional review board (IRB) or independent ethics committee (IEC).
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- Identifiable biospecimen is a biospecimen for which the identity of the subject is or may be readily ascertained by the investigator or associated with the biospecimen.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Types of Human Subjects Research
- NIH- and NIDCR-funded Human Subjects Research
- Conducting NIH- and NIDCR-funded Clinical Trials
- Clinical Researcher Toolkit & Educational Materials
- Contact Us
- 45 CFR Part 46.102