Date: August 15, 2012

Sender: Graham Fleming, Vice Chancellor for Research

To: Academic Senate Faculty; Deans; Directors; Department Chairs

Subject: Conflict of Interest (COI) Message for PHS/NIH-funded Investigators


Dear Colleagues,

In the summer of 2011, the U.S. Department of Health and Human Services and the Public Health Service (PHS) issued revised regulations on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS funding is Sought.” These regulations established new standards for financial disclosure that must be followed by institutions that apply for and receive research support from PHS agencies including the National Institutes of Health (NIH). This message is being issued to let you know about the new regulations and UC Berkeley’s approach to implementing them.

According to HHS/PHS, the revised regulations are intended to increase accountability, add transparency, enhance regulatory compliance and effective management, and strengthen governmental compliance oversight. The new regulations go into effect on August 24, 2012. These regulations differ in several significant ways from the existing rules for disclosure and review of personal financial interests related to PHS-funded research and place new burdens on the campus.

--Thresholds for disclosure of financial interests have been reduced;

--Disclosure, review and reporting obligations have been expanded;

--Mandatory and ongoing education and training is required and;

--Public accessibility to financial conflict of interest information, and more rigorous monitoring of conflict of interest management plans is required.

The 2011 revised regulations and recently updated FAQs prepared by the NIH can be accessed at http://grants.nih.gov/grants/policy/coi/index/htm. [current URL: http://grants.nih.gov/grants/policy/coi/index.htm]

We have launched several initiatives designed to make compliance as efficient as possible. The COI Committee website at http://researchcoi.berkeley.edu will provide the latest information once the UC policy conforming to the new regulations is posted on UCOP and campus websites on August 23, 2012.

We realize that while conformance with the regulations may be a challenge for the campus and for PIs, we also recognize the importance of ensuring compliance, as funding from PHS supports a significant portion of UCB’s extramural research portfolio.

More information, including information about the disclosure process and UCB’s plan for implementing the regulations is being prepared. If you have any immediate questions, please contact COI Coordinator and SPO Associate Director Jyl Baldwin at jbaldwin@berkeley.edu or at 642-8110.


source: UC Berkeley CALmessages: https://calmessages.berkeley.edu/archives/message/10520