01 December 2024 : Editorial
Editorial: The 2024 Revision of the Declaration of Helsinki and its Continued Role as a Code of Ethics to Guide Medical Research
Dinah V. Parums1E*DOI: 10.12659/MSM.947428
Med Sci Monit 2024; 30:e947428
Table 1 Summary of key revisions to the 2024 Declaration of Helsinki [1].
| Revision to the Declaration document | Description of the revision |
|---|---|
| Terminology | The term ‘participants’ has replaced ‘subjects’ throughout the Declaration document, and gender-neutral language has been adopted to respect individuals involved in research |
| Research inclusivity | The Declaration document now addresses all individuals, teams, and organizations involved in medical research, including physicians, as an acknowledgment of the interdisciplinary nature of modern research studies and the ethical requirements of all research participants |
| Engagement of study participants | The new Declaration document emphasizes meaningful engagement with research study participants before, during, and after the study has been undertaken |
| Recognition of participant vulnerability | Researchers are advised to consider the long-term and global benefits, risks, and safety of research studies and the fair and responsible inclusion of vulnerable populations who require adequate support. Vulnerable individuals include those who may be unable to provide consent |
| Participant data and biobanking | Paragraph 32 of the Declaration document has been rewritten to address informed consent requirements for collecting, storing, and secondary use of data and biological materials. Situations are recognized where obtaining consent for unforeseen secondary research may not be possible, and in these cases, an Ethics Committee review and approval are required |
| Governance of Biobanks and Health Databases (Declaration of Taipei) | The revised Declaration document cross-references the WMA Declaration of Taipei [], which provides guidelines on the governance of biobanks and health databases, including data collected for multiple and indefinite use16 |
| Public health emergencies | A new paragraph has been added to the Declaration document that mandates that ethical principles must be upheld even during public health emergencies |
| Unproven or non-evidence-based interventions | Revisions to the new Declaration document clarify that unproven interventions to alleviate pain or suffering must not bypass ethical safety measures or evade evaluation by controlled clinical trials |
| Study design and environmental sustainability | The new Declaration document strengthens environmental sustainability commitments, and highlights the importance of rigorous study design to prevent wasteful research methods |
| The role of Ethics Committees | The new Declaration document recommends that sufficient resources be available to ensure the independence of research Ethics Committees to oversee research practices |
| Participant language, preferences and values, and consent | Study participant language, values, and preferences should be considered when they give consent or when consent is obtained from a legally authorized representative on their behalf |