Is my study considered clinical research?
The NIH defines
Clinical Research as:
(1) Patient-oriented research. Research conducted
with human subjects (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
(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
research. HHS regulations (45
CFR Part 46.102) define a human subject as a living
person with whom an investigator conducts research:
- 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 )
offered further Guidance
on Research Involving Coded Private Information or Biological
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