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Regulating Human Germline Genome Editing: Medical Counseling, Ethical Permissibility, and Potentially Grave Threats.

1. Introduction

Gene editing is more coherent, technically more manageable, can be rearranged swiftly, and is rather affordable in comparison with the automation of zinc finger nuclease and transcription factor-like effector nucleases. (Kuo, 2019) Given that gene editing technologies have redesigned genetic engineering and are advanced to a greater extent, the significant risks will be better assessable. (Koplin et al., 2019) In a postgenomic perspective of germline editing, a wide-ranging interdiction on definite applications of the technology is justified (Androniceanu, 2017; Caruso et al., 2017; Ionescu, 2018; Mirica (Dumitrescu), 2018; Orazulike, 2018; Radulescu, 2017; Stewart and Mika, 2017), as the research required to evaluate the reliability of such intrusions would not be morally sound. (Guttinger, 2019)

2. Conceptual Framework and Literature Review

Employing CRISPR/Cas9 for human embryo genome editing may discontinue genetic diseases from being passed down to the future generation. (Taguchi et al., 2019) The likelihood of genome editing to disallow hereditary diseases, if established as free from danger, benefits from broad public support, while there is influential resistance to editing genomes to improve human characteristics. The dominant defense against unacceptable genome editing is the improbability of determining features (e.g. intelligence) which take shape from intricate interactions (Bratu, 2018; Drugau-Constantin, 2018; Lazaroiu, 2018; Nica, 2017a, b; Popescu Ljungholm, 2017; Radulescu, 2018; Tanankem Voufo et al., 2017) among various genes and settings. (Daley et al., 2019) Germline editing brings about alterations that an individual's children can inherit, in contrast with ones that cannot be transmitted to next generations. The likelihood of purposefully modifying descendants' genes is troublesome as regards early-stage embryo gene editing. (Greely, 2019)

3. Methodology and Empirical Analysis

Using and replicating data from Pew Research Center, I performed analyses and made estimates regarding U.S. adults who say changing a baby's genetic characteristics for certain reasons is an (in)appropriate use of medical technology (%) and U.S. adults who say gene editing giving healthy babies a much reduced risk of serious diseases and conditions is no different than other ways we try to better ourselves/crosses a line, meddling with nature (%). Data were analyzed using structural equation modeling.

4. Results and Discussion

The genetics breakthrough has lead to human genomes being sequenced and numerous of the molecular processes grasped, while genomic editing technologies have advanced. Genome editing should not be employed in human embryos for clinical reasons. (Harper and Schatten, 2019) Genome editing may bring about both enormous therapeutic potentiality and relevant likely risk. Sickle cell disease represents a first-rate choice for the clinical implementations of this tool, but there is insufficient understanding of patient community values and issues in relation to CRISPR-mediated somatic genome editing clinical trials. (Persaud et al., 2019) Dignity matters do not legitimize a wide-ranging interdiction on free from danger heritable genome editing, while necessarily reporting the carrying out of side constraints to set out that the value judgments concerning human characteristics (Burwell et al., 2018; Faggianelli et al., 2018; Mircica, 2018; Murali, 2018; Nica and Taylor, 2017; Ralston et al., 2018; Schinckus, 2018; Thiel, 2017) that are intrinsic in such routine do not cause a decreased basic consideration for individuals affected by them. (Segers and Mertes, 2019) (Tables 1-8)

5. Conclusions and Implications

Medicinal products derived from genome editing should be subjected to meticulous preclinical evaluation and undergo regulatory supervision for accurate risk appraisal in advance of initial assessment in humans. (Cathomen et al., 2019) Whether gene editing puts forward any essentially additional or distinct ethical concerns than those brought about by previous gene-altering technologies is unpredictable, particularly with reference to genetic germline changes in humans. (Lysaght, 2019) Notwithstanding the materialization of CRISPR, reliable and adequate gene editing for human improvement is out of reach of the present technological performance. If the genetic breakthroughs continually improve each year, consequently the betterments provided to individuals delivered in any specified year will swiftly become superseded. (Sparrow, 2019)

Funding

This paper was supported by Grant GE-1843758 from the Social Analytics Laboratory, Los Angeles, CA.

Author Contributions

The author confirms being the sole contributor of this work and approved it for publication.

Conflict of Interest Statement

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Raluca Balica

ralu.balica@yahoo.com

University of Craiova, Romania

Received 19 March 2019

Accepted 23 July 2019

doi:10.22381/RCP1820197
Table 1 U.S. adults in each religious commitment group who say changing
a baby's genetic characteristics for each of the following reasons is
... (%) Treat a serious disease or condition the baby would have at
birth

         Taking medical technology    Appropriate use of medical
         too far                      technology

High     42                           58
Medium   29                           71
Low      19                           81

Reduce risk of a serious disease or condition that could occur over
their lifetime

         Taking medical technology    Appropriate use of medical
         too far                      technology

High     51                           49
Medium   42                           58
Low      24                           76

Make the baby more intelligent

         Taking medical technology    Appropriate use of medical
         too far                      technology

High     89                           11
Medium   80                           20
Low      69                           31

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 2 U.S. adults who say changing a baby's genetic characteristics
for each of the following reasons is an appropriate use of medical
technology (%)

Changing a baby's genetic characteristics            Women   Men

To treat a serious disease/condition the baby        66      72
would have at birth
To reduce risk of a serious disease/condition        53      62
that could occur over their lifetime
To make the baby more intelligent                    15      21
Gene editing to change a baby's genetic
characteristics
If it required testing on human embryos to           22      39
develop these techniques

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 3 U.S. adults who say... is likely to happen if gene editing
giving babies a much reduced disease risk (%)

Possible negative outcomes
This option will be used before we fully understand the effects     70
Inequality will increase; will only be available to the wealthy     64
People who have had this will feel superior to those who do not     51
Possible positive outcomes
People who have had this will feel more confident about themselves  49
People who have had this will be more productive at their jobs      31
Widespread use will lead to new innovation and problem solving      46

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 4 U.S. adults who say that if development of gene editing
required testing on human embryos, it would be... (%)

Taking medical technology too far       69
Appropriate use of medical technology   31

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 5 U.S. adults who say that if development of gene editing
required testing on human embryos, it would be... (%)

                         Appropriate use of   Taking medical
                         medical technology   technology too far

U.S. adults              31                   69
Religious affiliation
Protestant               23                   77
White evangelical        10                   90
White mainline           29                   71
Black Protestant         26                   74
Catholic                 29                   71
White Catholic           27                   73
Hispanic Catholic        26                   74
Unaffiliated             48                   52
Atheist                  77                   23
Agnostic                 54                   46
Nothing in particular    40                   60
Race/Ethnicity
White                    36                   64
Black                    28                   72
Hispanic                 30                   70

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 6 U.S. adults who say gene editing giving babies reduced risk of
serious diseases would be an appropriate use of technology (%) If it
resulted in people...

Far healthier than any human known to date           38
Much healthier than the average person today         50
Always equally healthy as the average person today   51

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 7 U.S. adults who say that gene editing giving babies a much
reduced disease risk... (%)

Is no different than other ways we try to better ourselves   56
Crosses a line, meddling with nature                         44

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.

Table 8 U.S. adults who say gene editing giving healthy babies a much
reduced risk of serious diseases and conditions... (%)

                               is no different than other ways
                               we try to better ourselves

U.S. adults                    49
Protestant                     41
Catholic                       42
Unaffiliated                   62
White evangelical Protestant   32
White mainline Protestant      51
Black Protestant               44
White Catholic                 41
Hispanic Catholic              42
Atheist                        78
Agnostic                       77
Nothing in particular          53
White                          49
Black                          46
Hispanic                       38

                               crosses a line, meddling
                               with nature

U.S. adults                    51
Protestant                     59
Catholic                       58
Unaffiliated                   38
White evangelical Protestant   68
White mainline Protestant      49
Black Protestant               56
White Catholic                 59
Hispanic Catholic              58
Atheist                        22
Agnostic                       23
Nothing in particular          47
White                          51
Black                          54
Hispanic                       62

Sources: Pew Research Center; my survey among 6,400 individuals
conducted January 2019.
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Author:Balica, Raluca
Publication:Review of Contemporary Philosophy
Date:Jan 1, 2019
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