University of California, Berkeley, Exempt Category 7 for Certain Minimal-Risk Human Research Activities

The Committee for Protection of Human Subjects (CPHS) and the Office for Protection of Human Subjects (OPHS) are pleased to announce a new category for exempt review. This category, which we have added to the six categories of exemption described in federal regulations, is allowed within the flexibility available under UC Berkeley’s Federal wide Assurance (FWA) and was created to reduce researcher burden.

To qualify for exemption under UCB Category 7, a human subjects research project must be non-federally funded or regulated and comprised only of minimal-risk activities that will not induce distress beyond that of daily life and that could not reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.

These activities may include (but are not limited to) non-physically invasive interventions or performance of tasks such as: reading/writing/drawing tasks; physical activities such as walking, sitting, or manipulating an object; computer tasks and/or Internet searches; talking and/or listening to words, then making selections, or “think-aloud” exercises; viewing media; role-playing; completing a specific physical or mental action (“imagining”); passive monitoring of space (environment) with sensors; playing a game; and height/weight measurements.

To qualify, the research must not involve any exclusion listed in the CPHS Policy

For more detailed information, please see Determination of Exemption Policy and Exempt Research Guidelines.

If you have questions about Category 7 exempt research, please call the OPHS Analyst of the Day at (510) 642-7461 or email us at ophs@berkeley.edu.

cphs.berkeley.edu

Human Subjects Announcement for Haas Investigators

All research involving human subjects must receive prior approval from Berkeley’s Institutional Review Board (here known as the Office/Committee for the Protection of Human Subjects).