Incidental and Secondary Findings
Incidental and secondary findings can arise from a test or procedure that is being conducted. Incidental findings are results that are outside the original purpose for which a test was conducted; they are distinct from primary findings, which are the primary target of a test. In contrast, a secondary finding is an additional result that a practitioner is pursuing, perhaps in line with an expert recommendation (or consensus). The Presidential Commission for the Study of Bioethical Issues (December, 2013) published a table (adapted here) outlining the differences in findings resulting from a test or procedure.
| Type of result discovered | Description | Example |
|---|---|---|
| Primary finding |
Practitioner aims to discover A, and result is relevant to A |
In a child with an unknown vaccine history, a test done to determine a child’s immunity status before the chickenpox vaccine is administered. |
| Incidental finding (anticipatable) |
Practitioner aims to discover A, but learns B, a result known to be associated with the test or procedure at the time it takes place |
Discovering misattributed paternity when assessing a living kidney donor and potential recipient who believe they are biologically related. |
| Incidental finding  (unanticipatable) |
Practitioner aims to discover A, but learns C, a result not known to be associated with the test or procedure at the time it takes place |
When a DTC genetic testing company identifies a health risk based on a newly discovered genetic association not knowable at the time a previous sample was submitted. |
| Secondary finding |
Practitioner aims to discover A, and also actively seeks D per expert recommendation |
ACMG recommends that laboratories conducting large-scale genetic sequencing for any purpose should actively look for variants underlying 24 phenotypic traits. |
When conducting tests or procedures that can results in incidental or secondary findings, practitioners may want to consider some of the following points prior to beginning their research.
- Is there a clear informed consent process in place that conveys the plan for managing incidental and secondary findings?
- Is there a communication process in place that allows subjects to state their preferences about disclosure of results?
- Is there a communication process in place to discuss the plan for managing incidental and secondary findings with the patient?
- Are tools to engage patients in shared decision making available?
- Is there any testing available that minimizes the likelihood of incidental and secondary findings?
- Be aware of existing clinical guidelines/statements for the management of incidental and secondary findings
Developed by the NBSTRN Bioethics and Legal Issues Workgroup