The World Health Organization’s Genomics Programme has launched new principles for the ethical collection, access, use, and sharing of human genome data.
These newly established guidelines set a global benchmark for responsible genomic data practices, developed with input from the WHO Technical Advisory Group on Genomics (TAG-G) and international experts. As genomic technologies rapidly evolve, it’s essential to establish a strong framework to:
- Ensure Informed Consent and Privacy
Protect individual rights by promoting transparency, clear communication, and informed consent regarding data use. - Promote Equity and Inclusivity
Address disparities in genomic research and ensure equitable representation of diverse populations, with a focus on underrepresented groups from low- and middle-income countries (LMICs). - Foster Global Collaboration
Encourage cross-border partnerships to maximize the benefits of genomic data sharing, while adhering to stringent privacy and security standards. - Support Capacity Building
Strengthen local infrastructures and enhance genomic literacy to ensure sustainable and inclusive genomic practices worldwide.
These principles aim to guide researchers, policymakers, and healthcare providers in aligning their practices with WHO’s commitment to ethical genomics, offering actionable recommendations to navigate the key ethical, social, and legal challenges in this growing field.
John Reeder, the Director of the Research for Health Department at the World Health Organization, wrote on this occasion.
“As our understanding of the human genome increases, the potential of genomics to enhance our comprehension of health and disease – and ultimately improve individual and population health – continues to grow. In 2022, the WHO Science Council focused on genomics as the subject of its report Accelerating access to genomics for global health.
Collecting, accessing, using, and sharing genomic data from humans is fraught with ethical, legal, social, and cultural issues. Nevertheless, the potential benefits of genomics can only be realized if such data is collected, accessed, used, and shared. Consequently, the Science Council report set the promotion of ethical, legal, equitable, and responsible sharing of human genome data as a specific goal.
This complementary document seeks to achieve that goal by outlining globally applicable principles for collecting, accessing, using, and sharing human genome data. These principles serve as a compass to guide policymakers, researchers, clinicians, and all those involved in human genome data on how they should collect, access, use, and share human genome data in ways that advance genomics for individual and population health, protect individual and collective rights and interests, and foster public trust. Equally, they provide individuals, their families, and communities from whom human genome data is accessed with an understanding of the principles upon which their data will be collected, accessed, used, and shared.
The principles described recognize the importance and value of human genome data. Its use is critically important if we are to realize the promise of genomics for all, but this must be stewarded in such a way that identifies and mitigates the ethical, legal, social, and cultural issues that are likely to arise. These principles offer normative guidance and serve as a call to action, urging all of those involved in the use of human genome data to uphold and implement them.”
The Introduction of the Genomics Programme by WHO
The field of genomics holds immense potential to transform both individual and population health, benefiting current and future generations. However, realizing this potential requires the facilitation of human genome data collection, access, use, and sharing across various health and research sectors. Achieving this goal necessitates addressing the ethical, legal, societal, and cultural challenges that come with the use of genomic data. It is also important to recognize that there are inherent risks associated with both the use and the non-use of human genome data, which must be carefully balanced and mitigated to protect the rights of individuals, families, and communities, while promoting the health and well-being of all populations, now and in the future.
Efforts to increase the collection and sharing of human genome data must also take into account the mistrust that some individuals and communities may have, which can stem from past exploitative practices and imbalances in power and resources between different stakeholders. There is also a critical need to address the underrepresentation of various populations in existing genomic datasets, which can contribute to health inequities. To promote global equity in genomics, it is essential to ensure that diversity and representation are achieved without compromising privacy and confidentiality, while also ensuring that the scientific quality of the data is maintained. Additionally, the long-term, trans-generational impact of genomics must be considered, as decisions made today regarding the use and sharing of genetic data will affect future generations.
Integrating genomics into healthcare systems requires a comprehensive data lifecycle approach, with clear guidance on the ethical collection, access, use, and sharing of genomic data both within and across health and research sectors at local, national, and global levels. In line with the WHO Science Council’s 2022 report Accelerating Access to Genomics for Global Health, which emphasized the importance of promoting ethical, legal, equitable, and responsible sharing of genomic data, this document outlines the key principles necessary for advancing the ethical and responsible use of human genome data in global health initiatives.
Purpose and Scope of the Document
This document outlines globally applicable and interconnected principles for the collection, access, use, and sharing of human genome data. These principles aim to promote human health and well-being, facilitate responsible medical advances, and support scientific research, while adhering to human rights law. The guidelines complement and build upon existing laws, policies, frameworks, and other guiding documents in this area, encouraging further development where such frameworks do not yet exist.
The primary objectives of these principles are to:
- Promote social and cultural inclusiveness, equity, and justice.
- Ensure trustworthiness throughout the data lifecycle.
- Foster integrity and responsible stewardship.
- Maximize both communal and personal benefits.
- Advocate for the use of common principles in laws, policies, frameworks, and guidelines across countries and contexts.
Additionally, the principles aim to build and enhance the capacity and awareness of individuals, families, and communities whose genome data are collected, enabling them to have more control over their data. Implementing these principles requires a comprehensive approach across the entire data lifecycle, applicable to both prospective and retrospective collections of human genome data. These guidelines are intended to complement and inspire national and community-specific legal and ethical frameworks.
While the document focuses specifically on human genome data, WHO encourages the integration of health data alongside genomic information to aid interpretation, provided that associated risks are mitigated. The principles also extend to biological samples, which are often linked to genome data and have cultural significance. Collecting, accessing, using, and sharing these samples may require additional considerations beyond those highlighted for genome data.
The principles aim to establish normative standards for the collection, access, use, and sharing of human genome data, with practical recommendations for their implementation. Their application depends on the health and research context in which the data are used, as well as national legal and ethical frameworks and the capacity of those involved in managing the data. Given varying individual and collective values, careful deliberation and review may be needed when implementing these principles in certain contexts. These guidelines are designed for use by those responsible for governing and overseeing human genome data, as well as stakeholders across the data lifecycle, including individuals, families, communities, and the private sector.
Read the full document by visiting here.
About The World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations dedicated to global public health. Established on April 7, 1948, the WHO works to achieve the highest level of health for all people, with a focus on physical, mental, and social well-being. The organization is headquartered in Geneva, Switzerland, and operates through six regional offices and 150 field offices worldwide. WHO is governed by the World Health Assembly, composed of 194 member states, which sets priorities and oversees its work.
One of WHO’s main functions is to promote the control of epidemic and endemic diseases, such as HIV/AIDS, tuberculosis, malaria, and emerging health threats like COVID-19. It also works to improve public health education and training, particularly in developing countries, and to set international health standards, including for vaccines, pharmaceuticals, and biological products. WHO’s work includes conducting research, providing technical assistance to countries, and advocating for universal health coverage and health equity.
WHO has been pivotal in several major global health successes, most notably the eradication of smallpox in 1980 and its ongoing efforts to eradicate polio. In addition, it has led initiatives for the development of an Ebola vaccine and continues to address a range of global health challenges. Its work on non-communicable diseases, including cancer, heart disease, and diabetes, is also a major focus, alongside efforts to improve nutrition, mental health, and substance abuse prevention.
The WHO is funded primarily by contributions from its member states, both assessed and voluntary, along with private donations. The organization’s budget for the 2024–2025 period is over $6.8 billion. Through its global health leadership, the WHO continues to play a central role in coordinating international efforts to improve health outcomes and manage public health risks.
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