Washington, D.C., November 5, 2024 (PAHO) — In an effort to strengthen ethics in health research, the Pan American Health Organization (PAHO) is supporting more than ten countries in Latin America and the Caribbean in developing laws, regulations and policies to promote a robust ethical framework for research. This effort not only seeks to align countries of the Region with international standards but also to ensure that health research benefits their populations.
Bolivia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Nicaragua, Paraguay, Peru, and Trinidad and Tobago are currently working to renew their national health research frameworks. “Health research is essential; it is the foundation for cures for diseases and for strategies that prevent or alleviate the suffering of millions,” commented Dr. Carla Saenz, PAHO's regional advisor on bioethics.
This PAHO initiative focuses on ensuring that countries adopt international ethical standards based on the lessons learned during the pandemic. “COVID-19 has underscored the vital connection between research and health, leading many countries in the region to prioritize the ethical governance of health research,” said Saenz, who is also an author of a recent article in the Journal of the American Medical Association (JAMA) on the revision of the Declaration of Helsinki.
The Declaration of Helsinki, issued by the World Medical Association, establishes ethical principles for medical research involving human participants. The 2024 revision expands this declaration, addressing critical aspects such as the ethical handling of identifiable human data and materials.
“It is essential that countries align their legal frameworks with international ethical standards,” emphasized Saenz, noting that this is crucial for fostering public trust and integrity in research. This revision holds special significance for low- and middle-income countries in the Americas, where ethical standards are even more necessary in emergency situations.
Despite advances in the last decade, many countries face significant challenges. For example, some countries establish ethical standards only for a subset of clinical standards or have research ethics committees that operate without the oversight and support of health authorities. To address this, PAHO has designed a strategy that includes clear objectives and specific indicators to strengthen research ethics. A recent study of 22 countries in the region revealed that, although many have implemented legal instruments for the ethical conduct of research, there are still gaps in areas such as ethics training and clinical trial registration. “It is a call to action: all actors must come together to strengthen the understanding of research ethics,” said Saenz.
PAHO also highlights the importance of adopting comprehensive legal frameworks that address all forms of health research, not just clinical trials. “Protecting participants in all types of research, as well as promoting transparency and accountability, are fundamental to fostering public trust in research,” added the PAHO bioethics advisor.
PAHO recommends that countries should strengthen the national institutions that oversee ethics committees and promote a systematic approach to research ethics. Collaboration between health authorities, science and technology agencies, and research institutions is essential to develop policies that promote ethical research and responsible conduct in research.
Ten key points about the revised Declaration of Helsinki (2024):
- Ethical standards during emergencies: Specific standards are incorporated for research conducted during public health emergencies, based on previous experiences.
- Biological samples and data: The updated Declaration addresses the ethical handling of biological samples and human data.
- Research integrity: Integrity is underscored as an essential component of ethical research with human participants.
- Meaningful engagement: The need to involve society and communities in the research process is highlighted.
- Terminology change: “Participants” is used instead of “subjects” to reflect a more respectful approach.
- Need for a broader scope: While improvements have been made, there is a need to expand the scope to encompass all health research, not just medical research.
- Mandatory registration: The importance of registering all research involving human participants is emphasized to ensure transparency and trust.
- Environmental sustainability: Research is encouraged to be sustainable and minimize waste.
- Guidance for editors and sponsors: The duty to publicly share research results is emphasized.
- Learning from the past: This reflects a commitment to apply lessons from the pandemic to future research, promoting transparency and ethical practices.
