Ethically Sound: Anticipate and Communicate

Host:

Imagine you go to your doctor for a crick in your shoulder and after an X-ray, your doctor discovers a tumor in your lung. These so-called incidental findings can be lifesaving, but also can lead to uncertainty and distress, particularly if there is no cure. Would you want to know?

Welcome to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. I’m Hillary Wicai Viers. Today we’re joined by Commission Member Dr. Christine Grady, Chief of the Department of Bioethics at the National Institutes of Health Clinical Center. But first, we’ll hear from yoga teacher and award-winning journalist Carol Krucoff.

Carol Krucoff:

Few things get people's attention like telling them you have a brain tumor. I learned about my tumor accidentally back in 2004, at the end of an otherwise uneventful checkup, when my doctor said: “We need to schedule a repeat MRI to monitor your little brain tumor.” Stunned, I felt my heart flop against my ribs. “What brain tumor?” I stammered.

The doctor looked at me, aghast. “I'm so sorry,” she said. “I thought you knew.”

She proceeded to explain that an M.R.I. taken six months earlier—when I'd been hospitalized for severe hyponatremia caused by drinking too much water during a marathon—had revealed a 3 mm acoustic neuroma, about the size of a sesame seed.  Although the doctors had told me about the tumor, I was in a coma for four days and my memory of that period is impaired. Sitting in my doctor's office that day, her voice seemed far away, and I grabbed onto a few reassuring words: “noncancerous,” and “slow-growing.” I recall little else of what she said except that if my tumor grew, I might need brain surgery.

Advances in imaging technology have made it increasingly common for healthy, asymptomatic people like me to learn of such a disturbing “incidental finding”. Over the next 10 years, I watched my tumor grow slowly through regular MRIs.  I took comfort in the fact that I remained completely asymptomatic, and I tried to remain calm about the tumor’s creeping growth. But this experience made me question the wisdom of learning about an abnormality if all it offers is anxiety—as well as the potential for harm from treatments for something that might never affect my health. At my annual MRI in 2013, I learned that my tumor had grown to the size of a small walnut. Although I still had no symptoms, tests of my vestibular function—the system that contributes to balance –were now abnormal. So, in February 2014, I had gamma knife radiosurgery in an effort to halt the tumor’s growth. Perhaps my incidental finding had been a blessing after all. 

My two-year MRI showed that the tumor is stable—but regular scans are recommended, so I will continue to watch and wait. For me, this unsettling knowledge presents a spiritual opportunity. Like the ancient yogis who were taught to imagine death sitting on their shoulder, I have learned that having a heightened awareness of impermanence can serve to make the present moment that much sweeter.

Host:

While Carol’s incidental finding ultimately changed her outlook on life, as we heard, more information is not always better. Incidental findings might, but do not always, have important, actionable implications for our health; emotional as well as physical wellbeing. It would be rash—both ethically and practically speaking—to conclude that everything that can be sought should be sought, and reported, in all contexts. In its sixth major report, the Bioethics Commission reviewed the ethics of reporting incidental findings to individuals. Incidental findings—findings that lie outside the aim of a test or procedure—give rise to a wide range of practical and ethical challenges for recipients and practitioners.

Imagine. You’re participating in a memory study. As part of the study, the researchers scan your brain, and find more than they bargain for: a tumor. What do the researchers owe you, the participant? What do you want to know? Or…You and your brother decide to sign up for an online DNA testing service to learn about your ancestry. But the company discovers that you are actually half-siblings, with different biological fathers. Should the company share this information with you? How should they communicate this surprising piece of news?

Such discoveries are increasingly common. No one today is immune from the prospect of painfully discovering something unexpected. As the Bioethics Commission examined the ethical dimensions, it became clear that there were no consistent guidelines for how we best manage incidental findings. In fact, practitioners are getting conflicting advice.

In its 2013 report, Anticipate and Communicate, the Bioethics Commission made 17 specific recommendations for handling incidental and secondary findings in three different settings—clinical, research, and direct-to-consumer. The report’s overarching message is clear: Regardless of the setting and type of test or procedure, all practitioners should anticipate and plan for incidental findings so that patients, research participants, and consumers are informed ahead of time about what to expect if unexpected findings are discovered.

You can download Anticipate and Communicate, and all the Commission’s reports at www.bioethics.gov.

Host:

Here today to talk about the Bioethics Commission’s report, Anticipate and Communicate is Dr. Christine Grady. Dr. Christine Grady is Chief of the Department of Bioethics at the National Institutes of Health Clinical Center and a member of the Bioethics Commission. Welcome Dr. Grady, thank you for being here.

Tell me, why was the topic of incidental findings important to address?

Dr. Grady:

Well, medical practitioners and researchers have long struggled with how to handle something that they found that was incidental to the purpose of the medical or diagnostic exam or the research study that they were conducting. In recent years with advancing technological innovation, the amount of information that is, or can be available, has increased dramatically and with that, the likelihood of finding something incidentally as well. This issue rose to the forefront in genomic sequencing, and the 2012 report on Privacy and Progress in Whole Genome Sequencing recognized the ethical issues surrounding the return of incidental return of incidental genomic findings were still unsettled.

Although there had been considerable attention to this issue in the published literature, it had not been addressed by a national level bioethics commission since the National Bioethics Advisory Committee in 1999 issued its report on research involving human biological materials. And in the intervening years, a range of technologies had emerged that made the likelihood of discovering incidental findings much greater.

Host:

How has your work as a researcher and a nurse influenced your thinking on this issue?

Dr. Grady:

So, as a researcher, I’m acutely aware of the possibility and the challenges associated with uncovering information about people’s health that falls outside the purpose or the scope of the particular research. Ethically, it always seemed critical to me to think carefully about what one might find while doing research, and develop a plan in advance for how to handle it. And in fact, in Anticipate and Communicate, the Commission recommends precisely that; that researchers develop a plan for managing anticipatable incidental findings and a process for evaluating unanticipatable findings, and both of those should be reviewed by IRBs and described in the informed consent. I’ve also been an IRB member for a long time, and in that capacity have been involved in reviewing the research plans of investigators involved in multiple kinds of research, including genomic research, and in helping them to make decisions about what they’re going to do with incidental findings.

Host:

Why was it important to have multiple perspectives brought to bear on this question?

Dr. Grady:

Well, the report considers the ethical implications of incidental and secondary findings that arise in a wide range of contexts; including in the clinical context, the research context, and the direct-to-consumer testing context. So, having professionals in each of these contexts understanding that they have different professional duties and ethical obligations to the individuals whose results they are actually reviewing.

So, for example, in clinical care, clinicians have a fiduciary duty to their patients, and they’re supposed to act in their patient’s best interests. Whereas, in research, investigators have more limited duties to the research participants and in the direct-to-consumer context, the ethical obligations of the direct-to-consumer entities and their customers are less clear, and still developing. In addition, there’s a range of reactions to discovering an incidental finding. Sometimes finding and acting on an incidental finding can be lifesaving. In other cases, discovering an incidental finding leads to additional invasive, expensive, diagnostic tests or procedures, and accompanying stress and anxiety without any real corresponding benefit for the individual. So for these reasons, it was really very beneficial and helpful to hear from people who had received information about incidental findings and had vastly different experiences and perspectives on the matter.

Host:

How are the Commission’s recommendations being acted upon?

Dr. Grady:

So one way, I mentioned I was both an IRB member and a researcher, I know at the NIH there’s been a lot of discussion about the Commission’s recommendations from Anticipate and Communicate including, in a recent proposal to develop a secondary findings consultation service for research involving whole genome and exome sequencing here at the NIH. And there are other efforts to develop educational programs for practitioners, guidance for specific modalities, and studies of attitudes and practices related to incidental findings, some of which were inspired or informed by the President’s Commission work.

A particular example is change in the guidance from the American College of Medical Genetics and Genomics (ACMG). They had published recommendations for disclosing incidental findings in clinically indicated whole genome sequencing in early 2013, and in that publication, and after considerable debate, concluded that they would be giving findings to people without respect to what the patients or families wanted. In other words, patients and families didn’t have an option for opting out of getting those results. The Commission actually took a slightly different view and said that clinicians should respect a patient’s preference not to know about incidental or secondary findings to the extent that was consistent with the clinician’s fiduciary duties. And ACMG, noting that the Commission’s work had informed their decision, actually updated their original recommendations and said that patients should be informed during the consent process that they may opt out of such analysis, as long as they were made aware of the ramifications of doing that. And ACMG specifically stated that they have adopted some of the terminology that the Commission recommended as well. So they’re using the term “secondary findings” as opposed to just “incidental findings.”

Host:

Dr. Grady, it was a pleasure to have you with us today. Thank you.

You’ve been listening to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. Thanks for joining us. You can check out our full series online at bioethics.gov.