We had an overwhelming response to our webinar on the art of conducting an effective informed consent discussion. As a follow-up, presenter, Beth Harper of Clinical Performance Partners, answers some of the questions posed by attendees that focus on IRB approvals and the consenting process.
Our IRB is not keen on the research team using flip charts to educate as we consent. Have you ran into this issue?
I believe this is unfortunate, and I would want to inquire more about what their reluctance is. Most learners prefer the visual mode of learning (some research suggests that this is the preferred learning style of 60% of adult learners) so having visual aids to supplement the discussion can be very powerful. I would ask the IRB to provide more of a rationale of what their concerns are (e.g., is the format of a flip chart per se, the content, the actual visual images or messages, or something else?). Once you understand more of their concerns ,you can potentially explore other avenues such as multi-media presentations, re-formatted consent documents or other avenues that would still accomplish the goal of enhanced patient understanding while complying with the IRB’s policies.
Would such multi-media presentation/video clips need IRB approval?
Correct, anything that will be viewed or seen by the patient must undergo IRB/Ethics approval. In my experience, IRBs recognize that it is an expensive prospective to produce a video and then ask for changes once it is produced. Therefore, I believe many of them are comfortable reviewing the “storyline” with narration, screen shots and so forth in advance as part of their approval. This way they know what the video will convey without actually having to wait to see this before they render an opinion. In this capacity, they can offer suggestions for modifying text and imagery that you (the site), the sponsor or the patient recruitment organization can factor into the final production.
On the topic of enhanced consent forms, how have regulatory agencies & IRB’s responded to alternate formats such as newsletter/newspaper style, inclusion of pictures, etc.? Do these met with resistance or acceptance?
This is a great, but very broad question, and I can’t speak to the specific opinions of any regulatory agency or all IRB members. That said, there is a plethora of research on the need to improve patient understanding in clinical trials and a recognition from all stakeholders, I believe, that the current lengthy documents are not sufficient for enabling subject understanding. Generally speaking, in my experience and based on what has been published and presented at various industry conferences there is a growing appreciation for the various ways in which the patient education experience can be enhanced and that the organizations that are piloting different approaches are having good success.
Explore more regulatory considerations for informed consent and whether or not it’s ethical to delegate associated tasks during this upcoming webinar.
Are you seeing a trend to move towards electronic based consenting and would have concerns that it is not face-to-face?
I believe that the companies offering e-consent solutions are starting to get some traction conducting pilot projects. It is my understanding that these organizations really view the e-consenting process as a supplement to, not a replacement for, the discussion with the investigator and appropriate site personnel. Depending on the audience and when, where and how the e-consent is presented, this provides an opportunity for the patient to view a visually enhanced “storyline,” confirm their understanding at various points along the way through different types of knowledge validation questions, and also provide an opportunity for the patient to note any questions along the way. Then, when the e-consent is reviewed jointly by the prospective subject and investigator, the investigator can readily see the areas of confusion so that these sections can be reviewed in detail. Further the e-consents have different tracking and e-signature features but from a patient education perspective, the thinking is that this can help to quantify the patients’ understanding through the knowledge validation features and help to focus the live discussions on the topics of greatest concern or confusion for the patient.
How do you handle the patient that says “Dr. Smith says it is ok, so sign me up”?
Another challenging question! I might first approach this by reinforcing that you and “Dr. Smith” believe the research study will help to answer important research questions. I might then turn it back to the patient to ask them to reiterate what they remember from the conversation with Dr. Smith, whether they have any doubts or areas of confusion. I might then ask them to tell me what THEY think about signing up for the study and reinforcing that while both you and “Dr. Smith” think the research is important and that the individual might be a good candidate for the trial, the most important piece is that you, the individual be comfortable with the decision. I might conclude by having the candidate spend more time thinking about their decision and reinforcing that it’s really important that their choice be informed and that they make this free from any pressure or bias from the investigative site.
One issue that we have is getting those patients that are in a higher socio-economic status interested in clinical trials, how would you present to gain their interest?
I guess, this question could also apply to any ethnic or socio-economic group as well. It’s important to generally understand the motivations and interests of the audience to whom you are “selling” the product, in this case the prospect of participating in a clinical trial. I might first ask what they know or think about clinical research in general, as well as their condition and the current treatments available. For more educated audiences, you might consider providing additional journal articles or pointing prospective candidates to various websites where they can learn more about the value of research, how research has advanced conditions like theirs, and what the rationale and hope for the research is in the future. That said, it really all goes back to understanding the individual’s needs, interests and motivations and getting them to talk about these. Once you have a better understanding of where they are coming from, you can tailor the discussion to emphasize areas that are most important to them. In some cases, the altruistic appeal is what inspires individuals particularly where there is no hope of an individual benefit per se.
What is the difference between dishonest “selling” of clinical trial and true belief in value of trial? Is that up to the moral fiber of person who is doing recruiting?
This is a particularly difficult situation because, as you allude to in your question, this may come down to some judgments about the character of those involved in the research. At the most simple level however, I guess if the individuals involved in the research and consent discussion, knowingly believe that the research is bogus, or that the risks are disproportionate to the overall benefits of the research (individually or societal) yet they continue to promote the research for their own personal gain (publication, financial, other) then this would certainly constitute dishonest selling. In this case, I would also question how the research project was approved by the IRB, but that may be a different question. In essence, one firmly has to believe in the product that they are “selling” and believe that the prospective candidate or society at large could gain something from answering the important research question. Anything less than this might be considered dishonest.
Watch Beth’s free, on-demand webinar to learn more methods for improving the informed consent discussion.
What have you found is effective in concisely explaining the rationale behind randomization? I have found my subjects are uncomfortable with this aspect of clinical trials.
In an interesting article in the December 2010 issue of the Journal of Health Communications, titled “Metaphor Use and Health Literacy: A Pilot Study of Strategies to Explain Randomization in Cancer Clinical Trials,”
Janice Krieger and colleagues describe the results of their research study to evaluate the use of different metaphors to explain the concept of randomization.
In their study, participants were randomly assigned to watch a video that explained randomization using 1 of 3 message strategies:
- a low-literacy definition recommended by the NCI (“Randomization is a method used to ensure the research study is fair. It means that patients are assigned by chance to different treatment groups”)
- standard metaphor (i.e., flip of a coin)
- or a culturally derived metaphor explaining that randomization “was like determining the sex of a baby. The possibility of a boy is the same as the possibility of a girl”
While the paper describes many factors influencing clinical trials participation, they found that participants in the culturally derived metaphor condition experienced significantly higher intentions to participate in clinical trials compared with participants in the standard metaphor condition. They found that patients associated with the concept of using the “flip of a coin” to explain randomization.
This suggests re-thinking how you explain the concept of randomization. The authors of the paper stated they “believe that when people hear randomization described as a flip of a coin, they think of there being a winner and a loser … they don’t want to take part in a clinical trial if they think they may be risking something. That’s unfortunate, because participating in clinical trials is not a win or lose situation.”
Perhaps this sparks some additional ideas for how you can approach the explanation of the concept of randomization.
How do you handle families who dominate the discussion and negatively influence the patient?
As your question suggests, true informed consent is often a “family affair” and it is important that the relevant and appropriate individuals in the family unit buy-in to the research opportunity. It may be important to really validate and respond to the concerns of the family members — get them to voice their concerns and genuinely try to respond to these. In some situations it might be appropriate to suggest a separate meeting with the subject alone and the family members alone and then re-convene with all parties together. If however, the family is insistent that this is not in the best interests of the subject then this is probably not a viable candidate to pursue. While one may be able to successfully get them to sign up for the trial, maintaining their compliance, visit schedules and the like may become an impossible task throughout the trial if they don’t have family member support. It’s probably not worth it if you enter the study knowing the chances of gaining evaluable data in the long run are at risk.
What is the best way to present a study that has no potential benefit to the participant?
This is a great question that really speaks to the issue of having well articulated and rehearsed messages about WHY you are participating in the research project. Perhaps answering this important research question will further science or help future generations even if there is not direct individual benefit to the subject per se. Emphasizing any positives such as more closing monitoring of their condition, access to different types of diagnostic procedures or things that they might not otherwise have access to may be important features to highlight as well. Without of course, coercing the subject, finding and conveying the value of the research and ensuring that all parties interacting with the subjects have the same feeling and messages will be very important to conveying confidence in the project.
How do you assess a patients understanding? I feel uncomfortable asking open-ended questions; I don’t want them to feel like I am testing them.
Different researchers have written and spoken about different approaches such as the “teach-back” method whereby you ask the patient something along the lines of, ”I want to be sure I didn’t miss anything in my explanation to you, can you please tell me what you remember about X, Y, Z.” Providing a highlighter or little sticky flags for the prospective subject to note areas of confusion, or providing the subject with a pad of paper and pen to jot down questions might be helpful (if you aren’t working with an e-consent system that has some of these capabilities electronically). If there are no questions or highlights this in and of itself may tell you something, and if there are questions you could possibly probe further. Such as, ”I see that you had a question about X, tell me more about what was confusing about this section.” It really is an “art” to finessing the conversation and not appearing like you are quizzing the subject per se. Getting the candidate to talk is really the key — prompting them in any way that seems appropriate to the situation. Once they start talking, you can get a sense of what they understand and where you might have to go back and clarify points.
Watch these free, on-demand webinars to learn more methods for improving the informed consent process and reducing the number of consent declines:
On-Demand Webinar: Making Your Consent Forms Readable