Confidentiality

Introduction

The study protocol does not require the transmission of unique patient identifiers to the Study Coordinating Center. Thus, a high degree of patient confidentiality is ensured by the study design. Data concerning individual patients held by the Study Coordinating Center will not be shared with anyone except the patient’s physician and local study coordinator. Depending on the availability and quality of medical records, patient contact may not be required to gather data for this study. However, if patient contact is necessary, it will be unobtrusive and limited to a brief interview either during a regularly scheduled clinic visit or via telephone.

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 to patient identities.

Investigators should inform their hospital Institutional Review Board (IRB) or ethics committee of their intention to participate in this registry. As 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.

Patients will not undergo any interventions as part of this study. However, depending on the requirements of individual hospital ethics review committees, informed consent may be required for study patients, based on the right of patients to approve of the use of their confidential medical data in a research study. Typically, 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 central 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.

Please note that some ethics committees consider date of birth to be a unique patient identifier, which is not allowed on the CRF without informed patient consent. In such cases the month and year of birth, but not the day, may be allowed. This will be sufficient for purposes of this study.

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 hospital study coordinator, who maintains this list locally. The names of study patients are stored separately from study data transmitted to the Study Coordinating Center. Thus, unique patient identifiers are confidential to the investigators at each study hospital.
• Where required by the hospital ethics committee, all study patients will be informed that information about them is being entered into the registry database. Patients will be 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 employed in the IMPROVE Study 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 countries. Nevertheless, 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, where required, obtaining all required permissions prior to enrolling patients.

Role of the Sponsor

IMPROVE is sponsored by a grant from Sanofi to the Center for Outcomes Research (COR), based at the University of Massachusetts Medical School located in Worcester, Massachusetts. COR serves as the Study Coordinating Center for the registry, which is governed by a Scientific Advisory Committee, comprised of physicians representing each participating country and clinical scientists with experience in the design and analysis of registry data. Fred Anderson, PhD, Director of COR, is responsible for the proper scientific and ethical conduct of this study, including assurance that appropriate measures for the protection of participants, including hospitals, physicians, and patients, are instituted and followed.