In this feature of Ask ADAPTABLE, we speak with Dr. Laura Beskow, ADAPTABLE Co-investigator who, along with her team, led the development of the ADAPTABLE consent form.
Q: Why did ADAPTABLE need a new approach to consent form development?
LB: My work has been devoted to studying ethical issues in research and informed consent raises many challenges and questions. In general, consent forms are too long and complex. As a study, ADAPTABLE is an opportunity for a new national research paradigm – to do things differently and more efficiently. Patients have been involved in ADAPTABLE from the beginning so it was only natural to include them in the consent development.
We took the unique step of interviewing and gathering feedback from individuals with similar demographics to the potential study participants to develop an effective, patient‐oriented consent form that provides information in a concise, easy‐to‐understand manner while meeting regulatory requirements.
Q: What steps did you undertake in the consent form development process?
LB: We started with the protocol and tasked ourselves with how can we translate this technical content into something simple for prospective participants. We picked out details of the study that we thought would be particularly important and helpful for a prospective participant to make an informed decision. In addition, we made sure we drafted a document that met federal regulations for what needs to be in a consent document.
We generated an initial consent form based on the draft protocol, our ethical and regulatory knowledge of informed consent, and previous empirical research about participants’ understanding of and reactions to consent materials.
This initial consent form was four pages and the reading level measured at 7th grade level. We thought this was a great first start, but we wanted input from individuals like those that would be eligible for ADAPTABLE. We conducted a series of cognitive interviews with Duke cardiology patients and members of the Adaptors group. The Adaptors group is unique to ADAPTABLE; the group is made up of patient representatives from each of the participating clinical data research networks (CDRNs).
Q: What is a cognitive interview?
LB: Cognitive interviewing is a technique used to study the manner in which target audiences understand, mentally process, and respond to information. For example, for ADAPTABLE, we asked the interviewees to read the consent and then we asked them to answer the following questions about each section in the consent form:
- Can you please tell me in your own words what you understand this section to be saying?
- Is there anything confusing?
- Is there anything you especially like or find especially concerning about what this is saying?
- Is there any extra information or details here that you think are not needed?
Q: What did you learn from the interviews?
LB: Overall, we received very good feedback. Participants commended our efforts to develop a simple consent with patient input and appreciated the lack of “legalese” in the document.
Interviewees generally exhibited a high degree of understanding. Most interviewees understood the risks involved and what randomization meant. Few concerns were expressed about being randomized, other than wanting to check that it was okay with their doctor if they were assigned a dose other than the one they currently take. The interviewees did not identify any content that was extraneous and should be removed.
We developed a report that provides a summary of our findings, demographics of the interviewees, a copy of the consent marked to show regulatory compliance, and detailed information about how the consent was changed based on these interviews. We shared the report with the larger ADAPTABLE team and it generated quite a bit of excitement as this process we undertook to obtain and include patient feedback is not often the case in clinical research.
Q: Has this process been done before or is ADAPTABLE at the cutting edge of incorporating patient feedback into the informed consent?
LB: The work that I have done previously with consent for genomic and biobank research is similar, but was always in a hypothetical context. For example, asking questions such as “If there was a study with a biobank, how would you feel about it?” So in the case of ADAPTABLE, to be doing this research that will directly impact a consent form that will be used in a national study is very gratifying. We are not developing a consent on basic principles alone or what we think people might like to know, but instead we are getting actual patient input on what information they want to receive and if they understand that information.
Q: Would you say the process your team undertook is a real-world approach to craft an informed consent document?
LB: Yes. There has been a lot of research demonstrating that study participants do not understand the information in the typical consent and often will not read the entire form because it is too long. For this project, we are actively seeking input and using the feedback we receive as well as the knowledge that we have from our own experience and are able to put that all into practice.
Q: How do you confirm that a participant understands the main concepts of the study?
LB: I think it is a basic principle of informed consent that we take the time to help people be confident that they really understand the main concepts of the study. It is important for both the study team and the participant that when an individual signs a consent form that they feel good about their understanding of the study. This is true for all studies, but especially for ADAPTABLE since we are using web-based consent. We developed a 6-item multiple choice comprehension assessment tool that is essentially a quiz to assess a participant’s understanding of the study.
Q: How was the quiz developed?
LB: Our approach with the quiz was to focus on essential understanding—the concepts in the study that are so crucial for a participant to understand that if they don’t, we might question the validity of their consent. Similar to the development of the consent form, we conducted interviews and gathered input from patients and Adaptors on the quiz questions. After reading the consent form, we asked them to take the quiz. We would then ask them questions such as: What kinds of things did you think about when selecting your answer? How did you arrive at your final answer – did you remember the answer, guess, or find the wording of the question and/or answer options made the answer obvious?
Q: What is the ultimate goal of the ADAPTABLE consent?
LB: The goal for ADAPTABLE is to have a uniform consent process that is simple, participant focused, and yet acceptable at the site and IRB level. It is a very interesting and fascinating process, as we are asking everyone involved to think differently and in a new way about the consent process. In the end, we really want this to be a great consent for the patients and for them to be confident in their understanding of and decision about participating the study. In addition, we hope this might be a model for future studies and for research sites to understand that there are other ways to meet Common Rule requirements without excessive detail and legal jargon.
To learn more, listen to Dr. Laura Beskow’s presentation: Developing a Participant-Centric Consent Process for ADAPTABLE.