For DRC Use Only: #
Financial Conflict of Interest in Research
Management Plan
Investigator: [Researcher’s Name]
[The entity: [Name of Company] if applicable]
Preamble: As [[state role] in/for [name of Company], hereinafter called “Company”, if
applicable] [and/or inventor of the intellectual property (IP) (as defined below) owned by the
University of New Hampshire (UNH) and licensed to Company if applicable], I agree to
cooperate with officials of UNH in managing financial conflicts of interest arising from my
research at UNH pertaining to [summarize area of work] (the “IP”).
This Management Plan (the “Plan”), including any subsequent amendments, will be in effect
from the time of the UNH Disclosure Review Committee’s (DRC) acceptance of the Plan (as
indicated by signature of this document) until expressly revoked in writing via agreement signed
by me and the chair/co-chair of the DRC. The awards, patent applications, issued patents,
trademarks, and/or copyrights subject to this Plan (with any applicable conditions) are listed in
Appendix A. I will provide an updated Appendix A to the DRC when any new awards, patent
applications, issued patents, trademarks, and/or copyrights relating to the IP are awarded or
assigned to UNH.
On the first anniversary of enactment of this Plan, and annually thereafter, this Plan will be
reviewed by me and the DRC and updated as necessary. If there are no updates to the Plan, I
will so indicate. I agree that if my financial situation with regard to Company and/or the IP
changes, I will complete an updated Financial Conflict of Interest in Research (FCoIiR)
Disclosure Statement and submit it for DRC review within two weeks after any such changes
occur.
1. Interactions with Students and Staff
I recognize my duty to ensure that my financial interests in Company have no negative
impact on UNH students and staff participating in my research [with the IP remove if not
applicable], especially that there be no negative impact on the academic progress of
students. To carry out my duty, I will do the following:
a. Provide information on my financial conflicts of interest to UNH students, fellows,
trainees, and other employees I supervise in the course of my research [with the IP
remove if not applicable]. This information will be provided immediately to each newly
hired individual, and annually to each person employed in my research work involving
Company and/or the IP. The information will include explanations of my relationship with
Company and the right of UNH students and staff to take concerns about the effect of
my relationship with Company on their work, studies, or progress towards degree, to
their dean, assistant/associate dean, chair or director, or the UNH DRC. (See Appendix
B for my notification and communications plan.)
b. For the UNH graduate students conducting research sponsored by the Company and/or
involving the IP:
i.
I will not serve as sole advisor for graduate students’ master’s thesis or doctoral
dissertation research [with the IP remove if not applicable].
ii.
I will form each student’s thesis/dissertation Committee as soon as possible.
iii.
I will establish a research plan with milestones for each student, agreed to by the
student and Committee.
iv.
I will notify the Department of [department] Director of Graduate Studies of the
arrangements.
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
v.
vi.
I will inform the students that the Department of [department] Director of
Graduate Studies will contact them once each semester and the Committee will
review their work annually.
I will request that the Department of [department] Director of Graduate Studies
inform the Associate Dean of the Graduate School annually of each student’s
progress and any issues.
c. Refrain from placing any restrictions on the ability of UNH students and staff to receive,
analyze, or interpret data. I will not permit UNH students to participate in research
sponsored by Company and/or with the IP if the terms and conditions of participation
would prevent or inhibit them from meeting applicable UNH degree requirements, such
as completion and public defense of a thesis or dissertation.
d. Take reasonable steps to ensure that any UNH students or staff members who
independently have or acquire a reportable significant financial interest submit a FCoIiR
Disclosure Statement, following all applicable UNH policies.
e. Ensure that all significant involvement of UNH students and staff in research related to
Company [with the IP remove if not applicable] is conducted under formal UNH
agreements in order to assure that flow of money and attribution is traceable,
transparent, and in accordance with UNH awarding policies.
2. Co- Investigators
I will not serve as the Principal Investigator (PI) for both Company and UNH simultaneously
for any awards.
It is my responsibility to notify all co-investigators on any awards whose subject matter is
related to ongoing research [with the IP remove if not applicable] sponsored by or conducted
on behalf of Company of my financial conflicts of interest.
3. Publications and Presentations
My relationship with Company will not restrict publications or presentations resulting from
research at UNH, although publication may be delayed for the purpose of pre-publication
review for a period consistent with UNH policies. I and the UNH students, fellows, trainees,
and other research workers under my supervision in the course of research [with the IP
remove if not applicable] or research otherwise related to Company will disclose the
relationship with Company in publications and academic presentations where disclosure is
possible and appropriate.
When presenting scientific results at meetings that have recommendations for format and/or
content of disclosure, I will adopt the required format of the meeting. In addition, I will list
myself with dual affiliations (UNH first, then Company) in the author list of publications.
4. Intellectual Property
I understand and agree that inventorship and ownership of any new intellectual property
arising from my research [with the IP remove if not applicable] will continue to be determined
in accordance with the agreements between UNH and Company, and UNH policy. I further
understand and agree that inventorship and ownership of any new intellectual property
developed by UNH students and staff employed in my research [with the IP remove if not
applicable] will be governed by any applicable agreements and in accordance with UNH
policy.
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
5. Use of University Facilities and Services This section is only applicable to researchers
with interests in outside entities; please delete if not applicable.
I understand that the use of UNH facilities and services for my research [with the IP remove
if not applicable] with Company will be covered by a formal and approved research
agreement between UNH and Company. In addition, such use must be approved in
advance by the UNH [department] department chair and the UNH College of [college] dean,
as evidenced by their signatures on the UNH Sponsored Program Proposal Internal
Approval Routing Forms (“yellow sheet”) for all projects involving my research [with the IP
remove if not applicable]. I agree that any activity involving the use of UNH facilities for the
benefit of Company will be conducted in accordance with all relevant UNH policies.
I acknowledge that uses of UNH resources by or on behalf of Company will be reimbursed
appropriately. It is appropriate that collaborative research funded by external organizations
and conducted through formal agreements (described above) shall make beneficial use of
facilities, equipment, and staff from both UNH and from Company for accomplishing stated
research milestones. I will ensure that use by Company of UNH resources outside the scope
of these formal agreements will be well documented and any cost appropriately charged to
Company.
I will obtain written prior approval for revisions to award budgets for my research [with the IP
remove if not applicable] with Company, following UNH policies related to sponsored
projects.
6. Principal Investigator Salary
If UNH and Company are both parties to an award [involving the IP remove if not
applicable], and if I elect to receive salary from the award, I will receive salary as PI at only
one of the entities.
7. Project Oversight and Reporting
To monitor that there is no bias in the project design, conduct, and dissemination of
information related to the research, nor hardship to graduate students due to FCoIiR:
a. I will submit to the DRC on the first anniversary of enactment of this Plan, and
annually thereafter, a written report providing updated information related to
compliance with the terms of this management plan, and information regarding
students and staff involved in activities related to Company. I will include in this
annual report a self-certification of data integrity.
b. I will submit to oversight of an independent review team of data monitors or scientific
reviewers, the members of which have no relationship with the Company nor any
direct interest in the research. The team will consist of the assistant/associate dean
of my college and the chairperson of my department. Additional review team
members may be selected from within or outside UNH according to expertise
requirements and University policy, and will be subject to my consent, provided that
such consent will not be unreasonably withheld.
Every six months (based on the date of the signing of this Plan by the DRC co-chair)
I will provide to the review team a written report (and if necessary an oral
presentation) which will document:
i.
The data analyses and interpretation I conducted in pursuit of the research
during the reporting period, including a description of how the experiments
were conceived and designed. The review team will also be provided access
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
ii.
to the raw data involved in research related to Company, including
instrument output and notebooks.
The progress of graduate students and the involvement of other UNH
personnel in the conduct of research related to Company.
c. The review team will assess:
i.
Whether the work was conducted using appropriate scientific procedures;
ii.
The appropriateness of the data collection methods employed; and
iii.
Whether the data were recorded in a manner consistent with standard
laboratory procedures.
The review team may also conduct or recommend scientific reviews and audits of
UNH research relevant to Company and in cooperation with Company.
d. The review team will provide an annual written assessment report to the DRC with
the first report due one year from the date of the signing of this Plan by the DRC cochair, accompanied by a copy of the information that I provide to the reviewers.
Raw data and instrument output will be maintained per the UNH Policy on Ownership and
Management of Research Data (http://www.usnh.edu/olpm/UNH/VIII.Res/Default.html#C).
8. Human Subjects This section is only applicable to research involving human subjects;
please delete if not applicable.
If a project subject to this Plan involves human subjects, I agree that the following
components will apply:
 I will not be directly involved in the recruitment of human subjects, nor will I administer
the informed consent.
 I will not solely be involved in the interpretation of study results related to human
subjects, although I may be involved as part of a committee that evaluates and makes
final decisions about the appropriate interpretation and presentation of study results.
 For any study under the direct oversight of the UNH IRB, I will disclose the existence of
my Significant Financial Interest by using the following language in the informed consent
document:
“One or more of the investigators conducting this research has a financial interest in
or a patent for the development of this [add study specific information]. This means it
is possible that the results of this study could lead to personal profit for the individual
investigator(s) and/or the investigator’s institution. This project has been carefully
reviewed by the University of New Hampshire Institutional Review Board for the
Protection of Human Subjects in Research (UNH IRB) to ensure that your well-being
holds more importance than any study results. Any questions you might have about
this will be answered fully by Dr. [PI name] at [PI phone] or by the UNH IRB
Chairperson.”
9. Signatures
My signature below indicates my agreement to comply with all elements of this Plan. I
understand that this Plan will be effective upon UNH DRC acceptance, as indicated below.
__________________________/ _____
[Researcher’s name]
/ Date
Accepted on behalf of the UNH Disclosure Review Committee by
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
__________________________/ _____
Signature
Date
cc: Assistant/Associate Dean/Center Director [Assistant/Associate Dean’s/Center Director’s
name]
Department Chair [Department Chair’s name]
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
Appendix A
Awards Subject to This Management Plan
Patents (Issued and Pending Applications, including Provisional Patent Applications),
Trademarks (Issued and Pending Applications), Copyrights (Registered and not) and Intellectual
Property Disclosures Subject to This Management Plan. (If foreign patent applications are
counterparts to US patent applications do not list them; list only novel foreign patent
applications.)
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013
For DRC Use Only: #
Appendix B
Informing Students and Staff of Potential Conflicts of Interest
I will hold annual meetings with members of my UNH research group (students and staff) to
explain my financial conflict of interest, communicate the details of the FCoIiR Plan provisions
related to my research [with the IP remove if not applicable], and allow participants to ask
questions. I will speak individually with any new employee joining my UNH research group to
convey this information. Annually, I will provide to the independent reviewers a list of individuals
who have received the information.
I will follow these meetings with a written summary of the information for each UNH student or
staff member participating in this award. This is an example of the written summary I will use:
Dear Staff/Students,
As required by University of New Hampshire policy, I am notifying you that as (insert
relationship to company and name of company, and where applicable, description of IP,
e.g., an inventor of technology patented by UNH and as owner of the spinoff company X) I
can benefit financially from successful demonstration of [explanation of the technology/
invention]. The fact that I could personally benefit from a successful scientific demonstration
creates a financial conflict of interest in research, which I must periodically disclose.
To manage this financial conflict, it is my responsibility to ensure that a review board
conducts a review of my work annually and presents its report to the UNH Disclosure
Review Committee.
If my financial situation were to change, I would submit a revised disclosure statement
according to UNH policy, and inform you of those changes. If you acquire a significant
financial interest, you similarly must file disclosure statements.
If you have any concerns at any time about my research objectivity, I encourage you to
contact the Dean of the Graduate School (graduate students) or the [department]
Department Chair (undergraduate students and staff). If you have any questions about this
disclosure itself, please do not hesitate to discuss them with me.
Sincerely yours,
[Researcher’s Name]
[Researcher’s Title]
Financial Conflict of Interest in Research
Management Plan Template
Revised 3/8/2013