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As discussed in the previous blog, the Declaration of Helsinki is currently under revision with the two month public consultation period for the latest proposed revisions closing on 15 June.
Over the past 17 years, revisions to the Declaration have provided an interesting record of responses to public concerns about research ethics. Since 1996 the text on two controversial issues – the use of placebos and post-trial responsibilities - has been amended three times and further amendments are proposed in the current draft. The Working Group producing the draft revisions noted that the subject of placebos was again a major issue, which they sought to address by improving wording and providing for a more systematic approach, without weakening the protections in place.
The new text reads as follows (proposed additions and deletions to the text in the current paragraph 22 are shown in bold and strikethrough text respectively)
Proposed Paragraph 23
The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention(s), except in the following circumstances:
The use of placebo, or no treatmentintervention is acceptable in studies where no current proven intervention exists; or

  • Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, placebo or no treatment is necessary to determine the efficacy or safety of an intervention

  • and the patients who receive any intervention less effective than the best proven one, placebo or no treatment will not be subject to any additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.
In terms of post-study arrangements, the respective merits and disadvantages of fair benefits and reasonable availability were discussed extensively amongst the Working Group and the wording was amended to provide for more precise and specific requirements for post-study arrangements:
Currently paragraph 34 states:
At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits.
This is to be deleted entirely and replaced with:
Proposed paragraph 34
In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the study. This information should also be disclosed to participants during the informed consent process. All study participants should be informed about the outcome of the study.
Please let us know what you think of these proposed revisions.