Genetic Mapping and Its Social, Ethical, and Legal Implications Research Paper

Introduction

The ongoing progress in the field of biology and medicine appears to have a significant effect on the most fundamental principles of the society’s functioning in terms of providing perspectives for genome research. However, Greely pointed out that “the science of DNA, when applied to humans rather than bacteria or fruit flies, immediately suggested many and varied applications to human affairs.” This statement is also related to the practice of genetic mapping that has many legal, ethical, and social implications, which are capable of altering the essence of developmental dynamics within the society. The purpose of this paper is to analyze what social, ethical, and legal implications DNA mapping can have in the context of the current progress of genome research.

It is important to start the analysis by defining DNA mapping and its purpose. The full set of deoxyribonucleic acid (DNA) is known as a genome. The nucleus of any cell in a body includes DNA. Furthermore, two sets of chromosomes can be found in the nucleus. Forty-six chromosomes are observed, and each of them contains a DNA strand. Genetic or DNA mapping is the process of “assigning genes to specific chromosomes.” Thus, “genetic linkage maps determine where one genetic locus is relative to another based on how often they are inherited together.” In efforts to study the organization of human DNA, the Human Genome Project (HGP) was created. The HGP was designed as an international research project to unite the efforts of researchers and create a complete map related to the human genome. The decoding process included three stages: the sequence of nitrogenous bases representing DNA was determined; maps of locations of genes and chromosome sections were created, and the linkage maps to determine inherited traits were designed.

The HGP and the International HapMap have also launched the International HapMap Project in efforts to enhance the study of specific genes that can be related to common diseases. The HGP and the HapMap Project contributed to developing more genetic research, and the number of patent applications also increased. However, some countries chose to limit gene patents “as a way to minimize the negative impact on health care costs and the free flow of information in research.” Thus, in the United States, thousands of patents on genes and patents concerning the genetic material were issued. Still, the US government enacted the America Invents Act (AIA) in 2011, and the number of gene patents was decreased, but this law failed to outline particular effective regulations for gene patents.

Although the knowledge about the structure of DNA and composing genes will potentially lead to the development of efficient procedures in research, diagnosing, management, and prevention of illnesses, DNA mapping is associated with certain ethical, social, and legal issues that need to be taken into account and addressed. Cook-Deegan stated that “by studying a single genetic form of a disease, the hope is to find the gene causing the disease,” and “knowing the precise molecular defect suggests the possibility of ultimately fixing the gene, replacing the mutant form with a normal copy or merely adding a normal copy via gene therapy.” As a result, DNA mapping is viewed as an important process to contribute to medicine and healthcare if all associated implications are appropriately addressed.

Genetic Mapping Social and Ethical Implications

Social Implications

Whatever scientific benefits the society may achieve by mapping the human genome, the practice itself is a matter of profound social significance. Since humankind suffers from more than 3,000 inherited diseases, mapping the human genome could provide new knowledge regarding the genetic basis of human diseases. Thus, the possibility to determine specific genes responsible for the development of a disease can have a significant effect on diagnosing, managing, and preventing genetic disorders. The DNA-based diagnosis will develop depending on isolating more unique genes related to diseases. As a consequence, it will be possible to identify the probability of developing genetic defects in newborns. Thus, the prenatal diagnosis of genetic disorders will further improve concerning DNA mapping and analysis.

Also, investigations of risks related to occupational and environmental factors leading to certain disorders will develop because DNA mapping allows for stating whether people have some gene defects to provoke common diseases. Thus, “common diseases, such as cancer and diabetes, have complex causes that could be the result of base sequence changes on several genes encompassing several chromosomes.” As a result, from this point of view, it is important to support genetic mapping to guarantee that these diseases will be effectively treated or even avoided in the future. These were the primary goals of the HGP and the HapMap Project that provided vivid perspectives for researchers, scientists, and healthcare providers regarding the management of common illnesses.

On the other hand, the problem is that although genetic mapping has potential benefits for healthcare, careful interpretation is required as people can lack understanding of what it means that a particular gene is responsible for a disease they have. These people need guidance on how to interpret information on genetic markers and clinical diseases. The social issue associated with this aspect is that misinterpretations and manipulations of information regarding genetic construction can negatively affect people’s identities because diagnoses linking diseases and genes can contribute to developing social stigmatization and prejudice. In this case, the information about genes does not contribute to a persons’ welfare, but it only makes him or her rather vulnerable under certain conditions.

Furthermore, another social problem that may be a consequence of genetic mapping the use of this information by certain members of society. For example, insurance companies may use genetic mapping information to identify individuals who are “occupational or insurance risks” for them. As Greely points out, in the United States, discrimination in employment and insurance are key constraints associated with genetic testing. Thus, according to Greely, employers and insurance companies use genetic information about individuals to make decisions. Moreover, there are some additional concerns related to whether “genetic tests and their follow-up procedures are made part of a “minimum benefit package” under national health insurance …, or should they be available only to those people who can pay for them with private funds?” Thus, people without health insurance or funds will not be able to benefit from the advances of DNA mapping when those who have funds can take advantage of the procedure more than the rest of society.

Moreover, genetic mapping makes it possible for individuals to be 100% sure about what accounts for their ancestral lineage, and they will be in the position to trace their “blood” deeply into the past because of the increased availability of “haplotype testing” currently performed on a commercial basis. The problem is that being provided with an opportunity to find out even the smallest details about ancestral origins, individuals will be likely to reconsider their current ethnocultural identity, which can subsequently affect their behavioral patterns. As Schaid noted, “individuals are… reshaping their identities and changing how they report race or ethnicity in varying contexts as a result of receiving their DNA ancestry test results”. This tendency will result in undermining the legitimacy of the “race” and “ethnicity” terms, and these categories will attract more attention to society and policymakers.

One more issue is that a person’s ability to act as the society’s member directly relates to the peculiarities of his or her genetic makeup. This aspect raises much concern about whether biotechnology of genetic mapping may be used to justify the enactment of racially discriminative laws. As Brewer argued, “there is a clear danger that in this process (DNA mapping), new biological categories may be linked to… existing socially constructed categories of race and ethnicity,” and in this context, “haplotype mapping thus presents the temptation to treat populations as genetically distinct, biologically defined racial groups.” This statement can explain why many people in the United States perceive the paradigm of genomic mapping as rather controversial.

Moreover, genetic mapping is actively used for different criminological purposes today, and this establishes the objective precondition for law enforcement agencies to utilize it as an instrument for exercising stricter control over citizens. According to Greely, “the possible value of DNA for forensic purposes has led to the creation of databases that could invade privacy”. Thus, the concern is about the practice’s potential capacity to serve as the tool of undermining people’s constitutionally guaranteed rights and freedoms. In this context, the use of genetic mapping in criminology gives rise to not only social but also ethical and legal issues and implications.

Ethical Implications

There are many ethical implications related to genetic mapping. For example, in the aftermath of having mapped the genome of a particular individual, researchers will be able to tell the extent of his or her susceptibility to a variety of diseases. On the one hand, this information can help a person address the problem. On the other hand, these findings can cause this person to experience emotional distress, especially if the identified genetic defects concern his or her children. As Wattanapitayakul and Schommer pointed out, “children are the most vulnerable population affected by the risks of genetic testing” because “the impact of testing results is primarily imposed on the children’s families, especially the parents, due to anxiety, guilt, psychological distancing, over-protectiveness, and financial investment for a child with a possibly limited life span”. As a result, the application of genetic mapping to different categories of the population is a controversial ethical question.

Additionally, genetic counseling, which is the “process whereby an individual or family obtains information about a real or possible genetic problem,” has been actively used in the United States for decades. This counseling is proposed to couples who are planning children, but they have a risk of transmitting a genetic defect to their child. Genetic counseling is also important for pregnant women who need to know the genetic status of their fetus, as well as for parents of newborns. However, according to Greely, this type of testing can also create “conflicts between an individual’s possible duty to disclose genetic risks to a potential partner and his or her privacy and protection from discrimination.” As a result, genetic counseling provokes ethically problematic decision-making regarding marriage and childbearing, as well as the selection of embryos or fetuses that will be allowed to survive birth.

This ethically controversial situation raises many questions related to whether parents should allow children with genetic defects to be born and whether selective abortions are appropriate in this case. Greely refers to the example of abortions for Tay-Sachs disease, “in which children inevitably die after short, unpleasant lives.” If these abortions are allowed, the question is whether abortions for infants with the potential of developing Alzheimer’s disease or with BRCA1 mutations can also be allowed. Thus, if genetic mapping, screening, and counseling are ethical, can abortions be also ethical in this case?

The other side of this question is the perception of the human biological material and fetuses or embryos as products. Possibilities to manipulate genetic patterns and order certain traits allow for speaking about ordering and purchasing children as products. According to Annas, in this specific context of the availability of DNA mapping, “people could view themselves and each other as products that can be “manufactured” and subject to quality control measures.” As a result, if people are viewed as molecules and genes arranged or organized in a specific manner and if their embryos can be manipulated with the help of biotechnological procedures, it is almost impossible to avoid significant ethical issues. This problematic situation creates the background for the development of one more ethical dilemma associated with the case of “frozen embryos and surrogate mothers” because “if children are seen as products, the purchase and sale of the resulting children themselves, not only embryos, may be seen as reasonable.” From this perspective, genetic mapping and the manipulation of genes and embryos can lead to a situation when children are chosen and sold or rejected because of their genetic pattern and potential for the development of certain expected traits.

Some other ethical questions about the appropriate use of genetic information concern the limits on the traits that parents choose for their children to have. The problem is that scientists and researchers cannot agree on how ethical it is for prospective parents to genetically modify their offerings. In this context, it is possible to speak about the problem of “parental eugenics” when parents can plan the birth and select traits and qualities of their children depending on genetic mapping. This type of genetic advantage provokes many ethics-related debates among researchers because of potential issues for the development of society. There is a risk that genetic mapping can lead to a situation when biologists decide to utilize this technology to enhance future generations physiologically and mentally using genetic manipulation. Such experiments are actively discussed, and Greely stated that “moving human DNA into non-human animals strikes some as a profanation of humanity; mixing DNA from non-human species can be perceived as a violation of a perceived natural order”. A negative consequence of such experiments is the violation of norms and rules regarding the usage and manipulation of the human biological material.

Another issue is the use of genetic mapping and related technologies as the instrument for generating a commercial profit. The rapid proliferation of “recreational” DNA mapping conducted by the privately-owned laboratories on a commercial basis, which has taken place during the last decade, substantiates the validity of this suggestion. There are no standardized federal regulations for handling the human biological material used in the DNA-identifying procedures. Thus, this creates many prerequisites for such material to be resold without the consent of its owners and to be disposed of disrespectfully. As a result, researchers and experts are inclined to consider genetic mapping as unethical in many situations.

The problem is that the nature of genomic research presupposes that its findings can be rather deterministic. Thus, practitioners related to DNA mapping tend to exaggerate the deterministic power of genes as the driving force of morphogenesis. Such tendency can be explained concerning the fact that the stronger the people’s belief in the body-shaping omnipresence of genesis, the more likely it will be for them to decide in favor of ordering a genetic map. However, in light of the most recent discoveries in the field of molecular biology, the ideational outlook on genes’ functionality appears largely erroneous. As Dutfield pointed out, “the widespread assumption – one shared by patent applicants, attorneys and examiners – that genes operate independently and perform single functions is now demonstrably false. Indeed, the “gene” itself is beginning to look like a rather shaky concept.” After all, a person’s sense of self-identity is reflective of how he or she perceives the surrounding social environment and its place in it.

This ethical concern is explained concerning a specific biological process. The intricacies of this perception are determined by the spatial structuring of the neocortex that is the product of morphogenesis. What this means is that the formation of the brain in an embryo is guided by the same set of principles as the formation of geometrically congruent dunes in the desert, as it is noted by Ramakrishnan. This particular aspect once again points out to the fact that the influence of genes on the development of one’s sense of self-identity is rather minor. However, people continue to pay much attention to their genes to explain certain psychological aspects of their personality, as well as cultural aspects of their identity, and social aspects of their living. These processes can lead to the inappropriate use of DNA mapping in those cases when DNA analysis and research can be avoided.

Legal Implications

Given the innovative nature of genetic mapping and the fact that more and more physicians, biologists, anthropologists, and criminologists use it in their practice, it will be appropriate to suggest that today biotechnology exerts an even stronger influence on the functioning of the country’s legal domain. As Cho and Sankar observed, “mapping and sequencing the human genome … raises questions concerning possible copyright protection of the data and ownership of the intellectual property.” The researchers also asked, “Should it be possible to copyright sequences from the human genome and, if so, by whom? Should a central agency of the government own the patents for new materials, such as DNA clones generated by this project?” Today, the country’s jurisprudential system cannot adequately address the exponential pace of progress in genetic science. Therefore, many private practitioners of genetic mapping were able to turn the concerned biotechnology into a commercially profitable procedure that thrives on because of the public’s lack of awareness regarding the actual significance of DNA-related data.

Legal issues are also associated with employment rights and insurance discrimination. Insurance companies are not interested in signing contracts with those individuals for whom genetic mapping indicates certain DNA defects. To address the situation, more than twenty US states enacted the laws to prevent insurers from trying to obtain genetic information about their clients and subsequently use it for medical underwriting. Still, these acts do not contain clear provisions regarding how insurance companies ought to treat those who have been identified as being at risk of developing genetically predetermined diseases. Furthermore, according to Greely, “it is not clear whether the Americans with Disabilities Act prohibits employment discrimination based on genetic characteristics … Federal law does not generally prohibit either medical underwriting or preexisting condition limitations.” Thus, it will be appropriate to suggest that the legal situation with the newly emerged biotechnology presupposes that the rise of DNA mapping will contribute towards preserving the discriminative ethos within the society.

The legitimation of genetic mapping as the instrument of gathering biomedical information will contribute to further commercialization of the healthcare sector in the United States. This aspect can be illustrated concerning the activities of DNA-research laboratories’ self-positioning as legal entities. Still, while collecting and distributing information of clinical importance, these laboratories claim that the services that they provide are “educational” or “recreational” – something that substantially reduces the measure of the affiliated researchers’ legal liability. As Wagner noted, “when a consumer purchases a DNA ancestry test, the consumer is often forfeiting or waiving legal rights regarding the substantive law that will govern any dispute involving the DNA ancestry company.” Therefore, it is more appropriate to refer to the appropriation of the genome-charting technologies by both governmental authorities and healthcare contractors. This procedure can work to undermine the systemic integrity of how health-related services are being delivered to end-users in this country. As a result, the emergence and sub-sequential proliferation of genome mapping technology create more potential for developing legal issues associated with healthcare and its commercialization in the United States.

Besides, the issue of genome-related patents should also be discussed in the context of legal implications. It became a common practice among the providers of genetic mapping services in the US to apply to be issued a patent on the deciphered DNA sequences that may have a commercial value. According to Greely, “patents issued on human DNA confer on the holder a monopoly on the right to use that invention for a limited amount of time, now usually 20 years from the date of the patent application.” When assessed from a legal perspective, such practice cannot be deemed appropriate. The “inventions” in question do not adhere to the classical definition of an invention as something that connotes the notions of novelty and utilitarian usefulness. Moreover, there also remains much uncertainty as to what qualifies a patent claimant to be considered the rightful owner of the biological material that has been DNA-sequenced. All these aspects call for the readjustment of the current law on genetic mapping to be consistent with the realities of the twenty-first century.

Current Laws on Genetic Mapping

When it comes to discussing how the practice of genetic mapping is regulated in the United States and around the world, it is important to mention the fact that there is still no clarity regarding the law’s stance on the issue. The problem is that “most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.” Two factors contribute towards inducing the described state of affairs: the comparative innovativeness of the concerning biotechnology and the fact that DNA mapping is used for “recreational” purposes. Each state has its regulations that apply to the practice in question. Nevertheless, the federal government tries to exercise the overall authority over these genetic tests. This function is delegated to both the Food and Drug Administration (FDA) and the Centre for Medicare and Medicaid Services (CMS). To be accredited by these organizations, a particular DNA laboratory must prove that its activities adhere to the validity principles.

The Clinical Laboratory Improvement Amendments introduced by CMS in 1988 specify all the related technical details. Furthermore, the FDA has its regulatory framework concerning DNA mapping that helps to control the work of laboratories, testing, and reporting. While conceptualizing the criteria for genomic tests to be considered valid, both organizations try to ensure that the process of DNA mapping complies with the Fourth Amendment, on the one hand, and the ownership-related provisions of American common law, on the other hand. According to the latter, “in the United States, competent adults are not legally able to exercise one of the prime characteristics of a property right for their organs: they are not allowed to sell them.” This situation creates a certain legal collision since the biological material used in DNA tests is not covered by these provisions. As a result, DNA mapping in the US continues to be performed without an effective legal basis.

The same problematic situation regarding the legal regulation of genome sequencing is also observed around the world. On the one hand, governmental authorities strive to take advantage of the newly emerged biotechnology. On the other hand, they recognize that allowing it to have a lot of legal significance would impair the society’s proper functioning. For instance, in France, even though the DNA-related data is allowed to be presented to the court during the paternity-confirmation hearings, judges tend to consider it legally insignificant, especially if there is an overall negative sentiment towards DNA testing in the area where these hearings take place. To be recognized legally binding, the DNA-based evidence must comply with the applicable judicial criteria in each case. For example, in the United Kingdom, judges demand that to be admitted to the court as incriminating evidence during a murder or rape trial, the blood sample of a suspected culprit must match the biological material concerning no fewer than 15 genetic markers. Still, most genetic investigations, especially the ones concerned with gaining insights into one’s ancestral history, do not involve more than three markers.

Consequently, ineffective legal regulations related to genetic mapping in the United States and globally contribute to doubting geneticists’ claims regarding the use of DNA mapping as the actual pathway towards discovering one’s true identity in the context of criminology. To make this process effective, more clear, and strict laws and regulations are required. There appears to be a globally scaled tendency for the practice of DNA testing to be used in a variety of fields other than birth planning and criminology. Therefore, much attention should be paid to providing effective laws to monitor and control genetic mapping to make it not only ethical but also legal.

Possible Changes in the Genetic Mapping Law

Despite the enactment of the AIA in September 2011, it is possible to state that this legislation is not effective to address legal and ethical issues associated with genetic mapping. As a result, further changes in the DNA mapping law are required and expected. The further advancement of genetic mapping and counseling is expected, and this development will lead to appearing legal issues that need to be addressed. Lawmakers need to assess the applicability of any would-be enacted legislation to its contribution to maintaining stability within the society in terms of genetic mapping. When it comes to formulating the legal principles and standards on DNA mapping, politicians must also take into account the specifics of the moral and scientific climate in the country regarding this issue.

New regulations should be implemented to respond to the following issues: the accidental release of certain genetic material or organisms that can be dangerous and harmful to society; “cases involving wrongful birth” and life; confidentiality issues; and intrusional privacy issues. The progress of genetic mapping and its active use by people for their purposes can create even more issues to address and reflect in legal regulations. For instance, it is important to guarantee confidentiality and privacy regarding genetic information with the help of legal acts to avoid discrimination and stigmatization. Also, lawmakers should improve regulating the admittance of DNA-based evidence to the court during criminal and civil hearings to guarantee that there is no opportunity for the procured data to be compromised by an error or be inappropriately disclosed. The logic behind this can be viewed as associated with the principle of “legal universality”, according to which, a suspect cannot be convicted of having committed a crime as there remains even a slight doubt regarding his or her guilt.

The US legislation regarding genetic mapping should be oriented toward proposing new effective patent categories related to genome research and controlling the collaboration of researchers. Furthermore, it is also important to ensure concerning the laws that the collection of genetic material can be realized only after receiving individuals’ consent. This regulation is important to be strictly formulated to avoid problems associated with using DNA material in courts and other situations when the unethical and illegal use of the collected genetic information violates individuals’ rights. The improvement of legal regulation in this area is important because, according to Greely, different sources of genetic information can be retrieved without persons’ consent. Thus, “there seems to be little legal protection for such, often unintentionally, discarded materials; nor does there seem any practical way to enforce a prohibition on the collection of such materials.” As a result, laws regarding the collection of genetic information and regulations associated with genome patents need to be revised.

The work of laboratories specializing in genetic mapping should also be regulated. Even though the research activities of DNA laboratories are concerned with the matters of empirical science, the functioning of these organizations can be profit-driven, creating both ethical and legal issues. Therefore, to be legally accredited, DNA laboratories must prove that the services that they provide serve the function of helping clients without violating their rights. If this is not the case, the legal accreditation of such institutions should be revoked. As Shriver and Kittles noted, “individuals purchasing DNA ancestry tests are motivated for some reason (even if no empirical data is yet able to tell us what these motivations are). Customer satisfaction (and, correspondingly, customer dissatisfaction) may be tied to expectations of results.” Practically speaking, DNA laboratories should be required to provide a refund to the customers in case the latter is not satisfied with the purchased product or service. This will also contribute to discussing the practice of using human biomaterial as something intuitively ethically controversial.

Therefore, it will be logical to assume that while addressing the issue of DNA mapping, policymakers should keep the mentioned considerations in mind. The reason is that to be effective, the applied legal rules and regulations must be ontologically consistent with each other and with the subject matter that they have been designed to address. The current legislative discrepancies for genomic research, in general, and the practical application of the DNA sequencing technology, in particular, have to do with a lack of understanding of what accounts for the practice’s actual significance. The currently utilized legal provisions should be improved to guarantee that individuals’ genetic material, confidentiality, and privacy are protected despite purposes for which DNA analysis or mapping is conducted.

Conclusion

The practice of genetic DNA mapping is associated with a variety of social, ethical, and legal issues and implications because this procedure affects such aspects as the use of the human biological material, discrimination using genetic information, and the violation of privacy and confidentiality. Moreover, despite being deeply rooted in the domain of empirical science, genome research and genetic mapping continue to become increasingly commercialized. This tendency provides people with a partial answer regarding the true causes of the growing popularity of DNA tests. It seems that once it became apparent that there is commercial potential for the practice of researching people’s genetic ancestry, this particular pursuit has ceased contributing to the cause of social or scientific progress. Thus, policymakers need to concentrate on preventing the commercialization of DNA mapping and other related procedures because of the evident negative effects of this trend that can affect people not only in the United States but also globally.

As was implied earlier, there is a good reason to assume that as time goes on, the scope of the DNA mapping technology’s utilitarian usages will continue to expand. Such eventual development is predetermined by the laws of historical progress. This, however, does not mean that the biotechnology in question should be regarded as inappropriate despite related ethical and legal issues. However, it is possible to accept the opinion that, despite the strongly defined scientific appeal of the practice of subjecting human biomaterial to DNA analysis, it can lack axiomatic integrity. This suggestion refers to the fact that the conceptual premise of genome sequencing is reflective of the irrational beliefs that: a) after having taken place in the mitochondrial DNA, a particular mutation will continue to be replicated into posterity, b) the identical and yet biochemically unrelated mutations can’t reoccur within the genome.

It is possible to conclude that to be emotionally comfortable with conducting the DNA mapping procedure, one must be willing to assume that the mentioned beliefs represent an undisputed value. However, it will prove impossible to substantiate such an assumption with any factual evidence. This alone raises a certain concern about whether the objectives of just about any genomic research can be deemed consistent with the procedural subtleties of how it is being conducted in practice. Therefore, it will be logical to conclude this paper by stressing out that the time has come to reassess the de facto utility of DNA mapping, as well as the biotechnology’s role as the agent of social progress in the United States. Although the outlined approaches for doing are rather sketchy, there is a good reason to believe that they are indeed discursively valid. After all, the provided suggestions draw heavily on what is now being recognized to account for the systemic aspects of the technologically advanced society’s functioning. Thus, more legal regulations and acts are required to address current social, ethical, and legal issues related to genetic mapping in the US and worldwide.

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