Study suggests clarity in informed consent
Study suggests clarity in informed consent
High-risk population targeted
Researchers and review boards should pay close attention to informed consent comprehension among all research participants, but this attentiveness is especially needed for people from a high-risk population.
A study recently featured at the Public Responsibility in Medicine and Research (PRIM&R) 2011 conference found that a significant number of participants from a high-risk minority population had no knowledge about specific potential risks and/or benefits of the study in which they were enrolled.1 The study also recommends that investigators and study coordinators use culturally appropriate strategies to improve participants' knowledge of risks and benefits.1
"Most of the time, if you asked participants if they understood some of the adverse things that could happen to them in a clinical trial, they would say 'yes,'" says Jane Otado, PhD, research participant advocate at Howard University College of Medicine, Georgetown — Howard Universities Center for Clinical & Translational Science in Washington, DC. "However, when asked an open-ended question about what they understood, the majority did not answer the question. It could be that some studies are of minimal risk, and they might not think there are any risks."
When participants were asked about the benefits of participating in the study, they generally had an answer, which mostly involved wanting to help with research, she says.
Based on her study's findings, Otado suggests some ways investigators and review boards can improve the informed consent process:
• Provide clear and simple definitions of the medical concepts.
During the consent process, educate participants on the related disease and why the study is so important, as well as what the research process will involve, Otado suggests. She has found that research participants needed simple and clear definitions (i.e., using layman language) from research staff.
"You have to give them a definition first," she explains. "So if you're conducting an Alzheimer's study, then tell them what Alzheimer's disease is, what the disease process is, and make them understand the condition before you tell them about the research."
Researchers also might need to define research and explain how a clinical trial works and why it's important, Otado says.
Defining the disease and explanation of the study should be initiated with participants at the start of the informed consent process, she says. Researchers also could make educational materials that are handed to participants, although these materials should not be the sole means of educating them about the study.
"At the follow-up visits, you can go over the informed consent form," Otado says.
• Repeat and reinforce study procedures at study visits.
Researchers should reinforce the study procedures and informed consent periodically at follow-up visits, Otado says. As a research participant advocate, Otado at times observes the informed consent interviews.
"At the end of the interview, I would ask a participant, 'Can you tell me in your own words what the study is all about?'" she says.
Other questions to ask participants are these:
— Do you know how many times you'll be here? What procedures are done to you? Why is the study important?
— Do you know that you can stop participation at any time?
"The majority of people do not tell you they don't understand it, so ask them to tell you in their own words," Otado says. "They don't want to come across looking stupid."
Study coordinators could reassure participants that it's OK to ask questions.
• Use true/false questions to assess comprehension.
In some high-risk studies, it might be helpful to assess participants' understanding of each study risk and detail through a brief true-false quiz. For example, during a recent study of cocaine use, researchers asked participants about some main parts of the informed consent document with true-and-false questions, including these:
— Drugs used in this study are approved by the FDA. True or false?
— There are no possible risks or discomforts associated with my participation in this stud. True or false?
— I will receive individual counseling once a week. True or false?
• Observe and improve informed consent process.
Otado sometimes observes research coordinators as they conduct informed consent, and this strategy is another good one for improving the process.
For example, if Otado observes a research coordinator using words or acronyms such as DNA or cell line, she will note later that many lay people are unclear about what these terms mean and that they should be defined or broken down into simpler language.
"If someone says, 'We're looking for biomarkers,' what does that mean?" Otado says. "Make them understand and give examples, explaining your words."
An example might be to explain a genetic or biomarker test this way: "Everyone has a different genetic or biologic makeup, and we're interested in seeing how your specific makeup will influence a clinical outcome," Otado says.
Reference
- Otado JA, Kwagyan J, Thomas YF. Informed consent understanding among a high-risk minority population. Poster presented at the 2011 PRIM&R Advancing Ethical Research Conference. Dec. 2-4, 2011, National Harbor, MD.
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