Human Subjects Research at Colorado State University
The University is required to comply with the federal regulations governing review of research that involves human subjects (see the IRB Human Subjects Policy). Annually we must assure the Office for Human Research Protections (OHRP) that the University is complying with the requirements of 45 CFR 46. This is an NIH reference, but has been incorporated virtually verbatim into the regulations of 16 other federal agencies; additionally, the regulations state that the University will apply the same standards to all projects involving human subjects, regardless of funding or funding source. Activities are to be reviewed as proposals, and may not wait until funding for the activity is forthcoming.
45 CFR 46 includes two definitions critical to identifying whether a project must be reviewed:
- A systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge. (46.102(d)) For more information, view Is My Project Research?
- Individuals whose physiologic or behavioral characteristics or responses are the object of a study in a research project. Under the federal regulations human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. (46.102(f)) For more information, view Does My Project Involve “Human Subjects”?
The regulations then necessarily apply to evaluations, providing services, demonstration projects, and other activities not typically thought of as “research.” They are systematic collecting of data and they, by virtue of publication, public presentation, thesis, dissertation, or project report, contribute to generalizable knowledge. It is immaterial whether the project is funded by commercial entities, funded by governmental agencies, or unfunded. Any activity involving human subjects is subject to review, including soliciting questionnaires and surveys, videotaping activities, audio taping, observing behavior, and obtaining individually identifiable data about a person.