Current StudentsGraduate Student Handbook
Policy D: The University of Connecticut Health Center –
Policy and Procedures on Conflicts of Interest in Research
Section 1. INTRODUCTION
The purpose of this policy is to outline an institutional approach to
the identification and management of conflicts of interest, in a fashion
which will foster both the conduct of scholarly activities and ensure
compliance with Public Health Service and National Science Foundation
regulations.
Section 2. APPLICABLE REGULATIONS
At present, there are at least three sets of existing regulations (both
state and federal) which serve as the basis for this policy. Copies of
these regulations are available to all UCHC faculty and staff from the
Office of the Assistant Vice Chancellor for Research.
The Code of Ethics for Public Officials, Connecticut General Statutes,
Sec. 1-79 through 1-89 stipulates what types of activities are allowable
for state employees who may have financial interests in companies which
do business with the State of Connecticut.
The National Science Foundation (NSF) Investigator Financial Disclosure
Policy and the U. S. Public Health Service (PHS) regulations in 42 CFR
Part 50, and 45 CFR Part 94, under the heading of Objectivity in
Research become effective October 1, 1995, and carry the weight of
federal regulation. The federal policies stipulate requirements for:
a. annual financial disclosures on the part of ALL research
investigators;
b. institutional certification that all proposed and ongoing NIH/NSF
sponsored research is either free of conflicts of interest, or that such
conflicts are adequately managed; c. the implementation of an
institutional mechanism for managing conflicts of interest in research;
d. keeping NIH/NSF informed if UCHC is unable to satisfactorily manage
actual or potential conflicts of interest;
e. sanctions where appropriate; and,
f. maintenance of records relating to this policy, for at least three
years following the termination of a given project.
Section 3. DEFINITIONS
Business means any corporation, partnership, sole proprietorship, firm,
franchise, association, organization, holding company, joint stock
company, receivership, business or real estate trust, or any other legal
entity organized for profit or charitable purposes.
Conflict of Interest means a situation in which significant financial
interests in a business, or other personal considerations provided by a
business, may compromise, or have the appearance of compromising, an
investigator's professional judgment in conducting or reporting
research, the results of which could affect the aforementioned business,
either directly or indirectly.
Immediate Family means the investigator's spouse, minor children, and
any other persons living in the same household.
Investigator means the principal investigator and any other person at
UCHC who is responsible for the design, conduct or reporting of
research, and the investigator's immediate family. This shall include
faculty and research staff (research associates and assistants,
postdoctoral fellows, graduate students, visiting scientists, and
medical or dental students engaged in research conducted in the
department).
Participate means to be part of the described activity in any capacity,
including but not limited to serving as the principal investigator,
co-investigator, research collaborator or provider of direct patient
care. The term is not intended to apply to individuals who provide
primarily technical support or who are purely advisory, with no direct
access to the data (e.g., control over its collection or analysis) or,
in the case of clinical research, to the trial participants, unless they
are in a position to influence the study's results or have privileged
information as to the outcome.
Significant Financial Interest means 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). The
term does not include:
1. Salary, royalties, or other remuneration from UCHC;
2. Income from seminars, lectures, or teaching engagements sponsored by
public or non-profit entities;
3. Income from service on advisory committees or review panels for
public or non-profit entities; or
4. An equity interest that when aggregated for the investigator and the
investigator's spouse and dependent children, 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 interest in any
single entity;
or,
5. Salary, royalties or other payments that when aggregated for the
investigator and the investigator's spouse and dependent children over
the next 12 months, are not expected to exceed $10,000.
Research means a systematic investigation designed to develop or
contribute to generalizable knowledge relating broadly to public health,
including behavioral and social sciences research. The term encompasses
basic and applied research, and product development.
Technology means any compound, drug, device, diagnostic, medical, dental
or surgical procedure intended for use in health care or health care
delivery.
Section 4. KEY ELEMENTS OF THE POLICY
The UCHC Conflicts of Interest Policy is designed to identify actual or
potential sources of conflicts of interest in research; and to either
eliminate, reduce or manage such conflicts. As such, the following
sub-sections outline the procedures which will be followed to assure
compliance with this policy, and all applicable state and federal
regulations related to conflicts of interest.
4.1 Notification of Investigators
Upon adoption of this policy, a copy will be sent to all investigators
(as defined in Section 3 above), and it will be entered into the
Research Administration Electronic Information (Gopher) System. Any
changes of the policy will be annotated and distributed to all
investigators in the UCHC periodical, Research Notes, and will be
included in a revised version of the policy located on the Research
Administration Electronic Information (Gopher) System. This will be the
responsibility of the Office of the Assistant Vice Chancellor for
Research.
The Dean's Offices of the Schools of Medicine and Dental Medicine shall,
subsequent to the initial distribution of this policy, provide a copy of
the policy to all new faculty hired into those Schools, any visiting
faculty appointed on a non-paid basis, and all students (including
graduate students conducting research at UCHC) at time of matriculation.
The UCHC Department of Human Resources shall, subsequent to the initial
distribution of this policy, provide a copy of the policy to all new
research staff hired by UCHC.
4.2 Financial Disclosure Procedures
All UCHC Department Heads in the Schools of Medicine and Dental Medicine
shall annually distribute and collect the UCHC Conflict of Interest
Financial Disclosure form. The form will be sent to all investigators,
including faculty and research staff, e.g., research associates and
assistants, postdoctoral fellows, graduate students, visiting
scientists, and medical or dental students engaged in research conducted
in the department. For investigators who may join departmental research
efforts between annual distributions of the UCHC Conflict of Interest
Financial Disclosure form, Department Heads will ensure that the form is
completed and reviewed prior to the initiation of research by those
investigators.
Department Heads will also designate a departmental officer whose
responsibility will be to review the UCHC Conflict of Interest Financial
Disclosure forms to determine if a conflict of interest exists with
respect to the conduct of research of any investigator in that
department. If a conflict of interest is noted, the department will
forward the UCHC Conflict of Interest Financial Disclosure form to the
UCHC Conflict of Interest Management Committee.
In addition, investigators and department heads will be responsible for
ensuring that an updated UCHC Conflict of Interest Financial Disclosure
form shall be completed and filed at any time during a year when an
investigator's significant financial interests may change.
4.3 Review of Financial Disclosure and Certification of Conflict of
Interest Status
Upon review of the UCHC Conflict of Interest Financial Disclosure form,
the departmental conflict of interest officer shall be responsible for
notifying the department head of the conflict of interest status of all
investigators within that department. Certification that investigators
have complied with the requirement to complete the UCHC Conflict of
Interest Financial Disclosure form, and that NO Conflict of Interest
exists, will be accomplished as the Department Head signs off on the
UCHC Statement of Commitments and Proposal Approval form, each time an
investigator submits a proposal for extramural funding.
In the event a conflict of interest has been identified, the Department
Head shall notify the Assistant Vice Chancellor for Research that such a
conflict has been identified, and that steps have been initiated to
eliminate or manage the conflict of interest, as outlined in Section 4.5
below. During the period of resolution, no proposals for extramural
support (which are the subject of the conflict of interest) for the
investigator(s) shall be approved by that department. Once a resolution
of the conflict has been achieved, the Department Head will notify the
Assistant Vice Chancellor for Research of the terms of the resolution,
and authority to process all proposals will be reinstated.
In the event that the Health Center is unable to resolve the conflict
within 45 days of discovery, the department head shall notify the
Assistant Vice Chancellor for Research of this, and the facts
surrounding that case. In the event that notification of research
sponsors is required, the Assistant Vice President will be responsible
for effecting this notification.
4.4 Resolution and/or Management of Conflicts of Interest
If a conflict of interest has been identified as a result of the
procedures outlined in Section 4.3 above, Department Heads will be
responsible for taking the appropriate following action(s):
1. Notify the investigator(s) that as a result of the financial
disclosure process, a conflict of interest has been discovered in
relation to research in which the investigator(s) are involved.
2. Refer the matter to the Health Center's Conflict of Interest
Management Committee.
4.5 Conflict of Interest Management Committee
The Executive Vice President for Health Affairs is the chief executive and academic officer of the Health
Center. The Executive Vice President shall annually, upon the recommendation of the
Deans of the Schools of Medicine and Dental Medicine, appoint a Conflict
of Interest Management Committee composed of five (5) senior faculty,
one of whom will be appointed as chair. Every effort will be made to
have representation on this Committee of faculty who have experience in
industrially sponsored research, as well as basic and clinical research.
The Assistant Vice Chancellor for Research shall serve as an ex-officio
member of the committee.
The committee will be responsible for reviewing cases referred to it by
UCHC Department Heads in order to determine whether the financial
interest identified in the disclosure process could affect the design,
conduct, or reporting of the research of the affected investigator(s),
and determine what conditions or restrictions, if any, should be imposed
by the Health Center to manage such conflicts; or it may decide that the
probability that the financial interest would affect the design, conduct
or reporting of the research is too remote to warrant any specific
conditions or restrictions. The committee will be authorized to request
any other information that it deems necessary to assist it in this
determination.
Examples of conditions or restrictions that might be imposed to manage
actual or potential conflicts of interest include:
a. public disclosure of significant financial interests;
b. monitoring of the research by independent reviewers;
c. modification of the research plan;
d. disqualification from participation in all or a portion of the
research
e. subject to the conflict of interest;
f. divestiture of the financial interests; or,
g. severance of relationships that create actual or potential conflicts.
This committee's operating guidelines will be developed subsequent to
the adoption of this policy. Every effort will be made to maintain the
privacy of information gathered in the Committee's deliberations, within
the limits imposed by applicable laws and regulations.
4.6 Maintenance of Records
All records related to the implementation of this policy, e.g., Conflict
of Interest Financial Disclosure forms, minutes of meetings called to
resolve or manage conflicts, minutes of the meetings of the Health
Center Conflict of Interest Management Committee, notifications to
funding agencies, etc., shall be maintained in the home department of
the investigators in question. These records shall be maintained, with
an appropriate degree of security, for a period of at least three years
following the investigator's departure from UCHC.
Departmental conflict of interest records shall be subject to periodic
review for compliance with this policy by the UCHC Administration, or by
any sponsoring agency, per the regulations cited in Section 2 above.
4.7 Notification of Research Sponsors
The Assistant Vice Chancellor for Research shall be responsible for
timely notification of research sponsors, as may be required by the
sponsors' policies or agreements between UCHC and the sponsors, of any
actual or potential conflicts of interest; including any measures taken
to reduce, manage or eliminate such conflicts.
Section 5. APPEALS
In situations where the investigator(s) dispute the decision of a
conflict of interest management committee, the matter will be referred
to the Health Center's Faculty Review Board, whose decision regarding
the management of conflicts of interest shall be final.
Section 6. PROHIBITED ACTIVITIES
Consistent with the regulations outlined in Section 2, it is the policy
of the University of Connecticut Health Center that conflicts of
interest in research may be allowable, provided that an acceptable plan
of management, as outlined in Section 4 above, can be developed and
implemented in situations where such conflicts arise, as long as such
management plans are not in conflict with applicable state and federal
regulations.
The only exception to this is that investigators may not engage in
research activities sponsored by businesses in which those investigators
have an ownership interest equaling 5% or more of the outstanding stock
(or other ownership interests) of that business, as required by the
Connecticut General Statutes.
Section 7. SANCTIONS
Sanctions and penalties for those who knowingly and willfully disregard
this policy, or refuse to comply with its terms, will be determined by
the Dean of the appropriate School with advice from the investigator(s)
Department Head. Sanctions include, but are not restricted to:
Letter of reprimand
Notification to professional and/or scientific societies, funding
agencies and/or professional journals
Reassignment of duties
Termination of grant support
Adjustment of research space allocation
Adjustment of salary
Suspension
Dismissal
Section 8. CONFLICT OF INTEREST FINANCIAL DISCLOSURE FORM
University of Connecticut Health Center
Conflict of Interest Financial Disclosure form
(Please complete this form for each business with which you have a
relationship, and return to your departmental conflict of interest
officer. Review definitions on the reverse side of this form to help you
understand how to answer these questions.)
Name: Department:
Home Address: Telephone:
1. Do you, or any member of your family, have a significant financial
interest in a business whose activities relate in any way to your
research as a faculty member of the University of Connecticut Health
Center?
Yes _____ (If you check Yes, please continue to question 2)
No ______ (If you check No, please sign form and return to your
department head)
2. Please provide the following information about the significant
financial interest identified above.
Name of business.
_________________________________________________
Activities or Products of the business.
_________________________________________________
Is this business a for-profit entity?
_________________________________________________
Is this business publicly traded?
_________________________________________________
3. Please describe the nature of your, or your immediate family's
relationship to the business identified above, e.g., consulting,
employee, executive position, board of directors, honoraria, stock
ownership. Provide details about the nature of activities with the
business.
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
I have answered fully and to the best of my ability and will update this
form promptly if my circumstances change.
_________________________________________________
Signature Date
DEFINITIONS
Business means any corporation, partnership, sole proprietorship, firm,
franchise, association, organization, holding company, joint stock
company, receivership, business or real estate trust, or any other legal
entity organized for profit or charitable purposes.
Conflict of Interest means a situation in which significant financial
interests in a business, or other personal considerations provided by a
business, may compromise, or have the appearance of compromising, an
investigator's professional judgment in conducting or reporting
research, the results of which could affect the aforementioned business,
either directly or indirectly.
Immediate Family means the investigator's spouse, minor children, and
any other persons living in the same household.
Investigator means the principal investigator and any other person at
UCHC who is responsible for the design, conduct or reporting of
research, and the investigator's immediate family. This shall include
faculty and research staff (research associates and assistants,
postdoctoral fellows, graduate students, visiting scientists, and
medical or dental students engaged in research conducted in the
department).
Participate means to be part of the described activity in any capacity,
including but not limited to serving as the principal investigator,
co-investigator, research collaborator or provider of direct patient
care. The term is not intended to apply to individuals who provide
primarily technical support or who are purely advisory, with no direct
access to the data (e.g., control over its collection or analysis) or,
in the case of clinical research, to the trial participants, unless they
are in a position to influence the study's results or have privileged
information as to the outcome.
Significant Financial Interest means 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). The
term does not include:
1. Salary, royalties, or other remuneration from UCHC;
2. Income from seminars, lectures, or teaching engagements sponsored by
public or non-profit entities;
3. Income from service on advisory committees or review panels for
public or non-profit entities; or
4. An equity interest that when aggregated for the investigator and the
investigator's spouse and dependent children, 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 interest in any
single entity;
or,
5. Salary, royalties or other payments that when aggregated for the
investigator and the investigator's spouse and dependent children over
the next 12 months, are not expected to exceed $10,000.
Research means a systematic investigation designed to develop or
contribute to generalizable knowledge relating broadly to public health,
including behavioral and social sciences research. The term encompasses
basic and applied research, and product development.
Technology means any compound, drug, device, diagnostic, medical, dental
or surgical procedure intended for use in health care or health care
delivery.
Definitions in this Section have been adapted from the following
documents.
Harvard University Faculty Medicine, Policy on Conflict of Interest and
Commitment. Association of American Medical Colleges. Guidelines for
Dealing with Faculty Conflicts of Commitment and Conflicts of Interest
in Research 1990. Department of Health and Human Services. Federal
Register (59) 123,
06/28/94. Notice of Proposed Rule Making, Objectivity in Research,
p33242-33251. National Science Foundation. Important Notice No. 117,
Investigator Financial Disclosure Policy. June 30, 1994.
Section 9. REFERENCES
The following references on conflict of interest are intended to serve
as an educational resource for the UCHC research community. It is
neither an exhaustive, nor particularly current set of citations. It
will, however, provide interested parties with information about this
complicated and important issue.
Barinaga, M., Conflicts of Interest, Confusion on the Cutting Edge.
Science 1992; 257:616-619
Blumenthal, D., Academic-Industry Relationships in the Life Sciences.
JAMA 1992; 268:3344-3349
Djerassi, C., Basic Research, The Gray Zone. Science 1993; 261:972-973
Jackson, M. Guidelines for Dealing with Faculty Conflicts of Commitment
and Conflicts of Interest in Research. Association of American Medical
Colleges, 1990.
Kassirer, J. and Angell, M., Financial Conflicts of Interest in
Biomedical Research. NEJM 1993; 329:570-571
Korn, D., Conflicts of Interest in Academic Health Centers. Association
of Academic Health Centers, 1990.
Koshland, D., Conflict of Interest Policy. Science 1992; 257:595
Krimsky, S., Statement on University-Industry Relations, Conflict of
Interest and Disclosure. Testimony Before the House Subcommittee on
Regulation, Business Opportunities and Technology 1993
Marshall, E.. When Does Intellectual Passion Become Conflict of
Interest? Science 1992; 257:620-623
Relman, A., Dealing with Conflicts of Interest. NEJM 1985; 313:749-751
Rothman, K., Conflict of Interest, The New McCarthyism in Science. JAMA
1993; 269:2782-2784
Thompson, D., Understanding Financial Conflicts of Interest. NEJM 1993;
329:573-576
Section 10. EXAMPLES OF ACTIVITIES WHICH ARE NOT A CONFLICT OF INTEREST
The following synopsis is presented as another educational resource to
the UCHC research community. It is simply a set of different scenario
which have been gleaned from various institutional policies and
publications about conflicts of interest in research. For purposes of
this policy, the definition of conflict of interest is as stated in
Section 3 above.
ACTIVITIES WHICH ARE NOT CONFLICTS OF INTEREST
Receiving royalties for copyrights and patents obtained in accordance
with University policy and State law.
Receiving honoraria for giving seminars or guest lectures.
Duty to professional organizations, peer review panels, publication
boards, and accreditation bodies.
Ownership of company where there is no relationship to University
responsibilities.
Ownership in a company where the only involvement with the University
is paid consulting.
Ownership of mutual funds which may invest in companies that support
the investigator's research.
Section 11. CHANGED UCHC STATEMENT OF COMMITMENTS AND PROPOSAL APPROVAL
FORM
1. Revise box which deals with COI.
2. Revise PI's sign-off indicating that all investigators have read the
proposal, and have, if necessary, updated their COI forms. PI's sign off
to read as follows (COI language in italics, current language in regular
type):
I certify that all those involved in this proposal are aware of their
participation and obligations, including timely compliance with the
Health Center's Conflict of Interest Policy. I have read the invention
and patent understanding, and section on consulting, on the reverse side
of this form and agree to abide by the terms and conditions described
therein. I agree to accept responsibility for providing appropriate
training for myself and my staff on those risks which may be inherent in
this project.
3. Revise chairman's sign-off, indicating that there is no COI for
anyone involved in the project. Chairman's sign off to read as follows (COI
language in italics, current language in regular type):
The work described in the attached proposal is consistent with the
programs of this department(s). Requirements of space, personnel,
utilities and other facilities are available, have been committed or
will be provided by the grant or contract if awarded. The budget
specifies all expenses that can be reasonably anticipated. The
investigators involved in this project have all completed a Conflict of
Interest Financial Disclosure Form in compliance with the Health
Center's COI Policy.
4. Definition of COI for back of form.
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