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 they begin the questionnaire. Normally, written consent is not required with questionnaires. Consent is implied in the completion and return of the survey, provided that a detailed information letter has been given to each participant.

However, in view of the risks of harm, the research subjects in this study might be sent a consent form in the mail first. The researchers would send questionnaires only to subjects who consent to participate.

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

The researchers might need to assure the REB that all potential research subjects have had access to post-trauma counselling. Offers of post-trauma counselling, as part of the research process, to a group of potential subjects who have not received adequate counselling might be considered an inducement to participate. Also, if the employer sends the questionnaire to the research subjects, there may be an element of coercion.

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

Each potential research subject should be told:

• that he or she is being asked to participate in a research project
• who is conducting the research
• 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
• that he or she is free to not answer any question
• who will have access to the information collected, a description of the procedures used to protect confidentiality, and the anticipated uses of the data
• about the ways in which the research will be published, and how he or she will be informed of the results of the research
• about 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
• about any possibility of commercialization of the research findings
• about any actual or potential conflicts of interest
• the identity and contact information of an individual who can further explain or discuss the research.

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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?

Some of the survivors of the fire might be unable to provide free and informed consent because of physical injuries or emotional trauma sustained in the fire. The researchers should determine whether such individuals would be able to participate in the research as it has been designed. The researchers may consider modifying the research procedure to allow for their inclusion.

If the researchers decide that individuals who are legally incompetent have the ability to participate in the research, there are a number of conditions that must be met before such individuals can be asked to become research subjects:

• Legislation must allow 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 the individual's authorized representative.
• The research does not expose them to more than minimal risks without the potential for direct benefits for them.

Including these individuals in the research might be important in order to find out about the escape experiences of those who were seriously injured in the fire. However, some research subjects might be exposed to more than minimal risk of harm by research. That is, subjects may experience distress while the questionnaire is being completed, and possibly for sometime afterwards. As the main benefit arising from this study is advancement of knowledge, ethics review may conclude that including legally incompetent individuals in this research is not justifiable.

Should the researchers be able to ask that these individuals become research subjects, they should describe how:

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