Updates to Informed Consent Documentation ORI Operations

Informed Consent for Clinical Research

The Informed Consent Form (ICF) template at MHRI was updated Spring 2018.  As of January 21, 2019 this template is required for all new submissions being reviewed by the MHRI IRB which require consent.  The new ICF template conforms to the revised common rule as well as institutional changes including:

• Provision of a concise summary at the beginning of the consent form
• Integration of HIPAA language into the body of the consent form, allowing for a combined HIPAA authorization/consent form
• Revision to the signature block of the consent form, most notably removal of the requirement for an investigator signature

This ICF template may be downloaded from the MHRI website here and is also available in the library in the new eIRB system. 

ORI Operational Update

In order to improve customer service and IRB communication, the Office of Research Integrity (ORI) has assigned ORI Administrators to assist specific departments and identified a dedicated coordinator for IRB reliance agreements (use of external IRBs).

If you have a question/issue regarding a protocol or require pre-submission assistance, please contact the appropriate ORI administrator or coordinator listed below.  If you are unsure of who to contact, please email the Office of Research Integrity at MHRI-ORIHelpDesk@medstar.net.