UNIT 3 – REAL CONSENT AND INFORMED CONSENT.pptx

this ppt deals with the difference between real consent and informed consent through the landmark case laws in UK and US

1. UNIT 3 – REAL CONSENT AND INFORMED CONSENT Ms. R.YUVANAA PRIYADHARSHINI, SOL, SASTRA

2. CONSENT Consent under healthcare law is a patient's voluntary agreement to medical treatment, given after they receive sufficient, understandable information about the treatment's risks, benefits, and alternatives.  It protects the patient's right to autonomy and self-determination while also safeguarding healthcare providers from legal claims.  Key requirements for valid consent include the patient's competence, voluntariness, and adequate information, and the process must be a shared decision-making dialogue rather than a mere signature on a form. 

3. There are two major schools of thought which govern the law of consent in medicine. INFORMED CONSENT :- One is the doctrine of ‘ informed consent ,’ according to which it is the doctor's responsibility to disclose the necessary information to the patient to secure consent. Informed consent is a process in which a healthcare professional educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. REAL CONSENT :- Under the doctrine of ‘real consent’ the doctor must warn his patient of the risks inherent in the recommended treatment and the terms of giving such warning must be in accordance with the practice accepted at that time as considered proper by a responsible body of medical opinion. This is Bolam's law or ‘Real Consent.’

4. BOLAM’S TEST (REAL CONSENT) In the UK, establishing culpability in a medical setting can be complicated, and this is why the Bolam test is used, enabling medics to be assessed for breach of duty. The Bolam Test was first implemented following the 1957 case of Bolam vs Friern Hospital Management Committee. The case was related to an incident at the hospital whereby the patient – Mr. Bolam – received Electro Convulsive Therapy (ECT) which caused him serious fractures. Mr. Bolam argued that his doctor has been negligent for the following three reasons: 1.Muscle relaxation had not been administered before the procedure began. 2.Mr. Bolam had not been restrained during the procedure. 3.Mr. Bolam had not been warned of the potential risks of the procedure.

5. The result of the case was that it failed as it was deemed that the doctor had followed the medical protocol at the time, and patients were also not routinely advised of all of the small risks that could occur as a result of the procedure. This led to the legal system developing and implementing the Bolam Test as a way to measure medical negligence. The Bolam test is the standard test that is used to establish whether the duty of care has been breached. The Bolam test is essentially a test that is judged by the medical professional’s peers. They must be able to show that any medical professional who was in the same position as them would have done the same, giving the same outcome. In those circumstances, a case would fail.

6. REASONABLY PRUDENTIAL PATIENT TEST (INFORMED CONSENT) The Canterbury v. Spence case (1972) established the "patient-focused" standard for informed consent, requiring physicians to disclose all material risks—those a reasonable patient would consider important—of a medical procedure, rather than relying on what a physician might customarily disclose.  This landmark decision emphasized patient autonomy, establishing a legal duty for doctors to provide sufficient information for patients to make an informed, voluntary decision about their treatment.  The case is considered a foundational precedent for the modern doctrine of informed consent.  Canterbury vs. Spence The case of Canterbury v. Spence revolved around the plaintiff, a 19-year-old clerk typist working with the FBI. He was experiencing back pain and sought medical intervention from the defendant, a Washington Neurosurgeon, Dr. William T. Spence. The defendant performed a myelogram to determine the cause of the illness. Dr. Spence then performed a laminectomy on the plaintiff. The surgery was successful, but unfortunately, the claimant reportedly fell off the bed, causing him to suffer significant paralysis.

7. Due to his condition, the plaintiff sued the doctor for negligence, claiming he didn’t get his informed consent before performing the surgery. The doctor didn’t warn him that the procedure carried a 1% paralysis risk. The court held that the healthcare provider is legally required to provide any information a patient would wish to know concerning a particular medical intervention before performing surgery or procedure. Additionally, the doctor must obtain a patient’s informed consent before performing surgery or procedure. Patients must be able to make their own medical and health decisions. Before a patient agrees to treatment, the doctor must explain the risks, benefits, and alternatives. The patient must agree to the therapy after understanding the risks and advantages. Documenting informed consent should comprise five components: the procedure’s nature, risks and advantages, feasible alternatives, risks and benefits, and patient understanding. One of the acceptable legal approaches to adequate informed consent is the reasonable person standard , a legal standard used to determine whether a person can be held liable for negligence or a tort. It focuses on the information a typical patient needs to comprehend the decision. The criterion is founded on the idea that a reasonable person would take the same care to prevent injury to himself or another person.

8. SC on Real consent vs. Informed consent In Samira Kohli v. Dr. Prabha Manchanda  the Supreme Court has preferred ‘real consent’ followed in the UK over ‘informed consent’ followed in America, in the following terms: ‘We are of the view that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam test rather than the ‘reasonably prudential patient’ test evolved in Canterbury. It is for the doctor to decide, with reference to the condition of the patient, the nature of illness, and the prevailing established practices, how much information regarding risks and consequences should be given to the patients, and how they should be couched, having the best interests of the patient. A doctor cannot be held negligent either in regard to diagnosis or treatment or in disclosing the risks involved in a particular surgical procedure or treatment, if the doctor has acted with normal care, in accordance with recognized practices accepted as proper by a responsible body of medical men skilled in that particular field, even though there may be a body of opinion that takes a contrary view.’

9. The elements of real consent as prescribed in the present judgment are: The patient gives it voluntarily without any coercion The patient has the capacity and competence to give consent The patient has an adequate level of information about the nature of the procedure to which he is consenting