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GEN News Highlights : Dec 12, 2013

Presidential Panel Urges Researchers to Plan for Incidental Findings

Researchers, clinicians, and other generators of medical data beyond the stated goals of procedures or lab tests should plan for the possibility they’ll come back with “incidental findings,” then plan in advance whether and how to deliver such information to patients or consumers, a White House advisory panel concluded.

The Presidential Commission for the Study of Bioethical Issues called for shared decision making between practitioners and recipients of health information in a report released yesterday. “Anticipate, Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts” urged practitioners to reveal both incidental and secondary findings likely to arise or be sought from the tests and procedures performed on their patients or consumers—then agree on what will be communicated should incidental findings be discovered, and what further steps will be taken.

The report distinguished between incidental and “secondary” findings actively sought by practitioners that were not the primary target of research or a procedure.

“Clinicians should respect a patient’s preference not to know about incidental or secondary findings to the extent consistent with the clinician’s fiduciary duty,” the report stated.

The commission also urged researchers and other data generators to ensure patients or customers “have access to adequate information, guidance, and support” in making informed choices about what procedures to undergo, what information to seek, and what to do with data once received. Researchers and clinicians should present data graphically, and describe the chance of any person getting a disease suggested by the incidental data, rather than relate that risk to that of another person, the panel said.

“The reality is, we may find out more than we bargained for, yet practitioners are getting seemingly conflicting advice about how to manage such findings,” Commission Chair Amy Gutmann, Ph.D., president of the University of Pennsylvania, told reporters.

Also, the commission urged professional groups to develop guidelines categorizing findings likely to arise; agree on best practices for managing incidental and secondary findings; and share their guidelines with practitioners.

Earlier this year, the American College of Medical Genetics and Genomics (ACMG) developed a minimum list of 57 genes it suggested be sequenced for mutations for any of 24 disorders “where early intervention is likely to reduce or prevent serious morbidity or early mortality.” ACMG also recommended that patients not consenting to its minimum list of tests be denied screening for their primary complaint—a suggestion opposed by the U.K.’s PHG Foundation as “an example of coercive and paternalistic thinking.”

The commission also recommended federal agencies continue funding research into types and frequency of findings; as well as potential costs, benefits, and preferences by practitioners and recipients of identifying, disclosing, and managing findings.