As a research group interested in health informatics, the protection of personal information is a major concern. In order to ensure confidentiality of personal information and respect the privacy of the study participants, we have adopted these standards as the foundation of our electronic prescribing system.
Giving consent: an informed decision
Personal information will be accessed, uploaded, transmitted and analyzed over the course of the MOXXI research program. This is only possible once written authorization has been obtained from the participating patient. Written authorization is given by signing a consent form provided by the research team. The form contains enough information for individuals to make an informed, voluntary decision about who will have access to their health information and under what conditions.
Included in the consent:
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An explanation of the study and its objectives
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The expected duration of participation
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The expected contribution from the participant
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A statement regarding how confidentiality will be maintained for any information obtained during the project
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A MOXXI contact number in case of questions
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Information about the right to withdraw of consent
All participants have the right to withdraw from the study at any time by contacting the research team. As soon as they withdraw from the project, all transfer of that person's information is stopped and there is no penalty for ending participation. The normal services and standard of care will continue to be available to both consenting and non-consenting patients.
Access to patient information
Physicians who have agreed to participate in the project have access to past prescriptions, diagnostic information, emergency room and hospital visit dates of their patients who have provided written consent. The data is obtained from the Régie de l’assurance maladie du Québec (RAMQ) for pharmaceutical and medical services. Physicians do not have access to any information on the identity of other physicians or pharmacists who have provided services to these patients.
In order to evaluate the impact of the MOXXI system, the principal investigator, Dr. Robyn Tamblyn, and her research team will have access to data on the pharmaceutical, medical and hospital services received by patients over the duration of the project and for the 12 months preceding it. The team also has access to the list of medical problems of participating patients recorded by their physician using the MOXXI system. A record is kept of every occasion where a patient’s file is accessed by authorized parties.
Anonymization of information
In order to protect confidentiality for all participants whevever possible, all identification information is removed from the files before they are analyzed. Only Dr. Tamblyn or a specific team member will have acess to the original nominative information and it will accessed only for the purposes of quality assurance in the data. All team members who have access to patient information sign a data confidentiality agreement form with Dr. Tamblyn. No names will be released and only grouped data will be presented in publication of the project findings. The information gathered will only be used for the MOXXI project and will remain confidential.
Data storage
Data is stored only on the server for the MOXXI research program. The physician uses a secure (HTTPS) connection to connect to the MOXXI server. Access to the server is very limited and has the latest and most sophisticated protection against unauthorized intrusions and potential damage. This type of design offers a high level of data security in the event that a computer is lost or stolen.
Regulations and ethics approval
Within the project’s framework, personal data and information management conforms to law C-6 on electronic personal information as well as to the McGill University Health Center (MUHC) security standards.
The MOXXI program has been reviewed and approved by the Commission d’accès à l’information du Québec, the McGill University Research Ethics Board, the College of Physicians of Quebec and the Quebec Order of Pharmacists.