Treatment decisions in high-risk situations require a dynamic relationship between doctor and patient in which patient preferences and clinician recommendations contribute equally in shaping a final treatment decision.
The physician must help patients understand that all options—further testing, surgery, no action—carry risks and benefits. Disclosing the statistical probability of injury and other possible outcomes might help, but it can also hinder the process.
After assessing the reasons for a patient’s unrealistic hopefulness in the face of clear understanding, a clinician may believe that significant harm will come to the patient if he or she does not acknowledge the seriousness of the illness.
Requirements for informed consent are relatively vague and the exceptions are few, so it is in the physician’s best interest to inform patients about proposed treatment options, ascertain that they understand their choices, and secure their consent.
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.