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1. The Safety & Ethics Of Gene Editing

​​What is Gene Editing?

  • It is a type of genetic engineering in which DNA is inserted, deleted or replaced in the genome of an organism using artificially engineered nucleases, or “molecular scissors”.

  • These nucleases create site-specific double-strand breaks (DSBs) at desired locations (e.g. where anomalous gene is present). Such breaks are then repaired through recombination or inserting new gene, resulting in



  • Many proponents of gene editing justify its use on the basis of utilitarian principles, that we may have a duty to cure or prevent diseases.

  • Human genome editing can be used to treat many human diseases & genetic disorders like HIV/AIDS, haemophilia etc.

  • It could substantially bolster disease resistance in humans & increase life span.

  • It could form the basis of highly efficient & cost effective next generation antibiotics (based on bacteriophage viruses).

  • Gene editing can be used to protect endangered species or bring to life extinct species.

  • It can be used to grow healthier food (via fortification) and increasing harvest.

  • It has the potential to slow down the spread of diseases by eliminating its means of transmission. E.g. Gene editing can be used to introduce sterile mosquitoes into the environment.targeted mutation.


Safety Concerns

  • Balance Risks & Benefits: Due to the possibility of off-target effects (edits in the wrong place creating properties different from those that were intended) and Mosaicism (when some cells carry the edit but others do not, leading to presence of two or more populations of cells), safety is of primary concern.

  • Application of the technique to human germline: Until now, all therapeutic interventions in humans using genome editing have been performed in somatic cells (i.e. only patient gets affected, no chance of inheriting the altered genes by patient’s offspring). Safety concerns have been raised regarding genome editing in human germline, where unpredictable changes can be transmitted to following generations.

  • Ecological impacts: A ‘gene drive’ can propagate a set of genes with negative traits throughout a population which may lead to disappearance of whole targeted population with severe ecological consequences.

  • Difficulty in regulation: The precise genetic modifications obtained through CRISPR Cas9 technique makes it more difficult to identify a genetically modified organism once outside the lab and also to regulate such organisms in the market.

  • The moral question that arises is whether benefits from the use of such unpredictable technology outweigh potential threats.


Ethical Challenges around Gene Editing

  • Concerns over ‘Designer Babies’: Engineering human embryos raises the prospect of designer babies, where embryos are altered for social rather than medical reasons e.g. to increase height or intelligence.

  • Justice and Equity: There is concern that genome editing will only be accessible to the wealthy and will increase existing disparities in access to health care and other interventions. Taken to its extreme, germline editing could create classes of individuals defined by quality of their engineered genome (e.g. super-intelligence/extra-ordinary beauty). Thus the use of genetic enhancement would lead to an abhorrent form of social inequality, and that is unjust.

  • Informed consent: Critics say that it is impossible to obtain informed consent for germline therapy because the patients affected by the edits are the embryo and future generations. Testing new technology on humans which may have inter-generational adverse impact without necessary safeguards amounts to treating humans as means to an end, a violation of Kantian ethical principle.

  • Genome-Editing Research Involving Embryos: Many people have moral and religious objections to the use of human embryos for research. India & Canada doesn’t allow genome-editing research on embryos, while US has banned federal aid from being used to support germline gene editing.

  • Regulations for consumers: Regulation of patents is challenging as many economic interests are involved and may lead to litigations. The case of biotechnological companies patenting human genome sequences for therapeutic use puts too much emphasis on profits, which raises ethical issues.


Moral Analysis

  • Risk Benefit Argument: There is a common agreement that if gene editing techniques are inherently dangerous, they should not be used on humans as of now. But, scientists think that with enough research, our understanding of genetic manipulations will improve and so will their safety and effectiveness. In that scenario, it would cause good to a large number of people and would be accepted based on utilitarian principles.

  • Principle of Beneficence: We are morally obligated to do good to others and to refrain from doing them harm. If we have an obligation to help people using conventional medical care, don’t we also have a duty to help them using extraordinary means (genetic interventions)?

  • Principle of Autonomy: Proponents of both gene therapy and enhancement also appeal to the principle of autonomy, the idea that persons have a right of self-determination. Since we have reproductive freedom (right to produce children or not), we also have the right to take pre-emptive measures that could save them from a disease or disability. A counterargument is that the principle of autonomy is not absolute: there are limits to our right of self-determination, and genetic interventions (especially germ-line changes) take it to an extent where society as a whole would be harmed (against utilitarian principles).


Way Forward

  • The scientific community must lay down principles to distinguish between ‘good’ & ‘bad’ uses of gene editing:

  • Promoting Wellbeing: Research must be designed to increase human health and wellbeing. Early stage and uncertain applications must minimize risk.

  • Transparency: Researchers must fully disclose information about benefits, risks, and implications to stakeholders.

  • Due Care: Clinical research involving human patients must proceed cautiously and conservatively, only upon full evaluation of evidence, and under strict supervision.

  • Responsible Science: Research must adhere to the highest experimental and analytical standards.

  • Respect for Persons: Research must acknowledge the dignity of all individuals and that all individuals have equal moral value, regardless of their genetic profile.

  • Equity: Benefits & burdens of the research must be broadly and equitably accessible.

  • Transnational Cooperation: Researchers must commit to international collaboration to harmonize regulation of the application of genome editing technologies.

  • Bioethicists & researchers believe that human genome editing for reproductive purposes should not be attempted at this time until more safety and effectiveness research can be done, risks & benefits weighed, and a social consensus reached. All clinical trials proceeding in human germline editing should be permitted only when there are no reasonable alternative forms of disease prevention.

  • It is important to have continuing public deliberation to decide whether or not germline editing should be permissible. Till that time, studies that would make gene therapy safe and effective should continue.

December Ethical Issues

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