COI Program Announcement - Required Annual Disclosures

 IMPORTANT ANNOUNCEMENT FROM THE CONFLICT OF INTEREST PROGRAM – REQUIRED ANNUAL FINANCIAL DISCLOSURE FOR ALL INVESTIGATORS COMING IN MARCH 2012*

On August 25, 2011, the Department of Health and Human Services (“DHHS” or “Department”) published a new final rule regarding the disclosure and management of Significant Financial Interests at Institutions receiving any sponsored funding from a Public Health Service (“PHS”) agency.  This final rule, which the University must comply with in order to maintain its eligibility for federal funds, requires that the University make changes to its current Conflict of Interest Policy, RA20.  The COI Program has drafted revisions to RA20 in order to bring it into compliance with the new regulations and those changes are in the process of gaining the necessary approval.  One of the most significant changes to the disclosure of significant financial interests (e.g., consulting income > $5,000 from an entity, any equity in a non-publicly traded entity, sponsored/reimbursed travel from an entity) that will impact all University investigators, regardless of research funding, is the requirement to complete an annual financial disclosure.  Beginning March, 2012, all individuals that meet the definition of “Investigator,” persons responsible for the design, conduct or reporting of University research, will be required to make an annual financial disclosure.*

In order to accommodate the large volume of disclosures that are expected, the COI Program does plan to implement the new annual disclosure requirement in stages.  The first category of investigators expected to complete an annual disclosure will do so in March, 2012, and will include all investigators receiving or applying for research funding from either a PHS agency (e.g. FDA, NIH) or the National Science Foundation (“NSF”).  In the coming weeks, more details and information will be sent directly to those University Investigators receiving or applying for research funding from either PHS or NSF.  Additionally, the COI Program has added a page to its website that will contain relevant details and information concerning the new regulations, the revisions to University Policy RA20, and the new annual disclosure requirement (go here and select “Changes to COI Policy Coming in 2012”).  This page will be updated frequently in order to keep the research community as well informed as possible.  If you work in a unit/department that receives research funding from either a PHS agency or the NSF, please send a request to ORProtections@psu.edu if you would like to arrange for a member of the COI Program to come talk to your unit/department about how the federally required revisions and annual disclosure process will impact your investigators.

The following information sessions have been scheduled and investigators receiving or applying for research funding from PHS or NSF are encouraged to attend.  More details about the annual disclosure process and changes to RA20 based upon the new DHHS regulation will be discussed.  Seating for each session is limited to 140 people and will be filled on a first come basis:

January 30  4:00pm-5:00pm,  119 Osmond Lab (*Please note this was previously announced as Noon - the time changed)

February 7  4:00pm-5:00pm, 110 Wartik Lab

February 16  12:00pm-1:00pm, 112 Forestry Resources Building

*This message is not directed to investigators at the College of Medicine.  Prior to the new federal regulation and the implementation of required annual disclosures across the University, all investigators (and certain staff and administrators) at the College of Medicine have been required to make annual as well as transactional disclosures.