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Preamble
Duke University wishes to increase its cooperation with private industry
in the search for new and useful knowledge. Duke believes that it can,
while maintaining academic traditions and values that advance the search
for truth through free inquiry, find ways to combine its unique resources
with the resources of private industry to investigate important questions
of interest to the research sponsor, the university, its faculty, and
the public as a whole. This document is a statement of principles and
policies that will guide Duke in establishing fruitful research joint
ventures with private firms.
There are, to be sure, certain potential conflicts between the missions
of academic institutions and industrial sponsors of research. A fine university
perceives its raison d'etre to be the generation and dissemination of
knowledge for the benefit of society as a whole; viewing knowledge as
a public good, a university subscribes to the scientific tradition of
fully and promptly making public all research findings so that others
may build upon them. Industry, on the other hand, is usually interested
in recouping and profiting from its investments in research by capturing,
rather than freely sharing, the value of new knowledge. Universities are
also interested primarily in pursuing fundamental research and are less
interested in applications than industrial firms are apt to be.
Largely because of these differences in outlook, the production of new
knowledge in the United States has in the past been rather rigidly divided
between a public sector producing public goods (with universities supported
by governments and philanthropy as a vital element) and a private sector
producing information for proprietary use. The barriers between these
two sectors may have inhibited the production of valuable knowledge by
making it difficult to bring together the unique resources available only
in universities with the private capital and research capabilities of
industrial firms. While useful collaboration has occurred, the public
would benefit substantially if the conflicts perceived between the public
responsibilities of universities and the private interests of corporate
research sponsors could be resolved in light of a higher common objective,
the search for truth.
Duke believes that the overarching value to be served in these matters
is the pursuit of useful knowledge and that this goal can be advanced
both through maintenance of its own academic and scientific traditions
and through cooperative projects with interested parties. Where these
two paths to new knowledge necessarily diverge, Duke will seek to accommodate
the conflict whenever possible. In cases where the university is convinced
that special arrangements are necessary to protect a research sponsor's
essential interests, Duke will seek a constructive solution to a sponsor's
problems within the policy limits described here. However, as noted in
detail below, Duke must also be satisfied that its own commitments to
free inquiry, to education, to collegiality within the university, and
to enlarging the common pool of knowledge will not be prejudiced by the
terms of any particular arrangement.
The establishment and maintenance of research relationships with industry
will be facilitated if all parties recognize from the beginning that the
university adheres to certain principles and is guided in its actions
by certain policies. For such policies to be effective in a rapidly changing
environment, such as we have today, they must be wisely and flexibly interpreted.
Interpreting the policies, given below, will be the responsibility of
the Research Policy Committee which it is recommended be created with
the approval of this policy document. This committee is charged with advising
the Provost regarding the implementation of these policies, as well as
with recommending those changes in the policy that may prove necessary
or advisable.
The overriding goal of this policy is to promote close and imaginative
working relationships between the university and industry that will nurture
the development of new knowledge while still maintaining the integrity
and independence of the university, its faculty and students.
Circumstances may arise where it is considered to be in the university's
best interests for a particular principal investigator to do certain research
for a sponsor. In such cases, the investigator may feel some pressure
to participate in such research. It is especially important that investigators
be free not to accept grants or contracts which, in their view, circumscribe
their independence or control of their professional work.
POLICY: No principal investigator shall be required to participate
in a particular research effort as a condition of employment at the
university.
While public or private research sponsors may reasonably expect to define
broadly the project they will support, university principal investigators
may expect to have wide discretion in designing and modifying their sponsored
research. Although the sponsor may consult on matters of concern, generally
it is not appropriate for a sponsor to specify in detail how the work
is to be done.
POLICY: A sponsor shall have the privilege to define broadly the topic
of the research to be funded. The university principal investigator
shall have final authority over the design and control of that research.
From time to time the university may choose to establish, in cooperation
with a sponsor or sponsors, a research institute, center, or program that
is legally free-standing from the university, but which depends upon faculty
of the university for partial staffing. In such a situation, a sponsor
may seek a formal voice in how its committed funds are spent. The situation,
while offering important opportunities, also poses certain risks. In particular,
if inappropriate control over the unit's research program is provided
to the sponsor, the academic freedom of the faculty involved may be diminished.
POLICY: The university shall not participate in a joint free-standing
research unit that would restrict the academic freedom of the faculty.
The Provost, advised by the Research Policy Committee, shall determine
whether this risk exists and, if so, whether the level of risk is acceptable.
The review by the committee and the Provost shall take place before
the university decides whether to enter into an agreement to create
such a unit.
Tradition has long held that university researchers must be free
to publish their research results. This freedom is essential if the university
is to be the source of new knowledge for society. Therefore it must be
vigorously guarded. At the same time, good business practice requires
that sponsors protect their proprietary rights, trade secrets, or other
confidential information. These separate and legitimate interests may
diverge on questions relating to publication. Clearly, it is in both the
researcher's and the sponsor's best interests to find ways to protect
academic freedom while at the same time meeting the nondisclosure requirements
of the sponsor.
There are three ways in which a sponsor may affect the process of publication:
by reviewing materials prior to publication; by delaying the date of publication;
and by preventing publication.
The university has traditionally allowed a sponsor to review materials
prior to publication, but such review has been allowed only under certain
circumstances and has been limited to a reasonable period of time. This
practice has been followed in order to prevent inadvertent disclosure
of a sponsor's proprietary information and/or to allow the sponsor time
to file proper proprietary protection on research-generated technology.
Such a review may delay publication for no more than a brief period.
POLICY: A sponsor may, prior to publication, review materials resulting
from research it has sponsored in those cases where possible proprietary
right may be involved or where the university has been provided a sponsor's
proprietary information. Such reviews should not delay publication for
more than ninety (90) days, except with the approval of the Provost.
While having due regard for the sponsor's interests, the university
encourages the publication of research results. The university must retain
final authority over publication rights, including the right to publish.
As a matter of policy the final determination of what may be published
or not published normally will remain with the university.
POLICY: Final determination of what may be published or not published
shall remain with the university. The university will also retain the
right to make a final determination with respect to publication of computer
programs. Exceptions may be granted by the Provost only after detailed
review and upon the advice of the Research Policy Committee.
When a sponsored research project deals with proprietary information,
the sponsor may wish to restrict the researcher's freedom to discuss the
research with colleagues. While recognizing the need for researchers to
protect the sponsor's proprietary rights, the university recognizes a
concomitant responsibility to honor the researcher's membership in an
intellectual community. It is essential that the free exchange of ideas
among colleagues not be inappropriately restricted.
POLICY: Agreements to treat as confidential information generated by
research done at the university are ordinarily unacceptable. There may,
however, be situations where exceptions to these guidelines are consistent
with the university's education, professional, scholarly principles.
Such exceptions are granted by the Provost only after detailed review
and upon the advice of the Research Policy Committee.
It is also the responsibility of each individual researcher to protect
freedom to communicate with colleagues and to refuse to enter into sponsored
agreement that will restrict that freedom in unreasonable or unacceptable
ways.
One potential concern of a sponsor may be that a faculty member whose
research it is funding will do closely similar research for a second sponsor.
This could undermine the first sponsor's competitive and legal position.
To address this concern, the sponsor may sometimes ask the university
to include language in the sponsoring contract assuring that such parallel
research will not take place. The university has a different concern that
such language might limit the academic freedom of the researcher to do
research in related but different areas.
POLICY: A sponsor may request that a researcher, prior to entering
into additional sponsored research agreements to do research that is
closely similar to the research sponsored by that sponsor, will notify
the sponsor of that intention. In such situations, the university will
only consider restricting the freedom of the researcher to do such related
work if the first sponsor raises a concern about protecting its proprietary
rights prior to the signing of the second agreement. The university
will agree to restrict the activities of a researcher to do related
work only if there is a reasonable possibility that the work done for
the second sponsor will infringe on the proprietary rights of the first
sponsor under the pre-existing sponsored agreement.
A sponsor making a financial commitment to a particular research project
may desire to reduce its risk by stipulating the expected results as specifically
as possible. While recognizing the sponsor's right to require reports
to be provided by certain dates, the university is not able to guarantee
to a sponsor that a particular research project will succeed or produce
particular results. Instead, the university will commit to using best
efforts in conducting a research project.
POLICY: Since state-of-the-art research is by nature unpredictable
and without guarantee of success, research within the university is
conducted on a best efforts basis. However, a good faith effort will
be made to organize research projects in a manner which is sensitive
to the special needs and time constraints of the sponsor.
An essential aspect of education, in particular graduate education, is
the development and dissemination of new knowledge through publication
of research results. This reflects the academic community's belief that
the sharing of knowledge advances knowledge. In this context, the use
of confidential information in research poses risks. When faculty participate
in research that involves the handling of proprietary information, the
university believes that a student's participation under such circumstances
should be monitored by a third, disinterested party.
POLICY: In general, students shall not participate in projects which,
because of confidentiality or other factors, might constrain their right
to publish or communicate freely. Exceptions to this policy must be
approved in writing by the student's chairman (or chairmen, if the faculty
member is in a second department) or dean (or deans if the faculty member
is in a second school). The student shall also sign this document to
signify understanding of the issues involved. Copies of the signed document
must be sent to both faculty member and student before the student may
become involved in the project.
The university recognizes that benefits may accrue to students,
and in particular graduate students, who are able to participate in the
outside professional activities of faculty. Such participation may result
in intellectual growth, the acquisition of new skills in frontier areas
of knowledge, and additional income. At the same time, it is understood
that these arrangements are likely to change the relationships between
faculty and student in ways that are not always desirable. For example,
a graduate student who, though very able, is not making satisfactory progress
toward a degree because of absorption in a faculty member's growing new
business, may present a dilemma for the instructor/supervisor. It should
be added that the dilemma is one that the student may well be unaware
of or unconcerned about. Most students welcome involvement in a faculty
member's outside professional activity, and may not realize the potential
problem the situation may create for the faculty member.
POLICY: To protect the student and the university, the appropriate
chairman and dean must give prior approval, in writing, for any involvement
of students in the outside professional activities of faculty. The student
must also sign this document, to signify understanding of the issues
involved. Copies will be sent to both faculty member and student. The
chairman or dean is asked to review the case with particular care when
the faculty member is the student's thesis advisor or supervisor as
a teaching assistant, or if the student is already working full-time
as a research assistant. In situations where, in the chairman's and
dean's judgment, the quality of the student's education or other university
interests are in jeopardy, such arrangements should not be approved.
- Conflict of Interest: A conflict of interest can
be said to exist when a member of the university community has a relationship
with an outside organization such that his activities within the university
could be biased by that relationship in a direction which would ultimately
provide direct financial benefit to the individual or a close family
member.
- Conflict of Commitment: A conflict of commitment
can be said to exist when a member of the university community has a
relationship which requires a commitment of time or effort to nonuniversity
activities such that an individual, either implicitly or directly, cannot
meet the usual obligations to the university. Obligations to the university
are not discharged solely by meeting classes but require availability
of faculty to students outside the classroom, participation in various
committees, supervision of graduate and postdoctoral students, and progress
in research programs. Any relationship with an outside organization
which requires frequent and/or prolonged absence from the university
presents a conflict of commitment.
POLICY: Faculty members shall avoid relationships which constitute
a conflict of interest or a conflict of commitment.
- Disclosure to Chairmen/Deans: It has long been recognized
that consulting can, in certain situations, create in a faculty member
a conflict of interest or commitment. The university's policy of restricting
a faculty member's consulting to one day a week addresses this issue
in part. Other situations in which faculty may face a conflict of interest
or commitment include ownership (or management responsibilities) by
a faculty member or his immediate family of a significant financial
interest in an outside concern. Immediate family are defined as spouse
and minor children.
POLICY: To assure that chairmen and deans are informed about arrangements
which may pose a conflict of interest or commitment, faculty members
shall disclose to their chairman or dean once a year and in writing
their outside relationships with corporations or other business entities,
as consultant, advisor, or manager. Information disclosed must include
the name of the company, and the nature and scope of the relationship.
No information about financial arrangements need be provided.
- Disclosure to Senior Administrators
POLICY: Direct and active management obligations in such an enterprise
raise the possibility of a conflict of interest. A faculty member is
required to notify the Provost in writing prior to accepting any such
direct and active management obligation, and may assume that no conflict
of interest exists unless otherwise notified by the Provost. The Provost
may, at the time of acceptance or at a later time, require appropriate
action to assure that no conflict of interest exists.
- Research Policy Committee
POLICY: In cases where a faculty member wishes to appeal an interpretation
or decision made under this policy by a chairman, dean or provost, or
where a chairman, dean or provost wishes to consult others for advice
before making such a decision, the case may be brought to the Research
Policy Committee. On request from a faculty member, chairman, dean or
provost, the committee shall review the status of that faculty member's
(or his/her immediate family's) new or continuing significant financial
interest in or managerial relations with a private enterprise. The committee
shall report to the Provost whether in their opinion this involvement
may pose a conflict of interest or commitment.
- Definitions of Certain Terms Used in This
Policy: Significant financial interest in a private enterprise
means holding more than twenty percent of the equity, options or other
types of corporate security. Such interests, if held by a faculty member's
immediate family, shall fall within this definition. Direct and active
management obligations include serving as a member of the board of directors,
chief executive officer, chief operating officer, director of research,
treasurer or other senior line management officer.
- University Business with Faculty Enterprises:
The university's current policy governing its business dealings
(i.e., contracts) with companies owned or controlled entirely or in
substantial part by faculty is administered at present by the Conflict
of Interest Committee. We recommend that the Research Policy Committee
implement this policy instead, and that the Conflict of Interest Committee
be dissolved.
There are at least seven offices and nine committees that have research-related
responsibilities at the university. At present, coordination among these
units is primarily informal, although individual units have some formal
ties to each other as well.
The Governance Offices and Committees:
- Office of Research Support (campus schools)
- Office of Research Adminstration (School of Medicine)
- Office of Science and Technology
- Office of Sponsored Programs
- Office of University Development
- Medical Center Development Office
- Compliance Office (School of Medicine)
- Internal Audit
- Institutional Review Boards for Protection of Human Subjects
- for social and behavioral Science research
- for biomedical research
- Institutional Animal Care and Use Committee
- Biosafety Committee
- Committee on Conflict of Interest
- Patent Committee
- Small Grants Committee (School of Medicine)
- University Research Council (campus Schools)
- Research Policy Committee
The Research Policy Committee is responsible for reviewing university
research policy, maintaining liaison with existing research committees
and councils, and, at the request of the Provost, reviewing major institutional
proposals and smaller proposals that have important policy implications.
The membership:
The Research Policy Committee consists of representatives from both the
faculty and administration. The committee is chaired by the Vice Provost
for Research. Five faculty members, knowledgeable about research and sponsored
projects issues and representing a spectrum of fields, shall be appointed
by the Vice Provost for Research on the recommendation of the Academic
Council and with the concurrence of the Provost. Members who serve by
virtue of their office or are appointed by a senior administrator are:
- Dean of the Graduate School
- One member appointed by the Chancellor for Health Affairs
- One member appointed by the Vice President for Alumni Affairs and
Development
- One member appointed by the University Counsel
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