Ethical Issues

The Wednesday AccrualNet Post (5.22.13): International Clinical Trials' Day and Informed Consent

Last Updated: May 22, 2013
Annette Galassi's Image

This past Monday, May 20th was International Clinical Trials' Day (ICTD).  The objective is for this day to be a focal point for international communication events, meetings, debates, and celebrations of clinical research. Did you even know it was ICTD?  Did your organization do anything to mark the day?  It wouldn’t surprise me if the answer to these questions was “no.” 

I haven’t seen or heard much about ICTD here in the U.S.  – not even on our own NIH or web sites.  But events to mark this day seem to have taken hold in Europe. The European Clinical Research Infrastructures Network (ECRIN) held a meeting in Warsaw that focused on the use of placebo in clinical research.  And the UK’s National Institute of Health Research (NIHR) launched it’s ‘OK to ask’ campaign to encourage people to start conversations about taking part in research. 

Given that our focus this month is informed consent, and realizing that Monday was ICTD, I began to think about the informed consent process from an international perspective. Regardless of where we practice, we are all guided by the same principles of good clinical practice, including adequate protection of research participants.  Many countries have adopted GCP principles as laws and/or regulations.  But what is the informed consent document and process like in other countries?  Are the elements of informed consent that are required here in the U.S. similar to what is required in other countries? 

A few members of our AccrualNet community are from other countries.  A few members are involved in the conduct of international trials.  Please take a moment to tell us about informed consent from your perspective.

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