New COI Disclosures Required Prior to PHS Proposal Submission

Dear Colleagues:

On August 24, 2012, the revised Public Health Service (PHS) regulations
regarding financial conflict of interest (FCOI) will take effect.

UCI and its employees are required to comply with these regulations
because our campus applies for and receives research support from PHS
agencies (directly and through subawards to UCI). Research support
includes any activity for which research funding is available from a PHS
agency through a grant (e.g., research grant, career development award,
center grant, individual fellowship award, institutional training grant,
program project, etc.), cooperative agreement or contract. In addition,
these regulations apply to those sponsors adopting the PHS regulations .

Changes reflected in the revised PHS regulations include the following:

* Lower disclosure thresholds – $5,000 for publicly traded
entities and $0 for equity interests in non-publicly traded entities;

* Investigator disclosure regarding their Significant Financial
Interests (SFI) related to their institutional responsibilities – not
just those related to the specific research project in question;

* Disclosure of all sponsored and reimbursed travel –
reimbursements or travel sponsored by educational and governmental
institutions are exempted;

* Investigators must disclose new SFIs (including sponsored or
reimbursed travel) within thirty (30) days of discovering or acquiring a
new SFI; and

* Mandatory Investigator training regarding the PHS regulations
and UCI’s policy prior to engaging in the funded research.

The Vice Chancellor for Research (VCR) has issued several announcements
to the campus (including messages directed toward UCI faculty, Deans,
Directors, Officers and Administrators) regarding the implementation of
the revised PHS regulations, the mandatory training of Investigators and
UCI’s obligation to comply with the regulations. In those
announcements, he alerted the campus to potential delays that could
result from less-than-timely compliance regarding disclosure of SFIs and
completion of the mandated training for Investigators.

It is important to remember that the revised regulations require
disclosure of SFIs no later than at the time of application for the
funded research. As a result, the Office of Research (OR) cannot submit
proposals to PHS or sponsors adopting the PHS regulations until all
required disclosures have been received. Likewise, OR cannot release
awards from PHS or sponsors adopting the PHS regulations until all
Investigators have completed the mandated training. The timing of
disclosure submission and training requirement also applies to
subrecipient Investigators when the subrecipient organization will be
relying on UCI’s PHS FCOI policy and independent consultants if their
role on the project satisfies the definition of Investigator. It is
important to understand that the regulations define Investigator to mean
the principal investigator and any other person, regardless of title or
position, who is responsible for the design, conduct, or reporting of
research funded by PHS (or sponsors adopting the PHS regulations), or
proposed for such funding.

The UC Office of the President has prepared an on-line course for
Investigators called, “Compliance & Conflict of Interest for Researchers
Briefing” that is available through the UC Learning Center . This training must be completed by
Investigators to satisfy the mandatory training requirement. While this
information has already been shared broadly, I encourage all units to
remind their Investigators about the course and their responsibility for
completing the training.

To help inform administrative staff about the revised regulations and
how staff can play an important role in helping to promote compliance,
OR has developed a PHS FCOI traveling workshop. The workshop is
approximately one hour in length and is designed to help staff
understand the new requirements and the new processes, procedures and
forms that UCI will use to facilitate compliance. Most importantly, the
workshop is designed to come to you to minimize time away from the
office while maximizing the opportunity for staff to attend the
workshop. Staff from OR have already reached out to UCI’s schools and
research units to schedule this workshop. It will continued to be
offered through September 28 to help staff prepare for the October 5th
NIH proposal application deadline.

Additional information regarding the PHS regulations may be found on the
OR Conflict of Interest webpage and UCI’s policy
implementing the PHS regulations may be found on the OR Research Policy
Library webpage . If
you have any questions regarding the revised regulations, please contact
me at or at (949)
824-5677 or Grace Park, Conflict of Interest Administrator at or at (949) 824-7218.

Bruce Morgan

Assistant Vice Chancellor for Research Administration

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