In April 2014, the Presidential Commission for the Study of Bioethical Issues released a primer to help institutional review boards (IRBs) understand the Commission’s recommendations on incidental and secondary findings. The recommendations were made in the Bioethics Commission’s December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The primer summarizes the report’s recommendations for how to ethically manage the discovery of incidental and secondary findings.
Incidental findings are results outside of a study’s original purpose. They can be either “anticipatable,” or known to be associated with a particular procedure, or “unanticipatable,” meaning that they were unexpected. Secondary findings are also ancillary to the main goal of a study; however, they are actively sought in the study, occasionally based on the recommendations of outside experts. There are several kinds of tests associated with incidental or secondary findings including, biological specimen analysis, genetic sequencing and medical imaging—such as X-rays, computed tomography (CT) scans and ultrasounds—which can yield findings of clinical relevance to individuals or family members.
The primer states that researchers should clearly express the possibility of incidental or secondary findings to participants before they provide consent; IRBs should ensure that participants enter the study adequately informed about the possibility of these findings. “Researchers should communicate the fundamental aspects of their research—including the possibility of discovering incidental or secondary findings and the plan for their disclosure or management—so that participants can make fully informed decisions about whether to enroll. IRBs should review informed consent materials to ensure that researchers have included information about incidental and secondary findings and the plan for management of these findings.”
Researchers should build a management plan for additional findings based on the specific circumstances of their study. “Researchers should develop a plan based on evidence about the analytic and clinical validity of potential findings and their clinical or reproductive significance, and careful consideration of the benefits, risks, and costs of disclosure, including the risk that seeking or analyzing incidental and secondary findings might distract from the central goal of research.” Researchers can inquire about what information participants want to receive; participants might choose to only be informed about findings that are of high clinical significance. The primer points out that while researchers are ethically obligated to create a management plan for incidental findings, they are not required to search for secondary findings. Even if researchers decide not to disclose any incidental or secondary findings to participants, they must still properly communicate this plan.
The primer suggests that IRBs ensure that research teams have individuals familiar with anticipatable incidental findings associated with the study’s procedures. If a team does not have this expertise, IRBs may suggest that the team add members or seek experts for consultation. The primer is posted at http://bioethics.gov/sites/default/files/IRB%20Primer%20-%20Incidental%20and%20Secondary%20Findings.pdf.
This article is part of the Spring 2014 issue of Professional Ethics Report (PER). PER, which has been in publication since 1988, reports on news and events, programs and activities, and resources related to professional ethics issues, with a particular focus on those professions whose members are engaged in scientific research and its applications.