Pietro Bruschini, MD, has seen medical research from both sides.

As a physician with a long clinical career spanning pulmonary diseases, lung transplantation, and early lung cancer screening, he spent years at the bedside — including a major clinical commitment during the COVID-19 pandemic. He also served as a military physician. Today, he works in Medical Affairs at Pfizer within the Rare Disease area, bringing that depth of clinical experience into the pharmaceutical industry, where he has been for the past four years.

It is precisely that background that makes his choice of topic so fitting.

For his End of Program Project in the GMDP Academy Certification in Medicines Development program, in partnership with King’s College London, Pietro chose to analyze the 2024 revision of the Declaration of Helsinki — the international framework governing ethical principles for biomedical research involving human beings. A physician who witnessed firsthand the urgency and complexity of research conducted during a global health crisis is perhaps uniquely positioned to appreciate why a document like this matters, and what it means when it changes.

And change it did. The 2024 revision — the eighth since the Declaration was first adopted by the World Medical Association in 1964 — is one of the most substantial updates in the document’s history. It addresses everything from the ethical use of artificial intelligence and data privacy, to an expanded understanding of vulnerability, to entirely new guidance on research conducted during public health emergencies.

Pietro’s analysis is thorough, accessible, and written by someone who understands not just the regulatory landscape, but the human reality behind it.

We are proud to feature it as part of our Alumni Insights Series — a curated collection of standout End of Program Projects selected for publication based on their depth, clarity, and relevance to the field.

We invite you to read it below:

Main Modifications Introduced in the 2024 Revision of the Declaration of Helsinki Based on New Scientific Methods and Ethical Concepts

Fifty years after its first publication, the World Medical Association (WMA) has published the eighth version of the Declaration of Helsinki, the international reference document on ethical principles for biomedical research involving human beings, including research on biological samples of human origin and other identifiable data. The World Medical Association developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants following the atrocities committed by physicians conducting unethical medical research during the Second World War. Since the World Medical Association first adopted the Declaration of Helsinki in 1964, researchers, ethics review committees, and governments around the world have relied on the document’s high-level enduring principles to guide fundamental ethical considerations and decision-making. To ensure the Declaration of Helsinki, or DoH, continues to fulfill its purpose and to address evolving ethical challenges across the global research community, the World Medical Association invites periodic reviews of the document.

The 2024 update introduces substantial changes in terminology, ethical frameworks, and procedural guidance. It aims to reinforce the protection of research participants while promoting scientific integrity, inclusivity, and global equity. This essay discusses the main modifications introduced in the 2024 revision, focusing on how they reflect new scientific methods and ethical concepts.

Among the main updates is the shift in terminology from “subjects” to “participants.” The term “subjects” has been replaced with “participants” throughout the document. This change is more than semantic; it emphasizes the value of individuals, considering them active partners in the research process rather than passive subjects. This update reflects the recognition of the centrality of those participating in research, as they are “part” of it. Before this document, the subjects enrolled in research played a passive role — that is, the research was conducted “on” human subjects. The awareness that their role must be one of active participation has gradually developed; that is, research must be conducted “with” human subjects.

The revision also strengthens the emphasis on informed consent. The freedom of participants is emphasized by adding the adjective “free” to “informed consent” throughout, to express the importance of voluntariness, understood as the absence of conditioning or undue influence on the choice, for full awareness of an autonomous decision. Awareness can only be achieved after adequate information and “communication.” In particular, the addition of the reference to communication, alongside the traditional reference to information, is a significant change; it moves from one-way information transfer from researcher to participant to two-way communication in the interaction and relationship between participant and physician. Communication should use language that the Declaration explicitly requires to be “clear,” comprehensible, and appropriate to the individual’s ability to understand.

In addition, it clarifies that consent must be obtained not only for participation in research but also for the use of biological materials and identifiable data. This reflects growing concerns about data privacy and the ethical use of biospecimens in secondary research.

Additionally, a broader definition of vulnerability has been introduced, recognizing that it can be influenced by a range of conditions that may change over time or across different contexts, including social, political, or environmental conditions. The reference to vulnerability changes both linguistically and substantively: it refers not only to vulnerable populations but also to vulnerable “conditions,” which encompass not only age (minors and the elderly), gender, and ethnicity, but also socioeconomic and environmental conditions. The risks of exclusion “must” be considered and balanced against the risks of inclusion. This is a significant departure from the past. The revisions now highlight the ethical responsibility to carefully balance the inclusion and exclusion of vulnerable groups, as exclusion from research may in turn perpetuate their disparities. Participants must be protected, but research must be responsible and inclusive. When vulnerable populations are included in research, they must receive tailored protection and specific forms of support.

Furthermore, the Declaration highlights the importance of post-trial access to interventions that prove beneficial. Researchers and sponsors are expected to make provisions for continued access to effective treatments after the conclusion of a study, particularly in low-resource settings. This reflects a growing recognition of the ethical obligation to ensure that research participants are not merely used for data collection but also benefit from the outcomes.

A major ethical advancement in the 2024 revision is the strengthened commitment to justice and global equity. The Declaration now includes explicit references to distributive justice, emphasizing the fair distribution of the benefits, burdens, and risks of research. This principle is particularly relevant in international research, where disparities in resources and healthcare access can lead to exploitation. The revision encourages the inclusion of underrepresented and marginalized populations in research, provided that their participation is ethically justified and accompanied by appropriate protections. It also promotes community engagement, urging researchers to involve communities in the design, implementation, and dissemination of research. This participatory approach fosters mutual respect and ensures that research addresses the needs and values of those affected.

The 2024 revision introduces the concept of scientific integrity as a core ethical principle. This addition responds to increasing concerns about research misconduct, data falsification, and the reproducibility crisis in biomedical science. The Declaration now explicitly condemns fabrication, falsification, and plagiarism, and calls for robust mechanisms to prevent and address misconduct. Researchers are urged to design studies that are scientifically sound and socially valuable, avoiding unnecessary duplication and minimizing research waste. The revision emphasizes the importance of pre-registration of studies, publication of results regardless of outcome, and open access to data where appropriate. These measures aim to enhance transparency, accountability, and public trust in research.

Moreover, the Declaration recognizes the shared responsibility of researchers, institutions, sponsors, and ethics committees in upholding scientific integrity. It calls for training in research ethics and integrity, and for institutional policies that support ethical conduct throughout the research lifecycle.

In response to the digital transformation of biomedical research, the 2024 revision introduces new guidelines on data protection and the ethical use of artificial intelligence. The Declaration acknowledges that digital tools and AI can enhance research efficiency and precision but also pose significant risks to privacy, autonomy, and fairness.

Researchers are required to implement robust data protection measures, including encryption, anonymization, and secure storage. Consent procedures must clearly explain how data will be used, shared, and stored, especially when AI algorithms are involved. The Declaration warns against the use of opaque or biased algorithms and calls for transparency in AI-driven decision-making.

Ethics committees are encouraged to develop expertise in evaluating studies involving AI and digital technologies. This includes assessing the potential for algorithmic bias, the adequacy of data governance frameworks, and the impact on participant rights. The revision thus positions the Declaration as a forward-looking document capable of guiding ethical research in the digital age.

The COVID-19 pandemic underscored the need for ethical guidance in emergency research. The 2024 revision addresses this by introducing specific provisions for research conducted during public health crises, natural disasters, or humanitarian emergencies.

It acknowledges the urgency and complexity of such situations but insists that ethical standards must not be compromised. Researchers are required to obtain consent whenever possible, even under constrained conditions, and to ensure that participation is voluntary and informed. The Declaration also calls for expedited but rigorous ethical review processes to facilitate timely research without sacrificing participant protection.

Importantly, the revision reinforces the principle of post-trial responsibility in emergency contexts. Participants must be informed of the outcomes and provided with continued access to beneficial interventions. This ensures that ethical obligations extend beyond the immediate crisis and contribute to long-term health equity.

For the first time, the Declaration of Helsinki introduces the concept of environmental sustainability and recognizes the importance of considering the environmental impact of clinical trials. This reflects a growing awareness of the ecological impact of biomedical research; research must be designed and conducted to avoid or minimize environmental harm while promoting sustainability — an urgent necessity in the context of the current climate crisis.

Researchers are encouraged to adopt sustainable practices, such as reducing waste, conserving energy, and using environmentally friendly materials. Ethics committees are advised to consider the environmental footprint of research protocols and to promote sustainability as part of ethical review. This addition recognizes that ethical research must not only protect human participants but also contribute to the well-being of the planet and future generations.

In conclusion, the 2024 revision reflects the need to adapt ethical standards to the contemporary challenges of medical research, promoting greater protection of participants and more sustainable, transparent, and inclusive research.

Key modifications include the adoption of inclusive terminology, the recognition of dynamic vulnerability, the promotion of scientific integrity, and the emphasis on global equity. The Declaration also addresses emerging challenges related to data protection, emergency research, and environmental sustainability. The 2024 revision thus responds to the rapid advancements in biomedical research, the emergence of new technologies such as artificial intelligence (AI), and the growing emphasis on justice, transparency, and sustainability in research ethics.

Bibliography

Wen, B., Zhang, G., Zhan, C., Chen, C., & Yi, H. (2024). The 2024 revision of the Declaration of Helsinki: a modern ethical framework for medical research. Postgraduate Medical Journal, 101(1194), 371–382. https://doi.org/10.1093/postmj/qgae181

Bibbins-Domingo, K., Brubaker, L., & Curfman, G. (2024). The 2024 revision to the Declaration of Helsinki: modern ethics for medical research. JAMA, 333(1). https://jamanetwork.com/journals/jama/fullarticle/2825292

Kurihara, C., Greco, D., & Dhai, A. (Eds.). (2025). The 2024 Declaration of Helsinki: Global Efforts Towards the Highest Ethical Standards. Springer. https://doi.org/10.1007/978-981-96-9294-1

Parums, D. V. (2024). Editorial: The 2024 revision of the Declaration of Helsinki and its continued role as a code of ethics to guide medical research. Medical Science Monitor, 30, e947428. https://www.carilionclinic.org/declarationofhelsinkirevisions.pdf

World Medical Association. (2024). Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants. https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

Summary of the 2024 Revision of the Declaration of Helsinki

Modifications Based on New Scientific Methods

  1. Scientific Integrity and Prevention of Misconduct
    • A new section explicitly addresses scientific integrity, with a zero-tolerance stance on research fraud.
    • Ethical responsibility is emphasized at all levels: researchers, teams, and institutions.
  2. Data Protection and Artificial Intelligence
    • New guidelines address the ethical implications of AI and sensitive data management.
    • Privacy protection is reinforced, especially in studies involving biometric or genetic data.
  3. Environmental Sustainability in Research
    • For the first time, the Declaration includes ecological standards, encouraging research practices that reduce environmental impact.

Ethical and Conceptual Modifications

  1. From “Subjects” to “Participants”
    • The term “subjects” has been replaced with “participants” to promote respect for and autonomy of individuals involved.
  2. Concept of Vulnerability
    • The approach shifts from a static view (“vulnerable populations”) to a dynamic and contextual understanding (“vulnerability”), recognizing that anyone can be vulnerable in certain contexts.
  3. Global and Distributive Justice
    • Emphasis on equitable distribution of research benefits, risks, and burdens, with a call for social justice and inclusion.
  4. Community Engagement
    • Active involvement of communities in research design and execution is promoted to enhance transparency and trust.
  5. Dual Ethical Review for Transnational Studies
    • Studies conducted across multiple countries must undergo both local and international ethical review to ensure greater accountability.
  6. Research in Health Emergencies
    • Specific guidelines have been introduced for research during global crises (e.g., pandemics), balancing urgency with participant protection.

Other Relevant Updates

  • Informed Consent: Strengthened, with particular attention to biological materials and identifiable data.
  • Use of Placebo and Unproven Interventions: Ethical boundaries clarified.
  • Post-Trial Provisions: Increased focus on participants’ rights after study completion.

About the Author

Pietro Bruschini, MD, is a physician working in Medical Affairs at Pfizer within the Rare Disease area. He joined the pharmaceutical industry about four years ago after a long clinical career, including hospital-based experience in pulmonary diseases, lung transplantation, early lung cancer screening programs, and a major clinical commitment during the COVID‑19 pandemic, as well as prior service as a military physician.

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred