This RAND Europe study examines oversight frameworks for emerging technologies, including organoids, embryology, engineering biology and neurotechnology. AI and data platforms are cross-cutting technologies relevant to all areas. The study informs policy and research stakeholders, analysing oversight mechanisms across jurisdictions. It highlights challenges and opportunities, and proposes priority considerations for ethical future applications.

State-of-play and future trends on the development of oversight frameworks for emerging technologies

Part 2: Technology oversight report

Sana Zakaria, Ioli Howard, Eva Coringrato, Anna Louise Todsen, Imogen Wade, Devika Kapoor, Alec Ross, Katarina Pisani, Chryssa Politi, Martin Szomszor, Salil Gunashekar

ResearchPublished Dec 16, 2024

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This RAND Europe study commissioned by Wellcome explores the current and future oversight frameworks for emerging technologies, focusing on organoids, human embryology, engineering biology and neurotechnology. AI and data platforms are considered as cross-cutting technologies with relevance to all other focus areas. The study aims to inform policy and research stakeholders by analysing a variety of oversight mechanisms across jurisdictions identified in Part 1 [AH1] of this study.

Part 2 highlights the challenges and opportunities in regulating these technologies, emphasising the need for updated frameworks that address ethical, privacy, and collaboration issues. In Part 2, we use a mixed-methods approach, including desk research, interviews, SWOT analysis and expert elicitation, to examine existing and developing oversight mechanisms. We provide insights into legislative and non-regulatory standards, ethical guidelines and self-regulatory frameworks relevant to key debates on oversight of emerging technologies, including on the lack of specific regulatory frameworks for organoids, ethical challenges in human embryology, fragmented oversight in engineering biology, and privacy concerns in neurotechnology. The study also discusses the potential for dual-use scenarios in neurotechnology and the need for international collaboration in managing biosecurity threats in engineering biology.

The report proposes eight priority considerations for future oversight, emphasising the importance of equity, international alignment, risk mitigation, public involvement and adaptive practices. These considerations aim to enhance the global oversight ecosystem and ensure ethical and beneficial applications of emerging technologies. The study underscores the importance of developing comprehensive oversight frameworks that can adapt to rapid technological advancements and address global challenges.

Key Findings

Lack of specific frameworks for organoids

  • There is an absence of specific regulatory frameworks for organoids, with current oversight relying on broader stem cell and biomedical regulations. Emerging mechanisms, such as Japan's consent-to-govern approach, are gaining traction to address ethical challenges, particularly around donor consent and privacy concerns.

Challenges in human embryology oversight

  • Existing frameworks, like the UK's Human Fertilisation and Embryology Act, are outdated and not designed for new technologies such as AI in embryo selection. Disparate national regulations complicate international collaboration, and there is a need for frameworks to adapt to scientific advancements and public interest.

Fragmented oversight in engineering biology

  • The global landscape features disparate oversight mechanisms, creating obstacles for international collaboration. There is a need for alignment across diverse applications and jurisdictions, with potential solutions including cross-sector collaboration and international biosecurity measures.

Neurotechnology oversight gaps

  • Current regulations do not address the unique challenges posed by neurotechnologies, such as data privacy and dual-use concerns. Ethical guidelines, like Chile's neurorights, offer proactive models, but there is a need for stronger post-market surveillance and international guidelines to prevent misuse.

Priority considerations for future oversight

  • The report outlines eight priority considerations, including developing interconnected oversight networks, ensuring equity, harmonizing international governance, fostering public involvement, and integrating adaptive and anticipatory strategies into oversight frameworks.

Recommendations

  • Develop comprehensive process maps and establish networks of interconnected oversight mechanisms to support stakeholders in effectively navigating the labyrinth of relevant mechanisms in the technology oversight landscape.
  • Ensure that equity considerations are prioritised and integrated into all aspects of technology oversight to promote fairness and inclusivity.
  • Identify and establish common ground for practical and actionable international alignment to harmonise governance practices across borders.
  • Intensify efforts to develop internationally coordinated risk mitigation strategies as part of implementing oversight mechanisms to address global challenges posed by emerging technologies.
  • Support the implementation and scaling of innovative oversight mechanisms to effectively manage the complexities and dynamics of emerging technologies.
  • Facilitate proactive public involvement in the development of oversight frameworks to ensure transparency and accountability.
  • Incorporate adaptive practices into oversight processes to foster continuous learning, flexibility and agility in response to technological advancements.
  • Integrate anticipatory strategies into oversight frameworks to prepare for and address future developments in emerging technologies.

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Citation

RAND Style Manual

Zakaria, Sana, Ioli Howard, Eva Coringrato, Anna Louise Todsen, Imogen Wade, Devika Kapoor, Alec Ross, Katarina Pisani, Chryssa Politi, Martin Szomszor, and Salil Gunashekar, State-of-play and future trends on the development of oversight frameworks for emerging technologies: Part 2: Technology oversight report, RAND Corporation, RR-A3215-2, 2024. As of May 1, 2025: https://www.rand.org/pubs/research_reports/RRA3215-2.html

Chicago Manual of Style

Zakaria, Sana, Ioli Howard, Eva Coringrato, Anna Louise Todsen, Imogen Wade, Devika Kapoor, Alec Ross, Katarina Pisani, Chryssa Politi, Martin Szomszor, and Salil Gunashekar, State-of-play and future trends on the development of oversight frameworks for emerging technologies: Part 2: Technology oversight report. Santa Monica, CA: RAND Corporation, 2024. https://www.rand.org/pubs/research_reports/RRA3215-2.html.
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This research was prepared for Wellcome Trust and conducted by RAND Europe.

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