7.1 Although this study exposes the students to minimal risk, it is always a good idea to seek Institutional Review Board approval before proceeding with any study involving human subjects.

7.2 This is a complicated situation. This patient’s underlying disease appears to be impairing his decision-making capacity. If his wishes are consistent during his lucid periods, this choice may be considered his real preference and followed accordingly. However, because his decision-making capacity is questionable, family members should be contacted about the procedure. Getting a surrogate decision maker involved might help determine what his real wishes are.

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7.3 Confidentiality. While the results are not reported to your insurance company or placed on your medical records, the company that completed the procedure and mailed your results has the ability to link you to your data.

7.4 No. Observational studies can still meet all of these requirements and be deemed “ethical.”