There is a provision for of informed consent; however, the conditions for such a waiver were not met because: (1) the level of risk was not minimal; (2) the waiver did affect the rights and welfare of the subjects; (3) the research could still practicably have been carried out with informed consent; (4) subjects were not provided with information after the study to explain what occurred.

As I had suggested in my September 2010 column, Judge Richard Leon's decision was based in large part on his finding that Dr. Benowitz's ongoing conflict of interest with pharmaceutical companies rendered him unable to objectively consider the issue of dissolvable tobacco products (DTPs).

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