Projects with No Human Subjects
BRI Institutional Review Board is charged with protecting human subjects during research activities being conducted at Virginia Mason and BRI under the federal regulations. Some activities however may NOT be considered “human subjects” as defined by FDA and DHHS regulations and do not require IRB oversight (e.g. use of anonymous samples/data from and external entity, use of coded samples/data without ability to ever re-link, use of publically available data/samples available to the general public, etc.).
BRI IRB recommends individuals conducting projects with data/samples that “may” NOT be considered a “human subject” and/or needs a formal IRB determination for future publications/presentations, to complete a Human Subject Determination Form and submit to irb@benaroyareserach.org for review. See below for more information.
Human Subjects
DHHS regulations: "a living individual, about whom an investigator (whether professional or student) conducting research obtains;
- Data through intervention or interaction with the individual, or
- Identifiable private information."
FDA regulations: "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control." The activity involves human subjects if EITHER of the following checked YES:
- An individual will be a recipient of any test article (i.e. drug, medical device) or as a control.
- An individual on whose specimen a medical device will be used.