Understanding Patient Views About Informed Consent for Research on Medical Practices

Often, many medications are approved for a single medical condition. Think of high blood pressure, for example – one doctor might prescribe one medication, while another doctor prefers to prescribe a different medication. One way to find out which is actually the best choice is to study what is taking place in medical settings such as doctors’ offices and hospitals. Research on medical practices (ROMP) can happen in “real time,” going on as patients receive usual medical care. The usual approach to informed consent that is required by regulations, however, is complicated to carry out in these settings.

Pediatric pulmonologist and bioethics faculty Benjamin Wilfond, along with bioethics faculty Douglas Diekema and Stephanie Kraft and bioethics staff Ellen Kuwana and Kathryn Porter and other collaborators, has been exploring what the public, patients and regulators think about research on medical practices.

ROMP can include reviewing medical records of patients and randomizing patients to the different treatments. In 2014, the team created animated narrative videos to explain these concepts to use in focus groups, a national population survey and a patient survey. The team also conducted a survey of institutional review board (IRB) professionals who oversee research to see what they think are the best ways to conduct ROMP.

In 2015, the team conducted a randomized study in patients to compare the videos to regular text, comics and a “talking head” video.

“Many ethical guidelines are based on assumptions about what is important to people. But when we ask them, people might have concerns that we did not consider. Other times, the problems that we are worrying about are less concerning to them.”

Dr. Benjamin Wilfond

The team has learned that while many IRBs require a signed consent form for randomized ROMP, they allow medical record review to occur without patients being aware of it. Many patients, however, do not make this distinction. In both cases, more patients prefer to have their doctor let them know these activities are going on through a brief conversation, and to get recommendations from their doctor before deciding to join a ROMP study.

In 2016, the team created six videos about ROMP studies that involve the collection of blood for genetic research. This research is often referred to as biobanking research; the team conducted 20 focus group in three languages that used the metaphor of the “library of medical information” to explain biobanks. The team wanted to understand the attitudes of patients with diverse cultural, language and socioeconomic backgrounds. The team learned that patient willingness to join such studies depended on their trust of the institution.

The results from these projects suggest that modifying the standard regulatory approach to informed consent might be more consistent with public views. The team is planning to study whether modified approaches to informed consent in actual ROMP studies are better appreciated by patients.

Ultimate Goal

To improve how researchers communicate with patients about research on medical practices in ways that reflect patient concerns and priorities.

Primary Collaborators

  • David Magnus, Mildred Cho and Sandra Lee, Stanford University School of Medicine
  • Gary Ashwal and Alex Thomas, BoosterShot Media

Funding

  • National Center for Advancing Translational Sciences
  • National Libray of Medicine
  • The Greenwall Foundation

Representative Publications

For more information, please see TheValuesProject.Stanford.edu.