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White House Bioethics Report: 'Anticipate and Communicate' on Incidental Findings

NEW YORK (GenomeWeb News) – A White House advisory panel today recommended that any researchers, clinicians, and direct-to-consumer firms that generate genomic, imaging, or other types of biomedical data should plan to encounter incidental findings and should communicate with patients, study participants, and consumers about how these findings will be handled.

Seeking to get out in front of an issue it sees as a growing problem, The Presidential Commission for the Study of Bioethical Issues said today that incidental and secondary findings will come up in many contexts, and clinicians and researchers in particular need to be prepared for them.

The commission boiled the core of its recommendations down to a brief phrase, "anticipate and communicate."

"In every setting and for each type of procedure," Commission Chair Amy Gutmann said in a conference call yesterday, the commission recommends investigators, doctors, and DTC firms to "anticipate them and communicate them."

"In short, we recommend that 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, and so that incidental findings are appropriately communicated."

Whether it is a genome sequencing-based study, DNA sequencing in a clinic or by a private consumer genomics company, imaging-based research or treatments, or an array of other situations, incidental findings are becoming more common, and to date there are no broad guidelines addressing how these should be handled.

"Incidental findings can be life-saving, but also can lead to uncertainty and distress if they are unexpected or if they identify conditions for which there is no effective treatment available," Gutmann said.

In the report, "Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts," the commission urges stakeholders who may encounter incidental findings to have a plan.

But it is a broad recommendation. The commission is not telling anyone what their plan should be, how it should work, or how far it should go. The goal is to promote preparedness and to get institutions to implement systems based on planning dialogue that informs and engages patients, participants, and consumers.

The individual involvement is a critical component of the Commission's approach because people are likely to have different ideas about what they would or would not like to know about what was found in their genome or brain imaging scan.

"There's a wide variety of reactions [to receiving incidental findings]. Some people want them, some people don't. The reality is that we may find out more than we've bargained for," Gutmann explained.

James Evans, a professor at the University of North Carolina at Chapel Hill and editor-in-chief of Genetics in Medicine, told GenomeWeb Daily News today that the recommendations "are common sense."

"I mean that in a good way. These are very reasonable recommendations," he said. Most anyone who looks closely at the issue, he added, is likely to agree on the two main thrusts of the commission's guidance. "You need to anticipate the occurrence of these [findings] … and you need to have transparent communication with patients and subjects," he said.

The Bioethics Commission decided to tackle this problem after it drafted last year's report and recommendations on whole-genome sequencing and found incidental findings too complex and too broad a subject and worthy of its own examination.

Incidental findings have been around for a while, but genomics may have spurred the commission to focus on this issue because it is very different from other modalities, like imaging, in one big way, Evans told GWDN.

"[W]hile in other modalities incidental findings are possible and will happen, in genomics, especially in the context of whole-exome or whole-genome sequencing, incidental findings are essentially guaranteed. Basically, it's going to happen every time you do the test."

The commission looked over 16 reports from US organizations and 16 reports from international groups, and found there are "no consistent guidelines" for managing incidental findings, Gutmann explained.

The National Human Genome Research Institute has launched the Return of Results Consortium to begin to study this issue, funding research that focuses on how individuals respond to incidental findings in their genomes.

The most aggressive move so far on incidental findings has come from the American College of Medical Genetics and Genomics, which earlier this year released a set of guidelines for handling incidental result. The ACMG proposal is that incidental findings about a few genetic variants should be returned to individuals in most cases, because they would enable people to take preventive measures. The group recommended a list of potentially actionable and well-characterized and studied variants that should be maintained and added to over time.

The Bioethics Commission's new report recommends simply that it is important for those who may find incidental results to be prepared for them and to discuss with individuals how they would like them to be handled.

How these policies are created and implemented should be left up to professional organizations and institutes themselves, the commission suggested.

The report includes a number of recommendations, mostly ones that follow on the central themes of anticipation and communication. The body recommends that professional groups should develop guidelines that categorize findings that are likely to arise from different technologies and settings, and to develop best practices for managing them. It also advises that federal agencies and others should fund research to keep abreast of the "rapidly evolving types and frequency of findings," as well as costs, benefits, and harms.

Public and private groups also should prepare material and educational tools to inform practitioners, IRBs, and potential recipients about the ethical, practical, and legal implications of incidental findings, the commission recommended.

Evans thinks the "anticipate and communicate" philosophy behind the report matches up well with the needs of genomics researchers, who might be expected to warn prospective participants that there are likely to be incidental findings.

"[In genomics] it is all the more important to communicate to people the potential for [incidental findings] because they should be free to sign up or not sign up – that is a basic tenet of research – and should not be coerced one way or the other," he said.

In the clinical setting, he explained, this approach could be a bit more difficult because patients are not as free to say that they don't want to have a test (that presumably their doctor recommended for them) as a research participant is to just walk away from a study.

"But that's just the messy type of landscape that one lands in in clinical medicine. Unwanted outcomes are inherent in the practice of medicine," Evans said, noting that this scenario is precisely what makes the communication between clinicians and patients about such findings so important.