Last summer the Office of the Secretary of 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.” These regulations establish new standards that must be followed by institutions such as UCLA that apply for or receive research support from PHS agencies including the National Institutes of Health (NIH). This memo is being issued to let you know about the new regulations and UCLA’s approach to implementing them.
The revised regulations are intended to increase accountability, add transparency, enhance regulatory compliance and effective management of financial conflicts of interest, and strengthen governmental compliance oversight. They go into effect on August 24, 2012.
These regulations differ in many 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, 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. See the 2011 revised regulations and recently updated FAQs prepared by the NIH.
We have launched several initiatives designed to make compliance as efficient as possible. This includes:
- Development of a web based disclosure system and smart forms; and
- Development of a campus implementation policy that aligns as closely as possible to the regulatory requirements.
While we realize that conformance with the regulations will not be easy for the campus, we also recognize the importance of ensuring compliance, as funding from PHS supports a significant portion of UCLA’s portfolio of extramurally funded research.
More information, including details about the on-line disclosure system, and UCLA’s plan for implementing these regulations, will be forthcoming. If you have any immediate questions please do not hesitate to contact Assistant Vice Chancellor – Research Ann Pollack at firstname.lastname@example.org or at x40387.