Special Report: Improving Informed Consent
Improve clinical trial compliance by following these informed consent tips
Experts offer ideas, strategies to improve process
Clinical trial sites and research institutions increasingly are recognizing the need to improve the informed consent process, which is where compliance problems often occur.
"The long and the short of the issue is that informed consent documents have gotten to be far too long in length and far too dense in language for the vast majority of the population to actually read them and understand them," says Howard Dickler, MD, director for clinical research, division of biomedical and health sciences research with the Association of American Medical Colleges in Washington, DC. "And as such they are viewed by many people as an impediment to clinical research and an impediment to true informed consent," Dickler says.
New research into improving the informed consent process highlights the clumsiness and misunderstandings that permeate so many informed consent forms, experts note.
"It became clear to me in looking at consent forms, which in some cases are virtual legal documents, that there's a lot of complicated information that has to be conveyed in a meaningful sense," says Gordon Willis, PhD, a cognitive psychologist with the National Cancer Institute of Rockville, MD. "There is room for failure to communicate in this domain."
Willis has studied cognitive interviewing methods for 30 years for the purpose of understanding why people answer survey questions as they do. Recently, Willis has applied his knowledge to the study of evidence-based informed consent, publishing an article on the subject in the new journal, titled Journal of Empirical Research on Human Research Ethics.
"The problem has been that very often participants in research have not understood what they've agreed to and what is going to happen to them as research participants," says Cindy Brach, MPP, senior health policy researcher in the Center for Delivery, Organization, and Markets at the Agency for Healthcare Research and Quality (AHRQ) of Rockville, MD.
"Studies have shown that informed consent forms have been written at too high a grade level, often at college level or above," Brach says. "Furthermore, researchers have also documented that many participants do not understand the information that was in the informed consent form they signed."
AHRQ has been developing an informed consent and authorization toolkit. In addition to providing a sample informed consent and authorization form, written at the 6th grade level, the toolkit emphasizes that informed consent is a process, not a form; it gives guidance on how to conduct that process.
AHRQ plans to conduct cognitive testing of the tool kit, after which it will be released to the public, probably sometime within the next year, Brach says.
Misunderstandings about the purpose of clinical trials is so prevalent that one study published in JAMA found that 50% of parents of children who participated in clinical research did not understand the term "randomization," despite the fact that their children were participating in randomized trials and the term was described orally and in writing, says Eric Kodish, MD, professor and chairman, department of bioethics, Cleveland Clinic Foundation, Lerner College of Medicine, Case Western Reserve University in Cleveland, OH.1
"One third of parents didn't understand they had a choice to be in a study," Kodish says. "And you don't have informed consent if you don't know you have a choice."
There are a number of strategies that could be used to improve informed consent documents, says Steven Joffe, MD, MPH, an ethicist and assistant professor of pediatrics at Dana-Farber Cancer Institute, Children's Hospital Boston. "The structure of the informed consent document is one place to start. People may not think about a document as having a structure, but it has almost an architecture of how it's built."
Here are some suggestions for improving the informed consent process:
1. Use a teach-back process in one-on-one sessions.
After an investigator or clinical trials professional discusses the study with a participant, the teach-back method can be used to assess how well the participant understood the discussion.
"It's very helpful to assess what take-away messages participants have taken from the discussions," Joffe says.
Statements like "Tell me what the alternatives are if you decided not to be in the study," provide clinical trials professionals with a means for assessing whether the informed consent process has worked or whether there's more work to do, Joffe says.
To assess whether they understood the information, it isn't helpful to ask, "Do you understand?" Brach notes. "When patients are asked, 'Do you understand that?' they will say, 'Yes,' whether they understand or not," Brach says.
Instead use the teach-back method. "Ask them to explain what it is you said," Brach says. "It's very simple, but you don't want it to sound like a test."
For example, to introduce the teach-back, Brach suggests the clinical trials professional could say the following:
- "I want to make sure we have the same understanding..."
- "It's my job to explain things clearly. To make sure I did this..."
- "Can you tell me, in your own words..."
Brach urges those conducting the informed consent process to make sure that the subject has understood all the important elements by asking such questions as:
- "Tell me what you think will happen to you in this study." (To assess research purpose);
- "What do you expect to gain by taking part in this research?" (To assess benefits and compensation knowledge);
- "What risks would you be taking by being in this study?" (To assess knowledge of risks);
- "Who can you call if you have any questions?" (To assess knowledge of contact information).
Also, instead of asking participants if they have any questions, they could be asked, "So what questions do you still have?" Brach says. "This makes the presumption that you should have questions."
Evidence of the effectiveness of teach-back for informed consent for medical procedures can be found in AHRQ's "Patient Safety Practices Evidence Report—Procedures for Obtaining Informed Consent at this Web address: http://www.ahrq.gov/clinic/ptsafety/chap48.htm.
The National Quality Forum has created a clinician's guide to informed consent and the Teach Back process, which is available at the web address: http://www.qualityforum.org/docs/informed_consent/webtxInformedConsentUsersGuide+Provider+OrderMember+public09-13-05.pdf.
2. Make the process adaptive to various communications challenges.
"There are a lot of things you want to communicate, but there is a core of information that is most important," Joffe says. "It's important to identify what about this research is unique or different than what a person might experience if the person was receiving standard care."
For example, if there is a trial with five standard drugs and one experimental drug, then the investigator or clinical trials professional should let participants know which the experimental piece is and what is most relevant about the experimental drug, Joffe says.
The consent form should say how the risks are different and what potential benefits could come out of this research, Joffe adds.
Part of AHRQ's tool kit will include a map of what the informed consent process might look like, Brach says.
"For example, one part has to do with individuals who may not be proficient in English," Brach says. "If you are dealing with a subject who gives a hint of not being proficient in English, then you should provide an interpreter instead of using a family member for translation purposes."
3. Bring children into process when they are the participants.
"There's a difference between parental permission and autonomous adult informed consent," Kodish says. "Children are not the property of the adult, and psychologically, the decision-making process is different."
At Dana-Farber Cancer Institute, investigators focus on how to integrate children into the conversations about informed consent, Joffe says. Federal regulations provide some guidance about how to obtain assent from children, but there's a great deal of room for discussion, Joffe notes.
Make a strong commitment to engaging the child in a discussion that's appropriate for his or her developmental level, Joffe says. "We think there are extremes of very young or sick children who don't have the ability to engage in these discussions. For example, a three-year-old won't engage in discussion."
At the other end of the spectrum, there are older teenagers who are not acutely ill and who would like to be part of the discussion, and they might be able to make a decision as well as any 18 to 20 year old, who is treated as an adult, Joffe says.
"So we feel we should treat these older teens as though they are akin to adults," he says.
The gray area would be the 12-year-old, because there's a lot of variation among children at that age, Joffe says.
"We're committed to engaging them and hearing their viewpoint and concerns," Joffe says. "So we team parents and the child to make a decision together, an integrated decision as a unit."
The alternative is to take the child into one room and the parents into another and to discuss the study separately, he says. "But in our experience this doesn't work because most families want to make this decision together, and kids want their support," Joffe says.
The best strategy is to have a team that includes the physician, a registered nurse, and a psychologist work together in the informed consent process, Joffe says.
"At Dana-Farber, we make it our practice to involve nurses in these discussions whenever possible, and we think this works," Joffe adds.
- Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trial. JAMA. 2004;291(4):470-475.