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8 Special Considerations for Reporting of Results in NHANES
Pages 53-58

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From page 53...
... STATISTICAL AGENCY CONSIDERATIONS IN RELEASING DNA RESULTS Jennifer Madans mentioned some advantages of being part of the federal statistical system, which include an institutional commitment to long-term data collection and a commitment to maintaining the storage of specimens. While budgets will change, a project such as NHANES does not have the pressing worries that other population-based studies may have in terms of expired grants or investigator turnover.
From page 54...
... There are consequences involved with the timing of testing and reporting of results, Madans said. In the case where NHANES results are returned very soon after the initial participant encounter, how different is that from contacting people 5 or 10 years later to say "remember us, we Impact on survey • PercepƟon that government should participation or other not be collecƟng DNA components of the • Need for complex informed consent survey especially if specimens are banked Additional funding needed may divert • For immediate tesƟng funds from other • For recontact with subjects survey components or NCHS activities • Complex ethical requirements Impact on agency • Changing ethical requirements reputation especially if specimens are banked • PotenƟal for errors in reporƟng FIGURE 8-1  Potential unintended consequences or drawbacks to an expanded NHANES genomic data collection.
From page 55...
... Genetic information may yield information relevant to the welfare of others, for example, vertical transmission wherein learning something about one's own genetics tells one something about parental genetics. As Botkin noted, genetic information can be highly predictive of future disease; tests for BRCA1 and HNPCC have a higher predictive power than nongenetic tests for blood pressure and cholesterol.
From page 56...
... Genomic testing has variable clinical validity and variable clinical utility, depending on what is targeted. There usually is no urgency of action because for the most part genetic results do not need to be responded to 1  Concern about stigma resulting from genetic testing may have increased in response to increases in genetic research (see, e.g., Sankar et al., 2006, and World Health Organization (http://www.who.int/genomics/gender/en/index3.html [June 2014]
From page 57...
... Botkin said these differences make it easier to say "these are results that will not be returned," as opposed to saying "maybe these are returnable depending on the specific situation of the person." Further discussion at the end of the workshop session about incidental findings and return of results highlighted the fact that discrete analyzers have now replaced most automated laboratory equipment that used to routinely perform a wide range of tests on a panel, regardless of the test or tests ordered. A participant pointed out that laboratories now try to focus analyses to include only what has been ordered, and clinicians
From page 58...
... Further, the participant elaborated, CLIA requires laboratories to perform tests only at the written or electronic request of an authorized person, thereby further decreasing the likelihood that a laboratory would conduct a test without receiving a specific order from an authorized person to do so. In light of these developments and in view of ethical analyses suggesting that investigators do not have an obligation to search for incidental findings, it can be argued that any new standards saying that additional genomic analyses should routinely be done to identify actionable results would constitute genetic exceptionalism.


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