Changes to COI Policy Coming in 2012

Changes to the Federal Regulations Regarding Conflicts of Interest in Research

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.

Implementation Plan

 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 and will be posted to this site.

Informational Sessions Offered at University Park

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, 2012  4:00pm-5:00pm,  119 Osmond Lab
February 7, 2012  4:00pm-5:00pm, 110 Wartik Lab
February 16, 2012 12:00pm-1:00pm, 112 Forestry Resources Building

Informational Sessions Offered Online

Listen to the Information Session provided on February 16** by Debra Thurley, COI Program Assistant Director, by following this link (offered through Adobe Connect- check with your IT person if you are not able to view the recording): https://meeting.psu.edu/p47cxgyh0qk/

A copy of the PowerPoint Presentation can be found by clicking on the following: Disclosure of Significant Financial Interests Feb. 16, 2012 Information Session.

If you have any questions after listening to the recording, please send them to Sue Seman, sls426@psu.edu.  

**Please note that the microphone lost contact with the computer during the last minute of the presentation. This occurred at the end of the demo of COINS.  The information that Debra provided that was not recorded was a reminder to make sure that your pop-up blocker is turned off when using COINS.  She also mentioned that the pop-up windows in COINS do not automatically save your information; rather, you must click on “Ok” at the bottom of the pop-up window in order to save the information and close the pop-up (do not simply close the pop-up by clicking the “x” in the top, right corner).   So, Debra advised, if you step away from your computer for an extended period of time, please first save all the information you have entered by clicking the “OK” button at the bottom; otherwise, all of the information that you put into a pop-up window will be lost if your session times out while you are away. 

Department or College Wide Information Sessions

If you would like 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, please send a request to sls426@psu.edu.

Frequently Asked Questions

COI Staff plan to upload a document that contains the questions that were most frequently asked at the information sessions.  Please check back later for more information!

More information coming soon!