The Doctor and Patient relationship aspect of Medicine has changed drastically in the last twenty years. It has evolved from paternalism (the doctor makes the decision for the patient) to shared decision making where the patient is considered an equal partner in his/her own health related decisions. Informed consent is the cornerstone for this view. When a patient or a research subject makes an autonomous decision after understanding, the risks and benefits involved with the decision is Informed consent. Complete Informed consent covers the following components: competency, disclosure, comprehension and voluntary. Competency refers to the requirement for the individual to be of legal age and be mentally competent to understand the process. Disclosure relates to knowledge of the relevant risks and comprehension means fully understanding the pertinent and factual risks before consent. Voluntary is when the decision is without coercion or duress. (Colston, 2004)
Today Informed consent is a routine process required by law not only in the clinical setting but also in research. In United States, in clinical settings the physician performing the procedure obtains informed consent. The Joint Commission on Accreditation of Healthcare Organizations is responsible for overseeing the implementation of informed consent.
Since the implementation of Informed consent is dependent on the healthcare provider, it varies significantly and hence susceptible to lawsuits. There are no federal law listing the procedures, decisions and tests, which require Informed consent. Hence, it is upon the hospitals and medical professions to decide on the local guidelines for informed consent (Terry, 2010). The legal criteria for determining informed consent diverge from state to state. States have applied different standards when enunciating Informed consent. Some states base it upon what any physician with a similar background would disclose; others on what a reasonable patient would want to know and some on both of these principles. (Kalibara, 2010) Legal actions related to Informed consent are usually that of negligence or battery. Negligence is the patient claiming that the physician did not reveal full information. Battery is when the patient claims on unlawful touching by the doctor without proper consent. (Mazur, 2003)
Another issue related to implementing Informed consent is in determining how much information is required as material risk to a patient. A healthcare provider needs to disclose most common risks known to occur for a particular procedure or test. This further is dependent on the nature of the procedure and the patient’s relevant comorbidities. This information can vary depending on how well the physician knows the patient. Courts have attempted to provide some guidance, like the emphasis on consequences and their frequency. However, they uniformly fail to provide any definite guidance about scales the provider can use to measure materialistic risks. The...