DoH Public Consultation 2013
This page is open for information purpose only. The public consultation closed on 15 June 2013.
The revision process so far
The General Assembly of the World Medical Association adopted the current version of the Declaration of Helsinki in Seoul in October 2008. The adoption followed a long discussion about the use of placebos as comparators in research. The General Assembly voted with a large majority to allow the use of placebos with extreme care and when scientifically necessary, however
“The Chair [of the WMA Council] announced his intention to appoint a workgroup to look at the Declaration of Helsinki on an ongoing basis specifically on the issue of the use of placebos in medical research. This is clearly an extremely significant and difficult issue and the WMA must continue to examine it carefully. He stressed that he would ensure that all sides of the issue were represented in the composition of the workgroup.”(From the minutes of the WMA General Assembly, Seoul 2008)
The appointed workgroup re-examined the current literature and conducted comprehensive discussions surrounding the issue of placebo during two expert conferences in Brazil in 2010 and 2011. It came to the conclusion that the regulation on placebo use in the 2008 version is ethically the most acceptable, however that the wording could be improved and that a more systematic approach would cover the ethical issue more comprehensively. The workgroup also concluded that it would be worthwhile looking into other issues related to the Declaration of Helsinki, and reported back to the WMA Council and General Assembly accordingly.
In October 2011 the General Assembly of the World Medical Association decided to start a new process of revision of the Declaration of Helsinki. A workgroup was set up and given the mandate to develop a draft revised version of the Declaration to be presented to the WMA Ethics Committee. The workgroup asked National Medical Associations and other stakeholders to submit their comments on the 2008 Declaration of Helsinki via a call for comments sent out in May 2012.
The revised draft presented here is the result of the workgroup’s analysis of these comments, the earlier discussions on the use of placebo in research, and three expert conferences on the Declaration of Helsinki which were held in Rotterdam in June 2012, Cape Town in December 2012, and Tokyo in February/March 2013, as well as several workgroup meetings. The Council of the WMA decided in April 2013 to put out this draft version for public consultation.
The general approach
The workgroup was guided during the revision process by consensus on the following issues:
- The workgroup agreed that the unique character of the Declaration of Helsinki should be maintained. As a document of “Ethical Principles for Medical Research Involving Human Subjects” it is distinct from other ethical or technical guidelines for medical research involving human subjects. Therefore lengthy and detailed explanation and regulation of certain issues was avoided.
- The Declaration has a certain length; the 2008 version contains 2047 words. The workgroup agreed that the next version of the Declaration should not become much longer.
Main issues raised during the revision process
- There were several suggestions to name certain vulnerable groups explicitly in the Declaration and provide specific regulation for them, especially children. After internal deliberation and discussions with the participants of the conferences, the workgroup agreed that specific vulnerable groups should not be mentioned explicitly in the Declaration. A general regulation for vulnerable groups was seen to be more appropriate for this document because explicitly mentioning some vulnerable groups could be misinterpreted.
- The question was raised as to why the text is directed specifically at physicians. The workgroup agreed that this reflects the mandate of the WMA and did not find it appropriate to dictate binding principles to groups that the WMA does not represent. However, where there are clear and essential expectations of others, e.g. ethics committees or editors of scientific journals, these are clearly voiced.
- It was explained that the reason why the text refers to “medical ethics” and not “bioethics” is because the guidance in the Declaration of Helsinki refers to medical practice and medical deontology.
- The subject of placebos was again a major issue, which the workgroup addressed by improving the wording and introducing a more systematic approach.
- There is an acknowledged internal inconsistency in parts of the document (for example paragraphs 8 and 14) but the workgroup decided to leave these unchanged as the aspirational aspect has to be considered.
- In terms of post-study arrangements, the respective merits and disadvantages of fair benefits and reasonable availability were discussed extensively and the wording was amended appropriately.
- The qualifications and responsibilities of research ethics committees were also a central consideration which was addressed by the workgroup with amendments to the wording.
- The issue of biobanks was seen as important. An additional short wording was added, which was considered by the workgroup to be sufficient at this point in time.
Various stakeholders also suggested several additional aspects, which were discussed extensively by the workgroup and the delegates of the expert conferences, however could not be included.
The changes proposed in the document published here therefore provide for:
- Better readability by reorganising and restructuring the document with sub headings
- More protection for vulnerable groups
- More protection for participants by including the issue of compensation for the first time
- More precise and specific requirements for post-study arrangements
- A more systematic approach to the use of placebos, but no weakening of the ethics of placebo use
How to participate in the public consultation
The WMA kindly invites all experts and stakeholders to submit comments on this draft version via email to the WMA secretariat at email@example.com no later than 15 June 2013. The workgroup will thoroughly review all comments and consider all input; however please note that it may not be possible to take account of all the suggestions received in the new draft declaration.
The new draft revised version of the Declaration of Helsinki may be downloaded here, either in plain text, or in a version including comments explaining the alterations.
Although desirable, due to time considerations it will not be possible to provide documentation or consider comments submitted in languages other than English. The finished version of the document will be translated into Spanish and French by the WMA.
All submissions will be kept on file and may be made available to members of the public upon request to the WMA following completion of the revision process.