a. Is there an explanation of who will have access to the information collected?
b. If access or disclosure of the patient's health/registration information is required from the custodian (i.e. the patient's primary caregiver), does the consent
meet requirements of the Alberta Health Information Act section 34(2)?
c. Is the Research Ethics Review Committee (RERC) included as having access to the information?
d. Is the RERC of the College of Physicians & Surgeons of Alberta (CPSA) spelled out in full and correct?
e. Is the mandatory wording present and correct if notifying the primary care physician of the subject’s participation is optional?
The confidentiality clause should inform subjects that:
a. Personal health information will be collected as part of the study - include a description of what is considered “personal health information”.
b. Personal health information will be confidential, unless the sponsor and/or investigator are required by law to release the information.
c. Confidential information will be protected. (Describe how: e.g. using code numbers or other methods.)
d. Study records will be kept separate from a subject’s medical records.
e. Use of collected information is limited to the purpose(s) of the study.
f. Personal health information will be checked occasionally against a subject’s medical records by representatives of the sponsor. Therefore, representatives of the drug company paying for the research will be able to view subject medical records.
g. Others may need to view a subject’s records, including:
i. representatives from the College of Physicians & Surgeons of Alberta Research Ethics Review Committee
ii. the Health Products and Food Branch of Health Canada (if applicable)
iii. the United States Food and Drug Administration (if applicable) and/or
iv. other foreign regulatory agencies
h. Groups/persons outside Canada that/who view a subject’s medical records may be regulated by privacy laws less strict than those in Canada.
i. Study records must be kept for 25 years.
j. Subjects have the right to check their health records and ask for corrections to be made.
k. By signing the consent form, subjects give the investigator and sponsor permission to collect, use and disclose medical records as outlined in this section.
l. If providing notification of participation to the subject’s primary care physician is optional, the following statement must be included:
“If you have a personal physician, it is important that s/he know that you are entered into a research study
and may be taking a drug that could affect your health. With your permission, we will notify your personal
physician that you are enrolled in this study.”
“I consent to my primary care physician being notified of my participation in this study.
YES NO
Subject’s Initials_________”
(Note: If the investigator is the subject’s primary care physician, this statement is not required.)