Genetic Testing: Scientific Background for Policymakers. Congressional Research Service. Congress has considered, at various.
Download Citation on ResearchGate Genetic testing: Scientific background for policymakers Congress has considered, at various points in time, numerous. Download it once and read it on your Kindle device, PC, phones. To answer this question, it is first necessary to appreciate that some people consider genetic risk information to carry an additional, wider burden than medical information, because information about an individual's genetic health risks may also apply to that person's children, parents, siblings, and other relatives.
One implication of this so-called "genetic exceptionalism" is that genetic research requires a heightened level of scrutiny compared with many other types of biomedical research. Several measures exist to help provide this level of scrutiny, at least when it comes to traditional medical research. Specifically, a law called the Privacy Rule, implemented as part of the Health Insurance Portability and Accountability Act HIPAA in April , established federal regulations for the use and disclosure of protected health information.
Although the intention of these regulations was to further protect every individual's private medical information, the Privacy Rule has had an unforeseen negative impact on clinical, epidemiological, and genetic studies. Specifically, by complying with Privacy Rule regulations, research study offices incur significant cost increases Armstrong et al.
In addition, HIPAA restrictions on researchers have limited their ability to perform retrospective, chart-based research, as well as to prospectively evaluate patients through follow-up. For example, before the Privacy Rule, the Cardiovascular Center of the University of Michigan had established a registry of patients to be contacted at certain intervals so doctors could learn more about their treatment outcomes for acute coronary syndrome.
Initially, patients were contacted by phone and interviewed after giving their verbal consent. After the Privacy Rule went into effect, however, consent forms had to be mailed to eligible patients, and only those individuals who returned the forms could be contacted by phone for the interview. This change in policy resulted in a reduction in consent for follow-up from The Privacy Rule regulations also introduced selection bias in data collection, because only a subset of patients responded to mailed requests for review of their medical materials Armstrong et al.
In a national survey of clinical epidemiologists in , the HIPAA Privacy Rule was perceived to have a substantial, negative influence on health research involving human subjects, often adding uncertainty, cost, and delay Ness, What is most frustrating to researchers is the absence of evidence that such regulations are making patient records more secure.
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Also problematic is the fact that the rules apply to any sample or record, even archived samples in which the patient or surviving family members may be impossible to track down for consent. What might be the cost to society of the studies that are not being conducted because of such hurdles to obtaining research material?
And what is the most economical and fair way to protect an individual's privacy while meeting the public's need for better research-based medicine? The future challenge for policy makers lies in finding a solution that strikes an equitable balance between these two questions. Armstrong, D. Archives of Internal Medicine , — Ness, R.
Journal of the American Medical Association , — Bioethics in Genetics. Genetic Inequality: Human Genetic Engineering. Questionable Prognostic Value of Genetic Testing. Human Subjects and Diagnostic Genetic Testing. Prenatal Screen Detects Fetal Abnormalities. Legislative Landmarks of Forensics: California v. Greenwood and Shed DNA. Calculation of Complex Disease Risk. Gene Therapy.
Disability agency urges crackdown on prenatal genetic testing
Personalized Medicine: Hope or Hype? Pharmacogenetics, Personalized Medicine, and Race. Pharmacogenomics and Personalized Medicine. Medical Careers: Genetic Screening and Diagnostics. Genomics could enable the misuse and abuse of our most personal information. Aa Aa Aa.
When launched in , the Human Genome Project was heralded as a scientific endeavor that would provide answers to some of the most vexing questions about how genetic makeup influences human health. However, beyond the unquestionable benefits of the project, planners also foresaw the potential for misuse of genetic information. The group still exists today, and it has a diverse membership that includes genome scientists; medical geneticists; law, ethics, and philosophy experts; and consumers.
Guide Genetic Testing: Scientific Background for Policymakers
The ELSI Working Group sponsors research programs related to a number of areas, including genetic counseling , privacy, discrimination, education, and intellectual property. The group is also committed to exploring and proposing options for the development of sound professional and public policies related to human genome research and its applications. Among the most important of these proposals are those that involve legal protection of people's genetic information. Are Fears of Genetic Discrimination Justified?
Protecting Your Genetic Identity: GINA and HIPAA
Genetic discrimination? The Cost of Protecting Genetic Information.
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