From Principles to Practice: A look back at the 2024 Helsinki Declaration and 2025 GCP Updates

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The Declaration of Helsinki, established in 1964 by the World Medical Association (WMA), remains the cornerstone of ethical principles in medical research involving human beings. Originally conceived to prevent the repetition of unethical practices following World War II, it has evolved through multiple revisions to reflect advances in science, technology, and society. The 2024 revision marks one of the most substantial updates in decades, reinforcing participant rights, transparency, and accountability across all types of clinical investigations.

These updates are particularly relevant for medical device manufacturers, who must adapt their clinical investigation plans and documentation processes to a framework that now places participant partnership and ethical engagement at its center. Many of the new principles confirm what participants themselves have expressed through recent experience studies: that participation in research is not only about access to innovative treatments, but also about being respected, clearly informed, and meaningfully involved.

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Following this ethical reinforcement, the finalization of ICH Good Clinical Practice (GCP) E6(R3) in January 2025 marks the practical implementation of these same principles. Where the Declaration redefined why research must protect, respect, and engage participants, GCP R3 specifies how to operationalize those principles throughout the lifecycle of a clinical investigation. For device sponsors, this transition means rethinking study design, oversight, and data management within a participant-centered and digitally driven environment.

How GCP E6(R3) Reflects the 2024 Declaration of Helsinki

The 2024 revision of the Declaration of Helsinki set a renewed ethical foundation centered on participant partnership, transparency, and accountability. One year later, the ICH GCP E6(R3) guideline transformed those ethical priorities into operational standards for study design, conduct, and oversight. The table below summarizes how the ethical principles of the Declaration were translated into practical expectations. Click on the items below to see the full description:

• 1. From “subjects” to “participants”

  The term referring to humans participating in a clinical study was updated from “subject” to “participant”.

  Sponsors should also involve patient groups during protocol development, justify exclusions, and design representative, low-burden studies.

• 2. Mandatory compensation

  Insurance and indemnity coverage must be documented, reinforcing Sponsor accountability as the ultimately responsible party, even when tasks are delegated.

• 3. Data and biobank governance

  Validation of computerized systems, full traceability, cybersecurity, and audit trails are mandatory across the data lifecycle.

• 4. Community involvement and fairness

  Sponsors should seek participant feedback early and maintain transparent communication throughout the trial.

• 5. Electronic informed consent (eConsent)

  There is a formal recognition of eConsent.

  Remote and electronic consent must ensure documentation, readability, and participant understanding.

• 6. Expanded consent for secondary use

  It refers to strengthening how participants are informed and give permission for the future use of their data beyond the original clinical study purpose.

• 7. Post-trial access to beneficial interventions

  It refers to the ethical expectation that, after a clinical trial ends, participants should have appropriate access to study interventions that were shown to be beneficial, when it is medically justified and feasible.

• 8. Protection of vulnerable populations

  It refers to special safeguards for participants who may be at higher risk of coercion, undue influence, or inability to fully protect their own interests in a clinical study.

• 9. Proactive study quality planning

  Quality by Design (QbD) concept is introduced.

  It requires that quality is proactively built into the trial design and processes from the beginning, rather than relying mainly on monitoring, inspection, or corrective actions after problems occur.

• 10. Transparency and public disclosure

  There will be an increase in oversight and traceability through mandatory audit trails, risk-based monitoring (RBM), and documented reporting of trial outcomes.

• 11. Sustainability and environmental responsibility

  This concept refers to encouraging clinical studies to be planned and conducted in ways that minimize unnecessary environmental impact.

What Participants Can Expect from Now On

For anyone joining a clinical study in the coming years, participation should feel clearer, safer, and more personal. You can expect information written in plain language, the freedom to ask questions, and maintaining the right to withdraw at any time without consequence. Consent will be an ongoing conversation rather than a one-time signature, and study results should be available to you once the research is completed. If an investigational treatment proves beneficial, plans should be in place for continued access, and any harm must be compensated. Above all, you will be regarded as a partner, someone whose involvement, feedback, and trust are essential to advancing healthcare. Clinical research is entering a new phase where science progresses with people.