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BioTech
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Biotechnology and Bioethics
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Biotechnology and Bioethics

A special issue of BioTech (ISSN 2673-6284). This special issue belongs to the section "Biotechnology Regulation".

Deadline for manuscript submissions: closed (30 April 2023) | Viewed by 69334

Printed Edition Available!
A printed edition of this Special Issue is available here.

Special Issue Editor

Dr. Vasiliki Mollaki

E-Mail Website
Guest Editor
National Bioethics Commission, Neofytou Vamva 6, 10674 Athens, Greece
Interests: human genetics; molecular genetics; bioethics; medical ethics

Special Issue Information

Dear Colleagues,

Biotechnology has provided scientific advancements which can be applied to a wide range of other fields including medicine, agriculture, and environmental science. Advanced therapies, genetically modified organisms (GMOs), genome-editing technologies such as CRISPR, and synthetic organisms are just a few examples of biotechnological applications with a high scientific impact. In parallel with their advantages and utility, these applications have raised—and continue to raise—major ethical, legal, and social implications. Over the last few decades, more traditional but also novel biotechnological advancements have generated vivid debates on ethical dilemmas, which in certain cases had an impact on developing national or international policies.

This Special Issue will focus on the ethical, legal, and societal concerns raised by applications of biotechnology. Colleagues from multiple disciplines including biosciences, medicine, law, and philosophy are invited to submit contributions including (but not limited to) the following issues:

Genome-editing technologies, GMOs, advanced therapies (e.g., stem cell and gene therapies), synthetic biology, nanotechnology, 3D bioprinting, patents in biotechnology, and biosafety.

We welcome the following article types: original research articles, reviews, and opinions.

Dr. Vasiliki Mollaki
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. BioTech is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • Biotechnology
  • Ethics
  • Legal implications
  • Social implications
  • Genome editing
  • GMOs
  • Cell and gene therapies
  • Synthetic biology
  • Biosafety
  • Policy

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Published Papers (10 papers)

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Research

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14 pages, 291 KiB  
Article
Evolved Eugenics and Reinforcement of “Othering”: Renewed Ethico-Legal Perspectives of Genome Editing in Reproduction
by Pin Lean Lau
BioTech 2023, 12(3), 51; https://doi.org/10.3390/biotech12030051 - 11 Jul 2023
Cited by 1 | Viewed by 4721
Abstract
This article extends an exploration into renewed ethico-legal perspectives of genome editing technologies, examined from an evolved conceptualization of eugenics in contemporary human reproduction. Whilst the ethico-legal conundrums presented by genome-editing technologies in various aspects of modern medicine have thus far inspired a [...] Read more.
This article extends an exploration into renewed ethico-legal perspectives of genome editing technologies, examined from an evolved conceptualization of eugenics in contemporary human reproduction. Whilst the ethico-legal conundrums presented by genome-editing technologies in various aspects of modern medicine have thus far inspired a comprehensive trove of academic scholarship—and notwithstanding the World Health Organization’s (WHO) publication of guidelines on human genome editing in 2021—the legislative landscape for these technologies remain relatively unchanged. Accordingly, this paper presents the unresolved problematic questions that still require significant reflection. First, the paper highlights these questions, which primarily center around the tension between reproductive autonomy and the legal governance of reproductive/genome editing technologies by a democratic state. Secondly, the paper interrogates the evolved conceptualization of eugenics, exercised on the part of prospective parents as part of reproductive autonomy. By this, the paper predicates that it indirectly reinforces societal and systemic problems of discrimination and “othering”, increasing reproductive inequalities in excluded communities. Thirdly, the paper attempts to offer narratives of intersectionality as a facilitating tool in a continuing dialogue to build belonging, foster a healthy and balanced exercise of reproductive autonomy, and increase reproductive equalities. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
13 pages, 910 KiB  
Article
Privacy Implications of Contacting the At-Risk Relatives of Patients with Medically Actionable Genetic Predisposition, with Patient Consent: A Hypothetical Australian Case Study
by Jane Tiller, Kristen Nowak, Tiffany Boughtwood and Margaret Otlowski
BioTech 2023, 12(2), 45; https://doi.org/10.3390/biotech12020045 - 2 Jun 2023
Cited by 2 | Viewed by 2725
Abstract
Genetic risk information has relevance for patients’ blood relatives. However, cascade testing uptake in at-risk families is <50%. International research supports direct notification of at-risk relatives by health professionals (HPs), with patient consent. However, HPs express concerns about the privacy implications of this [...] Read more.
Genetic risk information has relevance for patients’ blood relatives. However, cascade testing uptake in at-risk families is <50%. International research supports direct notification of at-risk relatives by health professionals (HPs), with patient consent. However, HPs express concerns about the privacy implications of this practice. Our privacy analysis, grounded in a clinically relevant hypothetical scenario, considers the types of personal information involved in direct notification of at-risk relatives and the application of Australian privacy regulations. It finds that collecting relatives’ contact details, and using those details (with patient consent) to notify relatives of possible genetic risk, does not breach Australian privacy law, providing that HPs adhere to regulatory requirements. It finds the purported “right to know” does not prevent disclosure of genetic information to at-risk relatives. Finally, the analysis confirms that the discretion available to HPs does not equate to a positive duty to warn at-risk relatives. Thus, direct notification of a patient’s at-risk relatives regarding medically actionable genetic information, with patient consent, is not a breach of Australian privacy regulations, providing it is conducted in accordance with the applicable principles set out. Clinical services should consider offering this service to patients where appropriate. National guidelines would assist with the clarification of the discretion for HPs. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
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17 pages, 287 KiB  
Article
Public Perceptions Regarding Genomic Technologies Applied to Breeding Farm Animals: A Qualitative Study
by Francis Z. Naab, David Coles, Ellen Goddard and Lynn J. Frewer
BioTech 2021, 10(4), 28; https://doi.org/10.3390/biotech10040028 - 3 Dec 2021
Cited by 8 | Viewed by 4606
Abstract
The societal acceptability of different applications of genomic technologies to animal production systems will determine whether their innovation trajectories will reach the commercialisation stage. Importantly, technological implementation and commercialisation trajectories, regulation, and policy development need to take account of public priorities and attitudes. [...] Read more.
The societal acceptability of different applications of genomic technologies to animal production systems will determine whether their innovation trajectories will reach the commercialisation stage. Importantly, technological implementation and commercialisation trajectories, regulation, and policy development need to take account of public priorities and attitudes. More effective co-production practices will ensure the application of genomic technologies to animals aligns with public priorities and are acceptable to society. Consumer rejection of, and limited demand for, animal products developed using novel genomic technologies will determine whether they are integration into the food system. However, little is known about whether genomic technologies that accelerate breeding but do not introduce cross-species genetic changes are more acceptable to consumers than those that do. Five focus groups, held in the north east of England, were used to explore the perceptions of, and attitudes towards, the use of genomic technologies in breeding farm animals for the human food supply chain. Overall, study participants were more positive towards genomic technologies applied to promote animal welfare (e.g., improved disease resistance), environmental sustainability, and human health. Animal “disenhancement” was viewed negatively and increased food production alone was not perceived as a potential benefit. In comparison to gene editing, research participants were most negative about genetic modification and the application of gene drives, independent of the benefits delivered. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
10 pages, 254 KiB  
Article
Synthetic Biology: Old and New Dilemmas—The Case of Artificial Life
by Nikolaos Kolisis and Fragiskos Kolisis
BioTech 2021, 10(3), 16; https://doi.org/10.3390/biotech10030016 - 20 Jul 2021
Cited by 3 | Viewed by 6739
Abstract
This article aims to examine some of the ethical questions emerging from the use of already existing biotechnological tools and the issues which might occur by synthetic biology’s potential future possibilities. In the first part, the essence of synthetic biology and its relation [...] Read more.
This article aims to examine some of the ethical questions emerging from the use of already existing biotechnological tools and the issues which might occur by synthetic biology’s potential future possibilities. In the first part, the essence of synthetic biology and its relation to the contemporary biotechnological research is analyzed. In the second part, the article examines whether the new biotechnological inventions pose new or revive old moral questions about the ethics of science, engineering, and technology in general. After briefly addressing some of the various issues which are raised by experts, philosophers, but also the general public, concerning synthetic biology in general, it focuses on the topic of “artificial life creation” and presents moral reasons which may or may not allow it. The topic is approached by referring to consequentialist, deontological, but also, virtue theory arguments for and against it and the possibility of a partial permission of “artificial life” experiments, asking whether the benefits outweigh the risks and moral implications is explored. Finally, it proposes an argument in favor of the future exploration of biological innovation, underlying the need for a more balanced access to its beneficial results. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
8 pages, 188 KiB  
Article
Artificial Intelligence in Biomedicine: A Legal Insight
by Takis Vidalis
BioTech 2021, 10(3), 15; https://doi.org/10.3390/biotech10030015 - 14 Jul 2021
Cited by 4 | Viewed by 4188
Abstract
The involvement of artificial intelligence in biomedicine promises better support for decision-making both in conventional and research medical practice. Yet two important issues emerge in relation to personal data handling, and the influence of AI on patient/doctor relationships. The development of AI algorithms [...] Read more.
The involvement of artificial intelligence in biomedicine promises better support for decision-making both in conventional and research medical practice. Yet two important issues emerge in relation to personal data handling, and the influence of AI on patient/doctor relationships. The development of AI algorithms presupposes extensive processing of big data in biobanks, for which procedures of compliance with data protection need to be ensured. This article addresses this problem in the framework of the EU legislation (GDPR) and explains the legal prerequisites pertinent to various categories of health data. Furthermore, the self-learning systems of AI may affect the fulfillment of medical duties, particularly if the attending physicians rely on unsupervised applications operating beyond their direct control. The article argues that the patient informed consent prerequisite plays a key role here, not only in conventional medical acts but also in clinical research procedures. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
19 pages, 290 KiB  
Article
Ethical Challenges in Organoid Use
by Vasiliki Mollaki
BioTech 2021, 10(3), 12; https://doi.org/10.3390/biotech10030012 - 28 Jun 2021
Cited by 32 | Viewed by 9525
Abstract
Organoids hold great promises for numerous applications in biomedicine and biotechnology. Despite its potential in science, organoid technology poses complex ethical challenges that may hinder any future benefits for patients and society. This study aims to analyze the multifaceted ethical issues raised by [...] Read more.
Organoids hold great promises for numerous applications in biomedicine and biotechnology. Despite its potential in science, organoid technology poses complex ethical challenges that may hinder any future benefits for patients and society. This study aims to analyze the multifaceted ethical issues raised by organoids and recommend measures that must be taken at various levels to ensure the ethical use and application of this technology. Organoid technology raises several serious ethics issues related to the source of stem cells for organoid creation, informed consent and privacy of cell donors, the moral and legal status of organoids, the potential acquisition of human “characteristics or qualities”, use of gene editing, creation of chimeras, organoid transplantation, commercialization and patentability, issues of equity in the resulting treatments, potential misuse and dual use issues and long-term storage in biobanks. Existing guidelines and regulatory frameworks that are applicable to organoids are also discussed. It is concluded that despite the serious ethical challenges posed by organoid use and biobanking, we have a moral obligation to support organoid research and ensure that we do not lose any of the potential benefits that organoids offer. In this direction, a four-step approach is recommended, which includes existing regulations and guidelines, special regulatory provisions that may be needed, public engagement and continuous monitoring of the rapid advancements in the field. This approach may help maximize the biomedical and social benefits of organoid technology and contribute to future governance models in organoid technology. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)

Review

Jump to: Research, Other

31 pages, 4942 KiB  
Review
Gene Therapy for Genetic Syndromes: Understanding the Current State to Guide Future Care
by Marian L. Henderson, Jacob K. Zieba, Xiaopeng Li, Daniel B. Campbell, Michael R. Williams, Daniel L. Vogt, Caleb P. Bupp, Yvonne M. Edgerly, Surender Rajasekaran, Nicholas L. Hartog, Jeremy W. Prokop and Jena M. Krueger
BioTech 2024, 13(1), 1; https://doi.org/10.3390/biotech13010001 - 3 Jan 2024
Cited by 6 | Viewed by 13322
Abstract
Gene therapy holds promise as a life-changing option for individuals with genetic variants that give rise to disease. FDA-approved gene therapies for Spinal Muscular Atrophy (SMA), cerebral adrenoleukodystrophy, β-Thalassemia, hemophilia A/B, retinal dystrophy, and Duchenne Muscular Dystrophy have generated buzz around the ability [...] Read more.
Gene therapy holds promise as a life-changing option for individuals with genetic variants that give rise to disease. FDA-approved gene therapies for Spinal Muscular Atrophy (SMA), cerebral adrenoleukodystrophy, β-Thalassemia, hemophilia A/B, retinal dystrophy, and Duchenne Muscular Dystrophy have generated buzz around the ability to change the course of genetic syndromes. However, this excitement risks over-expansion into areas of genetic disease that may not fit the current state of gene therapy. While in situ (targeted to an area) and ex vivo (removal of cells, delivery, and administration of cells) approaches show promise, they have a limited target ability. Broader in vivo gene therapy trials have shown various continued challenges, including immune response, use of immune suppressants correlating to secondary infections, unknown outcomes of overexpression, and challenges in driving tissue-specific corrections. Viral delivery systems can be associated with adverse outcomes such as hepatotoxicity and lethality if uncontrolled. In some cases, these risks are far outweighed by the potentially lethal syndromes for which these systems are being developed. Therefore, it is critical to evaluate the field of genetic diseases to perform cost–benefit analyses for gene therapy. In this work, we present the current state while setting forth tools and resources to guide informed directions to avoid foreseeable issues in gene therapy that could prevent the field from continued success. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
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12 pages, 345 KiB  
Review
Review of the Oscillation of Research Regulations for Bioethics in the Republic of Korea: Comparison with Japan
by Seung-Hyo Hyeon, Juyoung An, Hwa-Shin Ryoo and Min-Kyu Lee
BioTech 2023, 12(2), 47; https://doi.org/10.3390/biotech12020047 - 15 Jun 2023
Viewed by 2302
Abstract
The Bioethics Act in the Republic of Korea has undergone great fluctuations akin to the pendulum of a clock. Since Professor Hwang’s research ethics issue, domestic embryonic stem cell research has lost its vitality. This study argues that the Republic of Korea needs [...] Read more.
The Bioethics Act in the Republic of Korea has undergone great fluctuations akin to the pendulum of a clock. Since Professor Hwang’s research ethics issue, domestic embryonic stem cell research has lost its vitality. This study argues that the Republic of Korea needs a reference point that does not waiver. This study examined the characteristics of life science- and ethics-related systems in the Republic of Korea and Japan. It also examined the pendulum-like policy changes in the Republic of Korea. It then compared the strengths and weaknesses between the Republic of Korea and Japan. Finally, we proposed a system improvement strategy for the development of bioethics research in Asian countries. In particular, this study argues that the advantages of Japan’s slow but stable system should be introduced. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
14 pages, 290 KiB  
Review
Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU
by Michael F. Eckerstorfer, Marcin Grabowski, Matteo Lener, Margret Engelhard, Samson Simon, Marion Dolezel, Andreas Heissenberger and Christoph Lüthi
BioTech 2021, 10(3), 10; https://doi.org/10.3390/biotech10030010 - 22 Jun 2021
Cited by 19 | Viewed by 10514
Abstract
An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically [...] Read more.
An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)

Other

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8 pages, 918 KiB  
Opinion
Treatment of Rheumatoid Arthritis with Gene Therapy Applications: Biosafety and Bioethical Considerations
by Zinovia Tsitrouli, Maria-Anna Akritidou, Savvas Genitsaris and Gijsbert van Willigen
BioTech 2021, 10(3), 11; https://doi.org/10.3390/biotech10030011 - 23 Jun 2021
Cited by 2 | Viewed by 6004
Abstract
Rheumatoid Arthritis (RA) is an autoimmune and inflammatory disease that affects the synovium (lining that surrounds the joints), causing the immune system to attack its own healthy tissues. Treatment options, to the current day, have serious limitations and merely offer short-term alleviation to [...] Read more.
Rheumatoid Arthritis (RA) is an autoimmune and inflammatory disease that affects the synovium (lining that surrounds the joints), causing the immune system to attack its own healthy tissues. Treatment options, to the current day, have serious limitations and merely offer short-term alleviation to the pain. Using a theoretical exercise based on literature, a new potentially viable therapy has been proposed. The new therapy focusses on a long-term treatment of RA based on gene therapy, which is only active when inflammation of the joint occurs. This treatment will prevent side effects of systemic application of drugs. Furthermore, the benefits of this treatment for the patient from a socio-economic perspective has been discussed, focusing on the quality of life of the patent and lower costs for the society. Full article
(This article belongs to the Special Issue Biotechnology and Bioethics)
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