So if genetic testing can be so beneficial, why is it ethically controversial? As President Bill Clinton once said, we must “recognize that this extraordinary march of human understanding imposes on us profound responsibilities, to make sure that the age of discovery can continue to reflect our most cherished values” ("President Clinton 's Comments on the Signing," 2013). Because of its nature, genetic testing leads to a whole host of potential problems including genetic discrimination, the use of human subjects, informed consent from subjects, privacy concerns, regulation of genetic tests, and intellectual property concerns ("Issues in Genetics," 2016). Some of these problems have already been addressed through legislation, while others have
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The field of genomics has greatly enhanced many experiments and the wealth of knowledge we have relating to certain hereditary diseases and other genetic matters. However, there must be regulations in place to protect human subjects. The main regulation in place stems through the Federal Policy for the Protection of Human Research Subjects, or the Common Rule (Code of Federal Regulations, Title 45, Part 46). According to the NIH website, the Common Rule “establishes rights and protections for participants in research, including an independent review of each research proposal and requires the active, informed, consent of participants” (Citation). Informed consent from a human subject is crucial because people need to understand that genetic tests may lead to any of the following: information about a broad range of conditions, some of which may be unexpected, the storage and use of genetic tests and results indefinitely, unknown risks associated with genetic testing itself, and privacy …show more content…
It is extremely important to keep genetic testing safe for the participants, and the best way to accomplish this is through putting in place regulations. Three federal agencies play a role in the regulation of genetic tests: CMS, FDA, and the FTC, each providing different levels of oversight to different types of genetic tests (Citation). The Center for Medicaid Services (CMS) regulates clinical labs through the Clinical Laboratory Improvement Amendments of 1988. This puts in place educational requirements for lab technicians, quality control of lab processing, and proficiency testing for lab staff. Though CLIA, research participants are ensured that the lab they are tested in will be safe and managed by people who know what they are
The field of genomics has greatly enhanced many experiments and the wealth of knowledge we have relating to certain hereditary diseases and other genetic matters. However, there must be regulations in place to protect human subjects. The main regulation in place stems through the Federal Policy for the Protection of Human Research Subjects, or the Common Rule (Code of Federal Regulations, Title 45, Part 46). According to the NIH website, the Common Rule “establishes rights and protections for participants in research, including an independent review of each research proposal and requires the active, informed, consent of participants” (Citation). Informed consent from a human subject is crucial because people need to understand that genetic tests may lead to any of the following: information about a broad range of conditions, some of which may be unexpected, the storage and use of genetic tests and results indefinitely, unknown risks associated with genetic testing itself, and privacy …show more content…
It is extremely important to keep genetic testing safe for the participants, and the best way to accomplish this is through putting in place regulations. Three federal agencies play a role in the regulation of genetic tests: CMS, FDA, and the FTC, each providing different levels of oversight to different types of genetic tests (Citation). The Center for Medicaid Services (CMS) regulates clinical labs through the Clinical Laboratory Improvement Amendments of 1988. This puts in place educational requirements for lab technicians, quality control of lab processing, and proficiency testing for lab staff. Though CLIA, research participants are ensured that the lab they are tested in will be safe and managed by people who know what they are