Challenging the Research Community to Think Differently about the Informed Consent Process

A conversation with Laura M. Beskow, MPH, PhD, ADAPTABLE Co-Investigator, Duke University

A core aspiration of PCORnet is to redirect the culture of clinical research from researcher-directed to patient-driven. In this spirit, the Duke Clinical Research Institute’s Program for Empirical Bioethics, headed by Dr. Laura Beskow, developed a patient-centered informed consent process for the ADAPTABLE study. Her team is committed to ensuring that patients better understand the information presented in consent forms. Because ADAPTABLE’s informed consent process is web-based, it requires an innovative approach to promoting understanding.

Dr. Beskow’s team sought to translate a technical-laden protocol into everyday language that patients can easily understand. Research suggests that many research participants do not understand the information in typical consent forms and may not even read them in their entirety. Yet, a basic principle of informed consent is making sure that patients understand what they are being asked to do. Dr. Beskow and her team identified details of the ADAPTABLE study that would be essential for a patient to understand in order to make an informed decision about whether or not to participate.

“Our first draft consent form was four pages long and written at a 7th grade reading level. It was a good start, but we didn’t stop there,” said Dr. Beskow. The team undertook two additional steps to ensure understanding and comprehension.

First, they conducted a series of cognitive interviews with heart disease patients from Duke Medicine and members of the Adaptors group about their understanding of the contents of the consent form. The Adaptors are a group of patient representatives from each of the clinical data research networks (CDRNs) participating in ADAPTABLE. After reading the consent form, the patients were asked questions like the following about each section:

  • 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?

“Overall, we received very positive feedback. Participants commended our efforts to develop a simple consent that was responsive to patient input and they appreciated the lack of ‘legalese’ in the document,” said Dr. Beskow. Interviewees generally understood the consent form, including  the risks involved and what it would mean to be randomized to an aspirin dose. Patients expressed few concerns about being randomized, other than wanting to check that it was okay with their doctors if they were assigned a dose different from the one they currently take. The interviewees did not identify any particular content that they thought should be removed from the consent form.

Second, Dr. Beskow and her team developed a short, multiple choice quiz to help participants assess their understanding of fundamental information about the study. The team interviewed and gathered input from patients and Adaptors just as they did when developing the consent form. In general, the team found that the interviewees responded well to the quiz. They answered most questions correctly and commented that the quiz covered the right information, helped to reinforce the important concepts in the consent form, and was not onerous to complete.

Dr. Beskow emphasized, “for ADAPTABLE, we challenged ourselves to build a consent form that is not only based on ethical and regulatory requirements, but also reflects real-world input from patients. Doing so resulted in a consent document that is simple, helpful, and informative—and driven by the needs of patients.”

For an interview with Dr. Beskow about the ADAPTABLE consent process and to view a recent presentation check out this feature of Ask ADAPTABLE.

The ADAPTABLE study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (Contract Number: ASP-1502-27079).

 All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee.


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