Preface
"The term conflict of interest... refers to situations in which
financial or other personal considerations may compromise, or have
the appearance of compromising, an investigator's professional
judgment in conducting or reporting research... conflicts become
detrimental when the potential rewards, financial or otherwise,
cause deviation from absolute objectivity in the design,
interpretation, and publication of research activities or in other
academic and professional decisions." - Association of American
Medical Colleges
Financial
Conflict of Interest Form
Background
Research is an important and vital part of the mission of St.
John's University (the University or SJU). The external sponsorship
of research can result in the development of complex relationships
between the University, its faculty, and staff, and the external
sponsor(s) who support specific programs. To assure that research
conducted under the auspices of the University is always of the
highest integrity, and in response to regulations issued in 1994
and 1995 by the federal government, St. John's University has
developed this policy on Financial Conflicts of Interest in
Research and Other Sponsored Programs.
The intention of this policy is to identify and eliminate or
manage any possible threat to the integrity of the research and
sponsored programs conducted by the SJU community.
This policy is applicable to all proposals for federal grant
and/or federal contract support (including federal flow-through
funding) of research projects and other sponsored programs
submitted on, or after, October 1, 1995.
Policy
Prior to the submission of a research proposal to any
federal agency, all researchers who plan to participate in, or
direct, a sponsored research project or other sponsored program
(sponsored program) under the auspices of the University must
disclose to the University any significant financial interests
which they or any members of their immediate family have in any
commercial enterprise that will in any way participate in the
sponsored program or that potentially may be affected by the
performance or completion of the proposed sponsored program.
Disclosure is accomplished through completion of a "Financial
Conflict of Interest Disclosure Form" (Disclosure Form) which is
subject to review by the individual's dean and the Office of Grants
and Sponsored Research (OGSR). Each Disclosure Form will be
reviewed to determine the existence of, or potential for, any
financial conflicts of interest.
For purposes of this policy statement, the following definitions
are provided:
- Researcher - includes the principal investigator and all
faculty and research staff members who will have responsibility for
the design and conduct of the research as well as the dissemination
of its results.
- Immediate Family - refers to the researcher's parents,
siblings, spouse, children and any equivalent relatives by
marriage. It also refers to any individual who resides on a regular
basis in the researcher's domicile.
- Sponsored Research Project or Other Sponsored Program
- includes a variety of possible activities and not research
alone. Sponsored Programs can include curriculum development
activity, public service projects, instrumentation and
infrastructure awards, training grants, conference grants and any
other activity funded either directly, or indirectly, by an agency
of the federal government.
- Significant Financial Interest - refers to anything of monetary
value, including, but not limited to, salary or other payments for
services (e.g., consulting fees or honoraria); equity interests
(e.g., stocks, stock options or other ownership interests); and
intellectual property rights (e.g., patents, copyrights and
royalties from such rights).
For purposes of this policy, Significant Financial Interest does
not include:
- salary, royalties, or other remuneration from St. John's
University
- income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities
- an equity interest in a business enterprise that, when
aggregated for the research and immediate family, meets both of the
following tests: does not exceed $10,000 in value as determined
through reference to public prices or other reasonable measures of
fair market value, and does not represent more than 5% ownership in
any single entity
- salary, royalties, or other payments over the next twelve
months when such payments are not expected to exceed $10,000 when
aggregated for the Researcher and Immediate Family.
The University will not permit the incurring of any expenses on
federal grant unless, or until, all identified conflicts of
interest have been eliminated or properly addressed through a
University-approved Resolution Plan.
If over the course of a sponsored program the University finds
that it is unable to satisfactorily manage a conflict of interest,
the Director of Grants and Sponsored Research will notify the
appropriate official at the federal funding agency (e.g. NSF's
Office of General Council or the relevant PHS Awarding Component)
as required by agency regulations.
Procedures
- All proposals for external support currently undergo an
institutional review process. As part of that process, the
University's "Request for External Funding" form is completed by
the project director/principal investigator and submitted for
endorsement by the chairperson, dean and OGSR. Effective October 1,
1995, in the case of proposals to federal agencies, project
directors and principal investigators must also submit a completed
"Financial Conflict of Interest Disclosure Form." Effective this
date, it is the responsibility of the offices of the Dean and the
OGSR to conduct the required explicit review for possible financial
conflicts of interest.
The principal investigator should provide the Disclosure Form to
his/her dean and OGSR before the grant application is submitted or
along with the University's "Request for External Funding" form.
The principal investigator will also have the responsibility of
ensuring that all researchers involved with the project will have
completed and submitted Disclosure Forms of their own in the same
timely manner.
- If it is determined that a researcher (or any member of his/her
immediate family) has a significant financial interest in a
commercial enterprise connected with the proposed sponsored
program, the principal investigator and/or researcher should
prepare a Resolution Plan to reduce, minimize or eliminate the
conflict of interest. This resolution plan must be approved by the
University before any expenditures are incurred against the federal
award.
As in the case of Disclosure Forms, the initial review of
Resolution Plans will be conducted by offices of the Dean and
OGSR.
If the project is funded and the Resolution Plan accepted, a
Memorandum of Understanding between the University and researcher
will be issued.
If the plan is rejected by the dean and/or OGSR, the matter may be
submitted by the principal investigator and researcher to the
Committee for Resolution of Financial Conflicts (CRFC). The CRFC
will consist of three members designated by the Executive Vice
President.
- In the event circumstances change regarding the significant
financial interest of a researcher engaged in a sponsored program
(or regarding the significant financial interest his/her immediate
family), the researcher must notify the University as soon as the
change becomes known. Revised Disclosure Forms are subject to the
same review process as an original submission .
- OGSR will maintain the confidentiality of the Disclosure
Statements, except as may be required by federal law or agency
award terms. In no case will a Disclosure Statement be released to
a federal agency without prior notification to the affected
individual.
- OGSR will maintain all Disclosure Statements and approved
Resolution Plans for a period of three years beyond the termination
or completion of the grant to which they relate, or until
resolution of any action involving those records, whichever is
longer.
Effective October 1, 1995, the National Institutes of Health and
National Science Foundation required grant recipients to establish
a Financial Conflict of Interest Policy. All persons who play a key
role in the performance of a project funded either directly or
indirectly by NIH or NSF are required to complete a Financial
Conflict of Interest Form at the time of proposal submission.
The completed form(s) should be submitted to Jared Littman in the Office
of Grants and Sponsored Research.