Let's say you have high blood pressure that can be treated with one of two medications.
Neither drug is experimental; both are within the standard of care. Your doctor doesn't have any medical reason to recommend one or the other. But she'd like to help the medical community figure out which one works best, and she's wondering if you would, too. If so, you can enroll in a randomized study, effective immediately.
The question is, what steps are necessary to ensure you understand and consent to the research?
One possibility is that your doctor informs you about the purpose of the research, its risks and benefits, and your alternatives to participating; she then documents the conversation and your decision in your medical record. A patient-friendly consent process is essential to the success of this type of research on clinical practices, say researchers at the Stanford Center for Biomedical Ethics (SCBE), and most patients are comfortable skipping a written consent form when the form might prove so cumbersome that the research couldn't go forward. Patients also prefer to talk about participating in these studies with their own doctors, not with researchers.
But draft guidance from the federal Office for Human Research Protections (OHRP), if finalized, would require formal written consent in any study that is designed to assess a risk, even if the same risk exists in ordinary clinical care. In other words, whether you get Hypertension Medication A vs. Hypertension Medication B is characterized as a research risk, even though the risk is inherent in the doctor visit whether you participate in the study or not.
"They make it seem really risky," said Stephanie Alessi Kraft, an SCBE clinical ethics fellow and the lead author of a paper in the American Medical Association Journal of Ethics that argues for reconsideration of the draft guidance. "We're talking about cases of genuine uncertainty and equipoise. In our research, we use the example of a gumball machine. You know you're going to get a gumball. You know you're going to get a medication that works. You just don't know what color."
In the paper, published online today, she and her colleagues write:
The OHRP draft guidance ... implies that the potential for harm associated with clinical uncertainty only exists when patients are randomized by research protocols, not in everyday practice.
"Our concern is that the draft guidance will force us into the position where we don't allow researchers to share risks in a way that is meaningful and understandable to patients," Alessi Kraft told me. And because of that, patients may not have the opportunity to participate in research they'd like to be part of.
Alessi Kraft acknowledges that safeguarding patients' well-being is crucial — "research protections are in place for a reason" — but she also wants their voices to be part of the conversation. She is hoping medical students and professionals will become more informed about how this issue affects patients and comment on the next version of the draft guidance.
"We can make these regulations, but really, it's about patients being affected by it both on the front end as participants and on the back end as beneficiaries," she says. "It's important to find ways to integrate their viewpoints going forward."
Previously: The public wants easier ways to participate in medical research, study shows, Build it (an easy way to join research studies) and the volunteers will come and Bioethicists say criticisms of preemie oxygen study could have "chilling effect" on clinical research
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