#27 Practical RWE – Publications


“Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research”

[as per §36 of the Declaration of Helsinki: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/]

As researchers, we have an ethical obligation to publish our results, both positive and negative.  This ensures that participants are not exposed to unnecessary duplicate experiments that  may have no benefit for either the participant or science or society.

Why do we need ethics committee approval to be able to publish our non-interventional study results?  It’s an ethical obligation [see §23 of the Declaration of Helsinki] and a legal requirement.

The International Committee of Medical Journal Editors (ICJME) has embraced the principles of the Declaration of Helsinki in their recommendations to those wishing to publish their clinical research results.

Specifically, the ICJME require:

  1. Evidence of Ethics Committee Approval: All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors should seek approval to conduct research from an independent local, regional or national review body (e.g., ethics committee, institutional review board), and be prepared to provide documentation when requested by editors.
  2. Evidence of Informed Consent: Patients have a right to privacy that should not be violated without informed consent. When informed consent has been obtained, it should be indicated in the published article.

[ICJME Recommendations – Protection of Research Participants: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html]

In essence, to publish results from non-interventional studies, researchers must comply with ICMJE guidelines, which require adherence to the Declaration of Helsinki and relevant local regulations. This includes securing ethics committee approval, safeguarding participant privacy, and obtaining informed consent for publication. These steps underscore the importance of ethical integrity and transparency in research.

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