Researchers and officials charged with the ethical
oversight of research are often reluctant to fully disclose
financial interests to potential clinical research
participants, according to the Conflict-of-Interest
Notification Study just published in the Journal of Law,
Medicine and Ethics. Instead, those interviewed suggest
a better approach for such disclosures would be to offer
potential research participants a range of dollars or to
even use adjectives such as a "substantial investment" to
describe the extent of a researcher's financial
interest.
The study — a survey of attitudes, beliefs and
practices among members of institutional review boards,
conflict-of-interest committees and researchers —
reveals a key reason for the reluctance among researchers
to share the full dollar amount: the belief that potential
research subjects may lack the sophistication to put
conflicts of interest in context, so they may overestimate
the influence of money on the researcher's behavior and
possibly refuse to participate in the study.
"The findings raise important questions about the
informed consent process," said principal investigator
Jeremy Sugarman, the Harvey M. Meyerhoff Professor of
Bioethics and Medicine at the
Berman
Bioethics Institute at Johns Hopkins. "Some researchers
appear to believe that because disclosing any dollar amount
could influence a person's decision of whether or not to
participate in a clinical trial, the dollar amount
shouldn't be revealed at all; instead, the person should
only be told that a financial interest exists. But there's
widespread disagreement on how to do it. Should researchers
name the source of their funds? Should the disclosure
highlight potential consequences of the financial
relationship? When and how should all of that be
disclosed?"
The ongoing Conflict-of-Interest Notification Study,
known as COINS, was initiated to establish a framework for
developing policy and practices for disclosing conflict of
interest in research. The $3 million five-year study is
funded by the National Heart, Lung and Blood Institute of
the National Institutes of Health and is conducted by Duke
University Medical Center, Wake Forest University and Johns
Hopkins.
Respondents in the study's latest results were
solicited from 40 academic medical centers, independent
hospitals and institutional review boards and unaffiliated
research entities.
All 40 of the researchers, conflict-of-interest
committee chairs and institutional review board chairs
interviewed said that when a financial interest does exist,
that interest should be disclosed, albeit in limited ways
short of full disclosure.
For example, some participants said they believe that
the sheer complexity required by full disclosures could
detract attention from the actual decision of whether or
not to participate in the trial. Such financial interests
range from intellectual property interests to consulting
fees to other special arrangements. Others said they
believe that full disclosure should be made to include the
dollar amount and source of funding but in a
straightforward, simple manner to minimize confusion among
potential clinical trial participants.
Kevin Weinfurt, deputy director of the Center for
Clinical and Genetic Economics at the Duke Clinical
Research Institute, said, "The ultimate goal of the project
is to provide a framework for establishing sound policy and
practices for disclosing conflict of interest in clinical
research. We are hoping that the data we're collecting will
benefit officials who are struggling with the best ways of
minimizing potential risks to study subjects and advancing
the cause of clinical science."
Many of the study's respondents suggested that
disclosure of financial interests take place at the
beginning of the informed consent process, when information
about the risks and benefits of participation are initially
presented.
While there are concerns about disclosing the full
dollar amounts of financial interests, respondents said
that the disclosure of the existence of such financial
interests should occur because it enables informed decision
making, promotes trust in researchers and research
institutions, and reduces the risk of legal liability.
The previous COINS study, Sugarman said, "demonstrated
a variety of conflict-of-interest policies at medical
institutions across the United States but no real settled
opinion on how to move forward. Now the latest results tell
us that researchers and their officials charged with
oversight want to disclose financial conflicts of interest
and almost always for the right reasons; they just disagree
on how to do it," he said. "There is a clear need to next
gather data on exactly how potential research participants
would use different forms of disclosure in their decision
making. That way, we might better respect the integrity of
the research enterprise while better protecting the rights
and interests of research participants."