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Open Collection of Student Writing (OCSW)

Ethical Issue Analysis

Introduction

Imagine a world in which where genetic disorders are almost non-existent and the ones that remain are easily treated.  This is potentially the promise of the new gene-editing technology called CRISPR-Cas9.  Scientists are beginning to use CRISPR to modify the genes in many different organisms.  Their nobly purported goal is to use it to benefit all of mankind.  However, substantial ethical concerns that necessarily create roadblocks to how this type of technology can be used have some bioengineers concerned about the future of their research.

CRISPR-Cas9 gives scientists the ability to take the genome and make edits to the DNA structure.  There are two molecules that are involved in this process.  The first is called Cas9, this is an enzyme called a nuclease that can cut into DNA.  The second molecule is called a gRNA or a guide RNA and its job is to ‘guide’ the Cas9 to the proper place on the genome.  Once the DNA has been removed by this system it is then repaired, however, as it is repaired it generally disables the gene (“What is CRISPR-Cas9?,” 2016).  Scientists have found a way to replace the cut DNA by adding a different piece of DNA that carries the desired sequence (McGovern Institute for Brain Research at MIT, 2014).

In 2015, a team of scientists in China led by Junjiu Huang used CRISPR to genetically modify human embryos (Sample, 2015).  On October 28th, 2016 Lu You led a team of scientists who used CRISPR to modify the immune cells of patients suffering from aggressive lung cancer.  These cells were cultured, grown and injected into the patients that they came from.  The hope is to successfully use CRISPR to enable these cells to demolish the cancer (Cyranoski, 2016).  CRISPR has also been used to modify mosquitoes to be malaria free (Sample, 2015), to remove retroviruses from pig DNA (McKie, 2015), and to create targeted mutations in cynomolgus monkeys (Shen, 2014).

The genetic modification of human embryos performed at Sun Yat-sen University in Guangzhou has begun our species down an unethical path which could ultimately cause “serious and unquantifiable safety issues…by altering the germline in a way that affects the next generation without their consent (Collins, 2015).”  The germline is genetic material found in reproductive cells that is passed down from one generation to the next (“What is CRISPR-Cas9?,” 2016).  Altering this genetic material has some profound consequences that need to be considered.  Although CRISPR appears to be a tool that will benefit mankind many are afraid that it will lead us down a “slippery slope” that will cause more harm than good.

Thesis

Serious ethical implications are at play when science grants itself license to effect genetic modification of germline genetic material fully knowing that, despite the potential benefits, a Pandora’s box of unintended consequences might result in a decidedly negative effect on future progeny.

Body

Medical Indications

Serious genetic birth defects are an ongoing challenge, they affect 6% of the total births each year worldwide (Zarocostas, 2006).  Many genetic birth defects are chronic and irreversible and some of them are critical and terminal.  Researchers are trying to find ways to combat these defects and several diseases with CRISPR technology.  People that suffer from diseases such as sickle cell anemia, severe combined immunodeficiency, beta-thalassemia, muscular dystrophy and cystic fibrosis may one day benefit.

The goals of treatment with CRISPR is to alter the genes that are causing these diseases and defects so they will no longer be a problem that mankind must face.  However, there are some roadblocks to this treatment.  One problem is that CRISPR can bind to unintended areas of DNA and cut out information that had nothing to do with the targeted gene.  This is called an “off-target” effect.  Another problem is when CRISPR doesn’t edit all of the intended cells creating a “genetic mosaicism” (Corbyn, 2015).

CRISPR could change the impact that birth defects and diseases have on the world.  This technology has not reached a point where physicians can guarantee that it will not cause harm to patients.  There are a lot of bugs that still need to be worked out before it can be used in a way that will truly help patients suffering from serious genetic disorders.  Although this may one day “promote the welfare of other people (Munson, 2012, p.894)” it is not there yet.

Patient Preference

The difficulty with the research led by Junjiu Huang arises in the fact that they are manipulating the germline.  Altering the human germline may have serious unforeseen consequences and this is a risk to future generations that simply isn’t acceptable.  The embryo that is having its genes edited and its future progeny are incapable of consent.  This violates the autonomy of the human being as well as an entire lineage of the human germline.  This technology could cause hidden changes in the genome that may come back some day causing a greater risk to the germline that outweighs the benefits.

This technology has no guarantees and testing it would likely need to be species specific.  CRISPR has already been used on mosquitos to eliminate their ability to carry malaria.  However, because of the unforeseen ecological risks researchers have been encouraged to keep the population contained (Sample, 2015).  Society must ask themselves that if this technology is so concerning that these mosquitoes shouldn’t be released then should it allow it to be used on humans?

Quality of Life

The quality of life for children with genetic birth defects has a broad range.  Defects such as gastroschisis can be repaired and have almost no effect on life expectancy whereas defects such as anencephaly usually result in death soon after birth (Facts about Anencephaly, 2015).  Twenty percent of all infant deaths are directly related to birth defects (Data & Statistics, 2016).  Treatments are not currently available for many birth defects, but CRISPR technology might be able to change that.  Once again there is no guarantee, though, that the benefits will outweigh the risks when the treatment of many of these birth defects would require germline mutations.

Contextual Features

There are several organizations that seek to establish guidelines for this type of research and they do so by discussing numerous ethical concerns.  For CRISPR research specifically, Unesco has come to an agreement that it is essential to maintain the preservation of the human germline.  There have also been several conventions to discuss this matter, such as the Oviedo Convention, and many have come to similar conclusions (Harris, 2015).

Financially, CRISPR has opened a whole new world of possibilities.  As opposed to previous methods of gene editing CRISPR is around 99% less expensive.  It has also decreased the time it takes to modify genes going from years to just weeks (Berman, 2016).   This allows for more research to be done at a significantly faster pace.  The time and cost decreases give researchers the ability to seek out innovative ways to use gene editing that weren’t possible before.

Religious concerns bring us back to the question faced almost every time science advances in the realm of genetics, are we playing God?  This is another way to look at the question of whether or not we should alter the germline.  Many believe that research involving embryos should not be done because it risks human lives and should be considered murder.  It is also important to note that the use of CRISPR technology is not yet proven to be safe.  This technology literally cuts DNA out and replaces it, this is no minor alteration and requires an extensive amount of further testing before it can be considered safe to use.  It is evident in the research done by Junjiu Huang that advances such as CRISPR will continue to require discussions due to religious and ethical concerns.

Alternative Options

There are those that disagree, like John Harris a professor emeritus in Science Ethics at the University of Manchester, with the assumption that altering the germline could be unethical.  John Harris (2015) lays out the fact that millions of children die from birth defects every year.  He believes that the risk for these children of dying from such diseases is a greater risk to our species than altering the germline is.

John Harris (2015) also goes on to dispute the claim that CRISPR makes changes in the germline that will affect humans that can not give consent.  This includes the embryo and future generations.  It is his belief that all humans make decisions that will one day affect future generations and those decisions are never questioned.  In his mind, “absence of consent” should not be seen as a reason to stop such research but should rather be seen as the reason such research should be continued.

CRISPR has the potential to save the lives of generations of people and their lack of consent should not halt the use of this technology.  If germline manipulation can eliminate the devastation associated with millions of people suffering from genetic defects then the risk is worthwhile.

Conclusion

 Gene editing technology is opening up a new realm of possibilities and looking forward there is a lot of speculation as to what it will do for medicine in the future.  CRISPR adds to that vision as it gives a financially feasible option that has not been available before.  This technology may just be the cure that has been sought out all these years for everything from cancer to birth defects.  However, there are still many discussions that need to occur about the ethics of using gene editing techniques.

If the use of gene editing with CRISPR can be proven to be safe and beneficial to patients suffering from diseases without altering the germline then it appears to be ethically acceptable.  The difficulty with this technology begins when discussing the human germline and the possibility of affecting future generations.  As long as there is no proof that CRISPR will not cause harm to future generations it should not be used.

References

Berman, R. (2016, November 30). China’s Already Tested CRISPR on a Human, and the U.S. is Next. Retrieved April 06, 2017, from http://bigthink.com/robby-berman/chinas-already-tested-crispr-on-a-human-and-the-us-is-next

Collins, F. S., M.D., Ph.D. (2015, August 28). Statement on NIH funding of research using gene-editing technologies in human embryos. Retrieved April 06, 2017, from https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos

Corbyn, Z. (2015, May 10). Crispr: is it a good idea to ‘upgrade’ our DNA? Retrieved April 06, 2017, from https://www.theguardian.com/science/2015/may/10/crispr-genome-editing-dna-upgrade-technology-genetic-disease

Cyranoski, D. (2016, November 15). CRISPR gene-editing tested in a person for the first time. Retrieved April 06, 2017, from http://www.nature.com/news/crispr-gene-editing-tested-in-a-person-for-the-first-time-1.20988?WT.mc_id=TWT_NatureNews

Data & Statistics. (2016, September 21). Retrieved April 06, 2017, from https://www.cdc.gov/ncbddd/birthdefects/data.html

Facts about Anencephaly. (2015, November 09). Retrieved April 06, 2017, from https://www.cdc.gov/ncbddd/birthdefects/anencephaly.html

Harris, J. (2015, December 02). Why human gene editing must not be stopped. Retrieved April 06, 2017, from https://www.theguardian.com/science/2015/dec/02/why-human-gene-editing-must-not-be-stopped

Lanphier, E., Urnov, F., Haecker, S. E., Werner, M., & Smolenski, J. (2015, March 12). Don’t edit the human germ line. Retrieved April 06, 2017, from http://www.nature.com/news/don-t-edit-the-human-germ-line-1.17111

McGovern Institute for Brain Research at MIT. (2014, November 05). Genome Editing with CRISPR-Cas9. Retrieved April 06, 2017, from https://www.youtube.com/watch?v=2pp17E4E-O8

McKie, R. (2015, November 28). Top biologists debate ban on gene-editing. Retrieved April 06, 2017, from https://www.theguardian.com/science/2015/nov/28/gene-editing-weapon-against-disease-or-ethical-nightmare

Munson, R. (2012).  Intervention and Reflection: Basic Issues in Bioethics. 9th edition.  Boston, MA: Clark Baxter.

Sample, I. (2015, November 23). ‘Anti-malarial mosquitoes’ created using controversial genetic technology. Retrieved April 06, 2017, from https://www.theguardian.com/science/2015/nov/23/anti-malarial-mosquitoes-created-using-controversial-genetic-technology

Sample, I. (2015, April 23). Scientists genetically modify human embryos in controversial world first. Retrieved April 06, 2017, from https://www.theguardian.com/science/2015/apr/23/scientists-genetically-modify-human-embryos-in-controversial-world-first

Shen, H. (2014, January 30). First monkeys with customized mutations born. Retrieved April 06, 2017, from http://www.nature.com/news/first-monkeys-with-customized-mutations-born-1.14611

What is CRISPR-Cas9? (2016, December 19). Retrieved April 06, 2017, from http://www.yourgenome.org/facts/what-is-crispr-cas9

Zarocostas, J. (2006, February 04). Serious birth defects kill at least three million children a year. Retrieved April 06, 2017, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360426/

 

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