Genomic sequencing to predict risk for breast cancer

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Reference no: EM133644099

Question

A 30-year-old female research subject participates in a study that involves genomic sequencing to predict risk for breast cancer. The test is performed in a CLIA-certified laboratory and results are verified. The test results show a mutation that is predictive of thalassemia, a rare inherited blood disorder. This disease may be mild (not requiring treatment) or severe (which may require a donor stem-cell transplant). At the time of the finding, the subject has no clinical symptoms of the disease. The subject had "opted out" of learning about IFs in the informed consent. The next step the researcher should take is: Inform the IRB of this finding and let the IRB determine whether or not the researcher should override the subject's preferences and disclose the results. Inform the subject of this unanticipated IF because it is actionable, even though it was not the aim of the study. Discuss the situation with the subject's family. Not inform the subject of this unanticipated IF because the subject "opted out" in the informed consent.

Reference no: EM133644099

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