Informed Consent

There have been significant changes in the doctor patient relationship with the impact of technology in day-to-day practice. More and more patients are aware of their rights and are keen to make free choice and decision on their treatment. This helps them to choose the treatment of their choice from the options available and to select a physician of their choice. Doctor''s decisions are being questioned regarding their correctness and there is a need to educate the patient, on what one offers by way of treatment. In some procedures and types of treatment, patient needs to be educated and informed of the merits and demerits of the treatment available. This will help the patient to make appropriate choice and also to accept some adverse outcome of treatment. Towards this end, all countries are looking afresh at the necessity of Informed Consent. Methods adopted by some countries are highlighted to help our physicians practice them in an appropriate way. A lot of remedial work needs to be done to minimize future litigation, as many doctors misunderstand their legal obligations and haven''t caught up with the change in judge''s thinking.Key Words: Doctor-patient relationship, Consumer ethics, Medical negligenceClinical ethics teaches physicians, a wide range of specific ethical issues e.g informed consent, truth telling, end-of-life decisions, advance directives (substitute decision making for incompetent patients) and increasing third-party constraints on the autonomy of both patients and physicians [1].There have been many changes, between 1965 and 1970 on the subject of medical ethics and physician-patient relationship. The traditional medical ethical principle required that the physician do what he thought would benefit the patient. The principle of mutual trust protected these decisions. The medical profession even refused to recognize the wishes of the patient and felt that he knows what is best for the patient – a paternalistic attitude. The physicians failed to accept that the patient is entitled to make his own free choice and decision-the principle of autonomy [2].Patients had earlier placed their faith in the physician''s higher education and the authority of his medical role. But of late doubts have been raised about the quality of doctor''s decision, as their decisions vary depending upon the facts that :

• a.He is a long trusted physician or an emergency room doctor seeing the patient for the first time,
• b.The patient is acutely ill or is suffering from a chronic illness,
• c.The procedure / treatment is a one time or it involves prolonged or repeated treatment,
• d.There are multiple / alternative choices or only one choice,
• e.Patient''s economic and social status, source of fund for treatment, and
• f.Doctor-patient relationship [3].

The rights (autonomy) of the patient have deeply eroded the old model of doctor-patient relationship. The emerging model prefers to treat a doctor as a service provider (medical) for hire, governed by negotiation and a commercial relationship. The consumer ethics has displaced the physician from their previous prominent status and allow patients to say, “Doctors are not Gods“. The patient has now the ability to select and dismiss their doctors. They have the resources and can express their preferences about making decisions on general or even specific treatments. They can ask questions, reject proposals, and often find allies in dealing not only with doctors but also hospitals from legal literature, support group, counsellors, and social workers [3].The clinical-ethical process of shared decision-making is mirrored by the legal doctrine of Informed Consent (IC). Informed consent is defined as voluntary acceptance by a competent patient of a plan for medical care after physician adequately discloses the proposed plan, its risks and benefits, and alternative approaches. This requires a process of effective communication and education between the physician and patient [1]. Informed consent is a process with the elements of autonomous authorization, free from coercion or manipulation, decision-making capacity, disclosures to the patients, and comprehension [4].In academic medicine, as teaching of medical ethics became formalized in the 1970s, moral principles of respect for autonomy, non-malfeasance (the obligation to avoid causing harm), beneficence (obligation to provide benefits and to balance benefits against risks), and justice, assumed a central role. Thirty years later, IC is still written with the intent to protect the medical profession from lawsuits. Indeed, court views of IC also include a therapeutic privilege for physicians not to inform a patient who may be harmed by the disclosed information [5].Over the past two decades a considerable volume of litigation in many countries have focused on the consent issue and the doctrine of informed consent has assumed a significant role in the medical negligence debate.