La OPS apoya a más de diez países de América Latina y el Caribe para mejorar la gobernanza ética de la investigación en salud – OPS/OMS
Washington, DC, 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 to develop laws, regulations and policies that promote a robust ethical framework for research. This initiative not only seeks to align these nations 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; The cures for diseases and the strategies that prevent or alleviate the suffering of millions depend on it,” commented Dr. Carla Saenz, PAHO regional bioethics advisor.
This PAHO effort focuses on ensuring that countries adopt international ethical standards, in light of the lessons learned during the pandemic. «COVID-19 has highlighted the vital connection between research and health, and has led many countries in the region to prioritize the ethical governance of health research,» said Saenz, who is also the author of a article recent 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 review expands on this statement, addressing critical aspects such as the ethical handling of data and identifiable human material.
“It is essential that nations align their legal frameworks with international ethical standards,” Sáenz stressed, highlighting that this is crucial to foster public trust and integrity in research. This review has special significance for low- and middle-income countries in the Americas, where ethical standards are even more necessary in emergency situations.
Despite progress in the last decade, many countries face significant challenges. For example, some countries only set ethical standards for a subset of clinical trials or have research ethics committees that operate without the oversight and support of national authorities.
To address this, PAHO has designed a strategy that includes clear objectives and specific indicators to strengthen ethics in research. United Nations study A recent study on 22 countries in the region revealed that, although many have implemented legal instruments to conduct research ethically, there are still gaps in areas such as ethics training and clinical trial registration. “It is a call to action: all actors must join together to strengthen the understanding of ethics in research,” said Sáenz.
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 essential to foster public trust in research,” added the PAHO bioethics advisor.
To move forward, PAHO recommends strengthening national institutions that oversee ethics committees and promoting 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 of research.
Ten key points about the revised Declaration of Helsinki (2024)
- Ethical standards during emergencies: Specific standards are incorporated for investigations during public health emergencies, based on previous experiences.
- Biological samples and data: The updated statement addresses the ethical handling of biological samples and human data.
- Research integrity: Integrity is highlighted as an essential component of ethical research with human participants.
- Significant participation: The need to involve society and communities in the research process is highlighted.
- Change of terminology: “Participants” are used instead of “subjects” to reflect a more respectful approach.
- Need for a broader reach: Although improvements have been made, it is necessary to expand the scope to all health research, not just medical research.
- Mandatory registration: The importance of recording 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 publishers and sponsors: The duty to make the results public is emphasized.
- Learning from the past: Reflects a commitment to apply lessons from the pandemic for future research, promoting transparency and ethical practices.
