Rethinking Informed Consent
by Laila Sayers
April 2008
Cultural understanding, technology and pragmatism are helping create new approaches to clinical research subject enrollment.
With increasing numbers of clinical trials involving potentially vulnerable and research-naïve patient populations, creating a simple and effective informed consent process that complies with regulatory requirements is more challenging than ever.
“Our research in the U.S. and Europe has shown that people are not necessarily aware of clinical research opportunities, and they don’t necessarily understand the process,” says Linda Wolf, leader of emerging markets and services at BBK Worldwide in Newton, Mass., USA. “So we know that education about the whole process is important for just about everybody.”
Education is especially critical at sites where illiteracy, language barriers and cultural conflicts can complicate the informed consent process. Dr. Haydn Scott, regional clinical director for the Asia Pacific division of Alcon Laboratories in Sydney, Australia, directs studies in countries such as India, Thailand, Taiwan and Malaysia. “These are countries that have not, up until the last few years, been seen as places for trials. The needs are very different,” he says. “In India, for example, there are more than 20 languages spoken across the country and eight different languages recognized by the government. For us there’s a challenge in making sure our documents are translated appropriately and approved by a local ethics committee in each region.”
At the same time, informed consent documents themselves have grown more complex. “Informed consent forms have to cover companies and ethics committees, and they have to meet ICH and regulatory requirements,” Scott says. “We now have one here that is 14 pages long. I think we’re at the crossroads where institutional ethics committees are starting to query this process.”
BBK develops materials and communication systems that supplement the GCP-defined informed consent process to help research sites communicate with patients about making an informed decision about study participation.
“One problem is that I don’t see a great deal of standardization of the process. Each institution has its own SOPs, and there is little systemic guidance on the topic,” Wolf says. “And how do you standardize comprehension on the patient side? It isn’t just about delivering the information—it’s about making sure that patients are digesting it. And it doesn’t stop with the consent form, because they can make the decision to stay or withdraw from the study at any time.”
In its communications to industry clients, BBK emphasizes that informed consent should be regarded as a process rather than the isolated act of signing a form.
Newer Methods
As researchers have gained more cultural understanding about patient populations, particularly in emerging countries, the concept of community consent has become more important. “Sometimes, in cultures in Africa or the Middle East, before an individual can make a health decision such as enrolling in a trial they have to consult with a spouse or with community leaders. That dynamic is something that can affect the quality of informed consent,” Wolf says.
Multimedia consent tools, video and Web interfaces also have grown increasingly popular. People charged with consenting patients recognize that not everyone learns in the same way, Wolf says. “While a 15- to 20-page legal scientific document may work for one patient, another may find it more difficult. We’re seeing video and DVD used more and more at sites. In some cases, patients also can be introduced to a study at home if they have access to the Web. That way, they can learn at their own pace and go through a comprehension check with questions and answers.”
“Many of our sites use a laptop computer where they can show a video of the process,” Scott says. “Of course, we also have to ensure that a doctor and study staff person who can speak the local language are present.”
The Human Element
Yet even with newer technology assisting with the informed consent process, researchers are finding there is no magic bullet. A 2004 review in the Journal of the American Medical Association found that multimedia and enhanced consent forms had only limited success in improving patient understanding. Dr. Jeremy Sugarman, the Harvey M. Meyerhoff professor of bioethics and medicine at the Berman Institute of Bioethics at Johns Hopkins University in Baltimore, Md., USA, says that many good ideas about improving informed consent have emerged in recent years, with very little evidence that they work. “The irony is that we’ve seen these new ideas introduced without having tested their safety or efficacy. If we introduce new methods, we ought to be doing so with good data.”
An example is a study Sugarman took part in during which he and other investigators introduced a quality assurance checklist for consent after patients enrolled in a clinical trial. But the study found that the questionnaire had no impact on the quality of the consent. “The tool intuitively sounded good, but the results turned out to be negative.”
Sugarman also has been investigating the role formative research can play in informing the design of trials and helping investigators mold the consent process to better fit the patient population’s particular needs. “Investigators came to us when they were designing a trial for a rheumatoid arthritis treatment,” Sugarman says. “Our formative research helped us determine patients’ educational needs and learn about barriers to enrollment.”
In the near future, the advent of personalized medicine might drive new ways of thinking about informed consent, Wolf says. “Because this type of clinical research project is focused on smaller numbers of people, it will be important to educate specific groups of patients about the uniqueness of what is being tested. What we hope to see is that the human element, which sometimes gets lost in research, remains paramount—we have to remember that our ultimate goal is treating individuals.”
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