Medical Ethics and Professionalism – Extended Notes – Consent in Medical Practice

Medical Ethics and Professionalism – Extended Notes – Consent in Medical Practice

• Consent in Medical
• Practice

Learning Tasks

• Define consent in medical practice
• Describe the forms of consent in medical practice
• Mention requirements for true consent in medical practice
• Mention legal implications from lack of consent in medical practice

Sub-Enabling Outcome

• 2.3.4 Apply principles of medical ethics in
• obtaining clients’ consent
• a) Define the term informed consent
• b) Explain types of consent
• c) Describe clinically significant of consent
• d) Describe informed consent for minors and
• adolescents
• e) Describe exceptions to consent
• f) Obtain clients’ consent
• Definition of Terms
• Consent: The clinical principle that each person has a right to self
• determination and is entitled to have their autonomy respected finds
• its expression in law through the notion of consent.
• Any intentional touching of a person without lawful justification or without
• their consent amount to the tort of battery and may also constitute a criminal
• offence.
• The law relating to consent is one of the most important to medical law,
• serving as the means of protecting and preserving the right of the patient to
• decide what is to happen to him/her.
• Consent can be in the form of expressed or implied.
• Expressed consent: Is when the patient explicitly agrees to what is
• proposed by the doctor, it does not need to be set out in any specific
• form and it does not need to be in writing.
• The vast majority of time when a patient is touched, it is done in the
• examination rooms where none of apparatus of consent is present.
• Consent forms: Have been part of hospital procedure for a long
• time.
• The form usually covers statements like ‘I confirm that I have explained the
• operation, investigation or treatment, and such appropriate options as are
• available and the type of anaesthetic, if any proposed to the patient in terms
• which in my judgement are suited to the understanding of the patient and/or
• to one of the parents or guardians of the patient’.
• The form is signed by both the doctor and the patient.
• Most of forms have a statement saying ‘I understand that any procedure in
• addition to the investigation or treatment described on this form will only be
• carried out if it is necessary and in my best interests and can be justified for

medical reasons.’

• Implied Consent

• Consent may just be implied meaning the client did not expressly authorize
• the doctor to conduct a procedure.
• Actions often speak louder than words. Holding up one bare arm to a
• doctor at a vaccination point is as clear as agree as if it were expressed in
• words.
• Even silence and inaction may, in some circumstances, be interpreted as
• expression of willingness.
• Failure to resist or protest indicates consent if a reasonable person who is
• aware of the consequences and capable of protest or resistance would
• voice his objection. A girl who is silent to an amorous proposal, cannot,
• afterwards complain of assault.

Requirements for a True Consent in

Medical Practice

• • There are three relevant issues which have to be determined:
• Did the patient have capacity in law? (Was the patient competent to give
• consent?)
• Was the person giving consent appropriately informed before hand?
• Was the consent voluntarily given?
• Each of these issues may be analyzed by reference to the nature and
• extent of the doctor’s duty, that is, to inform or to ensure
• voluntariness and competence.
• The need for consent derives from the law’s respect for patient’s
• right to decide. Consent, therefore, has a positive and a negative
• property.
• This means it is an exercise to make one’s own decisions to say ‘yes’
• (consent) or to say ‘no’ (refuse).
• It is also a right to change one’s mind. Hence the patient may
• withdraw their consent to treatment. Obviously, this could be done

before the procedure but it may also be done during the procedure.

General Issues

• In court issues, responsibility of proving absence of consent rests on
• the patient.
• Liability in trespass results in responsibility for all the consequence of
• the trespass and may be concurrent with criminal liability for assault.
• Consent must be to the actual physical ‘invasion’ in issue. It is a
• battery if the patient consents to removal of his left leg and the
• surgeon removes the right leg.
• Surgery may be authorized either by a provision in a standard
• consent form or by defence of necessity.
• Further treatment must be shown to be necessary at the time of the
• original operation.
• Doing surgery for removing woman’s ovaries without express
• consent, or any nonconsensual treatment may constitute serious
• professional misconduct.
• It is not sufficient that the doctor believes that what she/he does is in
• patient’s best interests or that 99% of patients would have consented.
• Advance directive of the patient must be respected.
• Failure to provide adequate information is actionable. It is the
• doctor’s duty to provide not just competent treatment, but
• competent advice as well.
• Consent for detained mental patients must be obtained for nonmental problems.
• Which medical procedures require
• informed consent?
• Treatment with high-risk medications, such as opioids.
• Tests and medical interventions that go inside your body, such asendoscopy.
• Childbirth interventions, such as forceps delivery or episiotomy.
• Surgery.
• Biopsy.
• Medical implants.
• Use of anesthesia.
• Use of radiation.
• Chemotherapy.
• Blood transfusions.
• Genetic testing.
• Clinical trials involving human research subjects (including psychology research).
• Procedures involving medical students.
• Certain vaccines.
• Any transfer of your personal information.

Case Study

• Scenario: In a famous British case, Re T., (adult: refusal of treatment)
• [1992] 4 All ER 649 (CA) in which an adult woman, apparently a Jehovah’s
• Witness, refused a life-saving blood transfusion. The judge concluded that
• her decision was legally effective on the basis that the patient was
• competent to understand the serious nature of her decision. The judge
• further said that this decision was right even though most would find it
• unreasonable and irrational
• Questions
• What are your opinions on this decision regarding the right to decide on
• any matter even if it is going to affect the client?
• Legal Implications from Lack of
• Consent
• Non-consensual medical treatments entitle the patient to sue for
• damages for battery which is committed.
• It is also possible to base a claim on the tort of negligence, which is
• the theory that the doctor has been negligent in failing to obtain the
• consent of the patient.
• Action for Battery
• An action for battery arises when the plaintiff has been touched in some
• way by defendant when there has been no consent, expressed or implied,
• to such touching.
• All that the plaintiff needs to establish in such an action is that the
• defendant wrongfully touched him/her. It is unnecessary to establish loss as
• a result of the touching and, therefore there is no problem as to the
• causation of damages to be overcome.
• By contrast, in an action based on tort of negligence, the plaintiff must
• establish that the defendant wrongfully touched him and that the
• negligence of the defendant in touching him without consent has led to
• injury for which damages are thought.
• There is a problem of factual causation to be tackled and, for this
• reason, the action for battery is an easier option for the plaintiff’s
• point of view.
• The action for battery is appropriate where there has been no
• consent at all to the physical contact in question. Thus, an action for
• battery is a suitable remedy if the patient has refused to submit to a
• procedure but the doctor has nevertheless, gone ahead in the face of

that refusal.

Case Study

• Scenario
• A surgeon was taken to court because when he was on duty, he operated
• on a lump on the back of the patient while the patient had actually
• consented to the operation on his toe. On his defence, the surgeon said
• that he noticed the lump and believed that instead of waiting for another
• operation, he believed that removing the lump would spare the patient
• extra suffering.
• Question
• Was the surgeon right or wrong in this case? Give reasons on whatever
• answers you provide.
• Acton for Negligence
• In essence, the aggrieved patient is claiming: ‘You did not inform me
• of possible risk involved. If you had informed me, I would not have
• consented to the procedure. You have failed in your duty of care, and
• as a result, I have sustained injury’.
• • The problem of negligence based on lack of consent is, therefore,
• that of causation. The court must be satisfied that the cause of the
• patient’s injury is due to the defendant’s failure to obtain valid
• consent of the patient was.
• To satisfy this requirement, the patient must prove that he would not
• have given his consent had he had the information of which he was

allegedly deprived.

Key Points

• Consent forms have been part of hospital procedure for a long time.
• Any intentional touching of a person without lawful justification or
• without their consent amounts to the tort of battery and may also
• constitute a criminal offence.
• A patient’s right to choice is not limited to decisions which others
• might regard as sensible.
• Exceptions to Medical consent
• Several exceptions to the requirement for informed consent include :
• (1) the patient is incapacitated,
• (2) life-threatening emergencies with inadequate time to obtain consent, and
• (3) voluntary waived consent.
• A medical emergency, in which an unconscious or delirious patient
• cannot
• The second is rare and involves certain court-ordered treatments or
• treatments and tests mandated by law.
• There is also a pseudo-exception: the therapeutic exception, which
• ostensibly allows the physician to withhold information from a patient
• if that information would psychologically harm the patient and thus
• imperil the patient's physical health. 301Select this paragraph to edit
• 1. A patient is at imminent risk of serious harm and is unable to give
• consent
• 2. Sharing relevant medical information could harm the patient
• Informed consent for minors and
• adolescents

303https://www.ncbi.nlm.nih.gov/pmc/articles

/PMC2840885/

• CONSENT
• In simple terms, it can be defined as an instrument of mutual
• communication between doctor and patient with an expression of
• authorization/permission/choice by the latter for the doctor to act in

a particular way.

IMPLIED VS. EXPRESSED CONSENT

• The very act of a patient entering a doctor's chamber and expressing
• his problem is taken as an implied (or implicit) consent for general
• physical examination and routine investigations.
• But, intimate examination, especially in a female, invasive tests and
• risky procedures require specific expressed consent.
• Expressed (explicit) consent[4,5] can be oral or written.
• Written consents are preferable in situations involving long-term
• follow-up, high-risk interventions and cosmetic procedures and
• surgeries.
• It is also needed for skin biopsy, psoralen with ultraviolet A (PUVA)
• therapy, intralesional injection, immunosuppressive therapy,
• electrocautery etc.[6]
• Consent is necessary for photographing a patient for
• scientific/educational/research purpose or for follow up. Specific
• consent must be taken if the identity of the patient is likely to be
• revealed while publishing.[7]
• Consent is a must for participation in clinical trials and research

projects.[8]

INFORMED CONSENT

• Informed consent must be preceded by disclosure of sufficient
• information.
• Consent can be challenged on the ground that adequate information
• has not been revealed to enable the patient to take a proper and
• knowledgeable decision.
• Therefore, accurate, adequate and relevant information must be
• provided truthfully in a form (using non-scientific terms) and language
• that the patient can understand.
• It cannot be a patient's signature on a dotted line obtained routinely

by a staff member.

DISCLOSURE OF INFORMATION

• The information disclosed[9] should include
• The condition/disorder/disease that the patient is having/suffering
• from
• Necessity for further testing
• Natural course of the condition and possible complications
• Consequences of non-treatment
• Treatment options available
• Potential risks and benefits of treatment options
• Duration and approximate cost of treatment
• Expected outcome
• Follow-up required
• Patient should be given opportunity to ask questions and clarify all
• doubts.
• There must not be any kind of coercion.
• Consent must be voluntary and patient should have the freedom to
• revoke the consent.
• Consent given under fear of injury/intimidation, misconception or

misrepresentation of facts can be held invalid.

PRE-REQUISITES

• Patient should be competent[10] to give consent; must be an adult
• and of sound mind
• In case of children, consent must be obtained from a parent.
• In case of incapacitated persons, close family members or legal
• guardians can give consent.
• Adequate information should be provided to a prudent patient
• during informed consent.
• Prudent patient means a reasonable or average patient.
• To decide whether adequate information has been given, courts rely
• on this “Prudent Patient Test”.
• It is not easy to answer the question, How much information is
• “adequate”? A netizen may expect and demand detailed information.
• On the other hand, an illiterate may say that “I do not understand
• anything, doctor, you decide what is best for me!”
• If a patient knowingly prefers not to get full information that attitude
• also needs to be respected as a part of patient's right to autonomy.
• Patients' perception of risk of a medical intervention is also highly
• individualistic, variable and unpredictable.
• The information provided to a patient should include all material
• risks.
• But, the list of risks and side effects cannot be exhaustive to the level
• of absurdity and impracticality.
• For example, hardly any patient can go through the product
• information leaflet included in any drug pack and if some body does,
• it is unlikely that the drug is consumed.
• the doctor should provide information that a prudent[3] or
• reasonable patient would expect to make a knowledgeable decision

about the course of action to be taken in the presence of alternatives.

EXCEPTIONS TO DISCLOSURE

• Therapeutic privilege
• If a doctor is of the opinion that certain information can seriously
• harm a patient's health – physical, mental or emotional – he has the
• privilege to withhold such information.
• But, it should be shared with close relatives. This situation usually
• does not occur in cutaneous aesthetic surgical procedures.
• Placebo
• Use of placebos in certain self-limiting conditions or in patients with
• high psychological overlay or in those who insist for some form of
• medication[10] is justified as there are high chances of benefit to the
• patient with negligible risk.
• Revealing the truth to the patient takes away the very purpose of

administration of placebo.

BLANKET CONSENT

• An all-encompassing consent to the effect “I authorize so and so to
• carry out any test/procedure/surgery in the course of my treatment”
• is not valid.
• It should be specific for a particular event.
• If, consent is taken for microdermabrasion, it cannot be valid for any
• other procedure like acid peel.
• Additional consent will have to be obtained before proceeding with
• the latter.
• If a consent form says that patient has consented to undergo laser
• resurfacing by Dr. X, the procedure cannot be done by Dr. Y, even if Dr.
• Y is Dr. X's assistant, unless it is specifically mentioned in the consent
• that the procedure may be carried out by Dr. X or Dr. Y (or his

authorized assistants).

DOCUMENTATION

• It is important to document the process of consent taking.
• It should be prepared in duplicate and a copy handed over to the
• patient.
• It should be dated and signed by the patient or guardian, the doctor
• and an independent witness
• Assisting nurse preferably should not be a witness. Like all other

medical records, it should be preserved for at least 3 years.

INFORMED REFUSAL

• Patient has got the right of self-determination.
• If, a doctor diagnoses varicella in a child, the parent may choose to

avail no treatment because of religious belief.

• Doctor's duty is to explain the possible consequences of nontreatment and benefits of treatment and leave the decision to the
• parent.
• Such informed refusals must be documented clearly.[6,10
• But, a patient's freedom cannot impinge on the rights of others or
• cause harm to a third party or community.
• Therefore, the said parent's freedom of choice cannot extend to
• sending the child to school, as the infection can spread to other
• children.
• Discharge against medical advice also falls into this category and
• needs to be properly recorded in the case sheet with signature of the
• patient/guardian.
• In an emergency situation, for example intestinal perforation, a
• doctor may have to operate even in the absence of consent, to save
• the life of the patient.
• It is possible that even with such an intervention, the patient may not
• survive
• Assuming that the doctor is competent and has exercised due care
• and diligence, doctor cannot be held responsible for patient's death,

as he has acted in good faith and in the best interest of the patient.

CONCLUSION

• Obtaining consent is not only an ethical obligation, but also a legal
• compulsion.
• The level of disclosure has to be case-specific. There cannot be
• anything called a standard consent form.
• No doctor can sit in comfort with the belief that the “consent” can
• certainly avoid legal liability.
• This is highlighted by the note of The California Supreme Court:[12]
• “One cannot know with certainty whether a consent is valid until a
• lawsuit has been filed and resolved.”
• One can only take adequate precaution and act with care and
• diligence. Maintaining good relationship with patient often works

better than the best informed consent!