Standardizing Informed Consent Templates and Data Sharing Agreements

Revised ICF and DUA templates available.

Standardizing Informed Consent Forms (ICFs) and Data Use Agreements (DUAs) across multiple sponsors may considerably streamline the data sharing process.

A multi-stakeholder working group at the MRCT Center released revised ICF and DUA templates at the March Data Transparency Conference. The revised DUA template provides legal text for a data sharing agreement between a recipient institution and a supplying institution. The ICF provides suggested text for prospectively informing participants on how broadly their data will be shared and with whom. Further comments on these documents are welcome and can be sent to MRCT@harvard.edu.

Learn More about the ICF Template for trials with external sponsors  and the ICF Template for trials with no external sponsors.