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Mandatory PHS Federal Conflict of Interest Requirements (Effective 8/24/12)

M E M O R A N D U M

 

To:          Identified PHS Funded Investigators

BCC:       Department Chairs, Research Administrators

From:      Craig Allison, Director of Research Compliance & Integrity (RCI)

Date:      8/17/2012

 

RE:          Mandatory PHS Federal Conflict of Interest Requirements (Effective 8/24/12)

On August 24, 2012, new and more stringent rules for the disclosure of financial interests will take effect for all research sponsored by the Public Health Service (PHS), including the National Institutes of Health (NIH). The new rules also apply to a handful of non-federal sponsors, including the American Cancer Society and the American Heart Association. To access a list of all agencies and sponsors who have adopted these new rules, click here. These agencies and sponsors are collectively referred to as “covered” agencies in this e-mail.

These new PHS financial conflict of interest (FCOI) rules apply to all “investigators” who engage in any research funded by a covered agency. “Investigators” are defined by PHS to include principal investigators and any other individual who, regardless of title or position, has responsibility for the design, conduct, or reporting of such covered research.  This includes, for example, any graduate student or post-doctoral fellow who meets the definition of investigator.

You are receiving this e-mail because our files indicate that you are (or may be) an investigator who is subject to these new FCOI rules.  Please note that these new FCOI training and disclosure requirements are separate and apart from any Conflict of Commitment reporting responsibilities you may have under APM-UCD 025.

Mandatory PHS Training Regarding New FCOI Rules

On August 6, 2012, you may have received an e-mail from Staff Development & Professional Services (sdps@ucdavis.edu) regarding training for general conflict of interest in research (2012 Compliance and Conflict of Interest for Researchers Briefing (COIR)) that is required by the Office of the President.  A component of this training satisfies the mandatory training under the new FCOI rules.

All investigators who are engaged in any research funded by a covered entity as of August 24, 2012 must complete this training prior to the receipt of any new funds from the covered entity via a Notice of Award.

All investigators who will engage in research funded by a covered entity after August 24, 2012 must complete the training prior to engaging in the research following receipt of funds via a Notice of Award.  Any investigator who is added to an existing research project after August 24, 2012 must complete the training prior to engaging in any research on the project.

If you were not contacted to complete the 2012 Compliance and Conflict of Interest for Researchers Briefing (COIR) and are required to complete PHS training under the new FCOI rules, you may satisfy the training requirement by going to UC Davis Learning Management System and searching for "COI-PHS."  Please follow the instructions below:

  1. Log in to the UC Learning Center using your UCD LoginID and Kerberos password.
  2. Search for keyword "COI-PHS" in the UC Learning Center search bar on the left of your screen.
  3. Select the Conflict of Interest class, and click "Start."  The online course will then launch.

Alternatively, you soon will be able to satisfy this training obligation through CITI training (the training module is currently in development and a link will be provided once available). It is imperative that you complete this mandatory training in a timely fashion to avoid any funding delays.

New (and More Stringent) Mandatory Financial Disclosures

Each investigator must separately submit to the Institution (UC Davis’ Research Compliance and Integrity) a financial disclosure statement (“Disclosure”). The Disclosure must identify financial interests of the investigator, spouses/ registered domestic partners, and dependent children that exceed the thresholds set by PHS and that relate to any of the investigator’s institutional responsibilities.

Disclosures must be made: (1) prior to the Notice of Award issue date for additional funds if you are already conducting covered research as of August 24, 2012; (2) no later than at the time of application for funding from a covered agency if the application is submitted after August 24, 2012; (3) annually; and (4) within 30 days after acquiring or discovering a financial interest that must be disclosed as defined by PHS.

The Office of Research is presently developing a “user-friendly” on-line disclosure form that complies with the regulations.  This on-line form will go “live” on August 24, 2012, and it will be accessible at researchcoi.ucdavis.edu.

For further information about the new rules, including the new thresholds for reporting (and the exemptions), please click here. I urge you to take a moment at this time to read this short document to develop a more detailed understanding of the new rules.  You can also visit the Financial Conflict of Interest page of the NIH website to view a comprehensive set of "frequently asked questions" about the new rules.

We anticipate heightened scrutiny from the federal government in evaluating our ongoing compliance with these new FCOI rules. Thus, it is vital that you timely comply with the new disclosure and training mandates to avoid any funding delays. Feel free to contact me at ccallison@ucdavis.edu or 530-752-2454 if you have any questions or need additional information.

 

Craig Allison, MPH, JD

Director of Research Compliance and Integrity (RCI)

University of California, Davis

Office of Research