New ways to make sure people are adequately informed
about the risks and benefits of taking
part in a clinical trial can be field-tested for
effectiveness as rigorously as new medical treatments
themselves, a study led by a Johns Hopkins bioethicist
suggests.
Informed consent, a mainstay of ethical clinical
trials, is the process by which potential
research subjects are asked to decide whether to
participate in research. The bedrock components of
the process include gaining an understanding of the study's
goals and benefits, as well as the risks and
roles of the subjects themselves.
"Many clinical researchers believe that the informed
consent process and documents need to be
better, and that people often consent without understanding
that the research is not intended to
benefit them personally," said Jeremy Sugarman, professor
of bioethics and medicine at the
Berman
Institute of Bioethics at Johns Hopkins. "Although
numerous improvements have been suggested, no
sound objective method existed to test them, leaving the
process open to costly or time-consuming
interventions that could ultimately have no effect," he
added.
Writing in the December 2007 Clinical Trials,
Sugarman and his colleagues, Philip W. Lavori of
Stanford University School of Medicine and Timothy J. Wilt
of the Minneapolis VA Center for Chronic
Disease Outcomes Research, describe a questionnaire tool
they developed and tested at 30 study
sites in five ongoing clinical trials for medical
treatments that include administering selenium and
vitamin E to prevent cancer and giving female veterans
therapy for post-traumatic stress disorder.
Though the tool ultimately proved ineffective in
improving informed consent with its use in this
experiment, Sugarman says the evaluation method they
developed is helpful in ruling out what doesn't
work.
Sugarman and his colleagues started with the idea that
if those seeking informed consent from
potential subjects were armed with reminders of the steps
needed to adequately educate them,
participants would be more likely to receive and understand
the information they need to make good
decisions.
Consequently, the investigators put together a short
self-monitoring questionnaire for
researchers to fill out after each time they obtained
informed consent. This questionnaire is a
checklist of 18 questions that review critical parts of the
informed consent process and was designed
to help ensure that potential participants understand what
is being asked of them.
In an experiment to test the questionnaire, clinical
trial administrators used it at half of the
study sites so that they could compare its impact.
Research staff at a phone bank spoke with study
subjects who minutes before had agreed to
join a clinical trial at all the study sites, asking a
series of questions to assess how much the subjects
understood about the trial, their role in the research and
what the trial's benefits would be. The
callers didn't know which subjects had joined the trials at
sites that used the questionnaire and which
had not.
When the researchers compared results from the calls
with participants at all the sites, they
found similar results, suggesting that the questionnaire
did nothing to improve informed consent. A
significant number of patients did not fully understand the
purpose of the research, the fact that the
research might not benefit them or the fact that agreeing
to participate was completely voluntary.
"Implementing changes to the informed consent process
is like taking new medicine — you
wouldn't want to take a drug if it was too expensive or
burdensome unless it's really helpful," Sugarman
said. "This study shows that we can do rigorous clinical
testing of informed consent, just like we can
do rigorous testing of drugs in clinical trials."
This study was funded by the Cooperative Studies
program of the Department of Veterans
Affairs' Office of Research and Development, Clinical
Science Research and Development Service.