If you have any questions about this study or your rights, please contact Dr. [insert study physicians name] at [insert address and phone #].
If you have any questions about your rights as a research subject, please contact [insert ethics contact or other neutral or disinterested party] at [insert address and phone number].
Will My Taking Part In This Study Be Kept Confidential?
The study doctor and staff will handle your personal health information in a confidential manner. Your health information will be used and disclosed as explained in the following Data Privacy Statements.
In this section, "personal health information" means information about a person that relates to things like the person's physical or family health history, health care, health care provider or substitute decision-maker and that directly identifies the person, and "study data" means study-related health information that does not directly identify a person (that is, it does not contain the person's name, address, health number or other identifying information) but that does contain an assigned code number for the person and/or the person's initials.
By signing the consent document for this study, you will give permission for the uses and disclosures of your personal health information that are described in this Data Privacy Statement. If you do not want to allow these uses, you should not participate in this study.
If you agree to participate in the study, your personal health information and study data will be maintained, used and shared in the following ways:
- The study monitor, the study auditor, the sponsor's clinical research staff and regulatory authorities might have access to your personal health information. This personal health information may include information from your health records such as your medical history, all lab results, ECG readings, specialist reports, and medications that you have been on in the past or currently. The records will be kept and disposed of in accordance with all applicable laws and regulations.
- The study doctor and staff will send your study data to the study sponsor, its associated companies and its representatives (the "sponsor"). Because the sponsor conducts business related to clinical research in many countries around the world, this may involve sending your study data outside of Canada. If your study data is sent to other countries, your privacy will remain protected as described in this section.
- Your study data will be used by the sponsor for research purposes to support the scientific objectives of the study. This may include studying how well the drug(s) or treatment(s) associated with the study worked and/or how safe they were; to better understand the conditions or illnesses being studied; and/or to improve the design of future studies.
- Your study data, either alone or combined with data from other studies, might be shared with regulatory authorities in Canada, such as Health Canada, and similar
Version: 26-October-2009Page 9 of 14Confidential