UW Research

May 31, 2012

New Financial Conflicts of Interest regulations: Initial announcement

  • New regulations go into effect August 24, 2012
  • Major changes for all PHS-funded investigators
  • Minor changes for all funded investigators
  • More detailed information to be provided during the summer
  • Please forward to all affected persons in your units

Dear Colleagues:

I am writing to let you know that the University of Washington’s (UW) policy on Financial Conflicts of Interest (FCOI) will be revised to comply with the new Public Health Service (PHS) FCOI regulations, which go into effect on August 24, 2012. UW investigators will continue to follow the current UW’s Significant Financial Interest (SFI) Disclosure Policy (GIM-10) until August 24, 2012.

Major changes include:

For all funded investigators

  • Lower monetary threshold
  • Electronic disclosure system

For PHS-funded investigators

  • Mandatory training requirements
  • Disclosure of all SFIs related to institutional responsibility
  • Disclosure of externally-funded travel
  • Public access to FCOI information

The information that follows will provide you with advance notice of upcoming changes to UW policy for FCOI mandated PHS regulations. We recognize that these requirements will increase administrative burden and we will make implementation of new regulations as straightforward as possible. The implementation processes to ensure compliance with the new regulations are still under development.

UW’s revised FCOI policy and its implementation plan will reflect the following federal regulatory changes:

For all investigators

Lower monetary threshold
The minimum threshold for reporting a SFI will be lowered from $10,000 to $5,000, with a $0 threshold for disclosure of equity in a non-publicly traded company.

Electronic disclosure system
All investigators disclosing SFI will use a new electronic disclosure system currently under development.

For investigators engaged in Public
Health Service (PHS)* funded research
* PHS agencies include NIH, FDA, CDC, AHRQ, HRSA, IHS, SAMHSA, and ATSDR

Mandatory training requirements
All PHS-funded “investigators” must complete online FCOI training (which will be provided by UW) prior to the expenditure of funds on any newly funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. An online training program will be available for UW personnel in June 2012.  Current PHS awards are not subject to these new requirements until the noncompeting continuation award. The definition of an “investigator” includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research; upcoming changes to the eGC-1 form in SAGE will permit the PI to identify which Key Personnel meet this definition on new proposals.

Disclosure of all SFIs related to institutional responsibilities
All SFIs related to institutional responsibilities must be reported by PHS-funded investigators. Previously, investigators were required to disclose only those SFIs related to PHS-funded research.

Disclosure of all externally-funded travel
PHS-funded investigators must disclose ALL travel reimbursements that are either sponsored by (i.e., paid by an outside entity) or reimbursed directly to the investigator from an outside entity for travel that occurs after August 24, 2012, with some exceptions. Exceptions include:  travel reimbursements from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.  Travel disclosures will be made using the electronic disclosure system. This disclosure requirement does NOT apply to funding provided to the investigator via the UW (e.g., as part of sponsored research projects; use of departmental discretionary or gift funds).

Public access to FCOI information
To comply with the regulations, the institution must make FCOI information for PHS-funded awards publicly available prior to the expenditure of any funds. This information will be posted on a UW FCOI website currently under development.

At this time, the UW does not centrally track new personnel added on to PHS-funded awards. Once this new policy goes into effect, we will need your help to ensure that new investigators are notified of these requirements.

We’ll keep you updated throughout the summer using email and the new FCOI website http://uw.edu/research/fcoi.  Extensive details about this new policy and the process for compliance will be provided in announcements and FAQs during the summer.

If you have any questions, please contact the Office of Research (research@uw.edu<mailto:research@uw.edu>).

Sincerely,

Jeff Cheek, Ph.D.
Associate Vice Provost for Research Compliance & Operations, Office of Research