Reporting Incidental Findings
When a person signs a consent form, they agree to certain uses of their information and the samples that are taken during a study. However, unforeseen circumstances can arise that are not addressed in the informed consent document. There are some serious and tangled ethical issues associated with incidental findings. When researchers investigate an individual’s DNA sequence for one purpose, they may discover something important that was not part of their original aim. These findings might have clinical significance to the person who gave the sample. For example, an individual may have his genome sequenced while participating in a research study on the heredity of intelligence. During the study, the researchers discover this individual has a mutation that will cause him to develop ALS (Lou Gehrig’s disease), an incurable neuromuscular disease that eventually causes death, later in life. The researchers must now decide what to do with this information. Because they are inherently unexpected, it is difficult to fully plan for incidental findings, but once they arise, researchers are faced with three ethical components they must meet: that the information is correct, that the disclosure of information follows the law, and that the welfare of the participants is protected. The most vague of those responsibilities is the “protection” of the participant. If the incidental finding relates to a condition that can be treated or prevented, most would agree that “protecting” the participant would require the researcher to tell the participant. However, for conditions that are untreatable and cause serious suffering or death, it becomes much more difficult for researchers to decide whether or not to report to a person who may be getting far more than they bargained for.
According to the National Human Genome Research Institute, a researcher should report incidental findings if those findings meet three categories: 1) they are findings that can be validated, 2) that those findings have health implications, and 3) that knowing the findings will be helpful in taking specific actions to improve the participant’s health.
The Belmont Report specifies three ethical principles for all research involving people. People must be given autonomy, and those who cannot have autonomy must be protected. Researchers must act in a way that contributes toward the wellness of their patients by “maximizing possible benefits and minimizing possible harms.” Finally, a person must be treated justly, in that equality of access is a consideration. However, in some cases it is unclear how to achieve these principles when incidental findings are involved.
CLICK HERE for an introduction to informed consent
CLICK HERE for a case study exploring the ethical conflict in reporting incidental findings
Meacham, Meredith C., Helene Starks, Wylie Burke, and Kelly Edwards. “Researcher Perspectives on Disclosure of Incidental Findings in Genetic Research.” Journal of Empirical Research on Human Research Ethics 5.3 (2010): 31-41. Print.