UNIVERSITY OF PITTSBURGH POLICY 11-01-04
CATEGORY: RESEARCH ADMINISTRATION
SECTION: Research
SUBJECT: Consultant Conflict of Interest
EFFECTIVE DATE: September 23, 1994
PAGE(S): 4 (plus 3 page attachment)
I. SCOPE
This document establishes policy guidelines and procedures for
conflict of interest issues pertaining to consultants.1
In general, conflicts of interest relate to the potential for
self-gain usually, but not always, of a fiscal nature. Potential
for self-gain can serve to undermine the judgment or objectivity
of faculty, administrators, researchers, or consultants such that
their mission and dedication to academic values and activities of
the University are compromised. Furthermore, not only bias, but
the appearance of bias in research, may undermine public trust in
the University.
The opportunity for consultants, who aid investigators or
scholars, to receive financial or other personal rewards from
their other endeavors is not intrinsically unacceptable, as long
as it does not adversely affect their objectivity, integrity, or
professional commitment. Hence, participation in a situation
with opportunity for personal gain does not constitute an
unacceptable situation of itself; it is the potential stimulus
for unacceptable behavior that must be addressed.
II. DEFINITIONS2
A. Conflict of Interest
A potential or actual conflict of interest exists when
commitments and obligations to the University or to widely
recognized professional norms are likely to be compromised
by a person's other interests or commitments, especially
economic, particularly if those interests or commitments are
not disclosed.
B. Consultants
A person (which includes a corporation or other entity) who
has been engaged for pay or other considerations to work on
a project is defined to be a consultant on that project if
the person's activities significantly affect the course of
the project. Illustrations (by no means exclusive) of such
activities include advice on the interpretation of data, the
construction of equipment, and the direction the program
should take.
A person whose only function is to give a talk to project
personnel, or to a wider audience that includes project
personnel, is not considered a consultant, even if that
person's remuneration comes in whole or in part from project
funds.
Collaborators and co-authors are not considered consultants.
C. Immediate Family
Dependents, the spouse, and all members of the household are
considered members of the immediate family. Circumstances
or relationships that must be disclosed or resolved as to a
consultant usually must also be disclosed or resolved if the
consultant knew or should have known that a member of his or
her immediate family had such a relationship.
D. Program Director
The Program Director, usually the principal investigator, is
the person who actually enlists the services of the
consultant.
E. Unit Head
The Unit Head, usually the chair of the department, the
director of the center or the dean, is the person to whom
the program director reports.
III. POLICY
A. Consultants retained by the University of Pittsburgh are
required to make regular, timely, and full confidential
disclosures to their program director of all significant
outside interests and activities related to their consulting
or research responsibilities that may give rise to conflicts
of interest. Typical potential conflict of interest
situations are illustrated on the Conflict of Interest
Statement for Consultants.
B. This Policy also imposes the obligation on program
directors, unit heads, and other supervisory administrators-
-themselves subject to the policy and its disclosure
requirements--to not encourage or condone impermissible
conflicts in their consultants.
C. Noncompliance with the requirements or provisions of this
Policy may be sanctioned in the same way as noncompliance
with any other University policy, including removal from the
particular project, letter of reprimand, probation,
suspension, or initiation of steps leading to termination of
employment or contractual relationships.
IV. GUIDELINES
A. Obligations
A person who accepts a consultant appointment has an
obligation to arrange other activities or commitments so as
not to conflict with his/her commitment to the University.
While employment outside the consulting contract is common,
some types of outside interests may generate a conflict of
interest and must be disclosed.
B. Confidentiality
In order to encourage disclosure of potential conflicts
without unduly intruding on the privacy of consultants or
their families, disclosures shall be treated confidentially
and shared only to the extent necessary for review and to
consider and resolve any conflicts.
C. Subsequent Disclosure
Financial, personal, or professional relationships that
raise a potential conflict of interest or its perception
shall be accurately disclosed in all formal communications
relating to the sponsored research, including those in
professional journals.
D. Withdrawal from Decisions
Consultants shall not exercise decision-making authority or
exert influence concerning any University relationship
affecting a company in which they or members of their
immediate family have a personal or professional interest.
V. PROCEDURES
A. General
All consultants must disclose any outside interests and
commitments that may generate conflicts of interest and
submit them to the supervising program director or unit head
upon employment. The Conflict of Interest Statement must be
refiled with each reappointment and whenever new facts
create a potential or actual conflict of interest.
Review after disclosure must take place promptly and help
consultants determine which interests are not in conflict,
which conflicting interests may be permissible, and which
conflicting interests place him or her at risk of
jeopardizing the integrity of his/her academic or
administrative work.
The choice of accurate disclosure in place of prohibitions
is based on the assumption that once a conflict is
recognized, it can be avoided or resolved. Disclosures
shall be kept confidential, except to the extent necessary
to review, consider, and resolve any conflicts. The
conflict of interest definition, guidelines, and procedures
at all times shall be read and interpreted in coordination
with the University Research Integrity Policy (11-01-01),
the Technology Transfer Policy (11-02-01), Continuing
Medical Education guidelines, and other relevant policies.
B. Program Directors
Program directors shall:
1. be responsible for ensuring that consultants involved
in their research projects submit a Conflict of
Interest Statement through them upon appointment or
reappointment and thereafter at least annually;
2. notify their unit heads if specific consultants have
conflicting outside interests, based on affirmative
answers and additional details in the Conflict of
Interest Statement; and
3. determine whether unit heads wish to review the
detailed information provided by the consultant and, if
so, notify the consultant that the unit head will be
reviewing the submitted Conflict of Interest Statement.
C. Unit Heads
Unit heads (or senior designees acting on their behalf) in a
timely fashion shall:
1. review all Conflict of Interest Statements for real,
apparent, or potential conflicts of interest;
2. request and document additional details including
precise dollar figures for ownership interests or
remuneration if such details appear necessary for a
sound determination of the presence or absence of an
impermissible conflict of interest;
3. meet with individual consultants to discuss collegially
how potential or actual conflicts shall be resolved;
and
4. recommend and initiate action to resolve the apparent,
potential, or real conflict.
Any program director who disagrees with the recommendation
of his/her unit head for resolving a consultant's conflicts
of interest may appeal once to the next higher level of
administration.
D. Consultants
All consultants must complete a Conflict of Interest
Statement with each appointment or reappointment, and
thereafter annually, and submit it promptly to their program
director or unit head, as appropriate. If, in the judgment
of the consultant, a potential or actual conflict arises,
the Conflict of Interest Statement should be updated
promptly. The unit heads receiving these forms are required
to keep them in a secure place.
E. Review Procedure
The Provost of the University has the ultimate authority to
determine how conflicts of interest should be prevented or
resolved.
Page 1 of 3
CONFLICT OF INTEREST SUMMARY
FOR CONSULTANTS
UNIVERSITY OF PITTSBURGH
(Policy 11-01-04)
All consultants must read this Conflict of Interest Summary
carefully and must sign the Conflict of Interest Statement on the
reverse of this page. The completed Statement is to be submitted to
the supervising Program Director. All personal information therein
will be confidential.
I. CONFLICT OF INTEREST DEFINED
In general, conflicts of interest relate to the potential for
self-gain usually, but not always, of a fiscal nature. Potential
for self-gain can serve to undermine the judgment or objectivity of
faculty, administrators, researchers, or consultants such that their
mission and dedication to academic values and activities of the
University are compromised. Furthermore, not only bias, but the
appearance of bias in research, may undermine public trust in the
University and may prove harmful to the consultant's reputation.
A potential or actual conflict of interest exists when commitments
and obligations to the University or to widely recognized
professional norms are likely to be compromised by a person's other
interests or commitments, especially economic, particularly if those
interests or commitments are not disclosed.
II. ILLUSTRATIVE CONFLICTS OF INTEREST
Not all outside interests and financial relationships place the
consultant in conflict with his/her obligations to the University
and to their profession. Not all conflicting interests are
necessarily impermissible. Timely and complete disclosure of
potential conflicts of interest may be a satisfactory remedy and
protects the consultant from suspicion and accusations of breach of
professional integrity. Below is an illustrative list of situations
and actions that should be disclosed because they can be viewed as
potential conflicts of interest.
1. Accepting gratuities or special favors from companies or
individuals who might be affected by the consultant's judgments
in the course of his/her consultantship at the University.
2. Giving well-paid lectures for companies or organizations whose
economic or political interests might be affected by the
consultant's evaluative work in the course of his/her
consultantship at the University.
3. Undertaking evaluative research as a consultant when the
consultant or the consultant's immediate family3 has a
financial, managerial, or ownership interest in the company
sponsoring the research or in the company producing the product
tested.
4. Providing privileged or otherwise special access to information
gained by the consultant in the course of his/her
consultantship to an entity in which the consultant has a
political or financial interest.
5. Purchasing by the consultant, costs to be paid by the
University, of equipment, instruments, or supplies from a firm
in which the consultant has a significant financial or other
interest.
6. Influencing the negotiation of contracts between the University
and outside organizations with which the consultant has a
financial interest or other relationship.
7. Hiring, or influencing the hiring of, a member of the
consultant's family as a participant on the project.
The above examples are by no means exhaustive, but they are
exemplary of potential conflicts of interest that must be disclosed,
forsworn, or otherwise resolved prior to the conflict materializing.
Page 2 of 3
CONFLICT OF INTEREST STATEMENT
FOR CONSULTANTS
(Policy 11-01-04)
I have read the list of illustrative conflict of interest situations and
actions on the reverse of this page. I have carefully reviewed my own
situations in light of these illustrations. (Check appropriate box
below.)
[_]To the best of my knowledge and belief, I am involved in no
situations or actions that might be regarded as a potential conflict
of interest with my anticipated duties as a consultant to the
University of Pittsburgh.
[_]It appears that I am involved in some situations or actions that
might be regarded as a potential conflict of interest with my
expected duties as a consultant to the University of Pittsburgh.
Details of each of these situations and/or actions are as follows (if
necessary, continue on another sheet).
1.
2.
3.
I agree to notify the University of Pittsburgh, through the Program
Director, promptly if any new situation or actions that might be regarded
as a potential conflict of interest with my duties as a consultant to the
University should develop at any time during my consultantship.
SIGNATURE ______________________________________________ DATE __________
NAME (Please print or type) _____________________________________________
HOME ADDRESS ____________________________________________________________
EMPLOYING UNIVERSITY OF PITTSBURGH UNIT _________________________________
PRIMARY (OUTSIDE) EMPLOYER ______________________________________________
ADDRESS _________________________________________________________________
=========================================================================
To be completed by the Program Director:
SOURCE OF FUNDS (GRANT) ________________________________________________
_________________________________________________________________________
Page 3 of 3
CERTIFICATION OF CONFLICT OF INTEREST STATEMENT
FOR CONSULTANTS
(To be sent to Office of Research)
(Policy 11-01-04)
SOURCE OF FUNDS (GRANT) ________________________________________________
_________________________________________________________________________
CONSULTANT ______________________________________________________________
Statement of Program Director
I certify that the consultant named on the attached Conflict of Interest
Statement is retained by me and, after discussion of the policy, to the
best of my knowledge and belief does not have any conflicts of interest
or has reported and resolved them.
SIGNATURE ______________________________________________ DATE __________
NAME (Please type or print) _____________________________________________
SCHOOL _____________________________ DEPARTMENT ________________________
(e.g., Engineering, Pharmacy, etc.)
CAMPUS ADDRESS __________________________________________________________
Statement of Unit Head
I certify that the person named above reports to me and to the best of my
knowledge and belief the consultant named on the attached Conflict of
Interest Statement does not have any conflicts of interest or has
reported and resolved them.
SIGNATURE ______________________________________________ DATE __________
NAME (Please type or print) _____________________________________________
TITLE ___________________________________________________________________
_______________________________
1 This policy is a modified version of the initial proposal by the
Conflict of Interest Committee, University of Pittsburgh, Health
Sciences Schools, with amendments by the University Research Council
and the TAF Senate Committee. Some of the language of the proposal
and of this policy has been taken from the "Guidelines for Dealing
with Faculty Conflicts of Commitment and Conflicts of Interest in
Research" by the Association of American Medical Colleges, Copyright
1990, AAMC, Washington, D.C.
2 Conflicts of Interest in Academic Health Centers: Policy Paper #1.
Washington, D.C.: 1400 Sixteenth Street, NW, Suite 410, Washington,
D.C. 20036 (1990). These definitions of conflict of interest and the
guidelines stated below were formulated in 1990 by the Association of
Academic Health Centers. The definition and guidelines are being used
with the permission of the Association. Some revisions have been made
to adapt the language of the definition and guidelines to the
University of Pittsburgh.
3 Dependents, the spouse, and all members of the household are considered
members of the immediate family. Circumstances or relationships that
must be disclosed or resolved as to a consultant usually must also be
disclosed or resolved if the consultant knew or should have known that a
member of his or her immediate family had such a relationship.