Facing a wide range of practices on how financial
conflicts of interest are disclosed to potential clinical
research participants, experts at Johns Hopkins, Duke and
Wake Forest universities have published new language
designed to help clinical researchers better disclose their
financial interests in research. Featured in the January
2007 issue of IRB: Ethics and Human Research, the
new language is designed to provide guidance for
researchers seeking to properly disclose the types of
financial interests most commonly found in clinical
research.
"There is near-universal agreement about the need for
clinical researchers to disclose financial interests to
research participants, but until now there has been little
guidance available on exactly how to do it," said principal
investigator Jeremy Sugarman, the Harvey M. Meyerhoff
Professor of Bioethics and Medicine at the
Johns
Hopkins Berman Institute of Bioethics. "Our team looked
beyond the need for disclosure. We researched how it should
be done. Using an empirically based approach, we have
helped create the right tools to do the right thing. The
new language is a model for others to use, test and improve
upon."
Developed as part of an ongoing $3 million project
called the Conflict of Interest Notification Study, or
COINS, the new disclosure statements are designed to be
used in written materials provided to potential research
participants before giving their informed consent.
"If you are thinking about participating in a clinical
research trial, you should understand what you are getting
yourself into, and that includes any financial interests
involved," said Kevin Weinfurt, deputy director of the
Center for Clinical and Genetic Economics at the Duke
Clinical Research Institute. "We also recognized that
people vary in their informational needs. So to provide
adequate disclosure to all people, we included a core
statement in the new disclosure language that's to be made
available to everyone. We then added an explicit invitation
for potential research participants to ask for more
detail."
After extensive focus group testing and multiple
rounds of review by representatives of institutional review
boards, the COINS project team has unveiled the following
generic disclosure for situations in which a financial
interest exists but does not present a measurable risk to a
research participant:
"The person leading this medical research study might
benefit financially from this study. The Institutional
Review Board and a committee at ABC University have
reviewed the possibility of a financial benefit. They
believe that the possible financial benefit to the person
leading the research is not likely to affect your safety
and/or the scientific quality of the study. If you would
like more information, please ask the researchers or the
study coordinator."
The new model language also includes specific language
for situations in which there may be risks to participants.
The team categorized this additional language by the nine
types of financial interests most commonly encountered in
clinical research, including salary support, money received
outside the study, per capita payments, finder's fees
restricted to research uses, unrestricted finder's fees,
researchers holding a patent, universities holding a
patent, researchers owning equity and university owning
equity.
"The determination of risk to potential research
participants can be complex and varies by research
institution. Individual institutions using the new language
may want to modify key phrases to suit their purposes,"
Sugarman said. "This is language that can help these
institutions craft better written materials. It can also
help serve as a model for how to accurately phrase
disclosure in discussions with potential research
participants. It could even be expanded and presented in
other formats, such as stand-alone pamphlets or videos
about clinical research."
Said Weinfurt, "The COINS project is about providing a
framework for establishing sound policy and practices for
the disclosure of conflicts of interest in clinical
research. Toward that end, we have developed something
practical: working disclosure language," he said. "We hope
that others will want to use the new language as a template
to further refine the options for appropriate disclosure
and, ultimately, minimize potential risks to research
subjects."
The Conflict of Interest Notification Study was
initiated to establish a framework for developing policy
and practices for disclosing conflicts 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. The new disclosure language for
researchers' use was developed through the use of focus
group testing, cognitive pre-testing to evaluate
participants' understanding and numerous, subsequent expert
panel reviews and revisions.
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