Revised WMA Declaration of Helsinki 2013: Improved Side-by-Side Comparison

Estimated reading time of this article: 2 minutes 41 seconds

The Declaration of Helsinki (DoH): Ethical Principles for Medical Research Involving Human Subjects was revised by the World Medical Association (WMA) at the 64th WMA General Assembly, Fortaleza, Brazil, October 2013.1

This new version of Declaration of Helsinki (2013) replaces the version of 2008 of 59th WMA General Assembly, Seoul, Republic of Korea, October 2008.

What has changed?

Finding the differences in new revisions of guidelines is not obvious. Unfortunately, the creators usually do not provide diffs between versions. This is a pity and complicates the understanding of everyone since no one really knows what has changed.

Improved Side-by-Side Comparison

My initial side-by-side comparison showed large differences of the documents. An analysis showed, that is due to text movements.

In order to be more useful, I tried to rearrange the versions structurally.

The new, improved side-by-side comparison (HTML, 196 KiB).

By clicking the above link, you will see the saved comparison as static HTML page. Differences are shown word-by-word.

Synchronization of versions for better comparison

For a better comparison I slightly modified the texts; I rearranged the paragraphs of the version 2008 where helpful. For validity, I changed almost nothing in the version 2013.

Modifications of the version 2008:

  • Moved the paragraphs to the same position as in the version 2013.
  • Split two paragraphs, tagged with [TOx], [FROMx], e.g. [TO5’], [FROM5]. Moved parts are enclosed in curly brackets “{}”.
  • Added synchronization tags, e.g. [SYNC3-4], whereas the first number is the paragraph number in the version 2008 and the second number is the paragraph number in the version 2013.
  • Added visible spaces “·” for synchronized line breaking.

Modifications of the version 2013:

  • Added synchronization tags, e.g. [SYNC3-4], whereas the first number is the paragraph number in the version 2008 and the second number is the paragraph number in the version 2013.
  • Added visible spaces “·” for synchronized line breaking.

Making of

I downloaded both versions2, converted them by hand to Markdown and synchronized the versions. Afterwards, I called the following script using Pandoc for normalization and html2diff for formatting.

#!/bin/bash

# Normalize
pandoc -f markdown_phpextra -t markdown_phpextra --atx-headers -o doh2013.sync.norm.md doh2013.sync.md
pandoc -f markdown_phpextra -t markdown_phpextra --atx-headers -o doh2008.sync.norm.md doh2008.sync.md

# Diff
diff -U9999999 --minimal doh2008.sync.norm.md doh2013.sync.norm.md > doh_2008_2013_sync.diff

# Generate pretty HTML
diff2html.py -o doh_2008_2013_sync.diff.html -i doh_2008_2013_sync.diff -a 1

All the necessary software is Open Source. So, you can repeat or improve it.

I have already created a similar comparison for a Swiss conflict of interest guideline (German) and could reuse this tool chain.

Hint

I created this comparison after seeing a tweet of Ben Goldacre.

anyone written an interesting commentary on new Declaration of Helsinki yet? Important changes? http://jama.jamanetwork.com/article.aspx?articleid=1760318

Remarks

The improved comparison shows the changes much clearer. The changes can now be analyzed in detail.

I haven’t yet analyzed the content of the texts and the changes yet.

  1. I hope this structural side-by-side comparison is helpful.
  2. I hope the creators of guideline revisions provide diffs and better archives in the future.

  1. World Medical Association (2013). WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects JAMA DOI: 10.1001/jama.2013.281053 ↩︎

  2. Finding the Declaration of Helsinki 2008 in the Internet was not easy. Revision control and archives could really be better. ↩︎

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