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January
2002 Reporter
"First
Contact, First Response" The AAMC Responds to the Threat of Terrorism
Paying
the Price to Become a Doctor: The Impact of Medical School Debt
AAMC
Releases Guidelines: Financial Conflicts of Interest in Human Subjects Research
Viewpoint:
CDC and "First Contact, First Response"
A Word
from the President
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AAMC Releases Guidelines
Financial Conflicts of Interest in Human Subjects Research
By Barbara A. Gabriel
In the wake of the Bayh-Dole Act of 1980, the past two decades
have seen unprecedented growth in the number of relationships between
academic medicine and the private sector, reflecting energetic efforts
to bring medical innovations to the marketplace. Bayh-Dole permits
universities to take title to inventions arising from federally
funded research but requires them to share with the inventor a portion
of any licensing revenues. The legislation created fertile ground
for nurturing the transfer of basic research findings to the developers
of beneficial products, giving rise to new incentives for researchers
and their institutions to pursue commercial applications for their
work.
The result has been the birth and growth of the biotechnology industry
and its major contributions to both enhanced quality of life and
domestic economic development. But the public's increased awareness
of the ability of researchers to advance medical knowledge to the
practical betterment of those suffering from both common and complex
diseases and illnesses has been accompanied by its demand that academic
scientists and institutions remain untarnished by the potential
financial gains of their research.
"The environment for research is different today, both because
of the rapidity of scientific advancements and the intense awareness
of medical schools and teaching hospitals of the potential revenue
from their inventions," explained David Korn, M.D., senior
vice president in the AAMC Division of Biomedical and Health Sciences
Research. "The kinds of scientific discoveries being made today
have more immediate commercial appeal, and institutions believe
they can generate revenue from them that can be used to support
their academic missions. Thus, the chances for missteps in conducting
or overseeing research are greater."
The potential fallout of such missteps grows dramatically when
the research in question involves the participation of human subjects.
"If an academic institution has a financial interest in a research
project and an adverse event causes harm to a human participant,
these two factors will automatically become connected by the press
and in the mind of the public," said Dr. Korn. "Institutions
that support human subjects research with industry funding will
always carry that risk."
To minimize the risk that financial interests will compromise,
or appear to compromise, the conduct of research, the AAMC in 1990
released the monograph "Guidelines for Dealing With Faculty
Conflicts of Commitment and Conflicts of Interest in Research."
Laying out a conceptual and philosophical framework for medical
schools and teaching hospitals wishing to adopt conflict of interest
policies, the 1990 monograph is described by Dr. Korn as "appropriate
and very influential in its time."
But in the wake of several tragedies befalling participants in
clinical trials in which financial interests featured prominently
(and the ensuing media frenzy that brought such cases to the attention
of legislators and the public), AAMC President Jordan J. Cohen,
M.D., announced the formation of a new Task Force on Financial Conflicts
of Interest in Clinical Research in October 2000. Chaired by William
Danforth, M.D., chancellor emeritus of Washington University, the
task force adopted as a starting point for its deliberations the
principles and guidelines developed by a select group of senior
leaders in academic medicine convened by Harvard Medical School
Dean Joseph B. Martin in early 2001.
Charged with producing more specific self-policing guidelines regarding
the professional conduct of academic scientists engaged in human
subjects research, the task force - with the approval of the AAMC
Executive Council - in December 2001 released the report "Protecting
Subjects, Preserving Trust, Promoting Progress: Guidelines for Developing
and Implementing a Policy Concerning Individual Financial Interests
in Human Subjects Research." The guidelines have been endorsed
by 26 of the 28 task force members, who represent the panoply of
human subjects research stakeholders, including clinical investigators;
patient representatives; medical school, teaching hospital, and
university leaders; and representatives from industry, law, and
the media. One task force member withdrew his name after unexpected
professional commitments prevented him from participating in drafting
the report; another member declined her endorsement, citing concerns
that the recommendations present an impediment to research innovation.
Jennifer Kulynych, J.D., Ph.D., director in the AAMC Division of
Biomedical and Health Sciences Research, was instrumental in coordinating
the efforts of the task force. "The guidelines contain no outright
prohibitions but instead propose higher standards for reporting,
review, and disclosure of all significant financial interests in
federally funded and privately sponsored research," said Dr.
Kulynych. "In an increasingly commercial research environment,
the watchword for the oversight of financial interests must be 'transparency.'
Our hope is that institutions will voluntarily embrace these guidelines,
and thereby perhaps make less necessary the perceived need for additional
federal regulation of financial interests."
Emphasizing that it does not assume that "financial interests
in human subjects research are categorically improper," the
report details guidelines for institutions seeking to develop policy
in this arena. Dr. Kulynych points out that at the core of the guidelines
is the recommendation that institutions presume that a "financially
interested individual" - defined by the report as any researcher
holding a significant financial interest in human subjects research
- may not conduct the research in question. However, the guidelines
go on to allow the presumption to be rebutted, and detail the circumstances
under which the investigator may demonstrate "compelling circumstances"
that would allow the research to be carried out under conditions
specified by a conflict of interest (COI) committee and approved
by the responsible institutional review board (IRB).
To this end, the guidelines do away with the distinction between
publicly and privately funded research and recommend that institutions
appoint a standing COI committee responsible for: 1) reviewing requests
made by financially interested individuals to conduct the research
in question, 2) documenting its subsequent findings in a summary
report of its recommendations, 3) sharing those findings with the
appropriate IRB and other responsible institution officials, and
4) specifying the monitoring procedures under which a financially
interested individual will be permitted to conduct human subjects
research.
Both Drs. Kulynych and Korn acknowledge that implementing the AAMC's
COI guidelines will not, in the short term, be cost-free. "It
will require resources," said Dr. Korn. "If an institution
already has a COI committee in place, the costs won't be as significant.
But if an institution has an underdeveloped or minimal COI process,
it will be a more costly undertaking, although a wise investment
for the future."
Dr. Korn also emphasized that the guidelines - which can be downloaded
at www.aamc.org/coitf - respect institutional autonomy and flexibility.
"This report permits an institution to adopt even more stringent
policies, and it in no way is meant to inhibit or impede productive
relationships between academic medical research and the private
sector," said Dr. Korn. "We do not wish to stifle the
entrepreneurial spirit that spurs medical innovation; rather, we
are attempting to create research relationships that are principled
and will withstand public scrutiny."
The next step for the AAMC task force, according to Dr. Kulynych,
will be the development of guidelines to monitor institutional financial
interests in human subjects research. She admitted such a task requires
navigating uncharted terrain. "There is no road map of existing
federal regulations to build upon," she acknowledged, "nor
even consensus within the academic community about such elementary
matters as definitions and boundaries. Our task force will break
new ground in providing clarity and fashioning guidance for this
aspect of human research protections."
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