History of the Helsinki Declaration and the 2024 Updates

The Helsinki Declaration, first adopted by the World Medical Association (WMA) in 1964, is a fundamental document that establishes ethical principles for medical research involving human participants. Over the years, it has been updated to reflect changes in scientific and ethical perspectives. The most recent revision before 2024 was in 2013 in Fortaleza, Brazil. In 2024, the WMA General Assembly in Helsinki, Finland, introduced new standards that address modern requirements, such as sustainability, digital ethics, community engagement, and anonymous data use.

These updates expand the ethical framework and reshape key principles in current medical practices. The Helsinki Declaration has supported establishing ethical standards like Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

The Helsinki Declaration and Its Derived Practices

Good Clinical Practice (GCP)

GCP is based on the ethical principles of the Helsinki Declaration and aims to protect participants’ rights and safety in clinical research. GCP’s core principles cover protecting participants' health, minimizing risks, and ensuring informed consent during study design. With the 2024 updates, GCP is expected to be enriched in the following areas:

• Environmental Responsibility: Clinical research must consider environmental impacts and optimize research processes with a sustainable approach.
• Community Engagement: Including participant and community values in the research process enhances GCP’s relevance, particularly in community-based studies.
• Digital Data Privacy: Strengthened measures for data privacy and security align GCP standards more closely with the needs of the digital age, ensuring the protection of participant information.

Good Laboratory Practice (GLP)

GLP mandates standard procedures in laboratory research to ensure scientific validity and reliability. This practice also stems from the Helsinki Declaration’s commitment to scientific rigor and ethical requirements. The 2024 updates contribute to GLP as follows:

• Scientific Integrity and Transparency: Researchers are encouraged to publish negative and inconclusive results, improving transparency and the reliability of studies.
• Secondary Data Use and Biological Materials: The secondary use of biological materials in laboratory studies now requires explicit consent and ethical review, adding an extra control layer for proper storage and use of biological materials per GLP principles.

Anonymous Data Usage

The 2024 Helsinki Declaration also includes essential updates regarding the use of anonymous data:

• Explicit Consent Requirement: Even when data is anonymized, explicit consent must be obtained for storing and using personal data in secondary research. This ensures participants are informed about potential future uses of their data.
• Ethics Committee Approval: Secondary use of archived anonymous data must receive approval from the relevant ethics committees to maintain ethical standards and protect participant rights.

Key Changes in the 2024 Version and Their Justifications

The 2024 updates are aimed at adapting to contemporary ethical, environmental, and social needs. Here are the main changes:

1. Environmental Sustainability:Change: A requirement to consider the environmental impact of research was introduced.Justification: This change is intended to reduce the environmental footprint of medical research and contribute to sustainable health practices.
2. Community Engagement and Inclusivity:Change: Researchers are now required to engage with participants and communities, integrating their values into the research process.Justification: This step is essential to ensure that research directly benefits communities and prevents inequities.
3. Data Privacy and Digital Ethics:Change: Additional privacy protections for personal data collection, processing, and storage in digital environments were introduced.Justification: As health data usage grows in the digital age, this change seeks to protect participants’ privacy.
4. Fair Access to Research Participation:Change: Provisions were made to include underrepresented groups equitably in research.Justification: This adjustment aims to reduce health disparities and improve the validity of research findings.
5. Research During Public Health Emergencies:Change: The importance of maintaining ethical standards during health emergencies was emphasized.Justification: Responding to recent global health crises, this update reinforces that ethical principles must remain intact even under pressure to achieve rapid results.
6. Secondary Use of Data and Biological Materials:Change: Explicit consent and ethics committee approval are now required for the secondary use of data and biological materials.Justification: As data repositories become more valuable, it is increasingly important to protect participants’ control over their data.

Impact on Clinical Practices

The 2024 updates bring significant changes to clinical practices, particularly in ethical, operational, and societal dimensions:

1. Increased Focus on Participant Rights: Requires stricter consent processes, improved transparency, and enhanced protection for vulnerable groups.
2. Environmental Sustainability: Clinical research now considers environmental impacts, targeting reduced waste and a smaller carbon footprint.
3. Community Engagement: Promotes active involvement of communities in research.
4. Data Privacy: Strengthens cybersecurity measures and ethical standards to ensure the protection of digital data.
5. Anonymous Data Usage: Requires ethics committee approval and explicit consent for secondary use of anonymous data.

Summary

The 2024 Helsinki Declaration aims to update ethical standards with a more inclusive perspective, encouraging medical research practices that respect the rights of participants, involve communities, promote environmental sustainability, and protect digital data. These changes enhance the credibility of clinical research, safeguarding participant rights and adapting to contemporary ethical standards.