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Policy
on Conflict of Interest for Research and Technology Activities
I. OVERVIEW
In the recent
past, Universities have undergone a profound transition in their
attitudes toward and interactions with the industrial sector of
our society. Entrepreneurial interactions are developing as a means
of seeking funds in our increasingly competitive environment, and
as an appropriate mechanism for keeping pace with advancing technology.
These interactions vary, and include the formation of industrial
consultantships and long-term collaboration for clinical trials.
These interactions are increasingly accompanied by questions regarding
appropriate rewards and obligations, and by broad demands for intellectual
properties. The fundamental premises of any guidelines for this
area is that all scientific findings should have the greatest potential
benefit to the public and that the investigator's academic freedom
and responsibilities should not be compromised or influenced by
these interactions.
To address
issues regarding conflict of interest, allowable compensation, and
compliance with regulations beyond the School, the University of
Michigan Medical School has defined and updated existing guidelines,
and will establish a Review Board on Conflict of Interest to consider
any situations which arise.
II. ACADEMIC
MISSION
Entrepreneurial
activities undertaken by individual faculty should not interfere
with the Medical School's academic mission. No contract, consultancy,
or outside endeavor should interfere with or compromise this primary
obligation. Similarly, an investigator's personal financial status
and external remuneration should remain separate from their research
activities conducted on behalf of the School.
Any program
involving industrial interface should have as its goals the support
of investigative, educational or clinical efforts at the institution;
the career development of faculty and trainee participants; the
enhancement of the Medical School's reputation of excellence; and
compliance with all University and State guidelines for the ethical
conduct of research and conflict of interest.
All faculty
considering participation in any program involving industrial interface
should allow their efforts to be guided by maintenance of academic
freedom, furtherance of the academic goals of their institution,
and enhancement of their institution's education and training opportunities.
A faculty member should be able to maintain the right to timely
oral and public disclosure, the right to refuse to participate in
an industrial program defined by their department and/or academic
unit, the ability to pursue projects unrelated to the goals of a
program, the ability to seek external funding for non-program related
research, and the ability to exercise their primary faculty responsibilities
without interference.
III. COMPLIANCE
WITH STATE REGULATIONS
All faculty
are expected to comply with State of Michigan Statute on Conflict
of Interest (M.C.L.A. 15.321, et seq.), which states that University
employees are not permitted to contract with the University, either
individually or on behalf of external business entities in which
the employee has an interest, unless the terms of any such proposed
contract are disclosed in full to the Executive Officers and approved
in advance by a two-thirds vote of the Regents. The Statute also
prohibits faculty from participating directly in negotiations or
to represent either party in transactions.
The existence
of this Statute mandates scrutiny of certain situations which may
occur beyond the School level. The Statue specifies, for example,
that Regental Review will be required for any direct or indirect
solicitation of contracts by faculty who hold more than 1% of a
company's non-listed stock or more than $25,000 in listed stock
of the company in question. The same scrutiny will be applied to
any company in which the faculty is a director, officer, or employee.
IV. CONFLICT
OF INTEREST REVIEW BOARD
The Medical
School will establish a Review Board on Conflict of Interest, which
will be advisory to the Dean and the School's Executive Committee.
This Board will review annual disclosures from all faculty; will
develop and interpret policies to resolve allegations and to address
non-compliance; will provide a mechanism for appeal; will report
any unresolved issues to Central Campus.
The Medical
School's Review Board on Conflict of Interest will require advance
review of situations involving: consultancies with companies from
which the investigator also receives research funding; and stock
holdings, options, bonuses, or other equity positions in the sponsoring
agency held by the individual or immediate family members. In general,
the Board is unlikely to support consultancies or research awards
from companies in which the investigator already has a significant
equity interest, but may consider consultancies that are shown to
be independent of award-related research. Such decisions will be
made on a case-by-case basis. Although the basic threshold would
assume insignificant holdings by a faculty member of a company's
outstanding stock, the actual thresholds to be determined in each
case by the Board will take into consideration the overall size
of the company, and the relationship involved between the actual
degree of financial gain for the investigator and the conduct of
their research.
V. APPEARANCE
OF CONFLICT OF INTEREST
In some instances,
the appearance of conflict of interest constitutes as great a potential
hazard for the investigator and the institution as actual conflict
of interest. Therefore, full disclosure by all faculty of any consultancies,
awards, or equity holdings is mandatory. All faculty are also expected
to adhere to existing University guidelines regarding conflict of
interest and outside employment.
The appearance
of conflict of interest could arise from the following situations:
benefit by an investigator from the financial outcome of their research;
referrals to a business in which they have an interest; interest
in a business which competes with the University; publishing or
presentation of research without disclosure of the investigator's
related financial interest; or allowing University responsibilities
to influence or benefit a company in which the investigator has
an interest. Two situations that would require special attention
are participation in technology development in a company in which
the investigator has an interest; and executive participation in
a start-up biomedical company.
Conflict of
interest may arise not only in situations related to personal financial
gain, but also those involving professional activities, such as
the biased review of manuscripts and grants, or in performance evaluation
of faculty, staff, and trainees.
VI. COMPENSATION
Any sponsored
research activity conducted by University faculty, including basic
science investigation or clinical trials, has the potential to lead
to a product or byproduct of commercial value. The principal purpose
of any research award, consultancy, or contract therefore should
not be solely personal financial gain for the investigator other
than direct compensation for actual effort committed to the project
or as royalties distributed under University guidelines.
An excessive
focus on personal financial gain within an academic setting could
influence objectivity in research. Therefore, an investigator should
not have a financial interest in the outcome of their research.
Accordingly, faculty therefore may accept research awards from industrial
sources only if there is no reciprocation involved or expected,
and should not make inappropriate use of any University facilities
or personnel for any private enterprise.
Acceptable
levels of compensation will be determined by the Medical School's
Review Board on Conflict of Interest, as indicated above.
Endorsed
by the University of Michigan Medical School Executive Committee
May 13, 1993.
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