CONFIDENTIALITY AGREEMENT - INDEPENDENT STUDY MONITOR

I have agreed to serve as an Independent Study Monitor (ISM) for the following research study being conducted at ThomasJeffersonUniversity:

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:

  • Proprietary information belonging to TJU, Thomas Jefferson University Hospital (TJUH), or Jefferson University Physicians (JUP) (collectively, Jefferson) or an outside entity;
  • 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;
  • Financial and business information identified as or known to be confidential; and
  • 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’sapplicable 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 thisConfidentiality Agreement.

By signing below, I voluntarily agree to abide by the terms of this Confidentiality Agreement.

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Printed Name Signature Date