A medical researcher is comparing the results of two surgical techniques to correct a skeletal deformity. There are many obvious risks of participating in this treatment trial, and subjects are carefully informed about the likelihood of infection, poor treatment outcome, further damage, and so on. The research design includes a questionnaire given to subjects about their quality of life before and after the surgery. The consent form does not include the questionnaire as a risk of harm because this is just a simple paper and pencil questionnaire; it does not add any risks of harm to the overall study design. It is okay to not add information about the potential risks of harm from quality of life questionnaire to the consent form.
a. True
b. False
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