Transcript Grant Submission at Tufts: Offices and Internal Policies

Public Health Service (PHS)
Financial Conflict of Interest (FCOI)
Regulations
The “New Rule”
JUNE 19, 2012
PAUL MURPHY, JD
DIRECTOR, RESEARCH
ADMINISTRATION
SERIES 2, SESSION 7
APPLICANTS & ADMINISTRATORS
PREAWARD LUNCHEON SERIES
Topics to be Covered
 Current Situation
 FCOI Regulations
 Definitions
 Major Changes to Regulations
 Examples
 Proposed Courses of Actions for Tufts
 Discussion/Questions/Comments
Current Situation
 Department of Health and Human Services (HHS) revised the
regulations on Responsibility of Applicants for Promoting
Objectivity in Research for which Public Health Service
Funding is Sought and Responsible Prospective Contractors
 Federal Register publish date: August 25, 2011
 Implementation no later than 365 days after publication of
the final rule in the Federal Register, i.e. August 24, 2012.
In the interim:
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Institutions comply with 1995 regulations
Institutions revise policies, establish procedures for compliance, and
train Investigators
NIH provides training materials for extramural community and NIH
staff, expands FCOI reports database
FCOI Regulations
 HHS is the only agency that has the Code of Federal
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Regulations governing financial conflicts of interest of
extramural investigators (other agencies have policies).
First promulgated in 1995
42 CFR Part 50 Subpart F (PHS-funded grants and
cooperative agreements)
45 CFR Part 94 (PHS-funded contracts)
These regulations promote objectivity in research by
establishing standards that provide a reasonable
expectation that the design, conduct, and reporting of
research funded under Public Health Service (PHS)
grants or cooperative agreements will be free from bias
resulting from Investigator financial conflicts of interest.
Definitions
 Significant Financial Interest (SFI) is a financial interest
of the Investigator (and those of the Investigator’s spouse and
dependent children) that:
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Reasonably appears to be related to the Investigator’s institutional
responsibilities (the Investigator’s professional responsibilities on
behalf of the Institution) and;
Consists of one or more of the interests identified as a Significant
Financial Interest in the regulations. This includes anything of monetary
value, such as (but not limited to):
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Salary or other payments for services (e.g., consulting fees or honoraria)
Equity interests (e.g., stocks, stock options or other ownership
interests)
Intellectual property rights (e.g., patents, copyrights and royalties from such
rights)
 Current policy asks whether the SFI reasonably
appears to be affected by this research project.
Definitions (con’t)
 Institutional Responsibilities (proposed) means an
Investigator's professional responsibilities on behalf of
Tufts University. That is, all activities that derive or
descend from the investigator’s standing or expertise and
are tied to those responsibilities and activities the
investigator was hired to perform and for which the
investigator is paid by the University.
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Some examples are, research, teaching, professional practice,
institutional committee memberships, and service on panels such as
Institutional Review Boards or Data and Safety Monitoring Boards.
 Financial Conflict of Interest (FCOI) is an
Investigator’s SFI that the Institution determines could
directly and significantly affect the design, conduct, or
reporting of PHS- funded research.
Major Changes
Significant Financial Interest (SFI)
 Minimum threshold of $5,000 generally applies to payments and equity interests
(currently $10,000 or 5% and less equity interest).
 Includes any equity interest in non-publicly traded entities
 Exclusions include income from seminars, lectures, or teaching, and service on
advisory or review panels for government agencies, institutions of higher education,
academic teaching hospitals, medical centers, or research institutes affiliated with an
institution of higher education.
 Excludes income from investment vehicles, such as mutual funds and retirement
accounts, as long as the Investigator does not directly control the investment decisions
made in these vehicles.
 Investigator Disclosure
 All SFIs related to Investigators’ institutional responsibilities.
 Institutions responsible for determining whether SFIs relate to PHS- funded research
and are FCOI (currently, the Investigator makes the determination). New rule will
require additional knowledgeable people including the investigator to make the
determination.
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Major Changes (con’t)
Disclosure of Travel (currently not required)
 Investigators also must disclose the occurrence of any reimbursed or
sponsored travel ( i.e., that which is paid on behalf of the Investigator and not
reimbursed to the Investigator so that the exact monetary value may not be readily
available), related to their institutional responsibilities; provided, however,
that this disclosure requirement does not apply to travel that is reimbursed or
sponsored by:
 Federal, state, or local government agency, an;
 Institution of higher education as defined at 20 U.S.C. 1001(a), and;
 Academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
 The details of this disclosure will include, at a minimum, the:
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Purpose of the trip
Identity of the sponsor/organizer
Destination
Duration.
Major Changes (con’t)
Reporting to PHS Awarding Component (NIH)
–Previous requirements, (grant/contract number, name of PD/PI, name of Investigator
with FCOI) with new rule, add:
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Name of the entity with which the Investigator has a FCOI
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Value of the financial interest
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Nature of FCOI, e.g., equity, consulting fees, honoraria
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A description of how the financial interest relates to PHS-funded research and the basis
for the Institution’s determination that the financial interest conflicts with such research
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Key elements of the Institution’s management plan
 Public Accessibility (currently not required)
 Before spending funds for PHS-supported research, an Institution shall ensure public
accessibility of information on certain SFIs that the Institution has determined are related to
the PHS-funded research and are FCOI, via a publicly accessible Web site or by a written
response to any requestor within 5 days of the request.
 A decision needs to be made on whether to have a public accessible website or
via a request.
 Investigator Training (currently required for training grants and others, but not all)
 FCOI training required for Investigators before engaging in PHS-funded research, every
four years thereafter, and immediately under designated circumstances.
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Major Changes (con’t)
Policy Applies to Subrecipients (currently required, except for
not having the subrecipient subject to Tufts’ policy if the sub doesn’t
have a policy)
 If an Investigator through the University carries out PHS-funded
research through a subrecipient, the University as the awardee
Institution will take reasonable steps to ensure that any
subrecipient Investigator complies with this policy by:
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Incorporating as part of a written agreement with the subrecipient terms that
establish whether the financial conflicts of interest policy of the awardee
Institution (Tufts) or that of the subrecipient will apply to the subrecipient's
Investigators.
 If the subrecipient does not have a policy, then they will be subject
to Tufts’ policy and complete a financial disclosure form.
 In the event of a FCOI, Tufts will be the organization that manages,
eliminates or reduces the conflict
Major Changes (con’t)
Retrospective Review (currently not required)
 Whenever :
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a financial conflict of interest is not identified or managed in a timely manner
including failure by the Investigator to disclose a significant financial interest
that is determined by the University to constitute a financial conflict of interest;
failure by the University to review or manage such a financial conflict of interest;
or
failure by the Investigator to comply with a financial conflict of interest
management plan:
 The University will, within 120 days of its determination of
noncompliance, complete a retrospective review of the
Investigator's activities and the PHS-funded research project to
determine whether any PHS-funded research, or portion thereof,
conducted during the time period of the noncompliance, was biased
in the design, conduct, or reporting of such research.
Examples
 An Investigator was instructing other physicians about the use
and benefits of a drug and being paid by the maker of that
drug.
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The Investigator determined that this income was not related to his/her
NIH grant so did not disclose the income.
The revised regulations require disclosure of all SFI related to the
Investigator’s institutional responsibilities, regardless of relationship to
a specific grant. The Institution determines relatedness to the NIHfunded research.
 An Investigator failed to disclose financial relationships with
drug companies to his/her Institution.
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When these relationships came to light, the Investigator claimed no
knowledge of the disclosure requirements.
The revised regulations include a training requirement to ensure that
Investigators are aware of their responsibilities.
Examples
(con’t)
 An Investigator received PHS funding for a conference on a specific
disease and gave a talk at the conference about the use of a drug,
while receiving funding from the maker of that drug
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The Investigator did not disclose the funding with the rationale that it was not
related to his/her research per se.
The requirements in the revised regulations are not limited to research grants,
and would cover such a case.
 In a case in which public postings by a pharmaceutical company did
not match the disclosures, it turned out that the discrepancies were
due in part to travel reimbursements reported by the company but
not disclosed by the Investigator.
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After this case came to light, the Institution considered including travel
reimbursement in their disclosure requirements.
Information on travel reimbursements and sponsored travel are included in the
disclosure requirements in the revised regulations to clarify this point.
Proposed Course of Action
1. Have two polices:
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b.
The new rule PHS policy covering
only federal proposals.
Apply the current policy, based on
the 1995 PHS regulations, to all
non-federal sponsors.
Discussion
Discussion/Questions/Comments