Public Consultation on a Draft Revised Version of the Declaration of Helsinki


Download the phase 2 public comment document

Email completed document no later than 24 June聽2024, 5pm Central Time聽(UTC-6)


Background

The WMAdeveloped the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants following the atrocities by physicians conducting unethical medical research during the Second World War. Since the WMAfirst adopted the Declaration of Helsinki in 1964, researchers, ethics review committees, and governments around the world now rely on the document鈥檚 high-level enduring principles to guide fundamental ethical considerations and decision-making.

To ensure the Declaration of Helsinki, or DoH, continues to fulfill its purpose and to address evolving ethical challenges across the global research community, the WMAinvites periodic reviews of the document. Given the document was last updated in 2013, the WMAappointed a new workgroup to facilitate the current revision of the Declaration of Helsinki.

The revision process is designed to be collaborative, transparent, and inclusive. The workgroup鈥檚 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.聽Resulting edits to the principles proposed by the workgroup are ultimately circulated worldwide for public comment periods for feedback.

In order to maximise input by all stakeholders and the public, we are providing two separate public comment periods. A phase 1 public comment period was held earlier this year, and a phase 2 comment period is opening now.

Open Now: Phase 2 Public Comment Period (3 June 鈥 24 June)

The workgroup鈥檚 proposed edits to date are now available for public comment. To submit your organization鈥檚 or your individual feedback, download the phase 2 public comment document and populate your comments in the row that corresponds to the DoH paragraph under review. If you wish to offer specific edits for consideration, indicate proposed new language with bold yellow highlighted language. Indicate any proposed deletions with a yellow highlighted strikethrough language. Please do not use Track Changes. 聽Please ensure all comments are properly attributed by including your name, title and organisation. Email the completed document to doh@wma.net no later than 24 June 2024, 5pm Central Time (UTC-6). Since this is the final comment period, submissions received after June 24 will not be considered.

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 麻豆果冻传媒, and the document is intended to be considered by the Council and the General Assembly in Helsinki, Finland in October 2024.

The workgroup includes WMAConstituent Members from Bangladesh, Belgium, Brazil, China, Denmark, Finland, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Nigeria, South Africa, Taiwan, United Kingdom, United States (Chair), Uruguay, Vatican and the WMAAssociate Members.