New and Revised Definitions
Revised Human Subjects Definition
The definition of “human subject” has been changed to include “identifiable biospecimens” based upon how data and/or biospecimens have been collected or will be used.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e) of the revised Common Rule)
Removal of four categories of activities from the definition of human subject research
The following activities are NOT considered to be human subject research:
Scholarly and journalistic activities that focus directly on the specific individuals about whom the info is collected: (e.g., oral history, journalism, biography, legal criticism, legal research, and historical scholarship)
Public health surveillance activities limited to those conducted, supported, requested, ordered, required, or authorized by a public health authority for public health importance (includes “timely situational awareness”)
Criminal justice or criminal investigational purposes
Authorized activities in support of intelligence, homeland security, defense, or other national security missions.
Addition of the definition of clinical trial
“Clinical trial” means 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 the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102(e) of the revised Common Rule).
Impact on Researchers: MINIMAL
UMASS IRB/HRPO has updated the guidance and forms to include the revised definition.