a. To what extent is personal identifiable information being collected
as part of this research?

The researchers will record demographic information, such as the research subject's name or initials, age, birth date, education, occupation and medical history. All of this information is personal identifiable information. The name of the research subject may identify the individual directly. Initials, age, birth date, education, occupation, medical history, and other information may identify an individual indirectly, when taken together in context.

b. What steps might help to ensure that the privacy and confidentiality
of individuals is protected?

Individuals have a reasonable expectation of privacy and should only be approached to participate in research by someone who has a justifiable reason to have access to those prospective participants and has a reason to know why they might participate in the research study. In this case the family doctor or nurse would likely inform the patient about the study. If the patient expresses interest, he or she may agree to be contacted by the researchers.

During the free and informed consent process, the researchers should describe the way the data will be used, as well as any anticipated secondary uses of the data. By consenting to participate in the research, the subjects allow researchers to use data about themselves for these defined purposes. Subjects should also be told that data will be sent to the sponsor and others who will be permitted to view study records (that is, sponsor delegates, regulatory agencies, and the REB).

The researchers might protect confidentiality of the data by assigning each research subject a code number, and using only that number to identify data about the subject. The researchers might also use locked rooms and filing cabinets to store any physical data. Electronic data might be stored on a non-networked computer protected by a password. Any data sent electronically should be encrypted.

When information collected through this research is disseminated, subjects will be anonymous. Normally, data will be presented in aggregate form to limit linking specific responses to individuals.

c. Might there be any limits on the researchers' ability to protect the
confidentiality of the data in this study?

Information collected in this study could possibly be liable to subpoena in judicial proceedings. As part of the free and informed consent process, the researchers should inform potential research subjects of any potential limits on their ability to protect confidentiality of the data.