Ethics in innovation: A guiding principle for science and science policy

Advancing rare disease clinical trials on an international scale: Barriers and emerging solutions

Rare diseases affect over 300 million people worldwide, yet only 5% of these conditions have approved treatments. A key obstacle to rare disease drug development is designing clinical trials that can accommodate small patient populations and high disease heterogeneity. Increasingly, rare disease clinical trials are being conducted across multiple countries, which improves patient recruitment and therapeutic validity. However, international clinical trials introduce complex regulatory, financial, legal, and ethical challenges. These challenges can impede trial execution and ultimately delay access to treatment, particularly in low- and middle-income countries (LMICs). In this review, we explore the evolving landscape of international rare disease clinical trials. We discuss current barriers and strategies to harmonize global regulations, incentivize financial investment, adapt intellectual property frameworks, and enhance LMIC participation. By identifying both structural gaps and promising initiatives, we aim to provide a resource that supports more effective and globally inclusive rare disease research.

Artificial intelligence in biomedical diagnostics: Recent advances and transitions to liable regulation

Artificial intelligence (AI) technology has revolutionized the healthcare industry by enhancing the accuracy, efficiency, cost-effectiveness, and automation of modern biomedical diagnostics. AI algorithms and models such as machine learning (ML), deep learning (DL), natural language processing (NLP), tensor computing, and generative artificial intelligence have made significant progress and are integral in biomedical diagnosis. However, the development of AI in the biomedical field faces challenges related to policy regulation and ethical issues that need to be addressed for continued progress. This article briefly reviews the recent progress of AI technology in biomedical diagnosis and related policy regulation issues. We aim to provide new insights into transforming AI for biomedical diagnosis towards more liable, effective regulation and improve adaptive innovation of enterprises.

Emerging biotechnologies: Dual-use potential and strategies to prevent misuse

Biotechnologies such as gene editing, bioinformatics, and bioprinting are rapidly advancing and finding impact across medicine and agriculture. Biotechnologies are being made readily available to everyone (democratized), accessible and modifiable via an internet-accessible electronic device (digitalized), and easily shared across borders (globalized). However, with speedy development comes risks and vulnerabilities that necessitate safeguards. Dual-use research of concern (DURC) biotechnology can be weaponized for acts of bioterrorism—the intentional spread of biological agents, such as viruses or bacteria, to harm living beings including humans, animals, and plants. Our increasing ability to fabricate and modify living cells and tissues for research and therapies through gene editing, bioinformatics, and bioprinting poses many new ethical questions and challenges with few clearly established regulatory pathways. Regulating access to and utilization of biotechnologies while continuing to foster their innovation is challenging. This review explores the potential misuse of several biotechnologies and possible consequences thereof and to identify successes and persisting gaps in current and proposed mitigation strategies for DURC biotechnologies.

A decennial review of health disparities among the growing Bi+ population in the United States

Nearly 14 million individuals in the United States (U.S.) currently identify as Bi+ (bisexual, pansexual and other terms), and this segment of the population–5.2% of adults–is growing each year. Yet, marginalization by monosexual (i.e., heterosexual and homosexual) communities has resulted in significant health disparities for Bi+ populations. With a focus on research that has emerged in the past decade, this review describes current conceptualizations of the mechanisms underlying Bi+ health disparities and available high-quality evidence for Bi+ health disparities related to healthcare access, mental health, diagnosis and prevention of HIV and Mpox virus, and other physical health conditions. As the Bi+ population includes substantial racial/ethnic and gender diversity, we discuss the intersection and nuanced effect of these demographic factors on Bi+ health disparities. Findings from this decennial Review reveal challenges and opportunities for policies to reduce health disparities among the rapidly growing Bi+ population in the U.S.

A leap in longevity? The future of aging research in the United States

Over three million Americans died in 2023, mostly due to age-related diseases such as cancer, heart disease, strokes, and diabetes. Most research of these maladies takes a disease-centric approach; that is, researchers consider their causes and treatments to be distinct and somewhat independent. However, an alternative known as the geroscience approach posits that aging can be a distinct biological phenomenon upstream of age-related diseases that can be targeted to prevent many of them simultaneously. In this review, we examine the relative scientific merits of each approach and analyze their current role in the landscape of U.S. biological research funding. Finally, we highlight future research funding opportunities for the prevention of age-related diseases and the extension of healthy lifespan in humans.

Exosomes: Regulation for neurodegenerative therapy requires a specialized approach

Those aged 65 years and older are at high risk for neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and dementia. These diseases are costly to the healthcare system, and the growing number of patients requires improved therapies. One approach that has shown therapeutic potential in preclinical research is exosome therapy. Despite the existence of rigorous clinical testing and manufacturing models, the U.S.’s current regulatory structure lacks the specificity to fully address exosome safety concerns. Notably, exosomes contain unique and heterogeneous content that can jeopardize patient safety if imprecisely regulated. Furthermore, safety and regulatory standards vary internationally. This paper introduces two potential options to standardize exosome treatment: creating a new regulatory classification system for exosomes in the U.S., and establishing a robust international reporting and regulatory system.

Tiny pollutants, big changes: Progress in microplastics research and U.S. policy

Microplastics are ubiquitous in the environment, and their environmental dispersion, ecological impacts, and potential health consequences are a cause for growing concern. In the United States, federal policies addressing microplastic pollution are limited to banning microbeads (a subcategory of microplastics) in personal care products and monitoring microplastics in food and water. While some individual states and cities are taking independent initiatives to combat microplastic pollution, these actions remain relatively scarce. Developing evidence-based policies that protect public health will require further research to understand the impact of microplastics on humans.

Navigating the regulatory seas for commercial maritime nuclear propulsion

As the global shipping industry pursues decarbonization to meet international climate goals, nuclear propulsion has emerged as a viable alternative to conventional diesel propulsion. Although no commercial nuclear ships operate outside of Russia today, nuclear cargo ships that have sailed out of the U.S., Germany, and Japan provide critical lessons on nuclear ship building, operation, and policy frameworks for future regulation. The path forward for nuclear regulation is complicated by outdated rules that bias towards old technology, nuanced international treaties, and a lack of clear processes for ship safety reviews. Additionally, ships powered by nuclear reactors are more susceptible to piracy of their technology, and as such, must address this ethical concern. To bring commercial nuclear ship propulsion closer to reality, interested nations can develop regulations that guide ship builders on how to seek approval for nuclear ships within existing standards and laws, support collaboration between nuclear and ship organizations, and engage in bilateral agreements that allow nuclear ships to travel between foreign ports. By leveraging historical experiences and modern advancements, we identify a roadmap for enabling the responsible adoption of nuclear propulsion in commercial shipping, contributing to both technological advancement and environmental sustainability.

Navigating the black box: Operational lenses for AI-enabled drone governance

Drones equipped with artificial intelligence (AI) now deliver medical supplies in remote regions, monitor environmental changes, and conduct military operations. Worldwide, regulators are racing to layer broad AI rules with drone-specific safety standards; however, the resulting patchwork is still fragmented and unevenly enforced. As AI decision-making processes are often opaque, governance approaches that rely on understanding internal system mechanics face significant challenges. In this review, we examine the existing governance landscape on AI-enabled drones and demonstrate why drones that share identical hardware and AI architecture raise different ethical and legal questions depending on their deployment context. By focusing on how missions are structured and what operational complexities they entail, and not on how AI systems reach decisions, our analysis offers conceptual lenses for policy development that acknowledge the reality of governing black-box systems. These qualitative and heuristic frameworks are designed to provide policymakers with a common vocabulary for analysis rather than offer prescriptive solutions.

Strategic alliances in the Indo-Pacific: Shaping global security and accelerating space innovation

The AUKUS (Australia, U.K., and U.S.) security partnership could significantly enhance trilateral coordination and protect critical national infrastructure through the integration of advanced space capabilities. This article describes the recent regulatory changes that could galvanize AUKUS and allied partners to exchange data and technology, interoperable spaceports, and other launch capabilities supporting next generation active defense initiatives. As the space economy surges in the next decade, this regulatory change is a first step in allied security in the space domain.

Technical and ethical debt in the AI fair use crisis

The widespread use of copyrighted data to train AI systems without permission triggered a prolonged “AI fair use crisis.” This paper explores the legal, policy, technical, and ethical dimensions of this issue through the lens of technical and ethical debt. It defines the crisis, examines how copyright concerns arise throughout the AI development life cycle, and reviews key issues from ongoing legal cases. The analysis concludes with a set of proposed approaches to address the AI fair use crisis.

Ensuring user autonomy in AI systems

AI systems are becoming deeply embedded in decision-making processes that affect individuals’ rights and opportunities. Ensuring user autonomy and informed consent in this context has become a pressing challenge. Existing regulatory frameworks struggle to keep pace with the rapid evolution of AI, leaving gaps in transparency, fairness, and accountability. Users often lack meaningful autonomy when interacting with AI systems, as they cannot easily initiate, modify, or fully understand these interactions through accessible, human-centered interfaces. This article examines the regulatory landscape surrounding AI systems in contexts where concerns about user autonomy, accountability, and legal responsibility are particularly pressing, as well as technical options for regulatory implementation. We examine how current and emerging AI policies address these challenges, analyzing their effectiveness in protecting user agency and decision-making power. We also explore global, national, and institutional regulatory approaches, highlighting differences in structure and enforcement. Finally, we investigate emerging adaptive policy solutions and enhanced consent mechanisms that may promote ethical AI governance and user empowerment in an era of increasing automation.

Data and AI governance: Promoting equity, ethics, and fairness in large language models

In this paper, we cover approaches to systematically govern, assess and quantify bias across the complete life cycle of machine learning models, from initial development and validation to ongoing production monitoring and guardrail implementation. Building upon our foundational work on the Bias Evaluation and Assessment Test Suite (BEATS) for Large Language Models, the authors share prevalent bias and fairness related gaps in Large Language Models (LLMs) and discuss data and AI governance framework to address Bias, Ethics, Fairness, and Factuality within LLMs. The data and AI governance approach discussed in this paper is suitable for practical, real-world applications, enabling rigorous benchmarking of LLMs prior to production deployment, facilitating continuous real-time evaluation, and proactively governing LLM generated responses. By implementing the data and AI governance across the life cycle of AI development, organizations can significantly enhance the safety and responsibility of their GenAI systems, effectively mitigating risks of discrimination and protecting against potential reputational or brand-related harm. Ultimately, through this article, we aim to contribute to advancement of the creation and deployment of socially responsible and ethically aligned generative artificial intelligence powered applications.

From pledges to performance: Strengthening corporate climate pledges

To understand how regulators are developing systematic frameworks to make climate pledges investible, robust, and actionable, MIT Science Policy Review spoke with Catherine McKenna, founder and principal of Climate and Nature Solutions, former chair of the United Nations High-Level Expert Group on Net-Zero Commitments for Non-State Entities, Canada’s Minister of Environment and Climate Change and Minister of Infrastructure, and negotiator of the Paris Agreement at COP21. Ms. McKenna has led discussions on global carbon markets, directed Canada’s landmark national climate plan, and oversaw the development of Canada’s first National Infrastructure Assessment to encourage net-zero emissions by 2050 in Canada. Through our conversation, we discuss the global economic and regulatory shifts required to create ethical and actionable pledges–specifically the need to regulate, set net zero targets, limit use of voluntary credits, align advocacy with action, include people and nature in a just transition, and increase accountability.

A conversation with Angie Drobnic Holan on misinformation, fact-checking, and the modern media landscape

MIT Science Policy Review spoke with Angie Drobnic Holan, the director of the International Fact-Checking Network (IFCN), about the challenges of combating mis- and disinformation on modern media platforms. The IFCN was launched in 2015, and its primary goal is to bring together and support the growing community of fact-checkers in their fight against misinformation. Previously, Holan served as editor-in-chief of the U.S. fact-checking site PolitiFact for 10 years. She has extensive experience fact-checking the presidency, Congress, and political campaigns, and was a reporter on the PolitiFact team that won the 2009 Pulitzer Prize for national reporting. Angie Drobnic Holan holds a Master’s in Journalism from Columbia University and a Master’s in Library Science from the University of South Florida. Her undergraduate degree is from the Plan II liberal arts program at the University of Texas at Austin.

TAILΦRing the future of medicine: An interview with Dr. Sabrina Green on Phage Therapy

MIT Science Policy Review spoke with Dr. Sabrina Green, a prominent bacteriophage (phage) therapy researcher, about the rise of antimicrobial resistance (AMR) as a global emergency, and the potential use of phage therapy to combat this threat. AMR describes the capacity of microorganisms, in this context bacteria, to withstand the effects of existing medications designed to eliminate them or halt their multiplication, such as antibiotics. AMR results from factors such as antibiotic overuse and inadequate infection control, making treatment extremely challenging. Phage therapy is a promising approach to combat AMR, utilizing viruses that target and destroy bacteria. Unlike broad-spectrum antibiotics that can cause allergies and disrupt our beneficial gut microbiome, bacteriophages are highly specific, limited to killing the specific bacterial target. While phage therapy has shown promise in treating individual “last-resort” cases, its broader application is complicated by technical, regulatory, and ethical hurdles that need to be addressed.

Dr. Sabrina Green is a postdoctoral researcher at KU Leuven who has extensive research experience in virology and bacteriology. A strong advocate for phage therapy awareness, she co-founded TAILΦR in the U.S. during her PhD, a phage center that developed therapeutic phages for 12 patient cases. Her work at Baylor College of Medicine and TAILΦR involved directing research, engaging with industry, and coordinating with clinicians and regulators to deliver phage therapy to patients.

How can AI be used to reduce public spending and increase government efficiency?

As Artificial Intelligence (AI) continues to redefine how governments operate by streamlining processes, reducing public spending, and working to rebuild citizen trust, MIT Science Policy Review spoke with Kay Firth-Butterfield, a global leader in Responsible AI and governance known for her pioneering contributions to the field of AI ethics. She was the world’s first C-suite appointee in AI ethics and has held prominent positions, including Head of AI and Machine Learning at the World Economic Forum and is currently CEO of the Good Tech Advisory. A lawyer, professor, and author, she has advised governments, think tanks, and corporations on AI policy, ethics, and regulation. Dr. Firth-Butterfield contributed to the development of the Asilomar AI Principles and has been a leading voice in shaping the ethical adoption of AI. Her expertise lies at the intersection of law, international relations, and AI governance. In our conversation, Ms. Firth-Butterfield discusses how AI can be harnessed to enhance state efficiency while also addressing its associated challenges and considerations for its responsible use.

The promise and peril of artificial intelligence: Lessons from Nobel Laureate Simon Johnson

MIT Science Policy Review spoke with economist and Nobel laureate Professor Simon Johnson about the pitfalls and promises of artificial intelligence (AI)- generated content, with a particular focus on research and academia. Prof. Johnson offered a nuanced perspective on AI-generated content, framing AI as a powerful tool, akin to past technological advancements, whose ultimate impact depends on human choices and intentional development.

Simon Johnson is the Ronald A. Kurtz (1954) Professor of Entrepreneurship at the MIT Sloan School of Management, where he leads the Global Economics and Management group. He is also co-director of the Shaping the Future of Work Initiative and a Research Affiliate at Blueprint Labs at MIT. In 2024, Johnson, Daron Acemoglu, and James A. Robinson were jointly awarded the Sveriges Riksbank Prize in Economic Sciences in memory of Alfred Nobel for their “studies of how institutions are formed and affect prosperity.”

Exploring the landscape and value of citizen science: Insights from Professor Darlene Cavalier

Citizen science initiatives are projects that engage the general public in science research through active participation in data collection, observation, analysis, and/or design of research questions. They have experienced significant growth in recent years, driven in part by increased interconnectedness facilitated by the internet. While some projects simply seek to foster recreational engagement in the scientific enterprise, others contribute critical data to ongoing research projects and conservation efforts.

One person making waves in the citizen science field is Professor Darlene Cavalier, Professor of Practice in the School for the Future of Innovation and Society at Arizona State University, founder of SciStarter, Science Cheerleaders, and cofounder of Expert and Citizen Assessment of Science and Technology (ECAST). SciStarter is an online platform that provides information about ongoing citizen science projects and hosts free training modules. MIT Science Policy Review spoke with Professor Cavalier to learn more about the impacts of citizen science initiatives, their ethical and policy considerations, and the trajectory and future of the field.

Bridging the gap: How Sabrina Shankman is shaping science communication and policy

MIT Science Policy Review spoke with Sabrina Shankman, a climate reporter at the Boston Globe, on her efforts to translate new scientific knowledge to the general public. The challenge of science communication exposes a wide gap in academia and industry: scientists often struggle to explain complex findings in accessible language, correct widespread misinformation, or engage with diverse public audiences who may distrust science or lack scientific literacy. It is increasingly important that more emphasis is placed on training scientists in science communication, and that part of the training incorporates expert advice from science journalists and reports.

Sabrina Shankman has been a climate reporter at the Boston Globe since 2021. As a reporter, her work is vital in bridging the gap between research and discovery. Her reporting sheds light on the climate crisis and the science and policy work being done at multiple levels to address the issue. In this interview, we talk about Shankman’s trajectory, experience, and challenges as a science reporter in hopes of illuminating this essential field and emphasizing the urgent need for accurate and accessible science communication and meaningful policy measures.

Cultivating creativity: Why scientists should embrace art

MIT Science Policy Review spoke with Professor Bahram Moasser about the importance of intersecting art and science to foster creativity and interdisciplinary thinking during scientific training. Prof. Moasser is an Associate Teaching Professor in the Department of Chemistry and Biochemistry at the University of Notre Dame. He has designed a core curriculum course that explores the shared virtues, values, methods, and practices of art and chemistry. In addition to conducting experiments to learn about the science of art, Prof. Moasser collaborates with curators at Notre Dame’s Raclin-Murphy Museum of Art to encourage students’ visual and art literacy.

Postcolonial techno-futurism: The challenges of siting telescopes on sacred lands

Postcolonial techno-futurism is the idea of centering Indigenous knowledge systems, sovereignty, and agency in shaping the future of scientific and technological advancements. In astronomy, this idea is particularly relevant through telescope siting controversies, most notably on Mauna Kea in Hawai’i and at the Atacama Large Millimeter/submillimeter Array (ALMA) in Chile. These sites, while chosen for their exceptional astronomical conditions, are also sacred ancestral lands for the Kānaka Maoli in Hawai’i and the Atacameño peoples in northern Chile. The construction of these large observatories has sparked protests and resistance, raising urgent questions about consent, land rights, and the role of Indigenous cosmologies in shaping scientific inquiry.

To better understand the ethics of siting major telescope projects on sacred lands, MIT Science Policy Review spoke with Rodrigo Córdova Rosado, a Puerto Rican astrophysicist and citizen of the Osage Nation whose work integrates Indigenous cosmologies with cutting-edge astrophysics. Rosado studies supermassive black hole feedback in quasars at Princeton University and also collaborates on bilingual educational initiatives that center Indigenous sky knowledge. Through our conversation, we discuss the importance of co-governance; free, prior, and informed consent; and embedding traditional ecological knowledge in every phase of scientific planning. This interview underscores that astronomy—and science broadly—must confront its colonial legacies and actively build equitable, co-governed partnerships with Indigenous communities. By treating consent as an ongoing practice, prioritizing data and environmental sovereignty, and celebrating and educating on diverse scientific traditions, we can transform telescopes on sacred lands into symbols of collaboration rather than contention. Future scientific projects will succeed only if they are born from mutual respect and shared purpose.