Confidentiality

Introduction

The GLORY protocol does not require the transmission of unique patient identifiers to the GLORY Study Coordinating Center. Thus, a high degree of patient confidentiality is ensured by the registry design. Data concerning individual patients that is held by the Study Coordinating Center will not be shared with anyone except the patient’s physician and local study coordinator. Any patient contact will be unobtrusive and limited to a brief interview either during a regularly scheduled clinic visit or via telephone and/or a mailed informational letter.

While the sponsor, Sanofi, and the members of the Scientific Advisory Committee will have access to the names of physicians participating in this project, they will not have access to individual hospital, physician, or patient outcome data or patient identities.

Investigators should inform their hospital Institutional Review Board (IRB) or ethics committee of their intention to participate in this registry. If dictated by hospital policy, it may be necessary to submit documentation for approval to participate. Model IRB/ethics committee documents are included in this chapter.

Depending on the requirements of individual hospital ethics review committees, informed consent might be required for all patients who will be followed after hospital discharge. This may involve identifying potential study patients while hospitalized and obtaining their consent for post discharge contact. Some ethics committees may allow patients to be contacted by telephone or letter following hospital discharge without receiving prior patient consent.

Patient identities remain confidential to the enrolling hospital. No information that could be used to identify individual registry patients will be submitted to, or held by, the Study Coordinating Center. The Study Coordinating Center will also protect the confidentiality of hospital-specific clinical data. Confidential electronic data will be protected by password and all paper copies of data and reports will be stored in a secure facility.

Specific Measures to Protect Confidentiality

Specific security checks include the following:

• All physician-specific data are stored in locked files at the Study Coordinating Center. Address labels containing site names are printed by the Study Coordinating Center and placed on sealed envelopes containing confidential reports, which are mailed to participating physicians.
• Patients are identified through a number assigned to them at enrollment by the local study coordinator, thus all patients’ names and data are kept confidential.
• All patients are informed that information about them is being entered into the registry database and, if required by the ethics committee, their consent is obtained and recorded. Patients are told that they are free to refuse to answer follow-up questions without affecting their medical care. They are told that all study findings will be handled in strictest confidence.
• Measures to ensure protection of the rights of patients, physicians, and sites have been reviewed and approved by the Institutional Review Board of the University of Massachusetts Medical School. Ethics committee review of this project may not be legally mandated in some regions. However, individual hospitals have the right to require local ethics committee review of this research. Thus, investigators are responsible for notifying their local hospital research ethics review committee of their intention to enroll patients and for obtaining all required permissions prior to enrolling patients.

Role of the Sponsor

As a service to physicians, Sanofi provides financial support to maintain the registry. Sanofi will have access to aggregate reports only, not to individual patient, physician, or hospital data. The sponsor will have a list of participating physicians, but will be unable to link physicians with their outcomes. Authority for the policies of this program and database are vested in the Scientific Advisory Committee. It is the duty of the committee to ensure that the data analysis methods and assumptions used in interpreting the data are valid and that confidentiality is maintained.