On Thursday, President Obama’s Bioethics Commission issued a new report on how doctors and researchers should handle incidental findings. The debate has been raging for about a decade. When you volunteer to participate in research that images the brain, what duties (if any) do researchers have to go beyond data collection to check your scan for abnormalities and let you know? When your doctor recommends gene sequencing to figure out your symptoms, should he or she check unrelated genes for other abnormalities? These situations raise puzzling questions about your right to decide what tests to undergo and your right to refuse unwanted results.
Our research and clinical technologies are now so powerful that they routinely generate extra information. Some of it will be accurate and some won’t. Some will be lifesaving, but other information will generate only anxiety and more tests. Researchers and clinicians have been looking for guidance on how to handle this problem.
The presidential commission made progress in its report. The members said that doctors and researchers should plan how to handle these incidental findings and tell people what findings may be discovered in a procedure, so they can consent to or refuse that procedure.
But the report creates problems as well. The commission seems to accept that today’s incidental finding may become tomorrow’s “secondary” finding — an extra finding deliberately sought rather than stumbled upon. For example, the American College of Medical Genetics and Genomics controversially recommended last spring that whenever gene sequencing is performed on a patient for a particular clinical reason (such as finding a way to treat a cancer), laboratories and clinicians should analyze at least 56 extra genetic variants unrelated to the reason for the sequencing. ACMG reasoned that as long as the patient’s genome was being sequenced anyway, checking genes conferring risk of other diseases that could be treated might prove useful.
This recommendation caused a firestorm, in part because of the potential to burden patients with bad news and the health care system with costs. When I go to my doctor with pain in my foot or a suspicious lesion on my forehead, she rightly works up that problem. She doesn’t launch investigations into 56 (or more) other potential problems unrelated to my complaint. By staying focused on my problem, the doctor helps protect my right to decide what tests to undertake and the kind of information I want to receive.
At crucial points like this, the report seems to lose sight of the importance of patients’ rights. Some people will want all tests and data offered, and some will not. ACMG said that any patient who needs gene sequencing for a condition must accept the analysis of 56 extra variants as part of the deal, and that patients who refuse the extra analysis cannot have the sequencing at all. The commission properly rejects this, saying the doctor has the option to respect patient choice. But it also says the doctor can do as ACMG recommends — reject the patient who refuses the extra analysis. And when people assert their right not to know about incidental findings, the commission says it is up to the clinician whether to respect that choice.
Forgotten here is that we are talking about the patient’s body, testing, data and future. It should be the patient’s decision whether to accept or refuse extra testing. Patients have the right even to refuse testing for a primary condition, much less add-on testing. Indeed, they have a protected right to refuse ventilator care or dialysis, even if the predicted consequence is death. And there are limits on clinicians’ ability to claim a conscientious objection and withdraw from caregiving. Otherwise, any time a clinician disagreed with a patient choice, the clinician could refuse further care, insisting that the patient go elsewhere.
The commission’s report locates a serious problem at the heart of the incidental-findings debate — the tension between clinician and researcher prerogatives and the choices of the people whose bodies, data and findings are at issue. Unfortunately, the report fails to offer ethical analysis to resolve that tension. The great Justice Benjamin Cardozo showed the way almost a century ago, writing that “every human being … has a right to determine what shall be done with his own body.” That right is now part of ethics and law, in both research and clinical care. People have the right to refuse extra testing and incidental findings. Core to the doctor’s professional duties is respect for patient choice.
Susan M. Wolf is McKnight Presidential Professor of Law, Medicine & Public Policy at the University of Minnesota. Her research on return of results and incidental findings is funded by the National Institutes of Health and Robert Wood Johnson Foundation.