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.
Asking for forgiveness may be oppressive to a patient or family still grappling with the fact of the harm, the impact of the harm, and their own emotional response to the harm.
In cost-effectiveness research, the cost of a medical intervention is reported as a dollar amount per quality-adjusted life year gained—the quality of health and the length of time over which the health state exists.
The Moseley study found no significant difference between those in the arthroscopic lavage and debridement arm of the study and those in the sham surgery arm.