Ethical framework on risk governance of synthetic biology

Bohua, Liao; Yuexin, Wang; Yakun, Ou; Kunlan, Zuo; Huan, Liu; Ruipeng, Lei

doi:10.1016/j.jobb.2023.03.002

Cited by 7 publications

(3 citation statements)

References 67 publications

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“…Social dynamics such as differing notions and rationales surrounding bioethics ( Szocik et al, 2021 ; Bohua et al, 2023 ), social acceptance ( Bauer and Bogner, 2020 ; Frow, 2020 ), also play a part.…”

Section: Discussionmentioning

confidence: 99%

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks

Undheim

2024

Front. Bioeng. Biotechnol.

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AI-enabled synthetic biology has tremendous potential but also significantly increases biorisks and brings about a new set of dual use concerns. The picture is complicated given the vast innovations envisioned to emerge by combining emerging technologies, as AI-enabled synthetic biology potentially scales up bioengineering into industrial biomanufacturing. However, the literature review indicates that goals such as maintaining a reasonable scope for innovation, or more ambitiously to foster a huge bioeconomy do not necessarily contrast with biosafety, but need to go hand in hand. This paper presents a literature review of the issues and describes emerging frameworks for policy and practice that transverse the options of command-and-control, stewardship, bottom-up, and laissez-faire governance. How to achieve early warning systems that enable prevention and mitigation of future AI-enabled biohazards from the lab, from deliberate misuse, or from the public realm, will constantly need to evolve, and adaptive, interactive approaches should emerge. Although biorisk is subject to an established governance regime, and scientists generally adhere to biosafety protocols, even experimental, but legitimate use by scientists could lead to unexpected developments. Recent advances in chatbots enabled by generative AI have revived fears that advanced biological insight can more easily get into the hands of malignant individuals or organizations. Given these sets of issues, society needs to rethink how AI-enabled synthetic biology should be governed. The suggested way to visualize the challenge at hand is whack-a-mole governance, although the emerging solutions are perhaps not so different either.

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Section: Discussionmentioning

confidence: 99%

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks

Undheim

2024

Front. Bioeng. Biotechnol.

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“…The environmental risks posed by synthetic biology primarily encompass: change or depletion of the environment; competition with native species; horizontal gene transfer; and pathogenicity or toxicity ( Hewett et al, 2016 ). The impact of synthetic organisms or pathogens is also contingent upon factors such as the species which is designed, the nature of the change, the site of release, and the characteristics of genetic modification, particularly when alterations transpire in the toxicity, infectivity, adaptability, and host interaction mechanisms of pathogenic organisms ( Bohua et al, 2023 ). In certain instances, once synthetic organisms or pathogens are inadvertently released, their harm may be amplified through ecological cycles, ultimately surpassing the carrying capacity of ecosystems and inflicting greater collateral damage.…”

Section: An Analysis Of the Safety Risks Pertaining To The Applicatio...mentioning

confidence: 99%

Safety risks and ethical governance of biomedical applications of synthetic biology

Ou,

Guo

2023

Front. Bioeng. Biotechnol.

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Background: In recent years, biomedicine has witnessed rapid advancements in applying synthetic biology. While these advancements have brought numerous benefits to patients, they have also given rise to a series of safety concerns.Methods: This article provides a succinct overview of the current research on synthetic biology’s application in biomedicine and systematically analyzes the safety risks associated with this field. Based on this analysis, the article proposes fundamental principles for addressing these issues and presents practical recommendations for ethical governance.Results: This article contends that the primary safety risks associated with the application of synthetic biology in biomedicine include participant safety, biosafety risks, and biosecurity risks. In order to effectively address these risks, it is essential to adhere to the principles of human-centeredness, non-maleficence, sustainability, and reasonable risk control. Guided by these fundamental principles and taking into account China’s specific circumstances, this article presents practical recommendations for ethical governance, which include strengthening ethical review, promoting the development and implementation of relevant policies, improving legal safeguards through top-level design, and enhancing technical capabilities for biocontainment.Conclusion: As an emerging field of scientific technology, synthetic biology presents numerous safety risks and challenges in its application within biomedicine. In order to address these risks and challenges, it is imperative that appropriate measures be implemented. From a Chinese perspective, the solutions we propose serve not only to advance the domestic development of synthetic biology but also to contribute to its global progress.

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“…While the Biosecurity Law —which forms the core of China’s national biosecurity legal system—has been enacted, and a legal framework for human genetic resources is under development, efforts to improve protection and supervision systems for human subjects in biomedical research and clinical trials of new biomedical technologies are ongoing ( Peng et al, 2022 ; Bohua et al, 2023 ). However, disagreements remain over these regulatory systems’ conceptualization, content, structure, and implementation.…”

Section: Policy Recommendationsmentioning

confidence: 99%

Analysis of ethics dumping and proposed solutions in the field of biomedical research in China

Liao,

Ma,

Lei

2023

Front. Pharmacol.

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As international academic exchanges and cooperation deepen, China has actively engaged in international biomedical research collaboration and achieved significant success. However, these accomplishments have been accompanied by ethical controversies and issues, with ethics dumping being a recurrently discussed focus among scholars. This paper reviews ethics dumping incidents in China’s biomedical research field and analyzes the underlying causes to answer why China is often susceptible to ethics dumping. We argue that the primary reasons include weak ethical awareness among some researchers, an oversimplified research evaluation system, gaps in relevant ethics governance and oversight mechanisms, and limited capabilities of certain ethics committees. To address these issues, we propose five ethics governance recommendations: establishing refined ethics committees at various levels and types; advancing theoretical and practical research on science and technology ethics governance; strengthening legislation and regulation related to emerging science and technology; emphasizing self-regulation and capacity building of research institutions; and providing special protection and healthcare for victims of ethics dumping. The aim is to enhance China’s research supervision system and prevent similar ethics dumping incidents from recurring.

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Ethical framework on risk governance of synthetic biology

Cited by 7 publications

References 67 publications

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks

The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks

Safety risks and ethical governance of biomedical applications of synthetic biology

Analysis of ethics dumping and proposed solutions in the field of biomedical research in China

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