FROM THE COMMITTEE ON HUMAN RESEARCH
Incidental findings in research with human participants: Ethical challenges for psychologists
By APA Committee on Human Research (CHR)
This commentary is one in an occasional series for PSA in which CHR addresses current ethical and regulatory issues surrounding human subject research. These commentaries are not official APA policy but represent the consensus view of the committee members and are intended to inform and stimulate thinking among researchers and administrators.
An issue of increasing importance in human participant research is that of “incidental findings.” Incidental findings have been defined as observations of potential clinical significance unexpectedly discovered in research participants and unrelated to the purpose or variables of the study (Illes, et al. 2006). A prominent example of an incidental finding is an unexpected abnormal finding, such as a brain tumor, on a research neuroimaging scan of a volunteer. This issue can occur in many other psychological research settings, including cognitive research (e.g., unexpectedly low memory scores in a control participant), mental health research (e.g., unexpected psychotic symptoms endorsed on a rating form by a research participant), or research that includes biochemical, molecular, or genomic testing (e.g., unanticipated identification of a genetic or other risk factor). Findings such as these have potentially serious implications for a participant’s medical health, psychological well-being, employment, and insurance coverage (Booth, Jackson, Wardlaw, Taylor & Waldman, 2010), as well for researchers and their institutions. The possibility of an incidental finding thus raises issues of an investigator’s responsibility to screen for, identify, and properly communicate unexpected abnormal findings to the research participant and other designated parties. This issue raises ethical, legal, and regulatory concerns, and in CHR’s view, calls for careful consideration by researchers.
Incidental findings raise a host of challenging questions, including:
What general standards and guidelines should govern the handling of incidental findings in human participant research?
What kinds of incidental findings should a psychologist researcher consider? In many kinds of psychological research, an incidental finding may be exceedingly unlikely.
In situations in which incidental findings are possible, what represents a significant incidental finding requiring follow-up with a research participant? Phrased differently, what threshold should apply for disclosure to a research participant of an incidental finding?
If disclosure is warranted, who should disclose the incidental finding and what should be the scope, form, and time frame for disclosure?
Should institutional review boards (IRBs) allow researchers to decline responsibility for detecting and communicating incidental findings, based on ethical, practical, and financial considerations?
Limited guidance is available for addressing these questions. Adapting some of the ethical approaches to incidental findings proposed in the brain imaging arena (Illes, et al., 2006), CHR offers the following general recommendations:
Determine the potential for incidental findings occurring in your research study at the outset of planning for the study, and not after the study has started.
If the potential for a significant incidental finding exists, establish a process to handle discovery and reporting of such findings. Be sure to build the costs of such a process into your study budget. This may require the inclusion of a professional competent to evaluate the incidental finding.
Determine the threshold for reporting incidental findings. Categorization of different outcomes and responses can be very helpful here. Identify appropriate individuals and establish a process (scope, form, time frame) for reporting the finding to the research participant and others (if applicable).
If monitoring and reporting incidental findings are not feasible or unduly burdensome, consult colleagues and your IRB to explore options.
As research becomes more complex and multi-disciplinary, the likelihood of researchers having to address incidental findings will increase. It is therefore incumbent on psychologists, and all scientists working with humans, to develop a set of ethical practices that will facilitate the appropriate handling of incidental findings without unduly burdening scientific enterprise and progress.
Booth T. C., Jackson, A., Wardlaw, J. M. Taylor, S. A., & Waldman, A. D. (2010). Incidental findings found in “healthy” volunteers during imaging performed for research: Current legal and ethical implications. British Journal of Radiology, 83, 456-465. doi: 10.1259/bjr/15877332
Illes, J., Kirschen, M. P., Edwards, E., Stanford, L. R., Bandettini, P., Cho, M. K., …members of the Working Group on Incidental Findings in Brain Imaging Research. (2006). Incidental findings in brain imaging research. Science, 311, 783-784. doi: 10.1126/science.1115429
CHR members are: Thomas Eissenberg (chair), Miriam F. Kelty, Daniel C. Marson, Vivian Ota Wang, Barbara Stanley, Mieke Verfaellie, and Frank Wong. Sangeeta Panicker serves as the staff liaison to the committee.