Declaration of Helsinki

Medical Research Involving Human Subjects


The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The current (2013) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes. The WMA would like to thank all those who submitted comments and suggestions for the most recent revision of the DoH.

In 2014, the WMA produced a celebratory publication to mark the 50th anniversary of the adoption of the Declaration of Helsinki. “The World Medical Association Declaration of Helsinki: 1964-2014 50 Years of Evolution of Medical Research Ethics” can be ordered online here.

Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki.

At the WMA Council meeting in April 2022, a workgroup was established to begin another revision of this important document. The American Medical Association (AMA) is leading this process.

The revision process is designed to be collaborative, transparent, and inclusive. The workgroup’s efforts are informed by regional and topical meetings spread over two years, where issues are discussed by local and international experts and engaged audiences with diverse opinions.  Resulting edits to the principles proposed by the workgroup are ultimately circulated worldwide for public comment periods for feedback.

The regional expert meetings are the following:

In order to maximize input by all stakeholders and the public, we are providing two separate public comment periods. A phase 1 public comment period is being held now to address issues from the first few regional meetings, and a phase 2 comment period will follow in the spring when additional topics have been addressed.

Open Now: Phase 1 Public Comment Period

The workgroup’s proposed edits to date are now available for public comment. To submit your or your organization’s feedback, download the phase 1 public comment document and populate any comments in the third column. If you wish to offer specific edits for consideration, indicate proposed new language with underlined bold text. Indicate any proposed deletions with a strikethrough. You can also leave any general or overarching comments at the top of the document. Please ensure all comments are properly attributed by including your name, title and organization, which will be included in the published comment document. Comments without attribution will not be considered. Finally, email the completed document to doh@wma.net by 7 February 2024.

Consideration for Adoption: General Assembly Meeting Helsinki, Finland

The workgroup intends to recommend a final updated draft of the Declaration of Helsinki to the Medical Ethics Committee of the World Medical Association, and the document is intended to be considered by the Council and the General Assembly in Helsinki, Finland in October 2024.

 

*Translations in languages other than the WMA official languages (English/Spanish/French) are available below:

  • Finnish translated by the Finnish Medical Association
  • German translated by the German Medical Association
  • Japanese translated by the Japan Medical Association
  • Portuguese version
  • Czech translated by the Czech Medical Association
  • Hungarian translated by the Center for Ethics and Law in Biomedicine, Hungary

*Previous archived versions below are for research and information purpose only, use the updated version as reference.