Dec 05 2013

A New Version of the Declaration of Helsinki

By Guest Contributor: Dawn Groenke, Senior Medical Writer at Cato Research

In October, the World Medical Association adopted a new version of the Declaration of Helsinki.  This revision was completed prior to the 50th anniversary of this document (to occur in June 2014) and included updates on issues that have been under discussion in the medical community since the last revision.  This is the 7th revision of the Declaration of Helsinki and there is a total 37 articles contained.

One of the notable revision is the structure of the document.  In the previous versions, there were three sections:

  • Introduction,
  • Principles for Medical Research,
  • Additional Principles for Medical Research Combined with Medical Care

For past revisions, new articles and statements were incorporated into the document in places where they seemed to be similar in theme to the current article.  Unfortunately, there was often separate articles on similar principles scattered throughout the declaration.  In the newly release version, there are 12 sections which groups statements on topics together which are:

  •  Preamble
  • General Principles
  • Risks, Burdens and Benefits
  • Vulnerable Groups and Individuals
  • Scientific Requirements and Research Protocols
  • Research Ethics Committees
  • Privacy and Confidentiality
  • Informed Consent
  • Use of Placebo
  • Post-Trial Provisions
  • Research Registration and Publication and Dissemination of Results
  • Unproven Interventions in Clinical Practice

This reorganization groups the articles by related topics to maintain the discussion of important issues.  These changes included splitting sentences in articles from previous reversions into separate sections or articles.

Along with the reorganization the new principles were added to the declaration.  One addition is the statement that subjects should be compensated for harm from the clinical trial.  Another new statement is that risks to subjects should be minimized and continuously monitored and assessed throughout the study.  There is the inclusion in the placebo use discussion about using an intervention less effective than the best proven intervention being considered similar to the use of placebo.  Additional language one in with the placebo language.  Also provision for post-trial access for all participants that should be disclosed in the consent process.

When the Declaration was initially released it was the only guidance on the ethics of medical research.  Since then there has been a growth in the number and types of clinical trials conducted, and there is now other guidance available including the good clinical practice guidelines produced by the International Conference on Harmonisation.