In alignment with the roll out of the Clinical Trial Management System (CTMS) by the Office of Clinical Research, the IRB has released updated language templates related to HIPAA and Electronic Medical Record. These templates are being provided for convenience in developing informed consent forms for new studies. The updated templates can be found on the “Forms and Templates” page of this website.
The updated language will ensure that subjects are adequately informed that:
1. All research staff at Penn with CTMS access can see patients’ electronic medical record information
2. Their electronic medical record is now linked to a separate system for managing research
The new language is required for all new studies being submitted as of March 1, 2017. The IRB will NOT require submission of a modification to update already approved consent forms. The decision to update previously approved consent forms should be assessed by the individual Principal Investigators and their associated research teams (the IRB highly recommends incorporating the updated text with another planned revision to the consent form and not to submit a specific revision to add this text only).
If you have questions about the new language or the CTMS, please contact the Office of Clinical Research. If you have questions about revising an existing consent form/HIPAA authorization form or submission of a new consent form/HIPAA authorization form, please contact the Institutional Review Board.