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DURHAM, N.C. -- Only 48 percent of U.S. academic medical
centers have a formal policy requiring that financial conflicts
of interest are disclosed to potential participants in their
clinical trials, a research team from Duke University Medical
Center, Wake Forest University and Johns Hopkins University has
found.

Among those institutions that do disclose this information
to participants, there was considerable variation in the type
of information and the way it is presented to potential
research participants, found the researchers.

In their "snapshot" of how academic medical centers are
managing the issue of conflicts of interest, the team sought to
discover how much, if any, information about corporate
sponsorship of clinical trials is reported to potential
participants. They also said they hoped their study and others
to come will help academic medical centers develop more
effective conflict of interest disclosure policies.

Their findings were reported in a paper published in the
February, 2006, edition of Academic Medicine.

The researchers said their findings indicate that
institutions are grappling in their own ways with this
important and complex issue. They added that more work is
needed to develop national consensus on what exactly
constitutes conflicts of interest and how information about
them should be presented to potential research
participants.

Financial interests that might create conflicts can range
from corporate support for the costs of the trial and its
personnel to a consulting contract to an investigator's
ownership of stock in the sponsor.

A number of agencies, such as the Association of American
Medical Colleges (AAMC), have recommended that one part of
managing financial conflict of interest is to include
information about it in the consent process that occurs between
patients and researchers before enrollment in clinical
trials.

"However, while the AAMC recommendations provide guidance
when it comes to what and how to disclose potential conflicts,
recommendations from other groups are not as clear," said
Duke's Kevin Weinfurt, Ph.D., first author of the paper. "We
wanted to see how institutions implemented the AAMC guidelines.
We believe that our analysis shows that significant questions
remain among academic medical centers about the exact goals of
disclosure and how best to achieve and communicate them."

For their analysis, the team reviewed the conflict of
interest policies from the 120 academic medical centers with
institutional review boards (IRB), committees of specialists
that evaluate clinical research protocols to ensure patient
safety. Each institution's policies were obtained either from
website searches or directly from the IRBs themselves. The
researchers conducted the survey in February and March of
2004.

The new analysis is the first of many on the role of
conflict of interest in medical research funded by a $3 million
grant from the National Institutes of Health. The researchers
said they hoped that results of the five-year effort --
"Conflict of Interest Notification Study" (COINS) – will help
provide data to help institutions develop conflict of interest
policies. COINS is headed by Jeremy Sugarman, M.D., a
bioethicist at Johns Hopkins University.

"The field is moving quite rapidly, with recommendations
like those from the AAMC being relatively new," Sugarman
explained. "We would expect official policies put into place by
institutions to lag behind guidance, but we are encouraged that
institutions are taking the issue of conflict of interest
seriously.

"I am not surprised, given the lack of data on the best way
of disclosing conflicts, that all institutions have not adopted
wholesale new and untested recommendations based on guidance
from outside bodies who are similarly concerned about this
important issue," Sugarman said.

When looking at an academic medical center's disclosure of
conflict of interest to their trial participants, the
researchers said there are three possible goals of disclosing
to participants.

"The first is to ensure that patients have all the
information they need in order to make an informed consent
about participating in a trial," Weinfurt explained. "The
information should be presented in such a way that patients
understand the nature and likely consequences of any financial
conflicts of interest."

The second possible goal of disclosure is to make sure that
the research in question adheres to legal or regulatory
requirements, said Weinfurt. The final goal of including
conflict of interest information in the consent process is that
it might serve as a deterrent to investigators or institutions
from engaging in significant conflicts of interest, since they
would have to disclose them to patients.

The researchers found a wide variety of ways different
institutions communicate this information to their patients --
ranging from detailed information in the consent forms to
required discussion between investigators and participants.
Some consent forms mentioned only the sponsor by name, while
others went into detail about where and how the sponsor's
support was being spent.

"From our study, it appears that most of the policies in
place at academic medical centers were the most consistent with
the goal of avoiding legal liability," Weinfurt said. "While it
is difficult to determine the motivation, it appears that the
language usage in consent forms better served the legal goal
than the informed choice or deterrent goal.

Both Weinfurt and Sugarman agreed that many institutions are
unsure about how to move forward with conflict of interest
disclosures, and they are looking for guidance. They believe
that this and subsequent COINS studies can lead to different
models that could then be tested.

"For example, would a simple disclosure that an individual
investigator could benefit from the results of study be better
understood by a participant than a long description of the
nature and possible implications of the financial
relationship?" Weinfurt said. "We are currently focusing on
these sorts of issues."

In addition to Weinfurt and Sugarman, other members of the
COINS team include, from Duke, Michaela Dinan, Jennifer
Allsbrook, Joelle Friedman, Robert Califf, M.D., and Kevin
Schulman, M.D. Also, Mark Hall, J.D., Wake Forest, is a member
of the team. The Duke researchers are all part of the Center
for Clinical and Genetic Economics, part of the Duke Clinical Research
Institute.