June 25, 2012
Last summer the US 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." The revised regulations and recently updated FAQs prepared by the NIH can be accessed at: http://grants1.nih.gov/grants/policy/coi/coi_faqs.htm.
These regulations establish new standards for Conflict of Interest reporting that must be followed by institutions that apply for or receive research support from PHS agencies, including the National Institutes of Health (NIH). This memo is issued to provide you more information about the regulations, which go into effect on August 24, 2012, and UCSD's approach to implementing them.
The regulations differ in many ways from the existing rules for disclosure and review of personal financial interests related to PHS funded research. Thresholds for disclosure of financial interests have been reduced, while review and reporting obligations have been expanded. Also included are new requirements for mandatory education/training, public accessibility of information, and monitoring of conflict of interest management plans.
We have launched several initiatives designed to make compliance as efficient as possible. These include:
* Development and implementation of a comprehensive electronic disclosure system; and
* Development of a campus implementation policy that aligns as closely as possible to the regulatory requirements.
More information, including details about the electronic disclosure system, and UCSD's plan for implementing these regulations, will be forthcoming. If you have any immediate questions please do not hesitate to contact Valerie Dixon, Director - Conflict of Interest Office at firstname.lastname@example.org or at x46465.