Genetic+Information+as+Personal+Property

=**Introduction**=

toc [|DNA] is the basic code of life that determines everything from appearance to certain health characteristics. The popularity of genetic testing increases as the technology to sequence genomes advances. There is easier access to genetic testing as direct-to-customer companies provide cheaper services. Insurance companies, forensic scientist, civilians, and researchers have a valid use for this information and sharing it makes advancements more possible. The legal property of this information is controversial because of the concerns that the public has about its misuse [10]. There are some laws and regulations in place, but all concern yet to be alleviated from the public [16]. The government legislature is rooted by the implementation of the Genetic Information Nondiscrimination Act. More legislation and regulation has since been implemented, yet there is still no concise owner of the information contained within DNA.

=**Applications**=

[[image:scienceandsociety3030/genetic_testing (1).jpg width="339" height="339" align="right" caption="source: (NIH GDS Policies 2017)"]]**Research and Development**
Genetic information is used in cancer research [4],[19], the development of new treatments for genetic diseases, understanding [|SNPs][4], [|CRISPR-Cas9] use, and many other applications. The sharing of information is important to facilitate developments in these areas[19]. Protection to individuals participating in research needs to be granted in order to encourage participation. Having transparency in the uses of genetic information by various individuals, organizations, and corporations is necessary for the continued participation in research.

**Health Insurance**
Health insurance companies could benefit from using genetic information in [|primary risk assessment]. This would allow for more accurate assessment, yet would not replace current risk assessment procedures[8]. The use of genetic information would only act a supplement to current procedures. If insurance companies were able to legally gain access to genetic information, they are still restricted from using that information for any sort of discrimination. The [|Genetic Information Nondiscrimination Act] provides these protections to individuals in order to ensure privacy[8]. Insurance companies like [|JRC Insurance Group] say in regards to getting genetic testing, “you could put that money to better use- perhaps with life insurance.[13]” There is still an understanding that this information could be used in a negative way, but currently, the norm adopted by insurance companies is to not use genetic information[8].

**Forensic Science**
Genetics have been used in forensic science since the discovery of DNA. The technology being used is rapidly advancing and now extends to [|massively parallel sequencing], [|molecular autopsies], and [|microbial forensics][2]. In order for this technology to develop further, information sharing is needed. Large genetic databases are what facilitate advancement and accuracy in forensic science and investigations[5]. There must be careful consideration of human rights and granted privacy in order for this technology to be used. The investigations must take place within legal restrictions but can also be granted protections and exemption in order to ensure accurate invitations.

**Direct-to-Customer Services**
Direct-to-customer genetic testing is increasing in popularity[8]. Aside is a picture of the kit provided by [|23andMe] to the customer to collect a DNA sample for testing. These companies provide information on family history, heritage, and genetic health-related diseases[20] based off of the interpretation of the DNA sample. These companies require consent before releasing any information for research. With the increase in popularity, comes more information that could be shared among researchers in order to facilitate development[16].

=**Regulation**=

**Gene Patenting**
Gene patenting is an important issue because researchers want to protect their intellectual property in the work that they have done[3]. Like any other patent, a gene patent is granted to the party who identified a specific DNA sequence. The owner then has complete dictation over the use of the gene. This became an issue when patents on specific segments of DNA hindered the research by the scientist who did not own the patent. Because of this problem, the Supreme Court of the United States was presented with the case of the [|Association for Molecular Pathology v. Myriad Genetics, Inc]. The decision made by the court was that if a DNA segment has been altered in some way, then a patent may be granted[3]. This manipulated DNA, otherwise known as [|cDNA] allows for researchers to protect their intellectual property without infringing on the research of others[3].

**NIH Genomic Data Sharing Policy**
In order to promote effective research, the [|NIH Genomic Data Sharing Policy] was instated in August 2014[9]. The sharing of information is incredibly beneficial in the advancements that come from a better understanding of genetics. Prior to the NIH GDSP, genetic information and databases were not regulated by a sharing policy, and thus the research that began preceding the NIH Genomic Data Sharing Policy will still operate under prior regulations[9].

**Genetic Information Nondiscrimination Act (GINA)**
The [|Genetic Information Nondiscrimination Act] provides protection to public from [|genetic discrimination] in regards to health insurance and employment[14]. This means that a health insurer is not allowed to demand genetic information that may lead to decisions regarding “eligibility, premiums, contribution amounts, or coverage terms[6].” This law extends to cover the use of genetic test results that may have revealed a genetic disease or family history. Additionally, GINA protects individuals from genetic discrimination by potential or current employers[6]. This means that genetic information is not a valid justification for any changes made to a person’s employment including firing, hiring, or promotion. This law also makes it illegal for an employer to increase or decrease pay because of your genetic information[6].

**Common Rule and the FDA**
Otherwise known as The Federal Policy for the Protection of Human Subjects, the [|Common Rule] provides protection to the public by requiring consent from a participant before any information can be used for research[14]. This rule applies to federally funded research projects. Consent is also required by the Food and Drug Administration under similar specifications to the Common Rule laws[14]. Federally and individually funded research projects require the participants to be informed about the potential uses and risk associated with the research. These laws help to ensure the privacy of participants in research from having their information being used negatively against them[14].

**Health Insurance Portability and Accountability Act**
In regards to personally identifiable health information, like someone’s genome, the [|Health Insurance Portability and Accountability Act] (HIPAA) protects against it being shared. This information is confidential within the entity by which it is held and it may not be disclosed without explicit consent[14].

**Certificates of Confidentiality (CoC)**
Since genetic information can be linked to identifiable characteristics such as a name, it becomes protected by [|CoC] when granted. Similar to the HIPAA, CoC protects against the disclosure of identifiable information when relating to research. The [|National Institute of Health] (NIH) issues these certificates and grant them to investigators and researchers. Certificates of Confidentiality help to protect investigators from having to disclose information about suspects, thus protecting the investigations. This protection extends to all levels of proceedings including “federal, state, and local levels[14].” Having this protection increases the public will to participate in research, thus promoting advancements in science and technology[14].

**Freedom of Information Act (FOIA)**
[|The Freedom of Information Act] was instated to provide transparency and grant the right to the public to view federal agency records[17]. There are exemptions to the Freedom of Information Act that help to protect against the exploitation of genetic information. The withholding of information in regards to medical files or law enforcement records, including genetic information, is allowed under the exemptions[17].

=**Controversy**=

There is significant concern about the negative use of genetic information for non-health-related reasons among the public[1]. This creates issues with research and development because people could be refusing to participate[15]. There is a lot of support for anti-discrimination laws[11], and GINA has helped to alleviate concern over the misuse of genetic information. Another concern is held within the market of exchanging genetic databases for money. If a direct-to-customer company were to go bankrupt, they would be able to sell their databases. People are concerned that insurance companies might buy this information, which could lead to it being used against them. A similar case happened in 2009 when the direct-to-customer company, deCODE[7], filed for bankruptcy. [|Amgen] bought the rights to the database for research use. This specific case helps to dismiss some public concern about the selling of genetic information.

=**Conclusion**=

There is significant regulation over the legal use of genetic information[8]. GINA protects against genetic discrimination. Other laws such as the FOIA, CoC, and NIH GDSP help to protect the privacy of citizens, especially when participating in research[12]. There is still concern from the public that their genetic information may be used against them, however. Direct-to-customer genetic testing companies, insurance companies, and researchers are attempting to increase the information given to the customer in order to help reduce concern. Reducing concern is an ongoing process that takes significant commitment, yet will be important to promote research and development. There are still questions about the legality of using genetic information in regards to health insurance, and there will continue to be cases for and against it as the popularity of testing continues to increase.

= References =

[1] AlmelingR, KushnerGadarianS. Publicopiniononpolicyissuesingeneticsandgenomics. JournalofGeneticsinMedicine. 2013 Nov 7.

[2] BudowleB, SchmedesSE, WendtFR. Increasingthereachofforensicgeneticswithmassivelyparallelsequencing. ForensicScience, MedicineandPathology. 2017.

[3] Cangenesbepatented? - GeneticsHomeReference. U.S. NationalLibraryofMedicine. 2017 Jun 13 [accessed 2017 Jun 14]. []

[4] CancerStatistics. NationalCancerInstitute. [accessed 2017 Jun 28]. []

[5] EgaliteN, GroismanIJ, GodardB. GeneticCounselingPracticeinNextGenerationSequencingResearch: ImplicationsfortheEthicalOversightoftheInformedConsentProcess. JournalofGeneticCounseling. 2014;23(4):661–670.

[6] GINAhelp.org - YourGINAResource. GINAhelp.org - YourGINAResource. [accessed 2017 Jun 28]. []

[7] HirschlerB. AmgenbuysIcelandicgenehunterDecodefor $415 million. Reuters. 2012 Dec 10 [accessed 2017 Jun 28]. []

[7a.] Informed Consent for Genomics Research. National Human Genome Research Institute (NHGRI). 2016 Jun 14 [accessed 2017 Jul 5]. https://www.genome.gov/27026588/informed-consent-for-genomics-research/

[8] JolyY, BurtonH, et. al. Lifeinsurance: genomicstratificationandriskclassification. EuropeanJournalofHumanGenetics. 2012 [accessed 2017 Jun 21].

[9] NIH GDS Policies. National Institutes of Health. 2017 Apr 14 [accessed 2017 Jul 5]. https://osp.od.nih.gov/scientific-sharing/policies/

[10] OconnorJ, MatthewsG. InformationalPrivacy, PublicHealth, andStateLaws. AmericanJournalofPublicHealth. 2011;101(10):1845–1850.

[11] OwnershipofGeneticInformation. GeneticsGeneration. 2015 [accessed 2017 Jun 14]. http://knowgenetics.org/ownership-of-genetic-information/

[12] ParkmanAA, FolandJ, AndersonB, DuquetteD, SobotkaH, LynnM, NottinghamS, DotsonWD, KolorK, CoxSL. PublicAwarenessofGeneticNondiscriminationLawsinFourStatesandPerceivedImportanceofLifeInsuranceProtections. JournalofGeneticCounseling. 2014;24(3):512–521.

[13] PendellC. DoesGeneticTestingAffectLifeInsurance? BestTermPlansforLifeInsurance – JRCInsuranceGroupheaderimage. 2017 Apr 12 [accessed 2017 Jun 14]. https://www.jrcinsurancegroup.com/does-genetic-testing-affect-life-insurance/

[14] PrivacyinGenomics. NationalHumanGenomeResearchInstitute (NHGRI). 2015 Apr 21 [accessed 2017 Jun 14]. https://www.genome.gov/27561246/privacy-in-genomics/

[15] RothsteinMA. CurrentsinContemporaryBioethics: TheCaseagainstPrecipitous, Population-Wide, Whole-GenomeSequencing. JournalofLaw, MedicineandEthics 40.3. 2012 [accessed 2017 Jun 15]:682–689.

[16] ScottSL. IAmNotSockButMightBeLater: PersonalGenomeSequencingandEthicalObligationsforLawyers. GeorgetownJournalofLegalEthics 26.4. 2013 [accessed 2017 Jun 15]:979–996.

[17] TheFreedomofInformationAct. U.S. DepartmentofState. 2016 Jan 11 [accessed 2017 Jul 5]. https://foia.state.gov/Learn/FOIA.aspx

[18] TunaM, AmosC. Genomicsequencingincancer. CancerLetters. 2013;340(2):161–170.

[19] ZukermanW. Geneticdiscriminationintheworkplace: towardslegalcertaintyinuncertaintimes. JournalofLawandMedicine. 2009 May [accessed 2017 Jun 27]:770–788.

[20] 23andMe. DNAGeneticTesting&Analysis. 23andMe. 2017 [accessed 2017 Jun 14]. https://www.23andme.com/about/consent/

[21] 23andMe. 23andMe - 23andMe added a new photo. 2014 Nov 10 [accessed 2017 Jul 9]. https://www.facebook.com/23andMe/photos/a.10150582352627802.467371.13372817801/10153266268287802/?type=3&theater