Exempt Protocol Review
New UCB 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 Determination of Exemption:
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: firstname.lastname@example.org.
Human Subjects Announcement for Haas Investigators
As you know, 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).
Recently, the Behavioral Lab at Haas obtained authorization to conduct in-house review for some research protocols. Haas investigators are now invited to avail themselves of that service. Two people, Silva Kurtisa <email@example.com> and Suzanne Stone <firstname.lastname@example.org>, have both been trained in the regulations and procedures and can help advise you. Silva is the director of the Behavioral Laboratory and her office is in F522 Haas. Silva has created this useful web page with information about the procedures. Suzanne has extensive experience on institutional review boards and works for Haas on a contract basis.
If your research falls into the technical category known as “exempt” then either Silva or Suzanne, acting as Haas Local Exempt Reviewer (the HaasLER), is authorized to review your application and (if appropriate) approve it. Exempt protocols have simpler application requirements and once they are approved, they are approved forever and do not require renewal. Usually researchers will consult with Silva for guidance on how to formulate their applications and then Suzanne reviews the formal application. You can expect a decision from her within a matter of days, and it helps if you consult with Silva or Suzanne before you submit it.
If you are starting a new research project, look into whether it might qualify as exempt before you apply for CPHS approval. A conversation with Silva might be a good place to start.
- Benefits of Xlab
- New Researchers
- Returning Researchers
- Xlab Hours