a. What free and informed consent procedure should be used in
this research?

Prospective research subjects must be given the opportunity to provide free and informed consent before the research begins. Normally, subjects would be asked to give written consent by signing the informed consent form. Measures should be in place to ensure that the information is relayed to potential subjects in a format and language that is understandable to them, and that they have adequate time to consider participation and ask questions. A procedure should also be in place to check that subjects' consent is maintained throughout their participation in the research.

b. What steps might be needed or useful to ensure that consent to
participate in this research is given freely?

In this research, the principal investigator may not have had direct contact with the research subjects because potential subjects are recommended for the study by the family doctor who is treating their hypertension. Care should still be taken to ensure that potential subjects do not feel obligated to enter the study because information about the study has been provided by someone associated with their medical care, and that they do not have the impression that their family doctor will no longer treat them if they do not agree to participate. Subjects must be told that they would be seen by this clinic regardless of their decision. Ability to get to the blood pressure clinic could also influence potential subjects.

c. What information should be provided to the potential research
subjects in the free and informed consent process?

According to the TCPS, each potential research subject should be told:

• that he or she is being invited to participate in a research study
• who is conducting the research and who is the sponsor
• the purpose of the research, the expected duration and nature of his or her participation, and what he or she will have to do if he or she participates in the research
• who will have access to the information collected, a description of the procedures used to protect confidentiality, and the anticipated uses of the data
• the ways in which the research will be published, and how he or she will be informed of the results of the research
• the harms and benefits associated with the research
• that he or she is free to not participate and has the right to stop participating at any time, without penalty
• about any possibility of commercialization of the research findings
• about any actual, potential conflicts of interest
• about alternatives to participating in the study, and alternative treatments
• about any costs, payments, reimbursement for expenses or compensation for injury
• that he or she would be informed of any new information relevant to continuing participation in the trial
• about circumstances under which the study might be stopped
• who to contact about his or her rights as a research subject
• the identity and contact information of an individual who can further explain or discuss the research.

The TCPS is a minimum standard; other regulations may also apply.

d. To what extent are the potential research subjects competent to
provide free and informed consent? What are the major issues
that must be addressed by the researcher in seeking free and
informed consent from those who are not competent?

The TCPS expresses the general requirement to restrict research involving incompetent subjects to questions that can be addressed only by their participation. Because high blood pressure is relatively common, their participation would not be necessary.