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 vigorously 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,” says Jeremy Sugarman, professor of bioethics and medicine at the Berman Institute of Bioethics at The Johns Hopkins University.
“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 adds.
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 from 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 in this experiment with its use, 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 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.
Volunteers 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 did not.
When the researchers compared results from the calls to participants at all of 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, that the research may not benefit them or 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 says. “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.”
Christen Brownlee | EurekAlert!
Drought hits rivers first and more strongly than agriculture
06.09.2018 | Max-Planck-Institut für Biogeochemie
Landslides triggered by human activity on the rise
23.08.2018 | European Geosciences Union
The building blocks of matter in our universe were formed in the first 10 microseconds of its existence, according to the currently accepted scientific picture. After the Big Bang about 13.7 billion years ago, matter consisted mainly of quarks and gluons, two types of elementary particles whose interactions are governed by quantum chromodynamics (QCD), the theory of strong interaction. In the early universe, these particles moved (nearly) freely in a quark-gluon plasma.
This is a joint press release of University Muenster and Heidelberg as well as the GSI Helmholtzzentrum für Schwerionenforschung in Darmstadt.
Then, in a phase transition, they combined and formed hadrons, among them the building blocks of atomic nuclei, protons and neutrons. In the current issue of...
Thin-film solar cells made of crystalline silicon are inexpensive and achieve efficiencies of a good 14 percent. However, they could do even better if their shiny surfaces reflected less light. A team led by Prof. Christiane Becker from the Helmholtz-Zentrum Berlin (HZB) has now patented a sophisticated new solution to this problem.
"It is not enough simply to bring more light into the cell," says Christiane Becker. Such surface structures can even ultimately reduce the efficiency by...
A study in the journal Bulletin of Marine Science describes a new, blood-red species of octocoral found in Panama. The species in the genus Thesea was discovered in the threatened low-light reef environment on Hannibal Bank, 60 kilometers off mainland Pacific Panama, by researchers at the Smithsonian Tropical Research Institute in Panama (STRI) and the Centro de Investigación en Ciencias del Mar y Limnología (CIMAR) at the University of Costa Rica.
Scientists established the new species, Thesea dalioi, by comparing its physical traits, such as branch thickness and the bright red colony color, with the...
Scientists have succeeded in observing the first long-distance transfer of information in a magnetic group of materials known as antiferromagnets.
An international team of researchers has mapped Nemo's genome, providing the research community with an invaluable resource to decode the response of fish to...
21.09.2018 | Event News
03.09.2018 | Event News
27.08.2018 | Event News
21.09.2018 | Physics and Astronomy
21.09.2018 | Life Sciences
21.09.2018 | Event News