National Institutes of Health (NIH) defines
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Clinical Research as:
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.
(1) Patient-oriented research. Research conducted
with human subjects
Human Subject (or on material of human origin such
as tissues, specimens and cognitive phenomena) for which
an investigator (or colleague) directly interacts with human
subjects. Excluded from this definition are in vitro studies
that utilize previously collected human tissues that cannot
be linked to a living individual. Patient-oriented research
includes: (a) mechanisms of human disease, (b) therapeutic
interventions, (c) clinical trials, or (d) development of
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
(2) Epidemiologic and behavioral studies.
(3) Outcomes research and health services research.
You will want to determine if your study meets the definition
for human subjects research, which is not the same as clinical
Health and Human Services(HHS) regulations (45
CFR Part 46.102) define a human subject as a living
person with whom an investigator conducts research:
a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage
- To obtain data through intervention or interaction with
a person or
- To obtain identifiable private information.
HHS has provided Human
Subject Decision Charts to help you determine whether
your research involves human subjects or could be considered
exempt. If your research meets the criteria for human
subjects research, you will find the remainder of the information
on this site helpful in your preparation, conduct and management
of your study.
In 2008, the Office for Human Research Protections ( OHRP
Office for Human Research Protections (OHRP) )
offered further Guidance
on Research Involving Coded Private Information
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage
Coded Private Information or Biological
Information for which a person can expect that observations or recording are not taking place, and the information will not be made public. Information must be individually identifiable to constitute human subjects research.
Identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol.
Many questions about human subjects and cell lines, repository
specimens/data, proposals with subprojects or exemptions
from human subjects research are answered in the FAQ’s
from Applicants presented on the NIH Office for Extramural
Research ( OER ) Human
Subjects Web Site.
FAQs on Investigators Responsibilities
of Federal Regulations Protection of Human Subjects
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov