12.3 Bioethics and genetic engineering
7 min read•august 14, 2024
and raise complex legal and ethical issues as technology advances. From to , these developments challenge our moral frameworks and regulatory systems.
Laws aim to balance scientific progress with safety and ethics. But oversight faces challenges like inconsistent international regulations and keeping pace with rapid innovations. Key concerns include , , and protecting future generations' rights.
Legal and Ethical Issues in Biotechnology
Ethical Concerns in Genetic Engineering
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- Genetic engineering involves the direct manipulation of an organism's genes using biotechnology, which raises significant ethical issues around how this technology should be developed and applied
- The is a key ethical concern in embryonic stem cell research
- There is debate over whether embryos have the same moral considerations as fully developed humans
- Destroying embryos for research purposes is seen by some as a violation of the embryo's moral status
- Human , which would pass changes to future generations, raises questions about the permissibility of this practice
- Germline editing could have unpredictable effects on future persons who cannot consent to the changes
- There are concerns that germline editing violates the and rights of future individuals
- Ensuring equitable access to beneficial genetic technologies is an important ethical consideration
- If access is limited to the wealthy, it could exacerbate existing social and health inequalities
- Distributing the benefits of genetic engineering fairly across society is a key challenge
- Unintended ecological consequences of releasing into the environment is another area of ethical concern
- Genetically engineered crops (corn, soybeans) or animals (salmon) could disrupt ecosystems in unforeseen ways
- There are worries about the long-term safety and sustainability of genetic modifications in the biosphere
Legal Issues in Regulating Genetic Engineering
- Regulation of genetic engineering research is a major legal issue
- Laws aim to ensure research is conducted safely and ethically
- However, overly restrictive regulations can stifle scientific innovation and progress
- over discoveries and inventions in genetic engineering are another key legal consideration
- on genes, engineered organisms, or processes can incentivize research but also limit access
- Balancing private intellectual property with public access to benefits is an ongoing challenge
- Safety requirements for and medical treatments using genetic engineering are critical legal issues
- Rigorous testing in animals and phased human trials are legally required to protect patient safety
- Accelerated approval pathways are sometimes used for breakthrough gene therapies for rare diseases
- Many jurisdictions place legal restrictions on using genetic engineering for
- Enhancing traits like intelligence or athleticism is often prohibited to prevent unfair advantages
- Distinguishing treatment vs. enhancement can be legally and ethically complex in practice
- The states that given the profound impacts, genetic engineering should be very carefully regulated until safety and social implications are thoroughly understood
- Proponents argue it is necessary to carefully control a powerful technology with immense consequences
- Critics contend that excessive precaution can stifle useful innovation and slow development of beneficial applications
Gene Editing and Human Rights
Implications of Gene Editing Capabilities
- Gene editing tools like are making it easier, cheaper and more precise to modify DNA sequences in living cells, rapidly accelerating capabilities in genetic engineering
- CRISPR allows targeted editing of genomes in unprecedented ways, from microbes to plants to animals
- The technique has spread rapidly in research labs around the world since its development in 2012
- aimed at curing disease are less controversial than germline editing of embryos
- Somatic therapies (CAR-T cells for cancer) only affect the treated individual and are seen as an extension of medicine
- Germline editing would alter the embryo in ways that are passed to future generations with unpredictable effects
- Many ethicists argue germline editing violates the of future persons
- Embryos cannot consent to having their genome edited in ways that will affect their descendants
- Germline editing is seen as a violation of the autonomy and self-determination rights of future generations
Equity and Fairness Issues in Gene Editing
- Unequal access to beneficial gene therapies could exacerbate health inequities between rich and poor
- High costs could limit accessibility of curative treatments (sickle cell disease) to disadvantaged populations
- This raises justice concerns about equitable sharing of benefits from scientific advances
- Genetic enhancement of traits like intelligence or athleticism would raise serious concerns about fairness and social equality
- Enhancements could give unfair social, economic and political advantages to those with access
- This could create new forms of discrimination and increase inequality in society
- Misuse of gene editing for eugenic applications, like selecting for specific traits in offspring, could undermine human rights
- It would compromise the child's right to an open future and enable new forms of discriminatory selection
- There are worries it could lead to greater intolerance of disability and diversity in society
- and governance are needed to define the line between acceptable and unacceptable uses
- Broad societal consensus is required on if/when germline editing or enhancement might be permissible
- Regulation, oversight and public participation in decision-making is critical to protect human rights
Law's Role in Regulating Genetic Engineering
Balancing Benefits and Risks Through Oversight
- Laws and regulations aim to balance enabling scientific progress with protecting safety and ethical values
- Overly permissive regulation risks allowing unethical or unsafe research and applications
- Overly restrictive regulation can impede development of beneficial therapies and technologies
- Oversight of genetic engineering often happens at multiple levels
- International level (UN declarations)
- National level (laws, regulatory agencies)
- Professional societies (research guidelines, ethics codes)
- Research institutions (ethics review boards, biosafety committees)
- Federally funded research is regulated more stringently than private sector research, creating inconsistencies
- Government funding comes with requirements for oversight, transparency and limits on embryo research
- Privately funded research has more flexibility to pursue controversial areas and face less scrutiny
- Ethical oversight focuses heavily on research while deployment of technologies receives less scrutiny
- Most oversight happens at the research stage in designing and conducting studies
- Less attention is paid to downstream uses and societal impacts of technologies once developed
Challenges in Effective Governance of Genetic Engineering
- Strict regulations can push cutting-edge research to countries with lax oversight
- Inconsistent international regulations create opportunities for researchers to evade restrictions
- Raises concerns about safety, ethics dumping and a race to the bottom in standards
- Some argue professional ethics codes and institutional policies are better suited than inflexible laws for rapidly evolving science
- Laws are slow to adapt to new technologies and can quickly become outdated
- Governance based on ethical principles and scientific best practices can be more responsive
- Achieving public trust and legitimacy in governance of genetic engineering is an ongoing challenge
- Perceived conflicts of interest and lack of transparency can undermine confidence in oversight
- Mechanisms for public input, deliberation and representation in policymaking are important
International Law for Bioethics and Biotechnology
Key International Frameworks
- UNESCO's Universal Declaration on Bioethics and Human Rights outlines key ethical principles for medicine and life sciences
- Respect for autonomy, consent, privacy and confidentiality
- Non-discrimination and non-stigmatization
- Equitable access to medical and scientific benefits
- However, as a non-binding declaration, it lacks strong enforcement power
- The UN's Convention on Biological Diversity addresses conservation, sustainable use, and equitable sharing of benefits from genetic resources
- Recognizes national sovereignty over genetic resources and calls for prior informed consent for access
- Establishes principles for fair and equitable sharing of benefits arising from use of genetic resources
- The Cartagena Protocol, a supplement to the CBD, regulates transboundary movement of living modified organisms
- Aims to protect biodiversity from potential risks of genetically modified organisms
- Establishes an advance informed agreement procedure for importing GMOs
- The World Trade Organization's TRIPS Agreement sets global standards for intellectual property rights over biotechnology innovations
- Requires countries to provide patent protection for biotechnology products and processes
- Has implications for access to medicines and sharing of benefits from genetic resources
Challenges in Global Governance of Biotechnology
- Harmonization of international laws is challenging given cultural and political diversity
- Countries have different values, priorities and capacities for regulation
- Tension between promoting innovation and precaution, as well as between IP and access
- International treaties often have limited practical impact due to weak enforcement mechanisms
- Compliance often relies on peer pressure and reputational incentives rather than sanctions
- Monitoring capacities and resources are often insufficient to ensure adherence
- Effective global governance increasingly relies on diverse networks of actors and institutions
- Multilateral organizations (UN, WHO, OECD)
- Non-governmental organizations (professional societies, patient advocates, environmental groups)
- Scientific and technical advisory bodies
- Corporations and industry associations
- Coordination and coherence between different international instruments and national laws remains an ongoing effort
- Overlapping scope and inconsistencies between agreements can create confusion and gaps
- Aligning standards and building synergies is critical for an integrated governance framework
Key Terms to Review (29)
Autonomy: Autonomy refers to the capacity of an individual to make informed, uncoerced decisions regarding their own life and actions. It is rooted in the principle of self-determination, emphasizing the importance of personal choice and freedom in both moral and legal contexts. The concept of autonomy connects deeply with issues of consent, personal rights, and the ethical implications of decision-making, especially in sensitive areas like healthcare, privacy, and regulatory frameworks.
Bioethics: Bioethics is a field that addresses the ethical implications of biological and medical research, particularly in the context of healthcare, life sciences, and technologies. It explores moral dilemmas related to health, reproduction, and genetic engineering, examining how these issues intersect with human rights, societal values, and legal frameworks.
Clinical trials: Clinical trials are research studies conducted with human participants to evaluate the safety, efficacy, and optimal dosing of new medical interventions, including drugs, therapies, and medical devices. They are essential for advancing medical knowledge and ensuring that new treatments meet regulatory standards before being approved for public use.
Crispr-cas9: CRISPR-Cas9 is a groundbreaking gene-editing technology that allows scientists to modify DNA with high precision, efficiency, and flexibility. This system uses a guide RNA to direct the Cas9 enzyme to a specific location in the genome, where it creates a double-strand break. This innovative method has vast implications for genetic engineering, opening doors for advancements in medicine, agriculture, and bioethics discussions surrounding genetic manipulation.
Embryonic stem cell research: Embryonic stem cell research involves the study and use of stem cells derived from early-stage embryos to understand development and to potentially create therapies for various diseases. This type of research holds promise for regenerative medicine, as these cells can differentiate into any cell type in the body, making them a powerful tool in medical science. However, it raises ethical concerns regarding the moral status of embryos and the implications of manipulating human life.
Equitable access: Equitable access refers to the principle that individuals should have fair and just opportunities to obtain resources, services, and benefits, regardless of their background or circumstances. This concept is especially crucial in the context of healthcare and technology, ensuring that everyone has the chance to benefit from advancements like genetic engineering without facing barriers such as socioeconomic status, geographic location, or discrimination.
Eugenics: Eugenics is a social and scientific movement aimed at improving the genetic quality of a human population through selective breeding and other interventions. This term connects to various ethical considerations surrounding genetic engineering, especially in terms of potential discrimination, the definition of 'desirable' traits, and the moral implications of manipulating human genetics.
Gene therapy: Gene therapy is a medical technique that aims to treat or prevent disease by modifying the genes within an individual's cells. This process can involve inserting, altering, or removing genes to correct genetic disorders or enhance the body's ability to fight diseases, such as cancer. Gene therapy is closely related to advancements in genetic engineering and raises significant bioethical considerations regarding its use and potential implications for society.
Genetic discrimination: Genetic discrimination refers to the unfair treatment of individuals based on their genetic information, which may reveal predispositions to certain health conditions or traits. This type of discrimination can manifest in various areas, including employment, insurance, and social interactions, and raises significant ethical concerns within the context of genetic engineering and bioethics. It highlights the tension between scientific advancements in understanding genetics and the need for protections against misuse of such information.
Genetic engineering: Genetic engineering is the direct manipulation of an organism's genes using biotechnology to alter its characteristics. This technology allows scientists to add, remove, or modify DNA sequences in living organisms, leading to potential applications in medicine, agriculture, and research. The ethical implications of genetic engineering raise significant bioethical questions about its use, including concerns about safety, consent, and long-term effects on biodiversity.
Genetically modified organisms: Genetically modified organisms (GMOs) are living entities whose genetic material has been altered through biotechnology for specific purposes, such as improving crop yields, enhancing resistance to pests, or developing pharmaceuticals. The creation and use of GMOs raise important ethical questions and concerns related to bioethics, including their impact on health, the environment, and food security.
Genome editing ethics: Genome editing ethics refers to the moral principles and considerations surrounding the use of technologies that modify the genetic material of living organisms, including humans. This field raises crucial questions about the implications of altering genes, particularly regarding safety, consent, and potential long-term effects on individuals and society. The debates in genome editing ethics focus on the responsibilities of researchers, the rights of patients, and the societal impacts of such groundbreaking technology.
Germline editing: Germline editing refers to the modification of the genes in the germ cells (sperm and eggs) of an organism, allowing for changes to be passed down to future generations. This technique can potentially eradicate genetic disorders, enhance certain traits, or create new genetic combinations, raising significant ethical questions about its implications on human evolution and societal norms.
Henrietta Lacks: Henrietta Lacks was an African American woman whose cancer cells were taken without her knowledge in 1951, leading to the creation of the HeLa cell line. This cell line has been pivotal in medical research and has contributed to numerous scientific breakthroughs, raising ethical concerns about consent, race, and medical experimentation.
Human enhancement applications: Human enhancement applications refer to technologies and methods used to improve human physical and mental capabilities beyond what is considered normal or necessary. This includes advancements in genetic engineering, biotechnology, and other innovations aimed at enhancing traits such as intelligence, strength, and longevity. These applications raise important ethical questions about the nature of humanity, equality, and the potential consequences of altering human characteristics.
Human germline editing: Human germline editing is the process of making changes to the genetic material of human embryos, sperm, or eggs that can be inherited by future generations. This technique aims to correct genetic disorders or enhance certain traits, raising significant ethical questions about its implications for humanity. The ability to edit the germline directly challenges traditional concepts of inheritance and poses moral dilemmas regarding what it means to be human.
Human rights: Human rights are fundamental entitlements that belong to every individual simply by virtue of being human. These rights are universal, inalienable, and indivisible, meaning they cannot be taken away and are applicable to all people regardless of nationality, ethnicity, or gender. The concept of human rights serves as a cornerstone for ethical discussions, particularly in bioethics and genetic engineering, where the implications of scientific advancements must be weighed against the respect for human dignity and individual freedoms.
Institutional Review Board (IRB): An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that the study is ethical and that participants' rights are protected. The IRB evaluates the potential risks and benefits of the research, helping to maintain ethical standards in studies, especially in fields like bioethics and genetic engineering where ethical concerns are particularly prominent.
Intellectual Property Rights: Intellectual property rights (IPR) are legal protections granted to creators and inventors for their original works and inventions, allowing them to control the use of their creations and to benefit financially from them. These rights encourage innovation and creativity by ensuring that creators can reap the rewards of their efforts, fostering an environment where new ideas can flourish. In the context of bioethics and genetic engineering, IPR raises important questions about ownership, ethical use, and the implications of patenting genetic material and biotechnological inventions.
Leon Kass: Leon Kass is a prominent American physician and philosopher known for his work in bioethics, particularly concerning genetic engineering and biotechnology. He has critically examined the ethical implications of advancements in these fields, advocating for a more cautious and reflective approach to human enhancement and reproductive technologies.
Moral status of embryos: The moral status of embryos refers to the ethical considerations regarding the rights and value assigned to embryos in the context of moral and legal discussions. This concept is pivotal when addressing issues like abortion, reproductive rights, and genetic engineering, as it influences how society perceives the beginning of human life and its implications for bioethics.
National Bioethics Advisory Commission: The National Bioethics Advisory Commission (NBAC) was a U.S. government body established in 1995 to address ethical issues arising from advances in biomedical and behavioral research. Its main purpose was to provide guidance and recommendations on the ethical, legal, and social implications of research, particularly focusing on genetics, human subjects, and emerging technologies.
Patents: Patents are legal rights granted by a government to an inventor, providing exclusive rights to produce, use, and sell an invention for a specified period, usually 20 years. This protection encourages innovation by allowing inventors to potentially profit from their inventions without the fear of competition. In the context of bioethics and genetic engineering, patents play a critical role in determining ownership over biotechnological advancements, including genetically modified organisms and medical therapies derived from genetic research.
Peter Singer: Peter Singer is an influential contemporary philosopher known for his work in bioethics, particularly concerning animal rights and utilitarianism. He advocates for ethical considerations in the realm of genetic engineering, emphasizing the moral implications of human actions on non-human life and the importance of reducing suffering. His ideas challenge traditional views and promote a utilitarian framework that assesses the consequences of actions on all sentient beings.
Precautionary principle: The precautionary principle is a strategy for approaching uncertain risks, suggesting that the absence of full scientific certainty should not be used as a reason to postpone measures to prevent potential harm to the public or the environment. This principle emphasizes the importance of preventive action in the face of uncertainty and shifts the burden of proof onto those advocating for potentially harmful activities or technologies.
Robust ethical frameworks: Robust ethical frameworks are comprehensive systems of principles and guidelines that help individuals and societies navigate complex moral issues, particularly in areas where the implications of actions can be profound. These frameworks are crucial in establishing standards for evaluating ethical dilemmas, ensuring that decisions are informed by a deep understanding of values, consequences, and societal impacts. In the context of bioethics and genetic engineering, these frameworks guide discussions on the ethical considerations of manipulating genetic material, balancing innovation with moral responsibility.
Somatic gene therapies: Somatic gene therapies involve the introduction, removal, or alteration of genetic material within the somatic cells of a patient to treat or prevent disease. Unlike germline therapies, which affect reproductive cells and can be passed to future generations, somatic therapies target specific tissues in the individual, aiming to correct genetic defects and improve health outcomes without impacting the patient’s offspring.
Tuskegee Study: The Tuskegee Study was an infamous clinical study conducted between 1932 and 1972 in Alabama, where African American men with syphilis were deliberately left untreated to study the disease's progression. This study is a critical example of ethical violations in medical research, illustrating the exploitation of marginalized populations and raising profound questions about consent and the ethical treatment of human subjects.
Unintended consequences: Unintended consequences refer to outcomes that are not anticipated or intended as a result of an action or decision. These can be positive, negative, or neutral, and they often occur in complex systems where multiple variables interact in unpredictable ways. Understanding unintended consequences is particularly important in areas like bioethics and genetic engineering, where interventions can lead to unforeseen effects on individuals, societies, and ecosystems.