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

Prospective research subjects should be given the opportunity to provide free and informed consent before the research begins. A procedure should also be in place to check that consent is maintained throughout the subjects' participation in the research.

The researchers should consider how Chinese culture might influence the design of an appropriate means for seeking free and informed consent. In traditional Chinese culture, the family functions as a collective decision-maker, and some Chinese-Canadians may give their family the right to provide informed consent on their behalf. In contrast, other Chinese-Canadians may wish to provide individual consent. The researchers might begin the free and informed consent process by asking the family how consent should be sought. The researchers should design several free and informed consent procedures: one that allows for collective consent, one that seeks free and informed consent individually after a family discussion, and one that uses both approaches. They should also consider what would happen if they come across disagreement among family members about the way consent should be sought.

Written information about the research should be available in Cantonese and English, and the researchers should be prepared to explain the research in both languages. Care should be taken in the translation of documents to ensure that the translation is correct (for example, there might be translation followed by back translation).

It is possible that some of the research subjects might be unable to read either Cantonese or English. The researchers might propose that they describe the research to these potential research subjects.

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

Because the principal investigator has connections with the Chinese community centre and may be friends with some of the research subjects, the researchers should ensure that these relationships do not unduly influence the research subjects' decision to participate in the research. For example, a member of the research team other than the principal investigator might undertake the recruitment phase of the project. The principal investigator would not be given access to the names of potential subjects who refused to participate in the research. Potential subjects would be told of these mechanisms to ensure the voluntariness of the consent during the free and informed consent process.

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

The potential research subjects should be told:

• that they are being asked to participate in a research project
• who is conducting the research
• the purpose of the research, the expected duration and nature of their participation, and what they will have to do if they participate in the research
• who will have access to the information collected, given a description of the procedures used to protect confidentiality, and told about the anticipated uses of the data
• about the ways in which the research will be published, and how they will be informed of the results of the research
• about the harms and benefits associated with the research
• that they are free not to participate and have the right to stop participating at any time
• about any actual or potential conflicts of interest.
  

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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?

This research might involve children or adult family members who are legally incompetent. These individuals may be asked to become research subjects if:

• legislation allows such individuals to participate in research
• the research question can be addressed only by including these individuals in research
• free and informed consent will be sought from each individual's authorized representative
• the research does not expose them to more than minimal risks without the potential for direct benefits for them.

e. Should the law allow legally incompetent individuals to
participate in research?

Ethics review would likely determine that it is appropriate to ask such individuals to participate because the research is within the range of minimal risk, and information collected from such individuals will help address the research question. Researchers will then be required to describe how:

• free and informed consent will be obtained from the authorized representative
• the wishes of the individual concerning participation will be ascertained.