scholarly journals EDITORIAL NEED OF OUR TIMES: IMPACT OF GENOME EDITING SCIENCES AND REQUISITE PREPAREDNESS FOR MOLECULAR BIOTERRORISM

2020 ◽  
Vol 70 (6) ◽  
pp. 1601-03
Author(s):  
Sikandar Hayat Khan
Keyword(s):  
Genome Editing ◽  
Germ Line ◽  
Life Forms ◽  
Human Embryos ◽  
Question Mark ◽  
Ethical Concerns ◽  
Point Of No Return ◽  
Synthetic Genomics ◽  
Community Struggles ◽  
Intelligent Creature

The pace of human evolution has accelerated at an unprecedented rate in the last couple of decades. Never ever before the mankind could witness a global hostage situation by a tiny invisible RNA creature. While the global community struggles at large finding plausible solutions in the information replete era, there are seriouslessons to be learnt. The tiny RNA monster has exposed the vulnerabilities of one the considered most intelligent creature posing a question mark about how to strike the intricate balance between preventive approaches and acquiring the postexposure immunity. The rapidly improving genome editing methods along with synthetic genomics has emerged as a double-edged weapon where on one side it opens newer therapeutic avenues to cure disease, but also its malicious use could results in disasters of limitless magnitudes.The delicate boundaries nature may face terrorism in newer clothes at the hands of nano technological tools to modify genome and synthesizing newer life forms. Unstoppable if it becomes can create man-made disasters with issues leading to emergence of black markets for cloning, designer humans ethnic-specific nucleotide editing for worse and possibly much more. The fiction we saw yesterday is today’s science and can lead the human race to point of no return. “He Jiankui affair” is still one of the genome editing dilemma widely criticized for ethical concerns emerging from germ line editing two human embryos for HIV using Cluster RegularlyInterspaced Short Palindromic Repeats (CRISPR) Cas technology.

scholarly journals Public and Stakeholder Engagement in Developing Human Heritable Genome Editing Policies: What Does it Mean and What Should it Mean?

2021 ◽  
Vol 3 ◽  
Author(s):  
Ana S. Iltis ◽  
Sarah Hoover ◽  
Kirstin R. W. Matthews
Keyword(s):  
Genome Editing ◽  
Stakeholder Engagement ◽  
Policy Development ◽  
Genetic Manipulation ◽  
Scientific Practice ◽  
Human Embryos ◽  
Unrealistic Optimism ◽  
Policy Makers ◽  
Ethical Concerns ◽  
New Treatments

As scientific research pushes the boundaries of knowledge, new discoveries and technologies often raise ethical and social questions. Public responses vary from surprise, to unrealistic optimism about imminent new treatments, confusion, and absolute opposition. Regardless of the intent, the use of a precise gene editing tool on human embryos, such as CRISPR-Cas9, is an example of such a controversial emerging technology. Substantive disagreement about the appropriate research pathways and permissible clinical applications is to be expected. Many ethical concerns, especially related to genetic manipulation of human embryos, are rooted in deeply held moral, religious, or ideological beliefs that science alone cannot address. Today, more scientists and scientific societies as well as policy makers are calling for public and stakeholder engagement in developing guidelines and policies governing scientific practice. We conducted a critical interpretive review of the literature on public and stakeholder engagement in science policy development regarding emerging technologies to determine the ideals that should guide engagement efforts of entities developing recommendations or guidelines on policy for such technologies. We identify and describe five ideals. To illustrate possible applications of these ideals, we review the engagement efforts described in three reports on heritable human genome editing and assess those efforts in light of these ideals. Finally, we recommend possible avenues for engagement that would advance those goals.

scholarly journals Frequent loss of heterozygosity in CRISPR-Cas9–edited early human embryos

2021 ◽  
Vol 118 (22) ◽  
pp. e2004832117
Author(s):  
Gregorio Alanis-Lobato ◽  
Jasmin Zohren ◽  
Afshan McCarthy ◽  
Norah M. E. Fogarty ◽  
Nada Kubikova ◽  
...  
Keyword(s):  
Genome Editing ◽  
Loss Of Heterozygosity ◽  
Germ Line ◽  
Basic Research ◽  
Preimplantation Embryos ◽  
Human Embryos ◽  
Gene Correction ◽  
Embryo Cells ◽  
Low Efficiency ◽  
Early Human

CRISPR-Cas9 genome editing is a promising technique for clinical applications, such as the correction of disease-associated alleles in somatic cells. The use of this approach has also been discussed in the context of heritable editing of the human germ line. However, studies assessing gene correction in early human embryos report low efficiency of mutation repair, high rates of mosaicism, and the possibility of unintended editing outcomes that may have pathologic consequences. We developed computational pipelines to assess single-cell genomics and transcriptomics datasets from OCT4 (POU5F1) CRISPR-Cas9–targeted and control human preimplantation embryos. This allowed us to evaluate on-target mutations that would be missed by more conventional genotyping techniques. We observed loss of heterozygosity in edited cells that spanned regions beyond the POU5F1 on-target locus, as well as segmental loss and gain of chromosome 6, on which the POU5F1 gene is located. Unintended genome editing outcomes were present in ∼16% of the human embryo cells analyzed and spanned 4–20 kb. Our observations are consistent with recent findings indicating complexity at on-target sites following CRISPR-Cas9 genome editing. Our work underscores the importance of further basic research to assess the safety of genome editing techniques in human embryos, which will inform debates about the potential clinical use of this technology.

The ethics of genome editing in the clinic: A dose of realism for healthcare leaders

2017 ◽  
Vol 30 (3) ◽  
pp. 159-163
Author(s):  
Tania Bubela ◽  
Yael Mansour ◽  
Dianne Nicol
Keyword(s):  
Genome Editing ◽  
Germ Line ◽  
Genetic Diseases ◽  
Somatic Cells ◽  
Clinical Translation ◽  
Preclinical Research ◽  
Societal Issues ◽  
Realistic Assessment ◽  
Healthcare Leaders

Genome editing technologies promise therapeutic advances for genetic diseases. We discuss the ethical and societal issues raised by these technologies, including their use in preclinical research, their potential to address mutations in somatic cells, and their potential to make germ line alterations that may be passed to subsequent generations. We call for a proportionate response from health leaders based on a realistic assessment of benefits, risks, and timelines for clinical translation.

Review of Article 27.3(b) and the Patenting of Life Forms: Hitting a BRIC Wall in the WTO?

2021 ◽  
Vol 26 (2) ◽  
pp. 289-318
Author(s):  
Jagjit Plahe ◽  
Nitesh Kukreja ◽  
Sunil Ponnamperuma
Keyword(s):  
Developing Countries ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Private Property ◽  
Life Forms ◽  
Private Property Rights ◽  
Ethical Concerns ◽  
The World ◽  
Over Time

Abstract Under Article 27.3(b) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO), all members are required to extend private property rights to life forms. Using official WTO documents, this article analyzes the negotiating positions of WTO members on life patents during a review of Article 27.3(b) which commenced in 1999 and is currently ongoing. Initially, developing countries raised serious ethical concerns regarding life patents, creating a clear North-South divide. However, over time the position of Brazil and India moved away from the ethics of life patents to the prevention of bio-piracy, a position supported by China. Russia too is supportive of life patents. A group of small developing countries have, however, continued to question the morality of life patents despite this “BRIC wall,” changing the dynamics of the negotiations from a North-South divide to one which now includes a South-South divide.

National and International Approaches to Human Germ-Line Gene Therapy

1994 ◽  
Vol 13 (1) ◽  
pp. 39-49 ◽  
Author(s):  
Andrea L. Bonnicksen
Keyword(s):  
Gene Therapy ◽  
Germ Line ◽  
Human Embryos ◽  
Foreseeable Future ◽  
National Policies ◽  
Medical Technologies ◽  
Line Therapy

Germ-line gene therapy, in which genetic flaws are corrected in the DNA of externally fertilized human embryos, lies in the distant yet foreseeable future. Worries about germ-line therapy have prompted international bodies to craft guidelines that are unusual for their anticipatory nature. Motivating these guidelines is the idea that a “transnational harmonization” of principles should be reached before national policies are developed. This article reviews selected national policies and international recommendations, and it concludes that national policies should be precedents for, rather than descendants of, international normative codes. The inclination to develop morally-based codes, which is implicit in transnational harmonization, will be more useful if grounded in empirically-based medical technologies and politically-tested policies rather than on abstract principles developed well in advance of technological feasibility.

scholarly journals Are we ready for genome editing in human embryos for clinical purposes?

2019 ◽  
Vol 62 (8) ◽  
pp. 103682 ◽  
Author(s):  
Joyce C. Harper ◽  
Gerald Schatten
Keyword(s):  
Genome Editing ◽  
Human Embryos

scholarly journals The technical risks of human gene editing

2019 ◽  
Vol 34 (11) ◽  
pp. 2104-2111 ◽  
Author(s):  
Benjamin Davies
Keyword(s):  
Genome Editing ◽  
Gene Editing ◽  
Human Gene ◽  
Ethical Concerns ◽  
Technical Risks ◽  
Genomic Mutation ◽  
Cas Gene

Abstract A recent report from Dr He Jiankui concerning the birth of twin girls harbouring mutations engineered by CRISPR/Cas nucleases has been met with international condemnation. Beside the serious ethical concerns, there are known technical risks associated with CRISPR/Cas gene editing which further raise questions about how these events could have been allowed to occur. Numerous studies have reported unexpected genomic mutation and mosaicism following the use of CRISPR/Cas nucleases, and it is currently unclear how prevalent these disadvantageous events are and how robust and sensitive the strategies to detect these unwanted events may be. Although Dr Jiankui’s study appears to have involved certain checks to ascertain these risks, the decision to implant the manipulated embryos, given these unknowns, must nonetheless be considered reckless. Here I review the technical concerns surrounding genome editing and consider the available data from Dr Jiankui in this context. Although the data remains unpublished, preventing a thorough assessment of what was performed, it seems clear that the rationale behind the undertaking was seriously flawed; the procedures involved substantial technical risks which, when added to the serious ethical concerns, fully justify the widespread criticism that the events have received.

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