Each patient has the right to be informed of all available healthcare options and to make that decision. One practical embodiment of this autonomy is the need for legally needed patient consent. In light of the Supreme Court's position, this article provides a draught SOP on patient consent.

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One of the trickiest ethical problems that physicians must deal with is consent to treatment. It's critical to comprehend the details. Any medical situation involves frequent decision-making. After making a diagnosis and considering the requirements of the patient, doctors must choose the best course of action. Patients must next assess what they are told and decide whether to go on with a certain course of therapy, get a second opinion, or reject a recommended procedure. If there is an emergency, these judgments may be taken swiftly in particular circumstances.

Consent is an important part of any medical procedure. Article 21 of the Indian Constitution guarantees the patient the right to autonomy and self-determination. He can say no to treatment unless it's an emergency. In that case, the doctor doesn't need to ask for permission to treat. In order to be legitimate, the consent must comply with applicable laws. A doctor who provides treatment without proper authorisation might be held legally responsible under tort and criminal law. Since the doctor is automatically assumed to be in a position of power under the law, he or she must get the patient's agreement after thoroughly explaining all the risks and benefits.

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What does "Informed consent in medicine" mean?

Patients must obtain sufficient information to make an informed choice regarding their care in order to provide their permission. This might include a doctor explaining the potential adverse effects, risks, and advantages of a course of therapy or informing a patient about potential alternative therapies. It might imply that patients are given enough time, if feasible, to weigh their alternatives and, if necessary, seek a second opinion. Patients must also be advised of any prescribed treatments and the potential consequences of delaying treatment in order to provide their informed consent.

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Why do we need informed consent?

Although there is no way to guarantee a favourable result in a healthcare context, informed consent at least makes sure that patients are aware of the risks associated with their treatment. The legislation also states that. Patients must sign documents confirming they understand the risks and agree with physicians to take life-saving measures if required.

By assuring comprehension, informed consent builds doctor-patient confidence. Reduces patient and doctor risk. Excellent risk and option communication help patients make the best decisions and reduce the legal risk for doctors.

Effective informed consent lets patients make their own choices. This implies doctors must provide patients with enough information to make an informed decision and enough time so they don't feel rushed. Pain, drugs, and various medical disorders may impair judgment and comprehension, therefore physicians must consider these when obtaining permission.

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Explaining informed consent in the health system?

By discussing a proposed medical procedure with their doctor, patients give their doctors the green light to treat them. This is known as "informed consent." Before a procedure, patients have the right to information about their treatment and may ask questions.

During the informed consent procedure, a physician may provide the following details:

• What the problem is
• What is the therapy or procedure is
• What risks and benefits there may be, and
• What other alternatives there are for care, including not getting treatment, should all be presented to the patient

When obtaining informed consent, a doctor should:

1. Evaluate their patient's capacity to grasp essential medical facts and any consequences of alternative treatment.
2. Provide all necessary information as precisely and compassionately as feasible.
3. Add information such as diagnosis, nature and purpose of a proposed treatment, potential costs and dangers, and all choices, including opting out of treatment.
4. Document the dialogue with the patient and include explicit written permission in the patient's medical record.

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Standard operating procedures: Their significance

The concept of a patient's autonomy is widely accepted. Each patient has the right to be informed of all available healthcare alternatives and to make that decision. One practical embodiment of this autonomy is the need for legally needed patient consent. Sadly, it is also a substantial source of worry for medical professionals, leading to pointless litigation.

The Supreme Court of India revised the Indian consent law in its historic Samira Kohli v. Dr Prabha Manchanda & Anr. the ruling, which was rendered in January 2008. (Canterbury).

"The type and amount of information that must be disclosed by the doctor to the patient in order to obtain consent need not be of the strict and high standard outlined in Canterbury, but rather should be of the kind and degree that is considered normal and appropriate by a group of medical professionals with expertise and experience in the relevant field."

-The court has stated.

Now it is up to medical professionals and organisations to decide on the best method for treating patients that will also be lawful. Therefore, the initiative by the Institute of Medicine & Law (IML) is an effort to draft a standard operating procedure (SOP) on patient consent in accordance with the Supreme Court's viewpoint by involving eminent physicians and medical societies in the drafting process and maintaining a consultative, participatory, and transparent environment throughout the entire process.

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Essentials of consent 

1. In a non-emergency circumstance, only get the patient's permission if they are an adult, competent, and oriented (in time, place, and person).
2. Identify and validate the mental competency of all adult patients, regardless of age. Don't automatically assume that aged or older patients lack mental capacity.
3. A confirmation from the next of kin, ideally a first-degree relative (not required), may be obtained in suitable circumstances, notably high-risk situations, or they may be requested to sign as a witness (Advisable).
4. Any relative, or even an unconnected acquaintance, neighbour, or attendant, may be requested to sign as a witness if the next of kin is not present at that time.
5. Obtain "proxy" consent from individuals who are competent to care for patients who are not. Any person the patient has given permission to act on their behalf may consent on their behalf. In some circumstances, witnesses' signatures may also be obtained. (Advisable).
6. When a patient is an adult, competent, and oriented patient, do not get their permission (instead of their own) by asking their spouse, kids, or parents. They could be required to sign as witnesses, nevertheless, particularly in high-risk situations involving elderly or extremely elderly patients, patients with cognitive impairments, and so on. (Advisable).
7. If a patient who is legally married is having an Artificial Reproductive Technique (ART) procedure, make sure both spouses have given their approval. Note the patient's marital status explicitly.
8. Obtain the patient's written permission as opposed to not obtaining one.
9. Get written permission only when necessary for major, minor, IPD, or OPD treatment procedures that involve intrusive intervention and are not regular. Obtain written consent (recommended but not required) before undergoing certain non-invasive therapeutic procedures like diathermy, lithotripsy, nuclear scans, CT scans with dye, BiPAP, chemotherapy, hormone replacement therapy, drugs with serious side effects, high-risk medications, high-dose steroids, immunosuppressants, and other such high-risk cases. Obtain the patient's informed permission in writing before doing any HIV/AIDS-related testing, as required by the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome. (Prevention and Control) Act, 2017.

 

No formal approval is needed in writing for,

• Routine investigations such as drawing blood.
• From OPD patients who regularly attend the facility, unless an invasive surgery needs to be done there. 
• For non-invasive diagnostic and therapeutic treatments including simple CT scans and ECGs, among others.

10.  Consent should not be treated as a regular or mechanical action. The act of signing the permission form is just one step in the consent procedure. It entails explaining the proposed therapy or intervention, talking with the patient, coming to a consensus, and then filling out and signing the permission form. Give the patient information that is pertinent to them or, their overall health state, social and financial circumstances, and will enable them to make an educated and autonomous decision.
11. Do not depart from what has been consented to and agreed upon unless a life is in danger, there are valid grounds for doing so, and it is solely in the patient's best interest.
12. Only get consent after making the relevant disclosures and providing a thorough explanation; do not coerce or deceive the patient into giving their permission. Whenever there are any national medical societies' recommendations for that specific treatment or intervention, abide by them.
13. Use a language or dialect that the patient can understand to explain and provide advice. The translator or interpreter must put his or her name on the permission form, sign it as a witness, and particularly note that they explained everything in the patient's native tongue before the patient signed it. This is especially important when dealing with overseas patients. Take the translator's or interpreter's proof of identification, and make sure they are both legally capable adults who are at least 18 years old.
14. Describe and provide advice in basic, non-medical words. The patient might be given brochures or informational pamphlets on the procedures or therapy (Advisable)
15. In suitable situations and only if readily accessible, explain and advise the patient on the many components of the suggested therapy or intervention using handwritten notes, diagrams, figures, photographs, models, or posters depicting organs, systems, or illnesses. Include them in the consent form. (Advisable).

Inform the patient and accurately note it in the consent:

1. The name of the operation, surgery, or therapy as prescribed by a physician.
2. The nature, goal (intended benefits), consequence, and result of the operation, surgery, or therapy, as well as the issue, condition, illness, or complication for which it is recommended.
3. The likely prognosis is in line with a standard medical procedure.
4. The hazards involved are the ones that happen the most often, not the uncommon ones.
5. Frequently occurring life-threatening and non-life-threatening complications/side-effects/consequences - Even rare complications/consequences that are likely to affect vision, hearing, motor, and brain functions, or may result in amputation, disability, paralysis, or serious bleeding are to be avoided (Advisable).
6. Special care and the extent, if any, that may be needed after a procedure, surgery, or another kind of therapy.
7. Alternatives that are available - The relative benefits and drawbacks of each option, together with the reason(s) for preference.
8. The patient's refusal may have consequences, many of which are negative.
9. The patient's agreement for any extra, alternative, or extended procedures that may be necessary should the surgeon run into unanticipated circumstances while performing the operation.
10. The potential for the cytological or histological investigation of any component, tissue, fluid, or organ taken from the patient's body during the operation.
11. In some aesthetic or non-therapeutic procedures, disclose or record expressly that anatomical or procedural restrictions may prevent the result from living up to the patient's expectations.
12. Names of the chief anaesthetist and chief surgeon are listed on page xii.
13. The permission form was explained to the patient in a language they both understood.

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Video consent

1. Pre-consent counselling sessions should only be recorded on video if the necessary equipment is readily accessible, particularly in high-risk situations.
2. Video recording is not a replacement for the patient's written informed permission, but rather a complement to it.
3. Ensure that the counselling room has signs indicating that it is covered by CCTV and that the patient is aware of this. (Advisable)
4. Clinical trials and transplant procedures are the only situations in which capturing permission on video is legally required.
5. Keep the video footage and the written permission form on file for the required amount of time.
6. Ensure that the video files are stored digitally in accordance with data protection legislation, to safeguard patient privacy, and provide adequate security against manipulation and data loss.

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Multi-stage treatment

1. Even if the various steps are planned to be completed on various dates, take a single, thorough consent outlining each stage one after the other.
2. Include a detailed and distinct list of each step in the consent.
3. At any point over the course of the therapy, let the patient withdraw their permission. Include a clear note about this component in the consent.
4. If the patient's health changes considerably or if there is any thought of deviating from the agreed-upon course of treatment after such agreement has been given, new consent must be obtained.

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High-risk consent

Take extensive high-risk consent, particularly inform the patient, and document it in the medical records if:

1. Patients or caregivers make strange demands, there are strange or suspicious situations, and so forth.
2. It's anticipated that the therapy and recuperation will take a very long period.
3. Failure rates are high.
4. The method, process, medication, or regimen is advanced, vital, or challenging.
5. Relapse is frequent.
6. Any co-morbid condition that could prevent the operation, procedure, or therapy from going as planned.
7. The patient is in a serious condition or is even in a high-risk situation.
8. Any organ or limb removal is a possibility.
9. Despite abnormal parameters, surgery, operation, or therapy is being performed.
10. The patient has the ability to cause problems.
11. The recommended approach, intervention, medicine, or regimen often results in significant or life-threatening problems or adverse effects.

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Independent witness

1. If the patient's permission involves a high level of risk, get it in the presence of at least one independent witness.
2. Ideally, the witness should not be affiliated with the patient, hospital, or doctor in any way—not even by blood. As an independent witness, a patient's relative who speaks English or the language of the permission form would be an excellent option.
3. The witness must indicate in his or her handwriting on the consent form that the patient has informed them that they were informed of the consent form's contents in the language or dialect they are familiar with and speak and that they have given their consent. The patient must then sign the consent form or leave their thumbprint there in front of the witness.
4. The witness must then initial the permission form and write in BOLD letters their name, relationship to the patient, and contact information. For the sake of traceability, a copy of the witness' identification documentation must be made and saved with the permission form.
5. An impartial witness for that patient may be the translator or interpreter whose services were engaged.
6. The witness should be able to be located in the future and should not be reluctant to appear in court or to provide statements or affidavits.

Create and provide the patient with an information leaflet or booklet, ideally in the local language or languages, outlining the therapy, risks, prognosis, and benefits of the interventions, particularly in cases of uncommon, novel, difficult, or hazardous treatments, operations, or procedures. The patient must be given enough time to think things over and make a choice after receiving the aforementioned information in advance. Include a copy of the pamphlet or booklet with the permission form, along with the patient's or the attendants' acknowledgement of receipt.

Obtaining permission from a patient who is illiterate, illiterate in English, or semiliterate

1. Take more precautions.
2. Provide the necessary information in the patient's native tongue or the dialect.
3. The patient must be requested to bring someone who can comprehend, interpret, and explain things to them to the doctor if he or she is unable to speak the dialect. A staff member or someone the doctor knows may be involved if the patient says they are unable to bring anybody, but only as a last option. Note this information directly in the consent (Advisable).
4. Get the patient's signature or thumbprint (left hand for men, right hand for women).
5. Obtain a witness' independent signature (Advisable).
6. Clearly document that permission was obtained after patient counselling in their native tongue.
7. Make sure the patient doesn't put anything on the agreement that the doctor or hospital personnel will not be able to understand.

• Take a thumb imprint on the permission from a "literate" patient who is unable to sign owing to any cause (left hand for men, right hand for women). Take appropriate approval from the patient's family, friends, or attendants on the permission and note particularly the purpose for taking a thumb imprint, if feasible.

• Therapeutic Privilege: A physician who withholds information from a patient for therapeutic reasons

1. Use this choice sparingly, in the patient's best interest, and only when not doing so will impede treatment, negatively impact the patient's condition or recovery, or in the case of specific disorders that are taboo.
2. Inform the patient's companions and/or relatives of the reasons any information was being withheld from them, and get their written confirmation that they were informed.
3. Get the other physicians treating the patient's perspective, and if they concur with your choice to keep information from the patient private, get their written approval (Advisable).
4. Any such request from the patient's companions or relatives, particularly spouses, kids, or parents, must be given careful consideration, but the doctor must always make the ultimate decision. Take their written request and identification documentation, and properly store both with their permission.

• Purely cosmetic procedures or treatments, which are typically carried out by dermatologists, cosmetologists, dentists, plastic surgeons, and similar professionals and where the acceptance of the results of such procedures or treatments is frequently highly subjective, perceptive, and sensitive - Obtain additional consent from the patient's spouse, parents, relatives, or friends only after obtaining the patient's express consent for the same (Advisable).

• Procedures that are a component of surgery for which the patient has given permission are not subject to a separate consent requirement. Make sure the patient has received a detailed explanation of this extra procedure and that it has been noted in the agreement.

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Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.