Accessible Search Form           Advanced Search

Skip left side navigation and go to content

CRG Home

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 new technologies.

(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.

Other resources:
In 2008, the Office for Human Research Protections ( OHRP ) offered further Guidance on Research Involving Coded Private Information or Biological SpecimensDownload PDF file..

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

Code of Federal Regulations Protection of Human Subjects

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

Twitter iconTwitterimage of external icon Facebook iconFacebookimage of external icon YouTube iconYouTubeimage of external icon Google+ iconGoogle+image of external icon