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.