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Teaching Hospitals Examine New Ways to Convey Research Risks, Benefits to Patients

AAMC Reporter: December 2013

—By Alicia Gallegos, special to the Reporter

Concerns over the effectiveness of traditional informed consent methods have long weighed on the research community. Now, some teaching hospitals are exploring new ways to make research benefits and risks clear to patients, while analyzing whether alternative models improve patient comprehension.

“There have been a lot of criticisms of informed consent practices,” said Heather Pierce, J.D., M.P.H., AAMC senior director of science policy and regulatory counsel. “The process is usually done by paper documents that are very long and have so much information that there is a concern about it being too much for some patients to digest.”

Informed consent documents may give cover for liability but might not truly be serving their purpose of informing patients, Pierce said. Recent reports and controversies have led to renewed attention about patient protections in research and whether current practices need updating. Last March, the U.S. Office for Human Research Protections (OHRP) claimed a national study of premature infants failed to provide parents with adequate disclosure of study risks. The OHRP’s findings led to outrage among some citizen interest groups. In a June letter, the OHRP indicated it does not believe the study’s design was unethical, but rather that the informed consent documents lacked proper description of reasonably foreseeable risks.

In response to a request for feedback by the Department of Health and Human Services (HHS) about studying standard of care interventions, the AAMC urged the HHS and OHRP to undertake a process for providing guidance that supports and facilitates comparative effectiveness research to determine safety.

AAMC Chief Scientific Officer Ann C. Bonham, Ph.D., wrote that the premature infant study “created a chilling environment for clinical research and may essentially discourage future clinician researchers from engaging in rigorous research to generate evidence for the best possible treatments for critically ill patients, leaving physicians in the difficult position of making clinical judgments on a case-by-case basis.”

The ethical questions sparked by the premature infant study emphasize the need for an improved informed consent process that places more focus on participant comprehension, said Ruth Macklin, Ph.D., a professor at Albert Einstein College of Medicine of Yeshiva University.

“The individuals obtaining consent should take time to ascertain that prospective subjects do understand the purpose of the research, the risks and potential benefits, and the procedures that will be done,” said Macklin, a member of the Institute of Medicine and the Board of Directors of the International Association of Bioethics. “Consent forms often overstate the benefits and also may understate the risks, but there is no substitute for a conversation—one that enables prospective subjects to ask questions. The use of videos, cartoons, and other visual aids might help a lot in today’s multimedia world.”

The current era of medical research is ripe for more innovative approaches to informed consent, said J. Lloyd Michener, M.D., professor and chair of the Department of Community and Family Medicine at Duke University School of Medicine.

“This is a great place in time for alternative methods, such as comic books and videos, and other ways of sharing information so that people understand what they are consenting to,” he said. “They’re not just handy; they’re central. The point of informed consent is to have someone informed and then to consent, not just sign a document.”

How much do patients understand about research?

At the University of California, San Diego (UC San Diego), researchers are poised to determine just what approaches might improve informed consent comprehension. In September, the university launched three projects aimed at bettering informed consent, protecting patient privacy, and advancing research.

The initiatives are part of the university’s Integrating Data for Analysis, Anonymization, and Sharing (iDASH) project, one of the National Centers for Biomedical Computing at the National Institutes of Health.

UC San Diego’s first project focuses on how well patients comprehend information during the consent process, said iDASH Director Lucila Ohno-Machado, M.D., Ph.D., professor of medicine at UC San Diego School of Medicine and founding chief of the Division of Biomedical Informatics. The project will explore cultural factors that influence the informed consent process and will develop strategies for increasing patient understanding of consent forms.

As part of the project, researchers are drawing up a quiz to test patients on how well they understand explanations. “Some people just sign [the document] and barely read it. We want to make sure they understand the risks and the potential benefits,” Ohno-Machado said.

Multimedia’s effect on informed consent

iDASH researchers also plan to utilize an Apple iPad video to convey informed consent information to potential research participants. Such multimedia tools are a growing strategy among researchers.

The University of Alabama (UAB) School of Medicine launched a study in late 2012 to examine the use of an iPad app to relay informed consent information. Patients enrolled in a “dummy” trial for osteoporosis will use an iPad app to watch videos that emphasize primary aspects of the study. Patients will have access to a recorded summary and a text-based form, as well as the ability to print a paper copy about the study. After each video, an interactive quiz allows patients who have questions to highlight words or phrases.

The iPad app study, which was funded by the Agency for Healthcare Research & Quality, should be completed within the next six months, said Kenneth Saag, M.D., M.Sc., a professor of medicine at UAB and director of UAB School of Medicine Center for Outcomes and Effectiveness Research and Education.

“The objective of the study is to understand the differences in the real world between the use of traditional pen-and-paper consent and a consent process utilizing a patient device,” he said. “The goal is to try to reduce the burden of doing clinical trials. One of the barriers for physicians is the difficulty of gaining informed consent—the time it takes, the lack of personnel. The idea is to develop tools that [offer] more efficiency of the informed consent process and greater comprehension for patients.”

A similar tool was used at Penn Medicine’s Roberts Proton Therapy Center. In 2011, researchers at the Perelman School of Medicine at the University of Pennsylvania began testing an Internet-based multimedia resource that contains a video of the informed consent process for proton therapy clinical trials. The tool allows patients to stop, start, and replay the video, as well as to play it for family members or caregivers.

“The tool was well accepted by patients and providers,” said James M. Metz, M.D., a professor and vice chair of the clinical division in Penn Medicine’s Department of Radiation Oncology. “Patients enjoyed the ability to share the videos with family members and friends, as many could not be present for the consultations, and it made it easier to relay this information.”

Penn Medicine researchers are hoping to obtain grant funding to expand the pilot project to offset the cost to create and host the video content, Metz said. “I do believe expanding the consent process with the addition of multimedia materials enhances the patient experience,” he added. “It also reduces provider time in the room reviewing the protocol, particularly multiple times when other family members or friends come to the clinic with the patient on each visit.”

Recent research reinforces Metz’s assertion. A March study conducted by the California Pacific Medical Center Research Institute in the online journal PLOS ONE found better comprehension among patients when standard informed consent language was combined with an interactive iPad system.

Researchers studied the results from 55 online surveys of patients who received informed consent information about a clinical research study via paper or iPad video. Patients who received the consent information electronically scored between 14 percent and 22 percent higher on test questions than the paper group.

Researchers must be open to trying new ideas and exploring inventive ways to enhance participant comprehension to truly advance the informed consent process, said Emily E. Anderson, Ph.D., M.P.H., assistant professor of bioethics in the Neiswanger Institute for Bioethics of Loyola University Chicago Stritch School of Medicine. “To really improve, we as a research community have to let go of some of the things we’ve been doing based on habit and routine,” she said. “We need to be willing to get innovative and test some strategies.”

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