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Advances in human health and welfare ultimately depend on research with human subjects. Properly controlled studies with human subjects are essential to verify any conclusions about normal physiology, mechanisms of disease, effectiveness of treatment, learning, or behavior.

Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.

Human Subjects Mechanistic and Minimal Risk Studies (R01 Clinical Trial Optional) Those that are NIH-defined clinical trials and are designed to address either: 1) mechanisms underlying human vision in health and disease; or 2) interventions that entail procedures with minimal risk to subjects.

, 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.

Code X4—Exemption category 4—secondary research involves the collection or study of identifiable private information or biospecimens, if the sources are publicly available, the information is recorded so subjects cannot be identified, the information collection and analysis is regulated under HIPAA, or the research is ...

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.

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

"Human Subjects Protections" is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research.