So What Are We Going to Do about Research Using Clinical Information and Samples?
In: IRB: ethics & human research, Band 26, Heft 6, S. 14
ISSN: 2326-2222
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In: IRB: ethics & human research, Band 26, Heft 6, S. 14
ISSN: 2326-2222
With the advent of new genetic technologies and the Human Genome Initiative, interest in the problems posed by genetic diagnostics in general, and by genetic screening in particular, has surfaced. Many recent works focus on the problems posed by the "new genetics" in the contexts of prenatal diagnosis, carrier detection, employment, and insurance. In the midst of all this discussion, the routine testing of newborns for genetic disorders seems relatively uncomplicated and has, in fact, become "a part of common practice and accepted public policy with little thought having been given to the implications." The relative lack of concern about newborn screening is understandable. The fact that a routine test can detect diseases that could have serious consequences if untreated but which could be alleviated by early intervention makes the use of routine testing on newborns seem inevitable. A growing number of commentators applaud this practical exclusion of parents from the decision-making process and assert that newborn screening is so desirable that states should require it as a matter of law. This Article argues that society should resist efforts to require that newborns be tested for an ever-increasing number of conditions. Part II of this Article examines why interdisciplinary research is essential in developing appropriate laws governing newborn screening. Part III presents an overview of the screening process by describing not only what screening can and cannot do, but also the general organization of current programs. Part IV draws upon several different areas of discourse that suggest reason for concern. First, a large body of empirical research is presented that demonstrates that newborn screening causes psychological and other harm to infants and their families. These consequences have not previously been considered by legal commentators. Second, this section suggests that the diagnosis of disease in the neonatal period, regardless of accuracy, can have adverse social and legal consequences for families and ...
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The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19. As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to "invent their own differing systems" to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses. Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada's nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false. On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials' action was "inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved." Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.
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Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care will be context-dependent, varying for different patients and clinical settings. This Article argues that a disciplined approach is needed, incorporating research to assess when and how genomic information can improve clinical outcomes, practice guidelines that direct optimal uses of genomic sequencing, and efforts to limit the production of genomic information unrelated to the clinical needs of the patient. Without this approach, genomic testing could add to current unsustainable healthcare costs and prove unaffordable in the long run.
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The ethical objections to mandating forensic profiling of newborns and/or compelling every citizen or visitor to submit to a buccal swab or to spit in a cup when they have done nothing wrong are not trivial. But newborns are already subject to compulsory medical screening, and people coming from foreign countries to the United States already submit to fingerprinting. It is also worth noting that concerns about coercion or invasions of privacy did not give pause to legislatures (or, for that matter, even the European Court) when authorizing compelled DNA sampling from arrestees, who should not forfeit genetic privacy interests simply by virtue of being arrested.
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We conducted in-depth, semi-structured interviews with LGBTQ+-identified individuals (n = 31) to explore the range of LGBTQ+ perspectives on genomic research using either sexual orientation or gender identity (SOGI) data. Most interviewees presumed that research would confirm genetic contributions to sexual orientation and gender identity. Primary hopes for such confirmation included validating LGBTQ+ identities, improved access to and quality of healthcare and other resources, and increased acceptance in familial, socio-cultural, and political environments. Areas of concern included threats of pathologizing and medicalizing LGBTQ+ identities and experiences, undermining reproductive rights, gatekeeping of health or social systems, and malicious testing or misuse of genetic results, particularly for LGBTQ+ youth. Overall, interviewees were divided on the acceptability of genomic research investigating genetic contributions to sexual orientation and gender identity. Participants emphasized researchers' ethical obligations to LGBTQ+ individuals and endorsed engagement with LGBTQ+ communities throughout all aspects of genomic research using SOGI data.
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Introduction -- Overview of family planning in the United States -- Title X goals, priorities, and accomplishments -- Program management and administration -- Collection of data to measure program outcomes -- References -- Data sources and methods -- Population research and voluntary family planning programs -- Title X family planning program regulations -- Program guidelines for project grants for family planning services -- Family planning program assessment rating tool -- Committee site visits -- Family planning annual report data elements -- Summary of previous Title X evaluations and reviews -- Title X and OPA-funded research -- Organization, funding, and management of the Title X program -- Measurement of quality in the Title X family planning program -- Committee and staff biographies
In: Alexandra L. Foulkes et al., Can Clinical Genetics Laboratories be Sued for Medical Malpractice? 29 Annals Health L. & Life Sci. 153 (2020).
SSRN
Working paper