See All Projects

Informed Consent

Focus Area: Ethical Frameworks

Informed Consent

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.

Informed Consent

Current Status: Drafts complete of key deliverables

Impact:

Sponsors will have access to informed consent language and a data use agreement template for broad data sharing purposes to use prospectively.

Objectives

  • 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

Key Milestones:

Related External Links:

European Medicines Agency: Publication of clinical data

Project Leader: Rebecca Li