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UMMS
Conflict of Interest Board Organization and Procedures
Approved
by Medical School Executive Committee
October 2002
Introduction
This document
explains the procedural issues involved in determination and management
of potential and actual conflicts of interest at the University
of Michigan Medical School (UMMS). The actual conflict of interest
rules are set forth in a series of documents and State and Federal
laws and regulations, referenced at the end of this document. Medical
School faculty and staff may contact the Office of Research and
Graduate Studies with questions about these procedures.
Purpose
UMMS will exercise
care in participating in research and other academic activities
in which the faculty investigators or professional staff involved
(or, to their knowledge, their spouses, or dependents) have interests
that create conflicts. Such agreements or sponsored activities will
be accepted if they:
1. Can be expected
with reasonable certainty to not compromise the integrity of those
investigations or undermine the employees' obligations to the University,
to the sponsor, or to the trainees, and
2. Can be satisfactorily
managed with appropriate administrative oversight.
Similarly,
the UMMS will exercise care in concluding technology transfer agreements
involving University employees. Such agreements will be managed
with appropriate administrative oversight.
UMMS has appointed
a Conflict of Interest Board (COI Board) to review disclosures by
faculty investigators and/or professional staff and to recommend
appropriate administrative oversight for any conflict of interest.
The COI Board is advisory to the Dean of UMMS and the Office of
the Vice President for Research (OVPR).
Scope
UMMS is committed
to maintaining its basic values of openness, scientific integrity,
and independence and its tradition and expectation that its faculty
and staff members will conduct their relationships with the University
and UMMS with candor and integrity.
UMMS faculty
and staff have the right to acquire and retain personal financial
interests (including personal income from the transfer of technology)
so long as those obligations and commitments do not interfere with
their primary responsibility to the University.
The University
of Michigan (UM) is required to have a policy for the disclosure
of personal financial information by faculty and staff engaged in
sponsored research and procedures for institutional review of the
relevance of such personal outside interests to the integrity of
the proposed sponsored research. This policy is required in order
to be eligible to receive federal funds from the Public Health Service
or the National Science Foundation. UMMS has additional specific
policies and procedures for disclosure and management of potential
conflicts of interest.
The UMMS policy
and the attached procedures (Attachment A) fulfill these external
obligations while minimizing the personal privacy concerns of researchers
and their families. The disclosure and review process also strives
to protect researchers from misplaced charges of conflict of interest
by providing a mechanism for objective review and approval of personal
outside financial interests.
The COI Board will review all disclosures by faculty and staff and/or
other conflicts identified by a faculty or staff member. The COI
Board will make a determination whether the proposed activity is
expected with reasonable certainty to not compromise the integrity
of those investigators or undermine the employees' obligations to
the University, UMMS, to the sponsor, or to trainees. The COI Board
will determine whether the activity can be satisfactorily managed
with appropriate administrative oversight.
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Definition
A conflict
of interest may take many forms, but arises when a faculty, staff
member, department or other University unit, in relationship to
an outside organization, is in a position to influence the University's
business, research, or other decisions in ways that could lead directly
or indirectly to financial gain for the faculty or staff member
or his or her family, or give improper advantage to others to the
detriment of the University.
Similarly,
the University of Michigan will exercise care in concluding technology
transfer agreements involving University employees. Such agreements
will be managed with appropriate administrative oversight.
Appointment
of the UMMS COI Board
The COI Board
of UMMS is appointed by the Dean of UMMS and approved by the UMMS
Executive Committee (EC). The Board shall recommend new Members
of the COI Board to the Dean on an annual or as needed basis. Upon
review and approval by the Dean, the Dean shall present the proposed
Board Member(s) to EC.
Members may
serve a maximum of three terms. Nominations for Members will be
solicited from the Chairs of the Medical Schoool as well as from
the current and past Members and Attendees of the COI Board. In
recommending a proposed Member of the Board, the COI Board should
consider the current composition and experience of the COI Board,
and the need for continuity of the COI Board.
Composition
The Board shall
consist of both Members and Attendees. No less than nine faculty
members shall be appointed as Members of the Board and shall serve
three-year rolling terms. Three Board Member terms shall expire
annually in January. Each Member shall retain his/her position for
his/her term and until such time as a successor is approved by EC.
A Member may resign his/her position by providing written notice
to the Dean of UMMS. Members serve at the pleasure of the Dean,
who may, at his/her discretion, remove a member prior to the end
of a term.
The Chair of
the COI Board shall be appointed by the Dean of the Medical School
and is a non-voting position. The Attendee positions are constant
and non-voting positions. The Members and Attendees of the COI Board
shall be comprised at a minimum of the following:
Members
• Two basic science faculty members
• One clinical faculty member involved in patient care
• One clinical research faculty member
• One Chairperson of a Medical School Clinical or Basic Science
Department
• One faculty member with entrepreneurial experience
• One junior faculty member
• Associate Dean for Research and Graduate Studies
• Executive Director, Administration and Chief Financial Officer,
Medical School Administration
• One faculty member from another school or college
Attendees
· University of Michigan Health System Legal Office
· Division of Research Development and Administration (DRDA)
· Technology Management Office
· Medical School Dean's Office Administration
· Medical School Institutional Review Board (Clinical Research
Services Director)
· General Clinical Research Center (Research Subject Advocate)
Observer
• Office of the Vice President for Research
Quorum
Each COI Board
meeting must have a quorum of Members where any action is to be
taken by the Board. Five Members of the COI Board present at a meeting
shall constitute a quorum at such meeting. The Chair of the COI
Board will not be counted as a Member for purposes of a quorum.
Members of the COI Board may participate in a meeting via teleconference
and will constitute presence for purpose of a quorum. Voting Members
may give a proxy for their vote to an Attendee or Member for any
issues regarding a determination by the Board.
Any action
to be taken at a COI Board meeting may be taken without a meeting
provided that the COI Board Members have provided consent to such
action. Any action taken without a meeting will be recorded in the
next meeting's notes or agenda.
Decisions
The University
has an established system for the identification of potential conflicts
so that they can be evaluated and managed where appropriate. The
current identification system is self-reporting through either outside
employment disclosures to the Medical School or disclosures of significant
financial interest to DRDA.
The conflict
management review system for the Medical School is its COI Board.
(There is a separate Board for the remainder of the UM campuses.)
The COI Board evaluates proposed conflict management plans provided
by individual(s) with potential conflicts. The COI Board serves
as the primary review for issues reported through faculty outside
employment disclosures for the Medical School and serves as the
secondary review for issues identified by either DRDA or Technology
Transfer. COI Board staff may assist the faculty and staff in developing
a proposal for managing a conflict that will be submitted to the
COI Board for their consideration.
The COI
Board may:
1. Determine
that the initial faculty disclosure is sufficient management
2. Approve
the management proposal without modification
3. Require
additional administrative oversight for management
4. Recommend
withdrawal of a sponsored research proposal or suspension of a technology
transfer arrangement
5. Refer the
draft management plan to the Institutional Review Board (IRB) for
its consideration (all projects involving human research participants)
If the conflict
is referred to one of the IRB Boards, the IRB may accept management
as proposed or require additional elements. The IRB may not reduce
the management oversight as proposed by the COI Board without prospective
approval of the COI Board.
The IRB may
impose additional management, and may for example:
a) Require
that the researcher not be the principal investigator
b) Require
that the conflicted individuals be prohibited from consenting patients/subjects
c) Require
the faculty member to disclose the nature of the conflict and management
plan to the patient/subject in the consent process, indicating that
the University believes the conflict is manageable.
Upon approval
by the IRB the COI Board will complete the review and approval of
the management plan.
Appeal
A decision
by the COI Board not to approve the submission of sponsored project
proposals or the suspension of a particular technology transfer
agreement may be appealed in writing to the Dean of the Medical
School. The appeal must be submitted within 30 days of the date
the COI Board notifies the faculty or staff member of its decision.
The written report of the COI Board will be provided to the Dean
upon his/her request.
Within 14 days
of receipt of a written appeal, the Dean will decide to endorse,
modify or reverse the decision of the COI Board based upon the written
materials provided. The Dean may impose conditions on the arrangement
before approval. If the Dean has a conflict of interest related
to the specific management plan in question, the Executive Vice
President for Medical Affairs will make the decision. The Dean will
notify the COI Board and faculty or staff member of his/her decision.
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Noncompliance
UMMS expects
its faculty and staff members to comply fully and promptly with
all UM Conflict of Interest policies, including requirements of
disclosure, and all relevant State and Federal laws and regulations.
If there is noncompliance then applicable University policy (see
Internal Requirements below) requires review by the University and
appropriate action to be taken.
For informational
purposes, actions following a finding of noncompliance can range
from:
1. A letter
to the faculty member from the Office of the Dean indicating that
a breach of policy has occurred;
2. Ineligibility of the faculty member for grant applications, IRB
approval or supervision of trainees;
3. Non-renewal of appointment or more serious sanctions as described
in Regents'
Bylaw 5.09.
Internal
Requirements
The following
University provisions relate to outside employment, conflict of
interest or related issues. The COI Board considers these provisions
in its determinations, as well as the external requirements and
guidance from external agencies listed in the sections below.
Regental
Limitations of Faculty Commitments
Conditions
governing permissible outside employment of a full-time instructional
staff member are in Regents' Bylaw 5.12. Each of the governing faculties
of the University is authorized to formulate unit policies implementing
the bylaw.
University
Limitation on Days of Outside Compensated Activities
Central University policy provides that no more than four full days
per month may be spent in (1) outside compensated activity or (2)
work within the University for which additional special stipend
compensation is paid. (Standard Practice Guide, 201.85.)
University
Policy on Avoidance of Conflicts of Interest
The University's
policy on avoidance of Conflicts of Interest requires that University
Employees not use their official University position of influence
to further personal gain, nor gain with their families or associates.
Standard Practice Guide 201.65-1.
Appointment
of Relatives or Others with Close Personal or External Business
Relationships
Standard Practice Guide 201.23 contains University policy on appointment
of individuals with close personal or external business relationships
and procedures to assure equal opportunity and to avoid the possibility
of favoritism.
Regents'
Policy Concerning Research Grants, Contracts, and Agreements
The Regents'
Policy, approved on April 17, 1987, establishes guidelines for the
acceptability of restrictions on openness in research grants, contracts,
and agreements. Standard Practice Guide 303.1 contains both the
text of the Regents' Policy and the implementation guidelines for
the policy.
Policy
on Intellectual Properties: Including Their Disclosure, Commercialization,
and Distribution of Revenues from Royalties and Sale of Equity Interest
http://www.umich.edu/~spgonlin/300
On June 16,
1987, the Regents approved a new policy to amplify Regents' Bylaw
3.10. (The policy was amended in 1996.) The Policy speaks to the
objectives of the University's technology transfer/intellectual
property development activities. It deals with disclosure to the
institution, three options for commercialization, acceptable provisions
in assignment and license agreements, and distribution of revenue
from royalties or sale of equity interest. The three options for
commercialization are licensing to third parties, licensing to employee-inventor
owned companies, and reassignment of ownership to inventors. (Standard
Practice Guide 303.4)
Policy
Statement on the Integrity of Scholarship and Investigating Allegations
of Misconduct in the Pursuit of Scholarship and Research
The Policy
defines serious academic misconduct and establishes a procedure
for investigating and reporting allegations of misconduct. Among
the categories of serious academic misconduct are falsification
of data, abuse of confidentiality, and dishonesty in publication.
Standard Practice Guide 303.2.
University
Policy on Work Outside the University
Standard Practice
Guide 201.65 applies to all University employees. It states that
"work outside the University is not prohibited, but it must
not detract from the performance of duties and responsibilities
of the University position nor may it create a conflict of interest."
Governmental
Activities
Regents' Bylaw
5.13 describes University policy regarding the holding of public
office (either elective or appointive) by a University staff member.
Business
Transactions
Regents' Bylaw
1.13 governs University compensation to Regents and University officers.
Purchasing
Conflicts It
is the responsibility of each member of the University staff and
of the Purchasing Department to assure that the University does
not knowingly enter into a purchase commitment which could result
in a conflict of interest situation. (Standard Practice Guide 507.1
paragraph IV.C.)
Research
Proposal Approval Form (PAF) Disclosure
Every proposal
for externally-sponsored research requires an internal document
called the Proposal Approval Form on which summary information about
the proposal is collected. The form requires certain certifications
and disclosures. It provides an opportunity for faculty investigators
to provide certification that no proposed investigator on the sponsored
project, nor his or her immediate family has a significant financial
interest in the proposed research. (PAF forms are available on the
Research web site, from DRDA, and from departmental offices.) The
Item below describes the policy governing positive disclosures.
University
Policy on Conflict of Interest in Sponsored Projects and Technology
Transfer
http://www.research.umich.edu/policies/um/conflict_procedures.html#procedures
When a faculty
researcher on a proposed research project or a member of his or
her immediate family has a significant financial or management interest
in a sponsored project, formal disclosures are required. Disclosures
are reviewed by designated faculty committees for determination
of whether a conflict of interest exists and, if so, whether the
conflict of interest might be managed. (The disclosure form and
the policy are available on the Research web site.)
Gifts
to Regents, Officers, and Faculty
Regents' Bylaw 2.15 reads in its entirety, "No individual Regent,
officer, member if the faculty, or other employee shall accept a
gift of substantial value from a student or students enrolled in
the University, and no such person shall accept a gift of substantial
value from any person having business relations with the University."
Regental
and Executive/Senior Officer Conflict of Interest
Policywww.michiganlegislature.org
Regents' Bylaw 1.14, revised September 1994, describes when
a Regent or executive/senior officer is considered to have a conflict
of interest and the steps to be taken in that event. The Bylaw is
in addition to any obligations imposed on a Regent or executive/senior
officer by state law (P.A. 1968, Nos. 317 and 318, as amended).
UMMS Conflict of Interest web site, with guidance and policy documents
External
Requirements
Many
external agencies have set forth policies and procedures regarding
financial conflicts of interest. The Public Health Service (National
Institutes of Health) and the National Science Foundation have regulations
and policies governing financial conflict of interest in proposals
to and awards from those agencies.
NIH: http://grants2.nih.gov/grants/guide/notice-files/not95-179.html
NSF: http://www.nsf.gov/search97cgi/vtopic
The State
of Michigan Statute on Conflict of Interest governs agreements between
the University and entities in which a University employee is an
owner, employee, or director. www.michiganlegislature.org
External
Guidance
Additionally
other external guidance regarding conflict of interest includes
but is not limited to:
Association of
American Medical Colleges
American
Medical Association
American
Hospital Association
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