This article is written by Sneha Mahawar from the Ramaiah Institute of Legal Studies. This article discusses the meaning and concept of informed consent. It further throws light on the legal aspect and the impact of the case, Chester vs. Afshar on the law of informed consent.
Meaning of informed consent
The term “informed” refers to knowing a fact or area of education. It is based on knowledge and found on the due understanding of a situation. Whereas, the term “consent” refers to express willingness, to grant, to allow, to assent, to agree in opinion or sentiment, to be of the same mind, to accord, to concur. In medical terms, it also includes causing an individual to sign a consent form.
The term “inform” has derived from the Latin word “informare” which means instructing, training, and educating. While, the term “consent” has derived from the Latin word “consentire” which means to agree, accord, it simply means to have complete knowledge about something which is necessary to know without any obscurity.
Henceforth, informed consent refers to consent to an action by another person given based upon a clear appreciation and understanding of the facts, implications, and consequences of the action. It refers to a process in which the patient is given full information and complete knowledge about his medical condition, the treatment to be given, any complications, any kind of risk, the procedure of treatment, etc. In other words, the doctor must inform and make the patient understand all the risks and benefits of undergoing medical treatment. The purpose of informed consent is to inform the patient or the person responsible for the patient about the consequences of the treatment and take their consent. However, the concept of informed consent is not just about the duty of a doctor but also about a patient’s responsibility.
The concept of informed consent
The concept of informed consent is inclusive of both the duty of a doctor as well as the responsibility of a patient. While a doctor must keep the patient fully informed about the treatment procedure. Similarly, it is the responsibility of a patient to understand the entire treatment procedure and give consent by signing the forms accordingly.
Duty of a doctor
- To inform the exact and true reports of a patient.
- To give full information about the treatment to be undertaken.
- To provide all the details regarding the benefits and risks of undergoing treatment.
- To inform the full name of the treatment procedure as spelled by the health care workers.
- To give the patient’s exact position without any obscurity.
- The consequences to be faced by the patient if the treatment is not given on time.
- The percentage of life risk involved by undergoing treatment, and vice-versa.
Responsibility of a patient
- To read all the facts and the circumstances before signing the informed consent form.
- To understand and give assent to the procedure of treatment.
- To ask questions in case of doubt and try to understand the information completely.
- To refer certain health care workers for assistance in the procedure of treatment.
Circumstances where another person can sign the consent form on the behalf of the patient
If the patient is a minor and lacks the ability to make decisions for their betterment, then the parents or the guardians of that minor have the authority to give assent on the consent form on the minor’s behalf.
If the patient has priorly given consent and directed another individual to make decisions in case of a medical emergency then that person has the authority to give assent on the consent form on the patient’s behalf.
Cannot give consent
If a patient lacks the ability to give consent, any other person taking responsibility for the patient can give consent. Generally, the other person is a close relative of the patient.
The legal aspect of informed consent
A doctor must provide the patient complete information regarding all possible benefits and risks involved in the procedure of treatment. However, the doctor can be held liable for medical negligence if the doctor is unable to perform such duties. Medical negligence is when the doctor does not treat the patient with utmost care and without adequate skills.
Cases where legal actions can be undertaken
Refusal to give consent
When a patient refuses to agree to the treatment, physicians are unable to treat them, even if they do, they will face legal consequences. In India, the doctor bears the burden of proof in justifying conduct that would be illegal if permission was not given. Up to a certain point, Indian courts may assume implied consent. Furthermore, detailed proof is needed for presentation at the Court of law.
In India, the age of the majority is set at 18 years by Section 3 of the Indian Majority Act, 1875. As a result, the person under the age of 18 is a minor who is unable to give consent. The consent of the parents would be deemed legal and valid.
Medical termination of pregnancy
For the termination of a pregnancy of a minor or a lunatic, parental consent is needed. The Medical Termination of Pregnancy Act, 1971 stipulates that no pregnancy can be terminated without the woman’s consent. Pregnancy shall only be terminated in good conscience and for the sake of a person’s wellbeing.
Recently, Rajya Sabha introduced the Medical Termination of Pregnancy (MTP) Bill of 2021. This bill constitutes new provisions for a special category of women. It creates a provision to provide safer abortions for rape survivors, victims of incest, minors, differently-abled women, etc. The new bill increases the time limit for getting abortions for women falling under the special category. It sets an upper limit of taking one doctor’s opinion for terminating a pregnancy of twenty weeks, and two doctors for terminating a pregnancy of twenty-four weeks.
Chester vs. Afshar
- In this case, Miss Chester was a travel writer who worked as a journalist.
- She eventually developed lumbar disc protrusion (lower back pain).
- For many years, it was kept under control with non-invasive, conventional care.
- As a result, her ability to walk was hampered by the severe weakening of her spinal discs, which also made it difficult for her to regulate her bladder.
- She consulted Mr. Afshar, a neurosurgeon, for his opinion.
- According to the medical records, Mr. Afshar recommended Miss Chester to have three intervertebral discs removed during an elective lumbar surgical operation as a solution to the issue.
- There was a 1-2 percent chance of developing cauda equina syndrome as a result of the surgery. Miss Chester was not made aware of the risk.
- Miss Chester was sadly one of the 1-2 percent that was paralysed.
- She claimed damages for breach of contractual duty and negligence against Mr. Afshar.
- The claimant stated that had she been informed about such risk she would not have consented to surgery or would at least have taken a second or third opinion.
- Whether the doctor was liable for failing to inform the risks?
- Whether the doctor was liable for the patient’s worsened back pain?
- In the Court of Appeal, it was held that Mr. Afshar was not negligent in performing the surgery and gave a decision in favor of the defendant.
- The case was re-appealed at the House of Lords. The House of Lords held in a 3:2 majority that the defendant had failed in his professional duty, satisfying the “but for” test and that the claimant deserved a remedy. The defendant had failed to carry out his professional duty and advise the patient about all the possible risks of the surgery. The ‘But for’ test was satisfied since the claimant would not have had the operation if the warning had been given. However, the risk of which she should have been warned was not created by the failure to warn. Nevertheless, a doctor has a duty to inform the patient about all the possible risks so that the patient makes an informed choice whether to undergo the treatment recommended.
Impact of Chester vs. Afshar
General Medical Council
Following the decision of Chester vs. Afshar, the General Medical Council released new guidelines. It emphasizes doctors’ obligation to work in collaboration with their patients to secure their consent to medical care.
Doctors are recommended to report treatment complications such as normal but mild side effects as well as uncommon but severe adverse consequences such as permanent injury or death. The guideline expressly specifies that when the risks exceed, informed consent from the patient is required.
National Health Service (NHS) Litigation Authority, 2004
The National Health Service (NHS) Litigation Authority, 2004 gave out recommendations such as :
- Extreme caution in obtaining approval was made more important than ever.
- Both major potential negative consequences must be warned about in a clear and understandable manner.
- The warnings must be well recorded in the notes.
- The patient may be asked to sign the appropriate entry to ensure that he or she has been warned, understands it, and acknowledges the harm.
- If care is rejected, it is equally necessary to make a complete entry in the notes, preferably signed by the claimant, including the explanation when it is granted.
- If possible, the clinician who discussed and is performing the procedure should seek and obtain consent.
Hempsons Solicitors, 2005
Following the judgment of Chester vs. Afshar, at the Hempsons Solicitors, the surgeons were advised to properly report in the patient’s records the risks about which they had alerted the patient and to make the patient sign the record.
The consequence of Chester’s application of all medicinal treatments is that all doctors will be required to follow this recommendation when treating any medication with possible serious side effects, which may be a serious side effect of Chester in and of itself.
Medical Protection Society, 2008
The Medical Protection Society concluded that the patient’s liberty and privacy needed that she be given ample time to make an educated and informed decision after the decision of the Chester case.
As a result of Chester v Afshar, it is important to take caution to alert patients about all complications relevant to their choice and, where time allows, to enable them to weigh their choices overtime before determining whether or not to seek treatment.
Department of Health, a Reference guide to consent for examination or treatment (2nd Edition) (2009)
The House of Lords ruled in Chester v Afshar that failing to alert a patient of the danger of harm inherent in surgery, no matter how remote the possibility of the accident arising, deprives the patient of the opportunity to make an informed decision.
According to the decision, it is recommended that health providers provide information on any major potential adverse effects and keep a database of the information provided.
Important case laws
Devi vs. West Midlands
In this case, a surgeon was performing surgery. In the course, the surgeon found that her womb had ruptured. The surgeon sterilized her without her knowledge or permission. The Court held the doctor guilty of medical negligence.
Gold vs. Haringey Health Authority
In this case, the defendant failed to notify the appellant of the loss rate for female sterilization. It was held that the defendants were found to be guilty of medical negligence for not disclosing proper facts to the plaintiff.
Hence, the most important aspect of informed consent is that it provides the patient with an assurance of their care and ensures that all potential health risks are addressed beforehand. In the case of Chester vs. Afshar, The House of Lords determined that, while failing to advise was not a direct cause of harm, it did result in negligence.
Lastly, the case-law of Chester vs. Afshar comes down to two ideal principles. Firstly, the patient must be informed of all risks (no matter how minor) and facts. Secondly, the patient must be allowed enough time to digest and reflect on the details provided about the risks associated with the procedure.
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