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By Melinda Young
Researchers and IRBs could learn a lot about what research participants want with informed consent and privacy if they ask.
One way to find out what research subjects think is called democratic deliberation. Using this technique, researchers found that most patients want someone to ask them before deidentified medical records are used for research.1
“It is an innovative technique used when we need to generate an informed and considerate consensus opinion from our fellow citizens,” says Reshma Jagsi, MD, DPhil, Newman Family professor, deputy chair of radiation oncology, and director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.
“Think of democratic deliberation as a citizens’ jury,” Jagsi says. “We can’t reasonably engage every single patient in the community in understanding some of the complexities in policy decisions. We learn by engaging a representative group of patients and give space to their deliberating with peers.”
In the study, the democratic deliberation process led to investigators learning that people want more control over their data than some researchers might think. “A first step is to have a better understanding of what patients desire in this context,” Jagsi says.
The researchers found that participants with cancer were most comfortable with their health information in secondary uses for purposes of university research about cancer or local hospitals using the information to ensure cancer patients received the right treatments. They were least comfortable with insurance companies using their information to determine which cancer treatments are eligible for coverage, or for hospitals using the information to market itself to cancer treatment patients.1
The goal is to include people in the deliberation that are representative of research participants undergoing informed consent. It is not a focus group, Jagsi says.
“It’s a unique process and distinct,” she explains. “It replicates a jury by presenting a case and information, and jurors have a chance to talk before rendering a verdict.”
Using the democratic deliberation process, Jagsi’s recent study saw results consistent with prior studies that used traditional techniques, such as surveys and interviews with patients. “What was striking about our findings was that a substantial proportion of the participants, even after deliberation, really did desire some degree of patient consent beyond notification,” Jagsi says.
“The argument has been that if patients really knew about the complex tradeoff involved, the quality of databases would suffer,” she says. “Many patients wanted to be asked for permission; they told us that they fully intended to give permission, but they wanted the opportunity to provide their permission.”
The study authors enrolled more than 200 patients with cancer. Those involved in deliberative sessions attended day-long educational events, small-group discussions, and completed several surveys. Investigators surveyed patients’ comfort with secondary uses of health information. Participants learned of several scenarios involving secondary use of electronic health information. They rated their comfort level with this use on a four-point scale.1
The democratic deliberation sessions used this setup:
• Attendees were randomly assigned to tables of four to eight people and one trained facilitator;
• Deliberations included an educational presentation and two small-group discussions;
• Researchers recorded, transcribed, and deidentified discussions;
• Participants heard presentations on “Disclosure and Consent,” and “Data Protection, Use, and Governance;”
• Facilitators asked participants to discuss the issue and vote to choose a corresponding policy;
• Participants were encouraged to defend their position on a policy, explain the rationale, and think like a citizen in a community about which policy would be best for society.
“I find that democratic deliberation is a very useful method, but I don’t suggest that everyone should use this method,” Jagsi says. “It’s very labor-intensive and expensive.”
The technique likely would not be practical for investigators or IRBs to employ on a regular basis, she notes. “It’s not realistic to expect individual researchers, planning particular use of data, to engage in full-on democratic deliberation,” she adds. “The point of this study was to inform large national databases, in this regard.”
Democratic deliberation could be useful at institutions that see multiple studies proposed for secondary usage of patients’ medical record data. “If you are seeing medical records used repeatedly from the same type of user, it certainly is important to get the public perspective on this use,” Jagsi says. “It’s important to understand that patients do feel quite strongly about this.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.