Consent & High Risk Procedure Policy
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Consent & High-Risk Procedure Policy
Sri Lakshmi Multi Speciality Hospital recognises that obtaining valid informed consent is a fundamental ethical, professional and legal obligation before performing any medical examination, invasive procedure, surgery, anaesthesia or other treatment requiring patient authorisation.
This Policy establishes a comprehensive framework for obtaining, documenting and maintaining informed consent, particularly for procedures involving significant clinical risks. It promotes patient autonomy, shared decision-making and transparency while strengthening medico-legal protection for patients, healthcare professionals and the Hospital.
This Policy has been developed with reference to the National Medical Commission (Registered Medical Practitioner – Professional Conduct) Regulations, 2023, the Consumer Protection Act, 2019, the Digital Personal Data Protection Act, 2023, the Clinical Establishments (Registration and Regulation) Act, 2010 (where applicable), the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 (where applicable), the Bharatiya Nyaya Sanhita, 2023 (BNS), the Bharatiya Nagarik Suraksha Sanhita, 2023 (BNSS), the Bharatiya Sakshya Adhiniyam, 2023, and recognised principles established by the Supreme Court of India in Samira Kohli v. Dr. Prabha Manchanda (2008), together with NABH Standards.
Purpose of this Policy
The purpose of this Policy is to establish uniform procedures for obtaining valid informed consent before medical treatment, diagnostic investigations, surgical interventions and other procedures that require patient authorisation.
The Policy aims to ensure that every patient or legally authorised representative receives sufficient information regarding the proposed treatment to make an informed and voluntary decision, while ensuring compliance with applicable Indian laws, professional ethics and recognised healthcare standards.
Patient Autonomy
Respecting every patient's right to make informed healthcare decisions.
Communication
Providing clear explanations before treatment.
Legal Compliance
Meeting Indian legal and professional requirements for informed consent.
Risk Management
Reducing medico-legal risks through proper documentation and communication.
Scope of this Policy
This Policy applies to all Registered Medical Practitioners, consultants, surgeons, anaesthesiologists, dentists, nurses, technicians and other healthcare professionals involved in obtaining, documenting or verifying patient consent within Sri Lakshmi Multi Speciality Hospital.
It applies to all invasive procedures, surgeries, anaesthesia, blood transfusions, diagnostic procedures, high-risk treatments and any other healthcare intervention requiring informed consent under applicable law or Hospital policy.
"No elective invasive procedure shall ordinarily be performed without obtaining valid informed consent, except where permitted by applicable law."
Fundamental Principles of Informed Consent
Informed consent is a process of communication between the treating Registered Medical Practitioner and the patient or legally authorised representative. Consent is considered valid only when it is voluntary, informed, specific to the proposed procedure and provided by a person with legal capacity to make the decision.
Before obtaining consent, the treating doctor shall explain the proposed treatment in language that the patient can reasonably understand, allowing sufficient opportunity to ask questions and seek clarification.
Hospital Commitment
Sri Lakshmi Multi Speciality Hospital is committed to ensuring that informed consent is obtained through honest communication, respect for patient autonomy, proper documentation and compliance with applicable Indian laws, judicial principles and NABH standards.
Procedures Requiring Written Consent
Written informed consent shall be obtained before performing any procedure that is invasive, carries significant risk, requires anaesthesia or sedation, or is otherwise specified by applicable law, professional standards or Hospital policy.
The treating Registered Medical Practitioner shall ensure that consent is obtained before the procedure is commenced, except in emergency situations where immediate treatment is legally permissible without prior consent.
Written Consent is Mandatory For
- Major surgical procedures.
- Minor surgical procedures.
- General, spinal, epidural and regional anaesthesia.
- Blood and blood component transfusions.
- Endoscopy and colonoscopy.
- Biopsy procedures.
- Central venous catheter insertion.
- Cardiac catheterisation, angiography and angioplasty.
- Chemotherapy and selected oncology treatments.
- Dialysis procedures.
- Mechanical ventilation and selected ICU procedures.
- Any other invasive or high-risk procedure identified by the Hospital.
High-Risk Procedures
Procedures involving significant clinical risks require enhanced communication, detailed counselling and specific written informed consent. The treating Registered Medical Practitioner shall ensure that the patient or legally authorised representative understands the nature of the procedure and its potential outcomes before consent is obtained.
Where multiple procedures may reasonably become necessary during surgery, these possibilities should be discussed with the patient in advance wherever practicable. Additional procedures not covered by the original consent should generally require fresh consent unless immediate intervention is necessary to prevent serious harm or save life.
"High-risk procedures require clear communication, meaningful patient understanding and documented informed consent."
Information to be Explained Before Obtaining Consent
Before obtaining informed consent, the treating Registered Medical Practitioner shall explain the proposed treatment in language that the patient can reasonably understand. The discussion shall be honest, balanced and appropriate to the patient's circumstances.
The Discussion Should Include
- The diagnosis or clinical condition.
- The purpose of the proposed procedure or treatment.
- Expected benefits.
- Material risks and reasonably foreseeable complications.
- Potential side effects.
- Reasonable alternative treatment options, where appropriate.
- Likely consequences of declining or delaying treatment.
- Expected recovery process and follow-up care.
- Estimated duration of hospitalisation, where applicable.
- An opportunity for the patient to ask questions and receive satisfactory answers.
Shared Decision-Making
Patients should be encouraged to participate actively in decisions regarding their healthcare after receiving sufficient information to make an informed choice.
Documentation of Informed Consent
The informed consent process shall be appropriately documented in the patient's medical record. Written consent forms shall be completed before the procedure, signed by the patient or legally authorised representative, the treating Registered Medical Practitioner and, where required by Hospital policy, witnessed by an appropriate person.
Consent forms shall become part of the permanent medical record and shall be retained in accordance with the Hospital's Record Retention & Legal Protection Policy and applicable legal requirements.
Special Consent Situations
Certain clinical situations require additional safeguards when obtaining informed consent. In such circumstances, the Hospital shall ensure that consent is obtained from the legally authorised person, or managed in accordance with applicable Indian law and accepted medical practice.
The treating Registered Medical Practitioner shall assess the patient's ability to understand the proposed treatment, communicate a decision and provide legally valid consent before proceeding with elective care.
Special Circumstances Include
- Minor patients requiring consent from a parent or legally authorised guardian, except where permitted by law.
- Unconscious or incapacitated patients.
- Patients with impaired decision-making capacity.
- Language or communication barriers requiring interpretation or appropriate assistance.
- Patients with hearing, visual or speech impairments requiring suitable communication support.
- Consent obtained through legally authorised representatives where applicable.
- Any other circumstance requiring enhanced legal or ethical safeguards.
Emergency Treatment Without Prior Consent
Where immediate medical intervention is necessary to save life or prevent serious deterioration in the patient's condition, and valid informed consent cannot reasonably be obtained, treatment may proceed to the extent permitted under applicable Indian law and accepted medical practice.
The reasons for proceeding without prior consent shall be fully documented in the patient's medical record, including the clinical necessity, the patient's condition and the circumstances preventing the obtaining of consent.
"Emergency life-saving treatment shall not be delayed solely because informed consent cannot reasonably be obtained."
Withdrawal of Consent
A patient with decision-making capacity or a legally authorised representative may withdraw consent before the commencement of a procedure. The treating Registered Medical Practitioner shall explain the potential medical consequences of withdrawing consent and document the discussion in the patient's medical record.
If consent is withdrawn after a procedure has commenced, the treating doctor shall exercise professional judgment regarding the safest course of action, giving paramount consideration to the patient's safety and applicable legal obligations.
Documentation Requirement
Every withdrawal of consent shall be documented, including the date, time, reason (where provided), counselling offered and signatures where appropriate.
Responsibilities of Healthcare Professionals
Every Registered Medical Practitioner, consultant, surgeon, anaesthesiologist, nurse and other authorised healthcare professional involved in patient care shall ensure that informed consent is obtained, documented and retained in accordance with this Policy and applicable Indian laws.
Professional Responsibilities
- Explain procedures honestly and clearly.
- Discuss material risks, expected benefits and reasonable alternatives.
- Answer patient questions before obtaining consent.
- Verify that consent is voluntary and informed.
- Ensure consent forms are properly completed and signed.
- Respect the patient's right to refuse or withdraw consent within the limits of applicable law.
- Maintain confidentiality of consent documentation.
- Participate in periodic consent and medico-legal training.
Professional Commitment
Proper informed consent strengthens patient trust, supports ethical medical practice and provides important medico-legal protection for patients, healthcare professionals and the Hospital.
Responsibilities of the Hospital
Sri Lakshmi Multi Speciality Hospital shall establish, implement and periodically review systems that ensure informed consent is obtained, documented and preserved in accordance with applicable Indian laws, professional standards and recognised ethical principles. The Hospital shall ensure that patients receive sufficient information to make informed healthcare decisions while protecting their dignity, autonomy and legal rights.
Hospital Management shall provide appropriate resources, approved consent forms, staff training and monitoring mechanisms to ensure consistent implementation of this Policy across all departments.
Hospital Commitments
- Provide standardised consent forms for clinical procedures.
- Ensure staff receive periodic training on informed consent.
- Maintain complete and secure consent documentation.
- Monitor compliance through internal audits.
- Protect patient confidentiality throughout the consent process.
- Promote ethical, patient-centred decision-making.
Governance Commitment
Hospital Management is committed to maintaining transparent, legally compliant and ethically sound consent practices that protect patients, healthcare professionals and the Hospital.
Retention of Consent Records
All signed consent forms shall form part of the patient's permanent medical record and shall be retained in accordance with the Hospital's Record Retention & Legal Protection Policy, applicable Indian laws and recognised healthcare standards.
Consent records relating to litigation, complaints, insurance claims, medico-legal cases or regulatory investigations shall be preserved until all legal proceedings are concluded and applicable retention obligations have been satisfied.
"Consent documentation is an essential medico-legal record and shall be preserved with the same level of security and confidentiality as the patient's medical record."
Continuous Improvement
Sri Lakshmi Multi Speciality Hospital shall periodically review consent practices, audit findings, patient feedback, medico-legal cases, judicial developments and changes in applicable laws to strengthen informed consent processes and patient communication.
Lessons learned from internal audits, clinical incidents, patient complaints and regulatory inspections shall be incorporated into staff education, policy revisions and quality improvement initiatives.
Quality Improvement
Continuous evaluation of consent practices improves patient safety, strengthens trust, supports ethical medical practice and enhances medico-legal preparedness.
Policy Review
This Consent & High-Risk Procedure Policy shall be reviewed periodically by Hospital Management to ensure continued compliance with applicable Indian laws, National Medical Commission Regulations, judicial decisions, Government notifications and NABH accreditation standards.
"Meaningful informed consent is a continuous process of communication, understanding and shared decision-making—not merely the signing of a form."
Contact Information
Questions regarding this Policy, informed consent procedures or patient rights may be directed to the Medical Superintendent, Hospital Administration or the Quality Department.
Sri Lakshmi Multi Speciality Hospital
Address:
No. 5/91, Near Apollo Hospital OMR,
Church Road, Perungudi,
Chennai – 600096,
Tamil Nadu, India.
Phone: +91 98407 92932
Email: contactus@slmsh.com
Regulatory & Standards Reference
This Consent & High-Risk Procedure Policy has been developed with reference to applicable Indian laws, judicial precedents, professional ethics and recognised healthcare quality standards governing informed consent, patient rights and clinical decision-making.
Applicable Indian Laws & Judicial Principles
- National Medical Commission (Registered Medical Practitioner – Professional Conduct) Regulations, 2023.
- Digital Personal Data Protection Act, 2023.
- Consumer Protection Act, 2019.
- Clinical Establishments (Registration and Regulation) Act, 2010 (where applicable).
- Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and applicable Rules.
- Bharatiya Nyaya Sanhita, 2023 (where applicable).
- Bharatiya Nagarik Suraksha Sanhita, 2023 (where applicable).
- Bharatiya Sakshya Adhiniyam, 2023.
- Supreme Court of India – Samira Kohli v. Dr. Prabha Manchanda & Another (2008) – Principles governing informed consent.
Quality & Accreditation Standards
- NABH Standards – Patient Rights & Education (PRE).
- NABH Standards – Care of Patients (COP).
- NABH Standards – Access, Assessment & Continuity of Care (AAC).
- NABH Standards – Medical Records Services (MRS).
- NABH Standards – Information Management System (IMS).
- NABH Standards – Governance & Leadership (GL).
- NABH Standards – Continuous Quality Improvement (CQI).
- Professional Medical Ethics and Patient-Centred Care Principles.
"Sri Lakshmi Multi Speciality Hospital is committed to ensuring that informed consent is obtained through transparent communication, voluntary patient participation, accurate documentation and respect for patient autonomy, in accordance with applicable Indian laws, Supreme Court principles, National Medical Commission Regulations and recognised NABH standards."