The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Anticipating and Communicating Incidental and Secondary Findings in Research

Incidental findings can arise during the course of some research studies involving human participants, presenting ongoing challenges for researchers. For example, some imaging technologies such as magnetic resonance imaging (MRI) or ultrasound can reveal aspects of a research participant’s physiology outside the area of interest to researchers. The research setting is distinct, warranting ethical guidance that is different from the clinical context, in part, because a primary purpose of research is to produce generalizable knowledge, or greater understanding of ourselves and the world. Nevertheless, because incidental findings might carry health implications for individual participants, researchers also have ethical obligations to consider individual harms and benefits of disclosing such results. Researchers, therefore, have dual obligations of beneficence to both participants and to public well-being.

In its most recent report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Bioethics Commission recommends that researchers:

  • Communicate to participants what anticipatable findings might be found, whether such findings will disclosed, and whether and how participants might opt out of receiving certain types of findings. Throughout the informed consent process, researchers should clearly communicate with potential participants about what results could be uncovered and what the plans are for managing such findings. The Bioethics Commission acknowledges that many people want to know about information with any potential health implications, but others might not want live with the uncertainty that can accompany some findings. Researchers have the obligation to communicate their plans for disclosure such that participants can accurately assess whether participation is consistent with their preferences to know or not to know.
  • Develop a plan to manage anticipatable incidental findings. The plan should be reviewed and approved by an institutional review board (IRB). Researchers have the responsibility to familiarize themselves with the technologies employed during the course of a study, and to understand what types of information can be revealed through their methods. By developing a plan in advance, researchers can anticipate what to do as a result of such findings— including disclosure or referral to clinical follow-up—and participants will be informed of what to expect if they agree to participate.
  • Develop a process for evaluating and managing unanticipatable findings. In addition to those findings that can be reasonably anticipated, researchers might also uncover findings which were not expected. Although the unexpected nature of such unanticipatable findings makes them difficult to manage, researchers should develop and communicate a plan in order to prepare for all eventualities as best they can. One option is for researchers to base this plan on common features of findings—for example whether a finding is life-saving, has unknown clinical significance, or carries no health implications. When such findings arise, researchers should collaborate with medical professionals to interpret the clinical significance of incidental findings.
  • Consider carefully the decision to actively look for secondary findings. Although technology might make it possible to seek out more information regarding individual participants’ health, many researchers are not clinicians; for example, a neuroscientist is not always a neurosurgeon. In addition, many research techniques are not optimally designed for clinical purposes. Research-grade scans can be of adequate quality for collecting data for research, but not useful for medical diagnosis. While some research can be designed—with the approval of an IRB—to more accurately detect health conditions, it is not ethically required, or appropriate, for all researchers to take on such tasks. Such a plan to look for secondary findings should be communicated to possible research participants during the informed consent process.

The Bioethics Commission’s report Anticipate and Communicate has important implications for researchers and for those considering participation in a research study. Researchers should anticipate the possibility of incidental findings ahead of time, and communicate with participants both before and after tests and procedures occur. In order for us, as a society, to make important scientific progress, researchers need to be able to fulfill their societal obligation to produce generalizable knowledge but also their responsibilities to individual research participants. The Bioethics Commission’s recommendations to plan and communicate management policies in advance give researchers flexibility while enabling participants to make informed, autonomous decisions about whether to volunteer for a particular research protocol.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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