BY JUDY ILLES, PHD, FRSC, AND MATTHEW P. KIRSCHEN, MD, PHD
How to anticipate — and respond to — unexpected findings in basic and clinical research.
One of the most resilient debates in science, medicine and ethics surrounds best
practices for handling incidental human research
findings that may be clinically significant.
Whether in imaging, genetic testing, behavioral
studies or a combination of modalities of
inquiry, at the heart of the debate about these
findings are questions about the blurring of
boundaries between research and clinical
practice and the risk of causing human subjects
anxiety when a researcher finds or suspects an
abnormality that may be benign or ultimately
prove to be a false positive.
Further fueling these discussions are issues
about the duty to warn participants about the
possibility of an incidental finding in advance of
a research study, the extent to which investigators
are obligated to look for abnormalities, and
how these unanticipated findings should be
communicated to participants.
Here we highlight two major categories of
challenges with respect to incidental findings that psychologists
ought to be thinking about: planning for incidental findings
in research and responding to them when they occur. We use
neuroimaging and genetics research to situate the discussion.
Planning for incidental findings
Both empirical and consensus-based attempts in the past to
wrangle with the issue of incidental findings in neuroimaging
and genetics research have yielded practical recommendations for
investigators and clinicians who engage in this type of research.
Guidance has created awareness about incidental findings
and compelled explicit and transparent consideration of their
management during study design, requests for ethics and human
subjects approval, the informed consent process and study
implementation. This approach is highlighted most recently
and significantly in the December report of the Presidential
Commission on the Study of Bioethics Issues, “Anticipate
and Communicate: Ethical Management of Incidental and
Secondary Findings in the Clinical, Research, and Direct-to-
Consumer Contexts.” The practical details about how to handle
incidental findings are largely left up to investigators and local
institutional review boards, which have benefited from both
writing in the peer-reviewed literature and online reports and
In the domain of brain imaging, and fMRI in particular,
one major issue in planning for incidental findings is whether
a physician who is qualified to interpret these scans, such
as a neuroradiologist or a neurologist, should be a required
collaborator on research protocols, and whether he or
she should read all MRI scans or only scans on which the
investigator detects a suspected anomaly. This has been a
hotly debated issue and is an especially complicated question
This installment of “Ethically Speaking” was
invited by members of APA’s Committee on
Human Research. Send your comments and
questions to email@example.com.