CONFIDENTIALITY AGREEMENT - INDEPENDENT STUDY MONITOR
I have agreed to serve as an Independent Study Monitor (ISM) for the following research study being conducted
at Thomas Jefferson University:
Title of Study:
Principal Investigator:
I understand that Confidential Information (defined below) may be made available to me, the confidentiality of
which I am obligated to protect. I understand that “Confidential Information” includes, but is not limited to,
information in any form (e.g. printed, electronic, spoken) containing or relating to the following:
o Proprietary information belonging to TJU, Thomas Jefferson University Hospital (TJUH), or Jefferson
University Physicians (JUP) (collectively, Jefferson) or an outside entity;
o Research information, including but not limited to, data collected in the course of scientific research,
scientific theory discussions, conclusions based on the results of research, and proposals for the funding
of scientific research;
o Financial and business information identified as or known to be confidential; and
o Individually identifiable protected health information (PHI), including any information describing or
pertaining to the physical or mental condition of an individual.
I understand that I must adhere to the applicable laws, regulations, policies and procedures to insure that
Confidential Information is properly accessed, used, maintained and disclosed and to prevent inappropriate or
unauthorized release.
I understand that there are specific laws governing the privacy and security of PHI. I acknowledge that PHI may
only be accessed, used, and disclosed as described in Jefferson’s applicable policies and Notice of Privacy
Practices, which I understand are consistent with the requirements of the Health Insurance Portability and
Accountability Act of 1996 and its regulations including Standards for the Privacy of Individually Identifiable
Health Information (collectively, HIPAA) and other privacy laws. If I have questions or concerns about the
access, use or disclosure of PHI, I will contact the TJU Compliance Officer (215-503-0762).
I agree to maintain the confidentiality of all Confidential Information, including PHI. I agree that I will not
access, use or disclose Confidential Information, including an individual’s PHI, unless I am authorized to do so.
If I become aware of a breach of confidentiality of Confidential Information, I will report the breach promptly to
the Director, Division of Human Subjects Protection (215-503-0203), or the TJU Compliance Officer.
I understand that my obligation to maintain the confidentiality of all Confidential Information continues after
my responsibilities as an ISM ends. Throughout my tenure as an ISM, I shall return or dispose of all
Confidential Information in my possession, as directed by the Director, Division of Human Subjects Protection.
I understand that an unauthorized disclosure of Confidential Information could result in legal claims and
substantial harm to Jefferson including its employees, students, patients, and research subjects.
I acknowledge that my activities as an ISM may be terminated if I violate this Confidentiality Agreement.
By signing below, I voluntarily agree to abide by the terms of this Confidentiality Agreement.
_____________________________
Printed Name
______________________________
Signature
_______________
Date