Health Information Privacy

CCfV has been a trusted research center in the Halifax community for nearly 30 years. All of our studies and clinical trials adhere to provincial and federal regulations and are reviewed and approved by a Research Ethics Board.

The information below explains how your health information collected during screening and study procedures will be managed.

How will my privacy be protected?

Your privacy and confidentiality will be respected. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. Your personal information or information that could identify you will not be revealed without your express consent unless required by law. If facts become known to the researchers which must be reported by law to public health authorities or legal authorities, then your personal information will be provided to the appropriate agency or authority. You may contact the study doctor to consult your study file and correct any errors. However, you may not be able to review some of your records related to the study until after the study has been completed.

If you decide to participate in this study, the study doctor and research team will use information about you as described in this consent form. This may include your name, address, phone number, email, medical history, date of birth, ethnicity, and information from your study visits. Studies involving humans now routinely collect information on race and ethnic origin as well as other characteristics of individuals because these characteristics may influence how people respond to different medications. Providing information on your race or ethnic origin is voluntary.

You will be given a unique study number as a participant in this study. This number will not include any personal information that could identify you (it will not include your name, Personal Health Number, Social Insurance Number, or initials, etc.). The number will be used on any research-related information and samples that go outside the study site. The list that matches your name to the unique study number that is used on research-related information is kept at the study site securely and will not be removed and/or released without your consent unless required by law.

Who will have access to my data?

Research records, personal and health information or other source records identifying you may be inspected in the presence of the Investigator or their designate by representatives of the Sponsor, representatives from the IWK Health Centre Research Ethics Board, the US Food & Drug Administration (FDA) and Health Canada or other regulatory agency inspectors to make sure that the study is being done properly. They can only see your personal information with the study doctors or staff nearby and cannot take anything away from the study site that contain your personal information. CCfV study staff from the IWK Health Centre, Dalhousie University, and Nova Scotia Health (NSH) will have access to your personal health information.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

Information about this study will also be available on the Health Canada’s Clinical Trials Database https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html. This website will not include information that can identify you. You can search this website at any time.

If the results of this study are published, your identity will remain confidential. It is expected that de-identified information collected during this study will be used in analyses and will be published/presented to the scientific community at meetings and in journals. This de-identified information may also be used as part of a submission to regulatory authorities around the world to support the approval of drugs used in this research.

While every effort will be made to protect the privacy of your information, absolute confidentiality cannot be guaranteed. This does not limit the duty of researchers and others to protect your privacy. You may take away your permission to use and share health data about you at any time by contacting the study doctor. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after that date; however, health data about you that has already been gathered may still be used and given to others as described in this form.

Your study records, including confidential information collected during the study, will be kept in a secure location for at least 15 years after study completion, as required by Canadian clinical trial regulations and then destroyed.

Your family physician will be notified of your participation in the study so that your study doctor and your family doctor can provide proper medical care, if you provide consent for us to do this.

What will happen with your study samples?

Some of your study samples will be sent to different laboratories for testing of the immune response against pertussis. The remaining samples will be sent to a biobank that the CDC is setting up so that samples from this and other studies can be used by investigators and other laboratories in the future to study different aspects of pertussis disease, diagnosis, or prevention. No testing will be done on your DNA or genetic material. All samples will be identified by only a study code; none of your personal information will be made available to the investigators or laboratories.

The laboratories include, but are not limited to, those located at CCfV and Dalhousie University in Halifax, NS, as well as at the CDC in Atlanta, Georgia, US, and Vanderbilt University in Nashville, Tennessee, US. In the future, other laboratories may apply to the CDC to use the samples stored in the biobank.

Collected samples will be stored until they are no longer needed and then will be destroyed. The samples collected for testing the immune response will be stored for a maximum of 25 years before being destroyed. The samples collected for the pertussis biobank will be stored as long as the biobank exists.

If you are not eligible to take part in the study, we would like to use your screening antibody blood, nasal wash and nasal aspirate samples. They will be anonymized (not be able to be linked back to you) and used by the CCfV lab or sent to another study laboratory to help develop and validate the lab testing.

Contact for future studies

You will be asked at the end of the study if we can contact you for future Canadian Center for Vaccinology (CCfV) studies. If you agree to be contacted, it does not mean that you have to take part in future studies. If you do not want to be contacted, we would like to know why. We will record your answer if you choose to give one. If you wish to be contacted, we will ask you to initial the signature page of this form to indicate this and reconfirm this when you have completed the study.

If you still wish to be contacted at the end of the study, we will collect information that will include your name, address, phone number, email address and date of birth, which we store in a secure area. If you indicate you agree today and change your mind later, it is not a problem and will not impact your care in any way.

What if I have study questions or problems?

If you have any questions or concerns, contact the Research Coordinator, Kara Redden, at 902-266-6510 or challengeme@iwk.nshealth.ca. You can reach the Research Coordinator Monday to Friday between the hours of 8 am and 4 pm. If you are calling after 4 pm, on the weekend, or on a holiday, please call 902-476-8837 to reach the on-call study nurse.