The parameters of informed consent.

PURPOSE

To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained.

METHODS

Summarization of current law obtained from legal treatises, reports of recent cases, and personal experience as a reviewer and expert.

RESULTS

Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research.

CONCLUSION

Demonstration of a well-conducted process, not merely of a paper, not only protects the physician from exposure to liability, but increases the patient's autonomy in decisions concerning health and encourages compliance with treatment.