March 31, 2015

CPHS and OPHS Announce 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 Federalwide 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 exclusions listed in the CPHS Policy Determination of Exemption.

For more detailed information, please see the CPHS Determination of Exemption Policy and CPHS 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:

March 19, 2015

NSF Publishes Public Access Plan

The National Science Foundation has announced a plan to increase public access to scientific publications and digital scientific data resulting from research the foundation funds.

According to the press release, “NSF will require that articles in peer-reviewed scholarly journals and papers in juried conference proceedings or transactions be deposited in a public access compliant repository and be available for download, reading and analysis within one year of publication.”

The NSF Public Access site states that the “NSF requirement will apply to new awards resulting from proposals submitted, or due, on or after the effective date of the Proposal & Award Policies & Procedures Guide (PAPPG) that will be issued in January 2016. This recommended change to the PAPPG will be announced in the Federal Register no later than April 2015 and will follow government-wide procedures for public notice and comment.”

The Association of Research Libraries maintains a list of federal agency public access plans and policies complying with the White House Office of Science and Technology Policy memorandum, Increasing Access to the Results of Federally Funded Scientific Research, issued in 2013.

NIH iEdison Invention Disclosure Requirement

The National Institutes of Health has issued a new requirement that all invention disclosures, related reports and documents must be submitted electronically using iEdison: Notice Regarding Requirement of Grantees and Contractors to Submit Invention Disclosures, Related Reports and Documents Via iEdison (NOT-OD-15-080).

Previously, NIH only “strongly supported” its use. Please note that all required iEdison submissions that are submitted via fax, mail, drop offs, etc. will not be accepted and will be returned to the submitter by NIH.

Information about how to use Interagency Edison and information about the iEdison system which is managed by NIH and used by more than 30 federal agency offices is available at NIH iEdison Invention Reporting.