A Prudent and Democratic Approach to Regulating CRISPR/Cas 9
By Daniel Cui
The purpose of this study is to determine a judicious and egalitarian method of regulating the recently discovered CRISPR/Cas9 gene-editing biotechnology and determining some of the major themes in its relevant ethical, social, legal, and religious issues that could potentially have a major impact on humanity in the future. Conclusions were drawn based on the 1975 Asilomar Conference regarding recombinant DNA and analyzing the ethical, social, legal, and religious implications. Because of this, gene-editing technology’s novelty and the fact that it has numerous unprecedented applications that may have unforeseen consequences, a multitude of issues would be raised by its use and implication. If these issues are neglected, CRISPR could negatively influence the human race and environment instead of benefiting the world and instigating progress.
Context & History of Asilomar
About four decades ago in 1975 after Watson and Crick’s prodigious discovery of DNA’s molecular structure (Reece 2011), new methods of manipulating and modifying DNA were arising. Because of the massive influx of research and the potential implications associated with the approaches, a moratorium was voluntarily declared by renowned researchers to halt the experiments, fearing that they may create new pathogens and encounter detrimental repercussions. Then, a group of prominent biologists and genetic engineers convened at Asilomar, California to analyze the risks and establish suitable guidelines for research (Hurlbut 2015). This was done to reduce the potentiality of biohazards and inhibit public intervention in controlling a sensitive situation that was famously known as the recombinant DNA controversy. While the meeting represented the researchers’ duty to uphold scientific responsibility, the polemic circumstances also allowed the scientific community to assert their control and dominance. In other words, the actions and precautions that could be taken, the risks that were deemed worthy of attention, and the permissible future scientific pursuits were in the hands of the handful of scientists and engineers at the convention who could make the necessary decisions and deliberations.
Furthermore, instead of focusing on the biosecurity of recombinant DNA and the ethics and morals of using the technology, Nobel laureate David Baltimore actually suggested that the discussion should be mostly comprised of risk assessment (Hurlbut 2015). Essentially, they used the logic that if the environment in the laboratory could be controlled and maintained, then the public wouldn’t need to intervene in the novel technology’s regulation. Therefore, the researchers thought they could pinpoint the risks that could be mitigated in the laboratory in order to prevent the issue from becoming too public. Once this was done, the group proclaimed their deliberations and decisions with transparency and openness so as to reduce the public’s anxiety and bolster society’s trust in the scientific community’s self-restraint and scientific responsibility.
Not only did this meeting help resolve the heated recombinant DNA controversy in 1975, but it also served as a model for future conventions regarding controversial novel technologies (Hurlbut 2015). As a result, it allowed the biotechnology field to flourish and paved the way for molecular biology as the scientists were in a position of authority while the public was in a passive position, only able to listen and learn from the discussion. This method of relying on scientific self-regulation and placing the scientists in a superior position and the public in a more inferior one became the standard convention for approaching all such controversies.
Method of Regulation
Though the Asilomar conference has been cited as the model for approaching all polemical issues in areas such as biotechnology, molecular biology, geoengineering, and artificial intelligence (Herzog 2015),the model has many flaws and can be enhanced in order to better ensure that the public’s trust and scientific responsibility are maintained while swiftly resolving the issues at hand. This especially applies to the advent of CRISPR/Cas9 since biosecurity and the ethical, social, and legal implications are questioned once again for a tool that virtually allows any educated individual to edit out and insert genes into any organism’s genomes.
In order to elucidate the flaws of the Asilomar convention for tackling biotechnology issues, it is necessary to analyze similar discussions. About two years ago, the Asilomar method for tackling biological controversies was used again when the American population learned that their taxes were used to create potentially malignant strains of H5N1 flu virus (K. I. Burns et al. 2012). In fact, the virus, which is typically transmitted by birds, is highly infectious and can cause severe respiratory disease. Fortunately, a nationwide pandemic did not occur; however, the research remained incognito and no questions were raised during scientific review and discussion (Hurlbut 2015). In other words, instead of focusing on biosecurity and risk assessment, the group of researchers relied on self-regulation, believing that they could control the laboratorial conditions in order to prevent public interference. As a consequence, the group endeavored to calm the overly anxious and aggravated population by explaining “the benefits of this important research” and that their experiments had been executed with “appropriate regulatory oversight” (Fouchier 2012).
Once again, self-regulation was the center of the discussion, and the public passively received the results of the scientists’ deliberations and decisions. Clearly, the Asilomar approach is not and is, instead, authoritative as it thrives on the notion that society does not have the right to engage in debates about the ethical importance of scientific projects until the scientists can decide on which issues are realistic and can be resolved in the lab. In fact, Senator Ted Kennedy characterized the approach as a usurpation of democracy, saying that “They were making public policy, and they were making it in private” (Culliton 1975). Therefore, the public could only blindly worry about the implications and potential consequences of such technologies, while the scientific community secretly premeditated, rendering the processes of deciding on what types of research are favorable invisible to a democratic investigation. It is true that the sophisticated scientific knowledge and lexicon required for such a discussion may be incomprehensible to the public. However, the ethical concerns must be made more transparent and need to be opened up for public opinion and debate. After all, it is the people’s right to make deliberations regarding the biosecurity, safety, and the moral implications of the scientific technologies that would be ultimately affecting their lives. Applying the Asilomar method to a CRISPR/Cas9 controversy would then be contrary to the democratic belief in this nation that all denizens have fair say and are able to contribute to a rapidly changing society, especially in a time when changing any part of any person and living thing’s genome is now possible. In order to come up with a more democratic and prudent method of tackling such issues, some reforms can be made to allow the public to have a fair amount of participation in scientific issues so that the people can express their views on how they envision their futures are affected by the scientific research and discoveries. These are namely using one’s goals and aspirations to advise both the research agenda and the technology’s potential uses, recognizing that a comprehensive understanding of the mechanism and the issue is not necessarily the justification for not allowing individuals to participate in scientific discussions, and, most importantly, allowing the general public to engage in scientific discussions and especially in ones that involve CRISPR/Cas9.
To begin with, it should be noted that one should prudently consider the restraint of not only the research’s clinical applications, but also the research agenda and process that comes before the application as well. On two occasions, namely one cited by the magazine Nature regarding gene-editing tools like CRISPR (Fouchier 2012) and one involving the Napa group, the former prohibited the applications of gene-editing technology and the types of research that would help realize those applications (Lanphier et al. 2015). On the other hand, the latter instance permitted to research in germ-line editing’s security and efficiency even though there was immense skepticism regarding the application of such methods. However, this division between the research and the applications prohibits a thorough ethical deliberation. For instance, decisions based solely on the research’s applications narrow down to an overly simplistic yes or no question that either halts or furthers the already established trajectory. Scientific responsibility, instead, requires that one’s goals and values should provide insight on both the trajectory for the novel technology itself and not just the innovation’s applications.
In addition, decisions regarding genetic engineering research and its efficacy and applications do not need to depend on a full comprehensive understanding of the science behind the technology’s mechanisms or, in this case, CRISPR/Cas9. On the contrary, the Napa group asserted that the public needed to be educated “by experts from the scientific and bioethics communities” in order for democratic discussion to exist successfully (Baltimore 2006). However, when talking about genetic engineering’s potentialities like the use of CRISPR and especially its applications in manipulating the human genome, one is making decisions about which aspects of human life can or cannot be changed or violated. A small group of biologists and scientists cannot make such controversial judgements about the lives of many without the public’s attention and concern. Therefore, society should have an active and fair role in determining the scientific aspirations and what good the biotechnology or CRISPR/Cas9 can bring to humanity and science.
Above all, there is no need for significant dependence on the scientific community regarding the moratorium and the deliberations about biosecurity and its related issues. Essentially, the public should have a greater presence in the discussion, and, between the scientists and the public, democracy should exist so that both groups of people can contribute equally and fairly to a critical ethical and regulatory discussion. According to J. Benjamin Hurlbut’s study, “Limits of Responsibility: Genome Editing, Asilomar, and the Politics of Deliberation,” the writer claims that “a prudent path forward” necessitates the recognition that “the technological possibilities we find before us already reflect prior moral commitments about what choices are appropriate, what powers of control we command, and what moral imaginations should regulate and restrain our technological aspirations.” Because each case serves as the precedent for the following one as the prior experiences provide a better perspective on what is desired and the moral restraints of those desires, the general population should be able to determine what they envision for the technology and the ethical and moral concerns regarding its use and application. Also, humanity, in general, desires to some extent to maintain ethical values as all individuals have a moral code that they abide for their own well-being and for the greater good of their society. Therefore, these are “commitments” that have to be bolstered by the general public and not just by the small population of erudite scientists.
Specific Ethical, Social, and Legal Issues Regarding CRISPR’s Applications
Though there are a plethora of distinct moral, social, and legal concerns associated with far-reaching biotechnologies like CRISPR/Cas9, there are some major themes that are critical for understanding the consequences and regulating the application of manipulating genomes using this technology. Based on the technology’s applications that specifically pertain to human gene-cell therapy and human germline editing, the major issues that arise with these uses of CRISPR and Cas9 include violation of natural order, human exploitation and harm, unpredictability in its use, and the inability to produce consistent and insightful results that match the immense amounts of funding. However, before CRISPR’s ethical, social, and legal issues regarding its applications are elucidated, one must be familiar with the technology’s mechanism and functionality.
Figure 1. Diagram showing the process by which the second type of CRISPR mechanism and the Cas9 gene are used to incorporate the foreign DNA into the bacteria’s DNA and sever the foreign DNA in vivo as part of the bacteria’s adaptive immunity (Reis et al. 2014). Number one shows how the foreign DNA is being incorporated into the bacteria’s genome at the CRISPR location. Number two shows how the section of the bacteria’s DNA between the trRNA section and the CRISPR loci is transcribed to produce trRNA and a CRISPR transcript. These are then processed into crRNA during crRNA biogenesis. Number three shows how the crRNA and trRNA is paired up with the Cas9 endonuclease to form a complex that helps to cleave the foreign DNA. It should also be noted that the Cas9 endonuclease requires that a short sequence of two-five nucleotides called a Protospacer-Associated Motif (PAM) in the invader’s DNA immediately follows the crRNA complementary sequence (Reece 2011).
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats (Reis 2014), is a series of short palindromic repeats of sections in DNA sequences. CRISPR and the associated enzyme, Cas9, are major components of an adaptive immunity system in bacteria. In other words, the CRISPR/Cas9 combination helps bacteria become resistant to viruses and bacteriophages that inject their DNA into the bacteria, allowing the foreign organisms to invade it. Using the CRISPR sections of their genomes, the bacteria can integrate the invader’s genome fragment into its CRISPR locus which helps to protect it from any foreign interferences (Reis 2014).
Three types of CRISPR mechanisms have been discovered. In type two, the most well-known of the three, the foreign DNA is cut up into smaller fragments and incorporated into the CRISPR sections (Figure 1). When this section of DNA and the Cas genes near the CRISPR have been expressed, a special type of RNA is produced called CRISPR RNA or crRNA as well as a Cas enzyme, namely Cas9 endonuclease (Reis 2014). With this CRISPR section activated, the crRNA, Cas protein, and another piece of RNA called tracer or trans-activating RNA helps to degrade the DNA of other foreign invaders, rendering the bacteria impervious to foreign invasions (Reis 2014). In most CRISPR mechanisms, many Cas proteins are produced, but what makes the type two mechanism unique is that only the Cas9 protein is needed. In order to function properly, Cas9 must be in a complex with the crRNA and trRNA, which help guide the complex to cleave the foreign DNA. Once this complex is assembled, the Cas9 protein then cuts the foreign DNA along two specific domains, rendering the foreign sequence harmless.
Figure 2. Diagram showing the processes executed by each of the three CRISPR variants. The first one shows how the Cas9 complex is able to create a double-strand break in the DNA and how the NHEJ and HDR pathways are able to restore the target DNA. The second one shows that the DNA strand is able to only cut one strand which doesn’t activate the NHEJ pathway. Instead, the HDR repair pathway must be used. The third one shows how the Cas9 complex is able to activate and repress the DNA using an activator and repressor. During activation, the activator allows the sequence to be expressed hence the reason why messenger RNA or mRNA is present. A repressor silences the expression of the target sequence during repression.
When this natural system was discovered in bacteria (Fouchier 2012) new potentials for adaptation in gene-editing arose. In 2012, Dr. Doudna’s and Dr. Emmanuelle Charpentier’s labs found that the Cas9 complex’s precision and predictability made it a suitable tool for editing out certain DNA segments and putting others in (Reis 2014). As a result of this potential application, three different variants of the Cas9 protein complex were developed (Figure 2.). All three used a simpler version of the one used in bacterial adaptive immunity, which consisted of a two-component system. Instead of using both crRNA and trRNA, scientists combined them into a single synthetic guide, or sgRNA, that helped to guide the Cas9 protein (Reis 2014). In the first of the three types, the Cas9 protein complex was a wild-type and was able to specifically cut double-stranded DNA. This would then activate the DNA’s double-strand repair machinery, resulting in insertions or deletions that would interfere with the targeted DNA sequence’s locus (Reis 2014). These double-strand breaks could be repaired using the cellular Non-Homologous End Joining (NHEJ) pathway or homology-directed repair (HDR) using a donor template that fit the homology of the target locus. Scientists then modified this wild-type complex in order to increase its precision by developing a mutant form, which was the second variant (Reis 2014). Instead of cutting both strands, the modified Cas9 would be able to cleave only one strand and not activate the repair system. To enable DNA repairing, a DNA template was provided using HDR that allowed for a reduced number of mutations in the original DNA sequence. In the third variant, the Cas9 complex was adapted to sequence-specifically target a section of DNA, bind to it, and then silence or activate its expression (Reis 2014). However, this version was stripped of its cleaving capabilities and could only control the activation of certain sequences as the Cas9 was nuclease-deficient and didn’t contain the enzyme for hydrolyzing nucleic acids.
CRISPR and Cas9’s astonishing efficiency, flexibility, and simplicity give it the potential to support a broad range of applications. Scientists have made targeted genome edits to many organisms such as humans, other mammals, plants, and bacteria. In fact, Chinese scientists in Chengdu’s West China Hospital at Sichuan University have recently used CRISPR on human subjects who had metastatic lung cancer (Cyranoski 2016). In order to accomplish this, the researchers took out a sample of the patient’s immune cells that used CRISPR to disable a gene called PD-1 which halted the immune response (Cyranoski 2016). This gene is normally used by cancer cells, but, by disabling it, the mutated cells wouldn’t be able to rely on it which would eventually halt their activity. Clearly, not only could this be applied to lung cancer, but this tool may be used to treat numerous other cancers, genetic disorders, and maladies that were once thought to be untreatable. Altering the DNA of pluripotent embryonic stem cells, undifferentiated cells that can give rise to different tissue cells could also be achieved in order to allow them to specifically differentiate into different tissues like, for example, cardiomyocytes in the heart, astrocytes in the brain, and oligodendrocytes in the nervous tissue. Furthermore, CRISPR could be used in germ-line editing in the near future in which the genetic makeup of the reproductive cells’ nuclei could be altered so that novel traits could be expressed and inherited from one generation to the next (Reece 2011). Therefore, it has become clear that modifying the genes of fertilized embryos and zygotes is now a possibility.
In molecular biology and biotechnology, one of the main focuses has been to create animal hybrids or chimeras by moving genes from one species to the genome of another, thus giving rise to a novel species that expresses some traits from both of the preceding species (Baltimore et. al 2015). However, inserting human DNA into non-human genomes or vice versa is extremely controversial and may soon become feasible with the advent of CRISPR/Cas9 technology. Many, in fact, view the engineering of hybrid organisms as a violation and disturbance of nature’s natural order. Developed and established by James Lovelock in the 1970s, the Gaia Theory reflects this concern with nature’s balance as it asserts that “the organic and inorganic components of Planet Earth have evolved together as single living, self-regulating system” (Bond 2013). Therefore, nature has affected its surrounding conditions and chemistry in order to maintain a healthy habitat using mechanisms like, for instance, homeostasis. However, humanity plays a detrimental role in nature’s self-regulation. Since the theory claims that nature has the autonomous ability to sustain an environment that is conducive to its own growth, interfering with nature may have negative consequences as it would disrupt the delicate balance that has been maintained by its self-regulating mechanisms. Genetically engineering new hybrid organisms using human DNA may then have negative repercussions as it would meddle with nature’s natural order. However, the Gaia paradigm is “beautiful but flawed” with no supporting conclusive evidence (Tyrell 2013). From the point of view of animal rights advocates, using CRISPR to create chimeras would also be extremely controversial. Such use of CRISPR/Cas9 may cause inhumane suffering or even death for the experimental subjects as the manipulation mechanisms still have not been completely elucidated as shown in the 2002 SCID experiment.
Another potential application of CRISPR is human gene therapy which involves the use of genes to treat or cure disease. Most of the time, this involves transferring the genes of one human into the genome of another (Baltimore et al. 2015). As shown in the Chinese CRISPR experiment in which the white blood cells of lung cancer patients were genetically edited, this application could potentially be beneficial and life-saving in the future as it could treat diseases that were once thought to be incurable like cancer, Diabetes, and AIDS. This treatment works by inserting the proper genes into the nuclei of the designated cells which would then express those genes to produce a beneficial protein. Since this therapy only involves inserting human genes into another human’s genetic sequence and is supposed to improve human health, there has been minimal ethical controversy about this use of genetic manipulation. Nevertheless, many have questioned the use of these therapy experiments on humans who are in desperate conditions, since the treatment has not produced consistent results yet and has been unpredictable in many cases. Furthermore, human gene therapy has received immense funding despite the fact that it has been unreliable. In fact, the first unequivocal success of human gene therapy occurred in 2002 in which ten French children with SCID (Severe Combined Immune Deficiency [Make them capital]) were treated with somatic gene cell therapy. However, the results were mixed as three of the children contracted leukemia through “insertional mutagenesis” from the retrovirus which was carrying the genes. Since then, there have been two other successes in 2004 and 2005, both not involving the use of CRISPR/Cas9 (Herzog 2010). Though there have been few successes, many research firms have failed to get any positive results. These gene cell therapy experiments usually receive major funding that can be upward of more than 30 million dollars. In 2005 alone, three major companies named Celladon, Ceregene, and Virxsys received 30 million, 32, million, and 52 million dollars in funding respectively (Rautsola 2007). Clearly, these are costly projects that may not even produce the desired outcomes. The first clinical trial using CRISPR commenced in October 28, 2016 during when a research firm in Chengdu, China managed to start an experiment using the technology to potentially help patients who had lung cancer (Cyranoski 2015). The modified cells were delivered, but no results have been announced yet.
In addition to human gene cell therapy, another application of CRISPR/Cas9 that has raised considerable ethical debate is germ line gene editing. In short, germline manipulation involves the intentional changing of the genetic material in embryos, zygotes, or reproductive cells like sperm and eggs in order to prevent genetic diseases or enhance certain traits (Greely 1998). These genes or alleles that are inserted into the genome are usually from parents or other humans. They could also theoretically come from the laboratory; nevertheless, this type of genetic manipulation would produce uncertain results as inserting new genes into a developing embryo’s genome could indefinitely affect the expression of other essential genes. This would then potentially harm the embryo and, therefore, human life. Also, if the altered embryo was able to grow successfully into a fetus and then a human being, the altered genome could then be passed on for generations which would have a unpredictable aftermath. Clearly, bolstering research in this area of genetic engineering would cross many ethical boundaries. Also, the consequences are uncertain and extremely complex to forecast. For this reason, human germline manipulation has been banned in 40 countries (Center for Genetics and Society). Following the advent of CRISPR however, germline manipulation was attempted twice by two Chinese research firms in 2014 and 2015. In both experiments, the CRISPR/Cas9 mechanism was used to edit genes that were associated with certain diseases, namely blood disease and the HIV virus. However, these trials were unsuccessful and alarmed researchers as genetic engineering tools were becoming cheaper and easier to use. As a consequence, from December 1 and December 3, 2015, researchers convened in Washington D.C. in the International Summit on Human Gene Editing and released a statement at the conclusion claiming that “it would be irresponsible to proceed with any clinical use of germline editing” until “relevant safety and efficacy issues” were settled (Baltimore 2006). Several days later on December 18th, the U.S. Federal Omnibus Bill was signed by President Obama that would provide 2 billion dollars to the National Institutes of Health for biological research (Muhkerjee 2006). However, the bill prevented the FDA from funding any research regarding germline manipulation and genetically engineering human embryos. Nonetheless, in the statement released by the summit, research could potentially be revived “as scientific knowledge advances and societal views evolve” and that such an application of genetic engineering and especially CRISPR/Cas9 “should be revisited on a regular basis” (Baltimore 2006). Germline manipulation would also violate the prevailing belief in the Gaia Theory and maintaining nature’s natural order. Many would, therefore, believe that one would be tampering with humanity’s purity and evolution by tampering with the genetic code, thereby affecting humanity’s genome for generations and beyond if the subject were to survive and reproduce. Clearly, while there are many applications of CRISPR/Cas9 technology, there are numerous issues that have to be considered and, until research has sufficiently evolved in this field, any use and research should be placed under appropriate regulatory oversight.
Comprehensive Religious Issues
In addition to the various ethical, social, and legal issues regarding CRISPR and Cas9 gene editing technology, there are some significant religious aspects and concerns regarding this mechanism that focus on human life’s sacrosanctity. In order to fully elucidate the religious perspectives on genetic engineering and CRISPR technology the following religions and their views will be considered: Christianity, Buddhism, Judaism, and Islam. Overall, it could be concluded that, from a religious perspective, maintaining the purity and worth of human life is of the utmost significance and trumps any use of genetic engineering that violates it.
Christianity, Buddhism, Judaism, and Islam all seem to express the same negative opinion on genetic engineering as they all believe in the preservation of human life and its purity (Eckman 2015). For instance, in Genesis 1 of the Christian bible, the dignity, virtue, and value of human life and its dominion status were asserted:
Then God said, “Let us make mankind in our image, in our likeness, so that they may
rule over the fish in the sea and the birds in the sky, over the livestock and all the wild animals, and over all the creatures that move along the ground.”
So God created mankind in his own image, in the image of God he created them; male
and female he created them. God blessed them and said to them, “Be fruitful and increase
in number; fill the earth and subdue it. Rule over the fish in the sea and the birds in the
sky and over every living creature that moves on the ground.” (Gen. 1:26-28)
Since humanity, according to the Bible, was God’s creation and was blessed by the supreme being to reign dominant over all other living and nonliving creations, genetically altering the biological code of any individual could be viewed as an act of sinful tampering of God’s work. In other words, the natural variation in human DNA and unique traits that gives rise to individuality can be attributed to God’s power and control. As a consequence, meddling with His creations and going against His could result in detrimental consequences. Therefore, as biotechnology advances, the preservation of humanity’s self-worth and value is now of the utmost importance in terms of religious sentiments. Furthermore, in ethicist Michael Sandel’s book titled The Case Against Perfection: Ethics in the Age of Genetic Engineering, the author writes, “In a world without givens, a world controlled by bioengineering, we would dictate our nature as well as practices and norms. We would gain unprecedented power to redefine the good... The more successfully we engineered IQ and muscle-to-fat ratio, the more central these measures would become to our idea of perfection... But it will never be a perfect world.” (Sandler 5) In this section, Sandler essentially asserts that, because of sin and humanity’s depravity, the world will always be imperfect and forever characterized by vice, disaster, tragedy, accidents, and mortality. Therefore, despite the revolutionary aspects of bioengineering and CRISPR/Cas9, humanity can only idealize perfection and will never be able to achieve it even during the dawn of innovative technological advancements. Because of this religious fact regarding humans’ earthly nature and its “sexual immorality, impurity, lust, evil desires and greed”(Colossians 3:5-6), the conditions and quality of life ethic must never surpass life’s ethical quality that is described in the Bible and declared by God.
In Judaism, Buddhism, and Islam, similar sentiments are expressed regarding the use of gene-editing technologies such as CRISPR/Cas9. Both religions, therefore, prohibit the use of gene-manipulation tools if the preservation of human life is violated. For instance, in Judaism, Jewish law or halakhah which emphasizes immensely on pikuakh nefesh which is the belief that the preservation of human life overrides any other religious commandments in the Torah with the exception of homicide, idolatry, and adultery (Wolff 2001). Violations of this commandment are only justifiable for genetic engineering if the risks and potential consequences are offset by the procedure’s effectiveness. As a result, research and clinical applications that involve treating genetic defects and treating genetic diseases and disorders would be allowed. However, more controversial and ethically flawed areas of inquiry such as cloning and germline manipulation would be prohibited. Moreover, any procedure that does not involve the preservation of human life would not be permitted by pikuakh nefesh (Wolff 2001). This commandment is also true for the genetic engineering of other animal species and plants as the manipulation of the DNA sequences of other organisms for non-preservational applications for humanity are banned as well. Buddhists, like Jews, have a very strict view on genetic engineering, but their logic differs from that of Judaism. Since one of the central beliefs in Buddhism is karma or how one’s actions in the present will affect one’s life in the future and beyond in the afterlife and that the state of the body affects the state of the mind, Buddhists have a dichotomous stance as well on the use of genetic manipulation as applications of gene-editing technology that interferes with one’s spiritual journey that is influenced by karma would be prohibited (Epstein 2001).
The Quran, the Islam’s holy scripture, expresses similar views as the other three religions. In one section, it essentially asserts that genetic engineering is going against Allah’s will and power and control over the creation of man: “... And he (Satan) said, 'I will assuredly take a fixed portion from Thy servants; 'And assuredly I will lead them astray and assuredly I will excite in them vain desires, and assuredly I will incite them and they will cut the ears of cattle...'... 'and assuredly I will incite them and they will effect a change in the creation of Allah.' And he who takes Satan as a friend besides Allah has certainly suffered a manifest loss.” (Quran 4:119-120) Similar to Christianity, because genetic engineering interferes with Allah’s creation of humanity, such technology would be prohibited as not only does tamper with Allah’s work, but it also places humanity in a superior position that is nearly god-like, stripping humans of humility (Ahmad 1998).
It is clear that the advent of the revolutionary CRISPR/Cas9 gene editing technology has a plethora of applications and areas in research that has yet to be thoroughly explored. With human gene therapy and germline manipulation just comprising some of its many uses, this biotechnology could potentially have unprecedented advancements in science and humanity’s development. However, since CRISPR and Cas9 gene-editing tools are still being elucidated and have numerous unique uses, a suitable method of regulation and its associated and critical ethical, social, legal, and religious issues need to be determined in order to ensure that the use of such technology won’t endanger safety and humanity’s moral values. As shown by the 1975 Asilomar conference regarding recombinant DNA, scientists have relied traditionally on self-regulation in the laboratory and preventing the public from being actively engaged in such discussions. Therefore, three main reforms were determined in order to make the process fairer and more egalitarian: using what one envisions to advise both the research agenda and the technology’s applications, recognizing that a comprehensive understanding of the mechanism and issue is not the necessary justification for not allowing individuals to participate in scientific discussions, and, most importantly, allowing the general public to engage in scientific discussions.
Furthermore, after analyzing the applications of CRISPR and Cas9 biotechnology which specifically pertained to human gene cell therapy and germline modification, it was evident that the upholding the Gaia Theory, human exploitation and harm, unpredictability, and the immense amount of financial resources needed to support such research and clinical application were the prevailing issues regarding this technology. Though these do not justify the means to prohibit CRISPR/Cas9 gene-editing research and use, it could be concluded that these are the major issues that need to be considered for its regulation. In terms of religious concerns, the situation becomes dichotomous as the preservation of human life is the ultimate concern and any use of genetic engineering that violates that commandment would be prohibited. By combining the ideas illustrated by the democratic approach to regulation and its relevant issues, one can then have a better perspective on CRISPR/Cas9 technology’s regulation and come to realize that safety and moral values cannot be completely exchanged for scientific pursuits. Though science is critical for the evolution and society’s advancement, it is also important to consider that humans have empathy and compassion for each other. Perhaps this quote from Brave New World by the renowned Aldous Huxley succinctly summarizes the conflict that science has with sympathy and morality that characterize human nature: “But I don't want comfort. I want God, I want poetry, I want real danger, I want freedom, I want goodness. I want sin.”
Ahmad, Mirza Tahir. "Genetic Engineering." Revelation, Rationality, Knowledge, and Truth. United Kingdom: Islam International Publications Limited, 1998. 627-33 Print.
Al-Qaradawi, Yusuf. "Halal Industry Development Corporation - How Does Islam View Genetic Engineering?" Halal Industry Development Corporation - How Does Islam View Genetic Engineering? Islamic Science University of Malaysia, 5 Dec. 2006. Web. 29 Dec. 2016. <http://www.hdcglobal.com/publisher/pid/b368dc7b039b-4335-9df3-8c015cbb33af/container//contentId/cc170e96-408d-485d-8ec3f63644df412c>.
Baltimore, David et al. “A Prudent Path Forward for Genomic Engineering and Germline Gene Modification.” Science (New York, N.Y.) 348.6230 (2015): 36–38. PMC.Web. 29 Dec. 2016.
Baltimore, David, Francoise Baylis, and Paul Berg. "On Human Gene Editing: International Summit Statement." National Academies Web Server www8.nationalacademies.org. International Summit on Human Gene Editing, Dec. 2015. Web. 29 Dec. 2016. <http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=1203 015a>. J. Culliton, “Kennedy: Pushing for More Public Input in Research,” Science 188(1975): 1188.
Bond, Michael. "Exploring Our Love/hate Relationship with Gaia." New Scientist. New Scientist, 21 Aug. 2013. Web. 28 Dec. 2016. <https://www.newscientist.com/article/mg21929311-600-exploring-our-lovehate relation ship-with-gaia/>
"CGS : About Human Germline Gene Editing." CGS : About Human Germline Gene Editing. Center for Genetics and Society, n.d. Web. 29 Dec. 2016.
Cyranoski, David. "CRISPR Gene-editing Tested in a Person for the First Time." Nature.com. Macmillan Publishers, 15 Nov. 2016. Web. 29 Dec. 2016.
Eckman, Jim. "The Ethics of Gene Editing - Issues In Perspective." Issues In Perspective The Ethics of Gene Editing Comments. Issues in Perspective, 16 May 2015. Web 29 Dec. 2016. <https://graceuniversity.edu/iip/2015/05/the-ethics-of-gene editing/>.
E. Lanphier et al. “ Don't Edit the Human Germ Line .” Nature 519 ( 2015 ): 410 – 11 .
Epstein, Ron. "Genetic Engineering: A Buddhist Assessment." The City of Ten Thousand. Buddhas.N.p., June 2001. Web. 29 Dec. 2016. Genesis. The Holy Bible New King James Version. Nashville:
Thomas Nelson, 2013. Print. Greely, Henry T. “Legal, Ethical, and Social Issues in Human Genome Research.” Annual Review of Anthropology, vol. 27, 1998, pp. 473–502. www.jstor.org/stable/223380.<http://www.geneticsandsociety.org/article.php?id 8711>.
Herzog, Roland W., Ou Cao, and Arun Srivastava. “Two Decades of Clinical Gene Therapy Success Is Finally Mounting.” Discovery medicine 9.45 (2010): 105 111. Print. Hurlbut, J. B. (2015), Limits of Responsibility: Genome Editing, Asilomar, and the Politics of Deliberation. Hastings Center Report, 45: 11–14. doi:10.1002/hast.484 <http://onlinelibrary.wiley.com/doi/10.1002/hast.484/full>.
Huxley, Aldous. Chapter 17. Brave New World. New York: Harper & Bros., 1946. 62. Print. K. I. Berns et al. “ Adaptations of Avian Flu Virus Are a Cause for Concern .” Science 335 (2012 ): 660 – 61 . Mukherjee, Sy. "UPDATED: House Passes $1.1T Spending Bill with NIH Boost, Pediatric
R. A. M. Fouchier , A. Garcia-Sastre , and Y. Kawaoka . “ Pause on Avian Flu Transmission Studies .” Nature 481 ( 2012 ): 443 - 43 .
Rautsola, Riku. "Funding Challenges for Gene Therapy | GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business." GEN. Genetic Engineering and Biotechnology News, 15 Jan. 2007. Web. 29 Dec. 2016. <http://www.genengnews.com/gen-articles/funding-challenges-for-gene therapy/1973>
Reece, Jane B., Lisa A. Urry, Michael L. Cain, Steven A. Wasserman, Peter V. Minorsky, and Robert B. Jackson. "Biotechnology." Campbell Biology. 9th ed. Glenview: Pearson Education, 2011. 396-426. Print.
Reis, Alex, Breton Hornblower, Brett Robb, and George Tzertzinis. "CRISPR/Cas9 and Targeted Genome Editing: A New Era in Molecular Biology." CRISPR/Cas9 and Targeted Genome Editing: A New Era in Molecular Biology | NEB. New England Biolabs, 2014. Web. 29 Dec. 2016.
Review Voucher Extension." BioPharma Dive. BioPharmaDIVE, 18 Dec. 2015. Web. 29 Dec. 2016 <http://www.biopharmadive.com/news/updated-house-passes-11tspending-bill-with-nih- boost-pediatric-review/410946/>.
Sandel, Michael J. The Case against Perfection: Ethics in the Age of Genetic Engineering. Cambridge, MA: Belknap of Harvard UP, 2007. Print.
The Qur’an. Trans. By M.A.S. Abdel Haleem. New York: Oxford University Press, 2005. Print. Tyrell, Toby. "My Verdict on Gaia Hypothesis: Beautiful but Flawed." New Scientist. NewScientist, 23 Oct. 2013. Web. 05 Jan. 2017. <https://www.newscientist.com/article/mg22029400-400-my-verdict-on-gaia hypothesis- beautiful-but-flawed/>.
Wolff, Akiva. Jewish Perspectives on Genetic Engineering. Rep. Jerusalem Center for Public Affairs, Oct. 2001. Web. 29 Dec. 2016. <http://www.jcpa.org/art/jep2.htm>.