Some positive revisions and updates made to The Helsinki Declaration (current public draft here). These revisions make an effort to improve safety of and benefit to clinical trial participants, especially those who are vulnerable (i.e. depending on age, illness, class status).
The update of The Helsinki Declaration also promotes transparency in the qualifications of those within and functioning of Research Ethics Committees.
Of particular interest is the sec. 36 update that holds "Researchers, authors, sponsors, editors and publishers" accountable to ethical obligations associated with publishing research results.
Although not an update, but included in the 2008 Declaration, it is important to note that The Helsinki Declaration still maintains that:
"Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication."
Sec. 36 is significant given the current clinical trial data publishing environment, wherein trial data is proprietary to the sponsoring company and unfavourable data is often suppressed. Furthermore, it is unclear whether the guest authors of ghostwritten clinical trial publications are provided with access to the data referred to within the publication (Fig. 1).
The update of The Helsinki Declaration also promotes transparency in the qualifications of those within and functioning of Research Ethics Committees.
Of particular interest is the sec. 36 update that holds "Researchers, authors, sponsors, editors and publishers" accountable to ethical obligations associated with publishing research results.
Although not an update, but included in the 2008 Declaration, it is important to note that The Helsinki Declaration still maintains that:
"Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication."
Sec. 36 is significant given the current clinical trial data publishing environment, wherein trial data is proprietary to the sponsoring company and unfavourable data is often suppressed. Furthermore, it is unclear whether the guest authors of ghostwritten clinical trial publications are provided with access to the data referred to within the publication (Fig. 1).
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