- The Pacemakers

21 Nov 2023
Dr. Raj Shekhar Yadav
Medicolegal
Last Edited 15 Dec 23

A doctor has to seek and secure the consent of the patient before commencing a treatment. He/She should discuss with patients the nature of proposed care, alternatives, and the risks, benefits and likely consequences of each option. Informed consent involves more than obtaining signatures on consent forms. Physicians should promote shared decision-making by educating patients, answering their questions, checking that they understand key issues,making recommendations, and helping them to deliberate. Patients can be overwhelmed by medical jargon, needlessly complicated explanations, or the provisions of too much information at once. Patients can make informed decisions only if they receive honest and understandable information.Competent, informed patients may refuse recommended interventions and choose among reasonable alternatives. If patients cannot give consent in an emergency and if delay of treatment while surrogates are contacted will place their lives or health in peril, treatment can be given without informed consent.People are presumed to want such emergency care unless they have previously indicated otherwise*.

The consent so obtained should be real and valid, which means that:

01.The patient should have the capacity and competence to consent;

02.His consent should be voluntary; and

03.His consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.

Adequate Information:

The 'adequate information' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose

(a) Nature and procedure of the treatment and its purposed benefits and effect

(b) Alternatives if any available, its benefits and effect

(d) Adverse consequences of refusing recommended treatment.

But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.

Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defense in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.

There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.

The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.

Respect for patients does not entitle patients to insist on any care they want. Physicians are not obligated to provide interventions that have no physiologic rationale, that have already failed, or that are contrary to evidence-based practice recommendations or good clinical judgment.

Do’s & Don’ts-

01. In case of adults and competent patients only patient has the authority to decide what can be done with his /her body so consent from patient himself/herself is mandatory. No other person (parents, spouse, children etc) can give consent on behalf of patient unless authorized by patient to do so.

02. If patient is minor consent of either parent should be taken. Consent of one parent is sufficient if there is difference of opinion between mother and father.

03. In case of life threatening emergency where delay may endanger the life of patient and patient is unconscious or incompetent then procedure can be done even with consent of hospital superintendent/ staff/independent witness but all the facts of the situation must be mentioned in detail in the case sheet along with photo ID of the person giving consent.

04. A surgeon or physician is authorized to do only that procedure for which patient has given consent. If during the course of surgery it is felt by surgeon that some additional procedure must be done in the interest of patient it cannot be done without consent for the same unless it’s life saving emergency for the patient. If patient is conscious at that time attendant cannot give consent for that additional procedure.

05. If patient is minor or unconscious or having some mental illness that affects the cognitive function of the patient or patient is not oriented to time, place and person or if the patient is in extreme agony due to pain or discomfort then consent should be taken from nearest first degree relative. If the disability or incompetence is temporary then doctor should wait for the patient to become competent.

06. In case the patient is illiterate then after explaining everything in the language/dialect patient understands, his/her thumb impression must be taken along with signature of an eye witness.

07. Consent form must be filled by a patient /attendant/doctor/nurse in one sitting and signed by patient.

08. Video can be recorded for additional proof and saved

09. Common complications of the procedure must be explained but it’s not desirable to explain rare, theoretical complications which may create fear in the mind of patient and he/she may be forced to choose the option which is less beneficial / fanciful.

Overall the purpose of consent should be honest, sincere, unbiased disclosure of all the pros and cons of the recommended procedure which the doctor feels is the best course of treatment for the given patient in the given situation. Patient should be well informed about all the potential consequences and he/should agree/disagree for the procedure without any force, fear or coercion.

In most of the hospitals in India consent part is often taken lightly and the treating doctors sometimes don’t devote enough time in the process. Often it’s left to the nurses or assistants who are hardly aware about the medico legal importance of consent.

* Ethical Issues in Clinical Medicine , Harrison's Principles of Internal Medicine

Consent - Do's & Don'ts

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