October 23, 2002
Faculty Council and Senate
Lee Anna Clark, Associate Provost
David Wynes, Assistant VP for Research
Conflict of Interest Policy revision
the fall of 2001, Provost Whitmore and Vice President Skorton formed and charged
a committee to review and revise the University of Iowa Policy on Conflicts of
Commitment and Interest. In
addition to the two of us, the committee included:
Carolyn Colvin, Professor of Curriculum and Instruction, and then-President/Past-President of the Faculty Senate
Donohoue, Professor of Pediatrics, then-Chair of the Conflict of Interest in
Research Review Committee
Todd, Professor of Anesthesia
Martin, General Counsel, VP-Research
Talman, Program Associate, Human Subjects Office
Wynes, Program Associate, Office of the Provost
document (appended) has been reviewed by—and extensively revised based on
feedback from—the collegiate Deans’ offices, the Staff Council, Professor
Shelley Kurtz, a primary author of the existing policy, and the Faculty Senate
are now presenting the document to you for your feedback.
We would like an opportunity to meet with you to review the revisions and
answer any questions you may have. For
your convenience, in addition to the revision, a copy of the current policy is
The appearance of the existing and revised policies is quite different. For that reason, we are not providing a line-edited version of the existing policy showing the changes made. We wish to emphasize, however, that we made very few changes to the basic standards in the policy, as these generally are dictated by state law and federal regulation. We provide here a summary of notable changes in the policy and the rationale for these changes:
The Policy is substantially shorter. This
was a primary goal of the revision process, because the existing policy is
complex and difficult to understand. The
simplification is, to a large extent, the result of removing redundant UI
policies and referencing their location in the Operations Manual at the end of
the Conflicts of Commitment and Interest Policy rather than incorporating them
into the policy itself as in the currently existing version.
The Policy more clearly delineates the three major types of conflict of interest
it addresses: conflict of
commitment, conflict of interest in the workplace, and conflict of interest in
Potential conflicts of commitment and conflicts of interest in the workplace now
require a written disclosure and management plan prior to engaging
the activity that is potentially conflictual. The existing policy mandates prior
disclosure but only recommends, not requires, that the disclosure be written.
Thus, it often was impossible to determine whether or not disclosure had
occurred. Therefore, this change was recommended by the University’s
internal auditor to ensure documentation of disclosures of conflicts as well as
the approval, management, or disapproval of the situation.
Web-based forms for disclosure are being developed by the Office of the
Conflict of interest in research has been expanded from sponsored research to
all research, irrespective of funding.
This is to provide a consistent process and recognize that financial
conflicts of interest can occur (and should be managed) whether or not there is
an outside sponsor of the activity.
Using technology in research when the researcher is named as an inventor on the
technology’s patent is now identified as a conflict requiring disclosure and
management. In the past, this was
not considered a conflict of interest if the University of Iowa held the patent
even though the inventor/investigator stood to gain financially from these
inventions under University policy. This
change recognizes the potential for financial benefit by the
6. The policy contains new restrictions on involvement in human subjects research by investigators with a conflict of interest. This change represents an evolution of concerns specifically related to human subjects research that is reflected in policy statements from the American Association of Medical Colleges, American Association of Universities, and the federal Office of Human Research Protections. Thus, these changes were required to bring the UI policy in line with current national norms.
An additional note. The
Board of Regents requires annual reporting of outside paid professional
activities by full-time faculty. In
the past, faculty have been required to disclose only the number of
“consulting” days per year, if the number of days exceeded the (relatively
low) threshold set by the Board of Regents.
However, both the Board of Regents and the UI internal auditor have
requested additional information about faculty’s involvement in outside paid
professional activities. Therefore,
because of the close relation between conflicts of interest and outside paid
professional activities, the Provost’s Office is revising its collection of
information about the latter in parallel with the conflict-of-interest policy
revision. Neither the existing nor
revised policy specifies the data to be provided to the Board of Regents, so
there are no revisions to the policy per se addressing these changes.
However, it is likely that this change in data collection for the Board
of Regents will affect faculty more than the policy revisions themselves.
We emphasize this here to clarify the distinction between the policy
revisions, about which we are seeking your feedback, and implementation of
changes in reporting “consulting activity” mandated by the Board of Regents.