Genetic policy of the United States

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Genetic testing is the analysis of human genes, proteins, and certain metabolites, in order to detect inherited disease-related propensities. These tests can predict the risk of disease in adults, as well as establish prenatal and infant prognoses. [1] The benefits can be substantial, but so can the risks. The possible adverse consequences of genetic tests include discrimination in employment and health insurance and breaches of privacy. Government policies are therefore needed to assure the proper use of genetic tests. The first piece of federal legislation came into effect in 2000.

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A second federal law, the Genetic Information Nondiscrimination Act (GINA), has two parts. Title I prohibits genetic discrimination in health insurance. Title II prohibits employment discrimination. [2]

Federal legislation

The first of two pieces of federal legislation to directly address the use of genetic information in the United States was the Executive Order Protecting Federal Employees. Signed into law by U.S. President Bill Clinton on February 8, 2000, the Executive Order prohibited all federal agencies and departments from using genetic information to discriminate in the hiring or promoting of federal employees. The Executive Order was endorsed by the American Medical Association, the American College of Medical Genetics, the National Society of Genetic Counselors, and the Genetic Alliance. The Executive Order also provided explicit genetic privacy regulations within the federal government. [3]

The second piece of federal legislation to address the use of genetic information and discrimination in the United States was the Genetic Information Nondiscrimination Act (GINA) of 2008. GINA protects U.S. citizens from genetic discrimination in employment as well as in health care and health insurance. The bill was signed into law on May 21, 2008 by President George W. Bush. Prior to the introduction of GINA in 2003, several bills of similar intent were introduced: the Genetic Privacy and Nondiscrimination Act of 1995, [4] the Genetic Fairness Act of 1996, [5] the Genetic Information Nondiscrimination in Health Insurance Act of 1995 [6] and the Genetic Confidentiality and Nondiscrimination Act of 1996. [7]

GINA laws do not protect people from genetic discrimination in every circumstance. It does not apply when an employer has fewer than 15 employees. It does not cover people in the U.S. military or those receiving health benefits through the Veterans Health Administration or Indian Health Service. GINA also does not protect against genetic discrimination in forms of insurance other than health insurance, such as life, disability, or long-term care insurance. [8]

State legislation

Currently, legislation pertaining to the use of genetic information and genetic discrimination at the state level varies by state. The first state laws regarding genetic information were typically designed to prohibit genetic discrimination, including prohibiting employers from demanding workers and applicants to provide genetic information as a condition of their employment. More recent laws have permitted individuals to undergo genetic testing when that individual is filing a compensation claim or has requested the test to demonstrate susceptibility to potentially toxic substances. [3]

See also

Related Research Articles

<span class="mw-page-title-main">Genetic testing</span> Medical test

Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or through biochemical analysis to measure specific protein output. In a medical setting, genetic testing can be used to diagnose or rule out suspected genetic disorders, predict risks for specific conditions, or gain information that can be used to customize medical treatments based on an individual's genetic makeup. Genetic testing can also be used to determine biological relatives, such as a child's biological parentage through DNA paternity testing, or be used to broadly predict an individual's ancestry. Genetic testing of plants and animals can be used for similar reasons as in humans, to gain information used for selective breeding, or for efforts to boost genetic diversity in endangered populations.

Medical privacy, or health privacy, is the practice of maintaining the security and confidentiality of patient records. It involves both the conversational discretion of health care providers and the security of medical records. The terms can also refer to the physical privacy of patients from other patients and providers while in a medical facility, and to modesty in medical settings. Modern concerns include the degree of disclosure to insurance companies, employers, and other third parties. The advent of electronic medical records (EMR) and patient care management systems (PCMS) have raised new concerns about privacy, balanced with efforts to reduce duplication of services and medical errors.

<span class="mw-page-title-main">Anti-discrimination law</span> Legislation designed to prevent discrimination against particular groups of people

Anti-discrimination law or non-discrimination law refers to legislation designed to prevent discrimination against particular groups of people; these groups are often referred to as protected groups or protected classes. Anti-discrimination laws vary by jurisdiction with regard to the types of discrimination that are prohibited, and also the groups that are protected by that legislation. Commonly, these types of legislation are designed to prevent discrimination in employment, housing, education, and other areas of social life, such as public accommodations. Anti-discrimination law may include protections for groups based on sex, age, race, ethnicity, nationality, disability, mental illness or ability, sexual orientation, gender, gender identity/expression, sex characteristics, religion, creed, or individual political opinions.

A genetic predisposition is a genetic characteristic which influences the possible phenotypic development of an individual organism within a species or population under the influence of environmental conditions. In medicine, genetic susceptibility to a disease refers to a genetic predisposition to a health problem, which may eventually be triggered by particular environmental or lifestyle factors, such as tobacco smoking or diet. Genetic testing is able to identify individuals who are genetically predisposed to certain diseases.

The Council for Responsible Genetics (CRG) was a nonprofit NGO with a focus on biotechnology.

Genetic discrimination occurs when people treat others differently because they have or are perceived to have a gene mutation(s) that causes or increases the risk of an inherited disorder. It may also refer to any and all discrimination based on the genotype of a person rather than their individual merits, including that related to race, although the latter would be more appropriately included under racial discrimination. Some legal scholars have argued for a more precise and broader definition of genetic discrimination: "Genetic discrimination should be defined as when an individual is subjected to negative treatment, not as a result of the individual's physical manifestation of disease or disability, but solely because of the individual's genetic composition." Genetic Discrimination is considered to have its foundations in genetic determinism and genetic essentialism, and is based on the concept of genism, i.e. distinctive human characteristics and capacities are determined by genes.

<span class="mw-page-title-main">Equal employment opportunity</span> Protection of US employees from types of employment discrimination

Equal employment opportunity is equal opportunity to attain or maintain employment in a company, organization, or other institution. Examples of legislation to foster it or to protect it from eroding include the U.S. Equal Employment Opportunity Commission, which was established by Title VII of the Civil Rights Act of 1964 to assist in the protection of United States employees from discrimination. The law was the first federal law designed to protect most US employees from employment discrimination based on that employee's race, color, religion, sex, or national origin.

Employment discrimination law in the United States derives from the common law, and is codified in numerous state, federal, and local laws. These laws prohibit discrimination based on certain characteristics or "protected categories." The United States Constitution also prohibits discrimination by federal and state governments against their public employees. Discrimination in the private sector is not directly constrained by the Constitution, but has become subject to a growing body of federal and state law, including the Title VII of the Civil Rights Act of 1964. Federal law prohibits discrimination in a number of areas, including recruiting, hiring, job evaluations, promotion policies, training, compensation and disciplinary action. State laws often extend protection to additional categories or employers.

<span class="mw-page-title-main">Executive Order 13087</span>

Executive Order 13087 was signed by U.S. President Bill Clinton on May 28, 1998, amending Executive Order 11478 to prohibit discrimination based on sexual orientation in the competitive service of the federal civilian workforce. The order also applies to employees of the government of the District of Columbia, and the United States Postal Service. However, it does not apply to positions and agencies in the excepted service, such as the Central Intelligence Agency, National Security Agency, and the Federal Bureau of Investigation.

<span class="mw-page-title-main">Genetic Information Nondiscrimination Act</span>

The Genetic Information Nondiscrimination Act of 2008, is an Act of Congress in the United States designed to prohibit some types of genetic discrimination. The act bars the use of genetic information in health insurance and employment: it prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future, and it bars employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions. Senator Ted Kennedy called it the "first major new civil rights bill of the new century." The Act contains amendments to the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code of 1986.

A protected group, protected class (US), or prohibited ground (Canada) is a category by which people qualified for special protection by a law, policy, or similar authority. In Canada and the United States, the term is frequently used in connection with employees and employment and housing. Where illegal discrimination on the basis of protected group status is concerned, a single act of discrimination may be based on more than one protected class. For example, discrimination based on antisemitism may relate to religion, ethnicity, national origin, or any combination of the three; discrimination against a pregnant woman might be based on sex, marital status, or both.

Jeremy Gruber is a lawyer, writer, and public policy advocate and is the senior vice president at Open Primaries. He is the former President and Executive Director of the Council for Responsible Genetics. He has testified before the United States Congress on genetic privacy and discrimination issues. He was a leader of the successful effort to enact the Genetic Information Nondiscrimination Act as well as a number of state laws that preceded it and led the successful campaign to roll back a controversial student genetic testing program at the University of California, Berkeley. In 2011, Gruber led an effort to successfully enact CalGINA-a California law that extends genetic privacy and nondiscrimination protections into areas such as life, long term care, and disability insurance, mortgages, elections and other areas.

<span class="mw-page-title-main">LGBT rights in Montana</span>

Lesbian, gay, bisexual, and transgender (LGBT) persons in the U.S. state of Montana may face some legal challenges not experienced by non-LGBT residents. Same-sex sexual activity has been legal in Montana since 1997. Same-sex couples and families headed by same-sex couples are eligible for all of the protections available to opposite-sex married couples, as same-sex marriage has been recognized since November 2014. State statutes do not address discrimination on the basis of sexual orientation and gender identity; however, the U.S. Supreme Court's ruling in Bostock v. Clayton County established that employment discrimination against LGBT people is illegal under federal law. A number of cities also provide protections in housing and public accommodations.

<span class="mw-page-title-main">LGBT rights in Oklahoma</span>

Lesbian, gay, bisexual, and transgender (LGBT) persons in the U.S. state of Oklahoma may face some legal challenges not experienced by non-LGBT residents. Same-sex sexual activity is legal in Oklahoma as a result of the U.S. Supreme Court decision in Lawrence v. Texas, although the state legislature has not repealed its sodomy laws. Both same-sex marriage and adoption by same-sex couples have been permitted since October 2014. State statutes do not prohibit discrimination based on sexual orientation or gender identity; however, the U.S. Supreme Court's ruling in Bostock v. Clayton County established that employment discrimination against LGBT people is illegal. This practice may still continue, as Oklahoma is an at-will employment state and it is still legal to fire an employee without requiring the employer to disclose any reason.

<span class="mw-page-title-main">LGBT employment discrimination in the United States</span>

LGBT employment discrimination in the United States is illegal under Title VII of the Civil Rights Act of 1964; employment discrimination on the basis of sexual orientation or gender identity is encompassed by the law's prohibition of employment discrimination on the basis of sex. Prior to the landmark cases Bostock v. Clayton County and R.G. & G.R. Harris Funeral Homes Inc. v. Equal Employment Opportunity Commission (2020), employment protections for LGBT people were patchwork; several states and localities explicitly prohibit harassment and bias in employment decisions on the basis of sexual orientation and/or gender identity, although some only cover public employees. Prior to the Bostock decision, the Equal Employment Opportunity Commission (EEOC) interpreted Title VII to cover LGBT employees; the EEOC determined that transgender employees were protected under Title VII in 2012, and extended the protection to encompass sexual orientation in 2015.

Genetic privacy involves the concept of personal privacy concerning the storing, repurposing, provision to third parties, and displaying of information pertaining to one's genetic information. This concept also encompasses privacy regarding the ability to identify specific individuals by their genetic sequence, and the potential to gain information on specific characteristics about that person via portions of their genetic information, such as their propensity for specific diseases or their immediate or distant ancestry.

Elective genetic and genomic testing are DNA tests performed for an individual who does not have an indication for testing. An elective genetic test analyzes selected sites in the human genome while an elective genomic test analyzes the entire human genome. Some elective genetic and genomic tests require a physician to order the test to ensure that individuals understand the risks and benefits of testing as well as the results. Other DNA-based tests, such as a genealogical DNA test do not require a physician's order. Elective testing is generally not paid for by health insurance companies. With the advent of personalized medicine, also called precision medicine, an increasing number of individuals are undertaking elective genetic and genomic testing.

DNA encryption is the process of hiding or perplexing genetic information by a computational method in order to improve genetic privacy in DNA sequencing processes. The human genome is complex and long, but it is very possible to interpret important, and identifying, information from smaller variabilities, rather than reading the entire genome. A whole human genome is a string of 3.2 billion base paired nucleotides, the building blocks of life, but between individuals the genetic variation differs only by 0.5%, an important 0.5% that accounts for all of human diversity, the pathology of different diseases, and ancestral story. Emerging strategies incorporate different methods, such as randomization algorithms and cryptographic approaches, to de-identify the genetic sequence from the individual, and fundamentally, isolate only the necessary information while protecting the rest of the genome from unnecessary inquiry. The priority now is to ascertain which methods are robust, and how policy should ensure the ongoing protection of genetic privacy.

Privacy laws vary from state to state within the United States of America. Several states have recently passed new legislation that adapt to changes in cyber security laws, medical privacy laws, and other privacy related laws. State laws are typically extensions of existing United States federal laws, expanding them or changing the implementation of the law.

The Genetic Non-Discrimination Act of 2017, also known as Bill S-201 during the 2nd Session of the 41st Parliament of Canada and the 1st Session of the 42nd Parliament of Canada, originated in a Private Member's Bill. It was introduced by Senators James Cowan and Jennifer O'Connell. The Act was designed to prevent, on the basis of genetics, discrimination which might "come in the form of unfair insurance practices, being passed over for a promotion, and even being fired. Unfortunately, there are a number of documented cases of genetic discrimination in Canada."

References

  1. Holtzman, N. A.; Shapiro, D. (1998). "Genetic testing and public policy". BMJ (Clinical Research Ed.). 316 (7134): 852–856. doi:10.1136/bmj.316.7134.852. PMC   1112777 . PMID   9549463.
  2. "What is genetic discrimination?" . Retrieved 14 January 2017.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 Genetics Legislation
  4. Genetic Privacy and Nondiscrimination Act of 1995 (1995; 104th Congress S. 1416) - GovTrack.us
  5. ""Genetic Fairness Act of 1996" - Bills - VoteReports". Archived from the original on 2012-07-27. Retrieved 2012-05-08.
  6. Genetic Information Nondiscrimination in Health Insurance Act of 1995 (1995; 104th Congress H.R. 2748) - GovTrack.us
  7. Genetics & Public Policy Center || GINA || About GINA || History
  8. "The GINA Legislation and Regulations" . Retrieved 14 January 2017.