MLC cases

1. CONSENTS : HOW TO MAKE THEM STRONGER TO
LEAD THE MEDICOLEGAL BATTLE
Dr Suhasani Jain
MBBS, MHS
Post Graduate in Medico Law and Ethics (NLS Bangalore)

2. “Every human being of adult year and sound
mind has a right to determine what will be
done with his body”
Justice Cardozo, 1914

3. Title: "Empowering Consent: The Key to
Patient-Centric Healthcare"
• Subtitle: "Creating Powerful Connections through
Informed Decision-Making"

4. Definition of Consent
• It Is a voluntary and informed agreement, typically given verbally or in
writing, by an individual who possesses the capacity to make decisions.
• In the context of healthcare and medical procedures, obtaining consent
is a crucial ethical and legal requirement.
• It involves the disclosure of relevant information about a proposed
treatment or intervention, ensuring that the person providing consent
understands the risks, benefits, alternatives, and potential
consequences of their decision.

5. • Establishing Trust:
– Obtaining consent builds trust between healthcare providers and patients. It demonstrates
transparency, honesty, and a commitment to involving patients in their care decisions.
• Respecting Patient Autonomy:
– Consent upholds the principle of patient autonomy, recognizing the right of individuals to make
decisions about their own bodies and healthcare. It empowers patients to actively participate in
the decision-making process.
• Legal and Ethical Obligations:
– Consent is a legal and ethical requirement in healthcare. It ensures that healthcare providers
adhere to standards that protect the rights and well-being of patients. Failure to obtain proper
consent may have legal consequences and ethical implications.
Why is Consent Important?

6. • Informed Consent:
– Informed consent involves providing patients with comprehensive information about a proposed medical
intervention, including its nature, risks, benefits, alternatives, and potential consequences. Patients then
voluntarily agree to the treatment based on their understanding.
• Implied Consent:
– Implied consent is assumed based on the patient's behavior, circumstances, or actions. It is generally
applicable in emergency situations where obtaining explicit verbal or written consent may not be feasible.
• Expressed Consent:
– Expressed consent is obtained explicitly, either verbally or in writing. It involves a clear and direct
communication of agreement from the patient regarding a specific medical procedure or intervention.
• Consent for Minors:
– Special consideration is given when obtaining consent for minors, as they may not have the legal capacity to
provide consent independently. In such cases, consent is typically obtained from a parent or legal guardian.
However, in certain situations, minors may be deemed mature enough to provide their own consent.
Types of Consent

7. • Information Disclosure:
– Healthcare providers must provide comprehensive and clear information about the proposed medical
intervention. This includes details about the nature of the procedure, potential risks and benefits, available
alternatives, and potential outcomes.
• Patient Understanding:
– It is crucial that patients have a sufficient level of comprehension regarding the information provided.
Healthcare providers should assess the patient's understanding, encourage questions, and use appropriate
communication methods to ensure clarity.
• Voluntariness:
– Informed consent must be given voluntarily without any coercion, pressure, or manipulation. Patients
should feel free to accept or refuse the proposed treatment without facing undue influence.
• Competence:
– Patients must have the mental and legal capacity to make decisions about their healthcare. If a patient lacks
the capacity (e.g., due to cognitive impairment), a legally authorized representative may provide consent on
their behalf.
Elements of Informed Consent

8. Consent Process
• Initiating the Consent Discussion:
– Healthcare providers initiate the conversation about the proposed medical intervention with the patient. This includes
explaining the nature of the procedure, its purpose, and providing information about potential risks, benefits, and
alternatives.
• Answering Patient Questions:
– Patients are encouraged to ask questions and seek clarification. Healthcare providers should be prepared to provide clear
and detailed answers, ensuring that the patient fully understands the information presented.
• Documenting Consent:
– Once the patient expresses understanding and voluntarily agrees to the proposed treatment, the consent is documented.
This documentation includes the details of the discussion, the specific treatment or procedure, and the patient's
agreement, either through a signed form or electronic record.
• Ongoing Communication:
– Consent is not a one-time event; it involves ongoing communication. Healthcare providers should maintain an open line
of communication with the patient throughout the course of treatment. This includes updating the patient on any
changes, addressing concerns, and obtaining additional consent if new interventions become necessary.

9. Challenges in Consent Process
• Emergency Situations:
– In urgent or emergency situations, there may be limited time for a detailed consent discussion. Healthcare
providers must balance the need for immediate intervention with efforts to provide essential information
and obtain consent whenever possible.
• Cultural Sensitivity:
– Diverse cultural perspectives may influence how individuals perceive and approach healthcare decisions.
Healthcare providers need to be culturally sensitive, understanding and respecting cultural norms and
values that may impact the consent process.
• Language Barriers:
– Communication difficulties arising from language differences can impede the proper understanding of
information. Translation services or interpreters may be necessary to ensure effective communication and
informed decision-making.
• Cognitive Impairment:
– Patients with cognitive impairments may have difficulties comprehending information or expressing their
preferences. In such cases, obtaining consent may involve working closely with family members, guardians,
or utilizing alternative communication methods.

10. Legal Aspects
• Overview of Relevant Laws and Regulations:
– Healthcare providers must adhere to specific laws and regulations governing the consent process. These
may include federal, state, or local laws that outline the requirements for obtaining valid consent, ensuring
information disclosure, and respecting patient rights.
• Consequences of Non-Compliance:
– Failure to comply with legal requirements regarding informed consent may have serious consequences.
Legal repercussions can include lawsuits, allegations of medical malpractice, and potential disciplinary
actions against healthcare providers or institutions.
Understanding and adhering to the legal framework surrounding informed consent is crucial for
healthcare professionals to ensure ethical practices, protect patient rights, and mitigate legal risks.
Regular training and updates on relevant laws are essential to staying compliant and providing quality
healthcare within the bounds of the law.

11. THE LEGAL BASIS OF CONSENT
Consent is perhaps the only principle that runs through all aspects of healthcare provisions today. It also
represents the legal and ethical expression of the basic right to have one's autonomy and self-
determination. If a medical practitioner attempts to treat a person without valid consent, then he will be
liable under both tort and criminal law. The tort is a civil wrong for which the aggrieved party may seek
compensation from the wrongdoer. The consequences would be payment of compensation (in civil) and
imprisonment (in criminal). To commence, the patient may sue the medical practitioner in tort for
trespass to a person. Alternatively, the health professional may be sued for negligence. In certain
extreme cases, there is a theoretical possibility of criminal prosecution for assault or battery. The
traditional definition of battery is an act that directly and either intentionally or negligently causes some
physical contact with another person without that person's consent. If a person has consented to
contact expressly or by implication, then there is no battery. It is a rare case in which a doctor would be
held liable for criminal breach, unless there is gross disrespect to the patient's bodily autonomy, for
instance, if a patient's organs are taken without his consent.

12. • Timings of Consent
– Best taken a day prior for all elective cases
• Validity of consent
– All consents are valid for …… duration after which in case if a
procedure is planned it should be repeated
• Spouse Consent
– It is advisable to take consent of spouse when the treatment or
procedure may adversely affect or limit sex functions, or result
in death of an unborn child.

13. • Spouse's consent is not a mandatory requirement for
organ donation under the Transplantation of Human
Organs and Tissues Act, 1994

15. Thank You !