|Year : 2019 | Volume
| Issue : 3 | Page : 158-161
How informed are you about informed consent?
Senior Consultant, Department of Vascular Surgery, Sultan Qaboos University Hospital, Muscat, Oman
|Date of Web Publication||29-Aug-2019|
Prof. Edwin Stephen
Senior Consultant, Department of Vascular Surgery, Sultan Qaboos University Hospital, Muscat
Source of Support: None, Conflict of Interest: None
The past decade has seen a rise in the awareness of patients, and their attendants have about their disease, options for treatment and their legal rights, thanks to easy access to the Internet, however accurate it may be. Surgeons need to be aware of the need to consent, which is now termed as “prior informed consent” as it is required by law to be taken prior to any examination or intervention. This article is meant to give the reader a quick overview about informed consent.
Keywords: Consent, doctor, Indian law, informed, medical, surgeon, surgical
|How to cite this article:|
Stephen E. How informed are you about informed consent?. Indian J Vasc Endovasc Surg 2019;6:158-61
| Introduction|| |
Every physician or surgeon that practices today is doing so under the influence of the law and ignorance of the law is no excuse for violating it. It is the duty of every doctor to be acquainted with that part of the law that concerns him/her. In recent years, there has been an exponential rise in malpractice litigations simply based on the lack of a consent or one that is adequate.
As per the Indian constitution, a patient has a legal right and liberty to autonomy and self-determination within Article 21. Constitutional courts have taken this a step further by including into this article “right to bodily privacy.”
If a doctor does not obtain a valid consent which can be either – expressed (verbal or written) or implied, then he/she is liable to be prosecuted under tort and criminal laws. A consent ensures that the patient is given an opportunity to make a choice and that the choice has been respected, for example, in the Malette and Shulamn case where a patient who was a “Jehovah's witness” received a transfusion in an emergency situation, despite the road accident victim carrying a card stating that blood products not be used in her treatment.
A doctor can be punished under section 350 of the Indian Penal Code (IPC) 1860 for using criminal force if the patient is treated without a consent, however, theoretical it may seem. The exceptions being treatment in an emergency situation, or treating a patient who is unconscious, of unsound mind or a child.
In the Dr. Thomas versus Smt. Elisa, AIR 1987 case the court found the doctor guilty of negligence for not operating on a patient with life-threatening peritonitis because she was not in a condition to give consent, and there were no relatives. The court stated that it was the doctor's ethical and legal duty to treat the patient to the best of his ability and that the lack of a valid consent was not a constraint in a life-threatening situation.
Litigation is on the rise in our country (in fact, the world over). Medical malpractice lawyers are easily contactable and do not hesitate to contact potential clients. A signed consent is questionable if it was taken without adequate information and time having been given to the patient/attendant. Doctors can no longer be ignorant, ignore, or be arrogant about the need for consent.
This article will impress upon the reader the need to obtain a valid consent and in the process explain some of the legal jargon, which, every doctor should be aware of in the clinical and research field.
| Origin of Term-Informed Consent|| |
There is evidence in the Egyptian, Greek, and Roman civilization of doctor's taking the approval of patient's prior to intervention. The patients in most cases look up to their treating doctor in faith and subject themselves to the physician/surgeon out of a sense of respect that has existed for centuries, but seems to be fading. As a result, patients tend not to ask queries, and the treating doctor does not take the initiative to inform the pros and cons to the patient or relatives.
On December 19th, 1946, an all American panel of judges conducted a trial on Nazi doctors and this lead to the origin of the Nuremberg Code, which clearly stated ethics of research involving human subjects.
America is considered to be country from where the word “Informed consent” originated and the aim was to ensure that a patient's dignity and independence was respected at the time of decision-making about treatment options.
It is observed that the American and Canadian courts are more “patient-oriented” in their approach, unlike the Indian and British courts, which are more “doctor oriented.”
| Legal Jargon Worth Knowing and Explained|| |
The Indian Contract Act (1872) states that two or more persons are said to be in consent when they agree on the same thing in the same sense.
A patient who presents to a doctor implies that he/she is agreeable to a relevant examination. The patient's demeanor would imply that they are willing to be questioned and examined. At all times, the clinician/researcher should be culturally, socially, and humanely sensitive. Thereby implying that if any intimate examination is required that would examination of intimate parts, the medical practitioner should obtain another consent.
Can be verbal or written and is a best obtained for all minor procedures. A chaperone who, also doubles up as a witness to consent, has to be present for any examination that can be considered intimate., Written consent must be taken for any interventional, surgical, anesthetic, or diagnostic procedure. The patient should not feel under pressure or be made to take the decision in haste, except in an emergency situation.
Real and valid consent
This is a prerequisite to consenting is that it should be voluntary and have been taken while the patient has the capacity and competence to make a decision after, adequate information has been given. The correctness or appropriateness of the treatment procedure, does not make the treatment legal, in the absence of consent for the treatment.
Criminal law and civil law of tort
This is the law wherein the wrongdoer has to compensate the aggrieved person/s. If this compensation is monetary, then it is in Civil, and if by imprisonment, then in criminal. If a patient's organ/s are removed without consent, then it is a criminal breach. According to the tort law, usage of force on any human, without prior justification (also called Battery), irrespective of the amount of force, is cause for legal action.
According to Section 90 of the IPC when consent has been given out of fear of injury, misconception of facts or silence, which is fraudulent, the consent is invalid. The criminal law more or less follows this approach.
That which is given after receiving the following information “The nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.”
Consent cannot be taken from anyone but the patient, as long he/she is competent–i.e., the patient is 18-year-old and over and is of sound mind. It has to be signed by both patient and doctor to be valid.
Professional regulations (Indian Medical Council, 2002)
These guidelines were issued to standardize practice across India.
In section 7.16, it states that before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation, which may result in sterility, the consent of both husband and wife is needed.
General guidelines are as follows:,,
- For routine treatment an implied consent is sufficient
- For detailed treatment, an expressed oral consent would suffice
- For complex types of treatment, a written expressed consent is a must.
| Consent for Research|| |
The Indian Council of Medical Research in its guidelines (clause 7.22) has clearly stated that any research or drug trial, where there is patient or volunteer contact, needs a consent to be taken and ethical considerations are to be kept in mind. Consent taken from the patient for trial of drug or therapy, which is not as per the guidelines, shall also be construed as misconduct.,
| Principles to Be Followed for Consent in Research|| |
- Consent is to be taken by the Principal investigator [PI] or a person assigned by the PI and should be signed, dated. Consent can only be taken once the Institutional Review Board has approved the study
- If the risks of the research are greater than minimal, then a third party witness would need to countersign the consent form
- Should a patient/volunteer be incapable of reading or writing then a witness who fully comprehends the information and can attest to the accuracy of the consent process needs to be present and should sign and date the document
- Use terms that are understandable and are designed to educate the patient, volunteer, or representative
- Give sufficient time for decision making. There should be no coersion. Person/s involved in the study should have time to read, understand, and clarify their doubts
- The consent should not include any words that waive or appear to waive the subject's legal rights. Avoid exculpatory language
- Ensure that it is clear that participation is voluntary and that refusal to participate will not involve any loss or penalty.
Clause 7.17 of the Indian Medical Council (IMC) a registered medical practitioner shall not publish photographs or case reports of his/her patients without their permission, in any medical or other journals in a manner by which their identity could be made out. If the identity is not to be disclosed, the consent is not needed.
| Consent for Intervention|| |
Consent when taken for a diagnostic procedure is not accepted as consent for therapeutic intervention as was evident in the Samira Kholi versus Dr. Prabha Manchanda, where a diagnostic laparoscopy for endometriosis led onto a hysterectomy, after, consent was taken from the patient's mother, while the patient was still under anesthesia. An additional procedure can only be performed without prior consent, if it will preserve the life and health of the patient and if it would be unreasonable to wait till the patient regains full consciousness and takes a decision. Therefore, if it is anticipated that a diagnostic procedure would require therapeutic intervention, then a common consent can be taken.
An informed consent cannot be “all encompassing,” in that the signed consent states that “I authorize so and so to carry out any test/procedure/surgery in the course of my treatment.” This would be invalid. It has to be procedure-specific even for a re-exploration.,
Consent for anesthesia, unless under local anesthesia administered by the surgeon, has to be taken by the anesthetist, documented, dated, and signed by the patient/relative/guardian.
Video recording of consent can be done after prior permission, and this approval documented and signed.
A witness signature is vital, especially when the patient is illiterate and would be consenting with his/her thumb impression.
| How Detailed Should a Consent Be?|| |
The basis of a consent is that the patient/attendant should be able to make a judicious decision based on the information shared. This can be by the doctor or a member of the treating team. If the risks, including the risk of mortality, are minimal or remote, then they need not be mentioned.
Exceptions to when a doctor withholds information include:
- Patient refusal to be informed; this should be documented
- If the doctor feels that providing information to a patient who is anxious or disturbed would not be processed rationally by him and is likely to psychologically harm him, the information may be withheld from him (therapeutic privilege); the doctor should then communicate with patient's close relative, family doctor or both.
| Intervention in Children|| |
As per the IPC, section 89, a child >12 years of age can consent to physical/medical examination.
For children <18 years of age, consent for intervention must be taken preferably from a parent and in the absence of parent/s from a surrogate/proxy decision-maker who is the next of kin (adult child/sibling/lawful guardian).
| Lack of Consent in the Case of an Emergency|| |
Section 88 of the IPC protects the medical practitioner as it states that where a person performs certain acts in “good faith” for the benefit of another, it is not an offence. The exemption, however, does not extend to euthanasia or grievous hurt.
In the Dr. TT Thomas versus Smt. Elisa and Ors case, the surgeon was held up for negligence for not operating on a patient with life-threatening peritonitis from a perforated appendix, only because the patient was not in a condition to give consent and her relatives were not available.
The Indian Supreme court reiterated in the Paramanand Katara versus Union of India case that it is the doctors ethical and legal duty to treat the patient to the best of his/her ability and that the lack of a valid consent is not a constraint in life-threatening situations.,
| Can a Patient Refuse Treatment?|| |
Yes, a patient can refuse and/or seek discharge from the hospital against medical advice. This needs to documented and signed. It is illegal to detain a patient against his/her will.
A patient can withdraw consent while the procedure is being performed and the doctor is obliged to stop, unless, stopping the procedure put's the patient's life at risk and stop once that risk no longer exists. The procedure can only continue once the patient agrees after the concerns raised are addressed.
| How Long the Documentation Should Be Retained?|| |
The IMC (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 (4) states that every physician shall maintain the medical records pertaining to his/her indoor patients for 3 years from the date of commencement of the treatment.
| Errors to Be Avoided|| |
- Never consider a procedure too trivial for a consent or take a blanket consent. Consent should be procedure specific
- The patient is the one to consent if he/she is competent, of sound mind and is not intoxicated or a minor
- Using terminology and language that a patient does not understand or comprehend
- Not having a witness when the patient is a minor, is of unsound mind or illiterate
- Document the information (including handing over of patient information sheets) given and ensure that the consent is signed and dated by the patient/attendant/lawful guardian, a witness, and the surgeon or a member of the team
- Consent for re-exploration, repeat of the procedure, and blood transfusion is mandatory
- Alterations to the consent form have to be authorized by the patient
- Do not consider a consent to be “defence” for professional negligence.
| Conclusion|| |
Prior informed consent from a patient for any procedure is critical for safe medical practice and not merely a procedural formality. It will safeguard the practitioner from litigation and uncalled for harassment. Professional indemnity insurance will not cover lapses in obtaining a valid consent as it is considered to be intentional assault.
Clear and effective communication in imparting information using short, simple sentences, preferably with minimal medical terminology, pictorial depiction, and in a language, the patient understands, is the basis of a good informed consent.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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