The National Institutes of Health (NIH) among other funding agencies require applicants to address protections and protocols for research involving human subjects and clinical trials.
Definition of Human Subjects Research
According to 45 CFR 46, human subjects research involves "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."
Definition of a Clinical Trial
A clinical trial, according to the NIH, is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. You can determine whether your project using the NIH Decision Tool. UO's Research Compliance Services also provides helpful guidance on clinical trials.
PHS Form Required for NIH Applications
The NIH provides a short video to walk applicants through Public Health Services or PHS form needed for applicants engaging in either human subjects or clinical trial research. If you plan to undertake either, you should consult with Research Compliances Services regarding your project.