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We further analyzed the within-site consistency in handling incidental findings for the six sites where we had collected four or more consent forms.
This information may then serve as basis on which future recommendations for handling incidental findings in both the clinical setting and in research studies may be based.
There may be different policies for handling research results and handling incidental findings in research even if the clinical significance (clinical validity and clinical utility) may be a common denominator for these policies.
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Jumping into the fray of a controversial topic, the Presidential Commission for the Study of Bioethical Issues released a report this afternoon on how to handle incidental findings, discoveries about an individual's DNA and other health-related information that show up while hunting for something else.
Over the course of a year, a committee led by Green and Leslie Biesecker, chief of the Genetic Disease Research Branch at the National Human Genome Research Institute in Bethesda, Maryland, has been weighing how to handle "incidental findings" that turn up when a genome or exome is sequenced for some other medical reason.
As calls increase for the expanded use of broad or even open consent, and as controversy grows about how best to handle incidental genomic findings, these approaches, informed by normative analysis and empirical data, will continue to evolve alongside the science.
In our sample, we encountered 13 distinct methods or strategies used by REBs to handle incidental findings (see Table 4).
For example, we found evidence of substantial between-site and within-site variability in the strategies approved to handle incidental findings.
There is also a question on how to handle incidental findings in genetic research that may be important for the welfare of donors/subjects.
Accordingly, reported variability could reflect the fact that the institutional and research context varies between sites (e.g., having access to clinicians or not in strategies deployed to handle incidental findings).
After finding limited information on how to handle incidental genetic findings and individual research results when adding genome-wide analyses to clinical trials, the GARNET Incidental Findings Subcommittee set out to develop an approach as part of the goal of developing and disseminating methods for adding genome-wide technologies to randomized clinical trials (Box 1).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com