Focus Area: Ethical Frameworks
With the announcement of the EMA’s final policy on publication of clinical trial data in October 2014, all clinical study reports submitted after January 1, 2015 will be available for download by the public.
The policy states that “informed consent will be respected.” However many studies that will be submitted for registration after January 1, 2015 will not have consented participants with this type of data sharing communicated clearly in the consent form.
Current Status: Drafts complete of key deliverables
Sponsors will have access to informed consent language and a data use agreement template for broad data sharing purposes to use prospectively.
- Perform a retrospective analysis of data sharing language in informed consent forms
- Draft appropriate informed consent forms (ICF) that would enable broader data sharing
- Draft a Data Use Agreement (DUA) template to enable sharing of clinical trials data
- May 2014 – Retrospective analysis of data sharing language in informed consent forms completed
- September 2014 – Drafts of the DUA template and informed consent language completed
- March 2015 – Revised drafts of DUA template and informed consent forms (for studies with external sponsors and studies without external sponsors released)
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Project Leader: Rebecca Li