The legal definition of a patient and the corresponding duties of the physician have been debated in state courts for over a century, and many aspects of the question are still unresolved.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Is this a conflict over a team member’s practice style or is it a breach professional boundaries? Is it appropriate for team members to make this judgment, or should it instead come from the team leader?