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Confidentiality
All patients' names and the data obtained from patient medical records will be kept confidential. Patients will be identified through a number assigned to them at study enrollment by the coordinator at each hospital. When required by the hospital ethics committee, patients who are contacted as part of the 6-month follow-up will be informed that information about them is being entered into the GRACE registry and their consent will be obtained and recorded. Patients will be told that they are free to refuse to answer follow-up questions without affecting their medical care. They will be told that all study findings will be handled in strictest confidence. Where mandated by national law or local hospital regulation, ethics committees in the collaborating hospitals will be required to approve the study protocol before a hospital can participate.
Patient Consent, Ethics, and Confidentiality
Overview | Specific Measures to Protect Patient Confidentiality | Role of the Sponsor
Although there are no imposed interventions, informed patient consent may be required by hospital ethics review committees, particularly since the collection of follow-up data may require some form of patient contact. Any patient contact will be unobtrusive and limited to a brief telephone interview or mailed questionnaire. Depending on the requirements of individual hospital ethics review committees informed consent may be required for patients who will be contacted after hospital discharge. This may involve identifying potential study patients while hospitalized and obtaining their consent for post-discharge contact at that time. Some ethics committees may allow patients to be contacted by telephone or letter following hospital discharge without formal consent prior to initial telephone or mail contact.
Patient identities will remain as confidential information to the participating hospital. No information that could be used to uniquely identify individual study patients will be submitted to or held by the data management or coordinating centers for GRACE. The Data Management and Study Coordinating Centers will protect confidentiality of hospital-specific clinical data. All confidential data will be protected by using passwords for electronic data and by storing all paper copies of data and reports in a secure facility. Hospitals should inform their Institutional Review Board (IRB) or ethics committee of their intention to participate in GRACE. If dictated by hospital policy, it will be necessary to submit documentation for approval to participate in the study.
All patient, clinic, and physician information is strictly confidential. Confidentiality is maintained through the following security checks:
- All physician-specific data are stored in a locked file in GRACE Data Management and Scientific Coordinating Centers. Address labels containing GRACE site names are printed by the Data Management Centers and placed on sealed envelopes containing confidential reports, which will be mailed to participating physicians.
- The GRACE protocol does not require the transmission of patient identifiers, such as name, address or social insurance numbers, outside of participating hospitals. Thus, a high degree of patient confidentiality is ensured by the study design. All data concerning individual patients held by the Data Management and Scientific Coordinating Centers will not be shared with anyone except the patient and his physicians. Confidential data will be stored in locked filing cabinets at the University of Massachusetts Medical School and at Premier Research Worldwide. Computer files will be protected by password. While the sponsor, Sanofi, and the members of the GRACE Scientific Advisory Committee 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.
- Measures to ensure protection of the rights of patients, physicians, and hospitals 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 countries. However, individual hospitals have the right to require local ethics committee review of this research and investigators are responsible for notifying their local hospital research ethics review committee of their intention to enroll patients into GRACE and to obtain all required permissions prior to enrolling patients.
As a service to physicians, Sanofi provides financial support to maintain the database. Sanofi has access to aggregate reports only, not to individual patient, physician, or hospital data. The sponsor has a list of participating physicians, but is unable to link physicians with their outcomes. Authority for the policies of the GRACE program and database are vested in the GRACE Scientific Advisory Committee. It is the duty of the committee to ensure that data analysis methods and assumptions used in interpreting the data are valid and that confidentiality is maintained.
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