The informed consent consists of information on risks, benefits, alternatives and who will perform the procedure and it is explained by the concerned consultant in a language, which the patient can understand.
Informed consent is taken during the following occasions
List of informed consent
- Consent Form For Treatment Cost
- Consent Form for Applying Restraint
- Consent From For HIV Testing
- Consent Form for Procedure
- Consent Form For Critical Illness information
- Consent Form for Intubation
- Consent Form for Applying Ventilator Support
- Consent Form for High-Risk Procedures
- Consent Form for Refusal of Examination / Treatment
- Consent Form for Discharge/Leaving Against Medical Advice
- Consent Form for Major Surgical Procedure
- Consent Form for Specific Surgery
- Consent Form for Sedation during Procedure
- Consent Form for Use of General & Local Anaesthesia
- Consent for Release of Information
- Consent for Isolation of patients
- Informed consent for MRI
- TV USG Consent
- Informed consent for X-Ray
- Informed consent for USG guided procedure
- Consent Form I-131 Therapy for Ca Thyroid
- Refusal of 2decho
In a normal condition, a patient shall sign the consent form.
A surrogate decision-maker may sign the consent on behalf of the patient if:
- The patient is a minor (less than 18 years of age)
- The patient desires the surrogate to sign on his/her behalf. ( to be mention on consent)
- The patient is mentally incapable of making an informed consent.
- The patient is mentally incapacitated.
- The patient is unconscious
- The patient has received sedation within 3 hours
- The patient is physically incapable of signing the form
- As per the hospital policy, general consent is obtained from the patient for treatment when the patient enters the organization for Admission.
- The patient and his / her family members are explained by the front office staff about the contents and scope of the general consent.
- General consent is taken when the nature and probable risks of the procedure or treatment are of such a common and ordinary nature so as to be within the patient’s understanding and knowledge (e.g. injections, etc.)
- The consent taken at the time of Registration is only limited to basic investigations and treatment.
- Informed consent includes information regarding the procedure, it‘s risks, benefits, alternatives and as to who will perform the procedure in a language that they can understand.
- The consent will have the name of the doctor performing the procedure. In case if a procedure requires more than one doctor from different specialities, then the same will have to be explained to the patient and consent shall include the name of the principal surgeon from each speciality who is performing the procedure.
- Each doctor will explain his role and address all aspects required for informed consent. If it is a ―doctor under training, the same is specified, however, the name of the qualified doctor supervising the procedure is being mentioned.
- A consent form is prepared in language that the patient understands.
- Informed consent is obtained after the patient/ relative has understood the nature and probable risks of the procedure or treatment are of such a common and ordinary in nature so as to be within the patient’s understanding and knowledge.
- Patient/ relative has to give his / her consent of willingness in writing in different formats provided for different types of procedures.
- Informed consent is also obtained when a clinician proposes to engage in or performs human experimentation or other research/educational projects and shall obtain written informed consent if the participation is agreed by the patient/ family and it also mentions that the patient has the right to withdraw/discontinue the participation any time.
- Consent is also taken from the patient and his family when they decide to discharge from the hospital against medical advice. In such cases, consent is taken only after explaining the risks of such a decision.
- The doctor performing the procedure/ intervention, administering anaesthesia, nursing staff administering high-risk medication, drawing sample for HIV testing, transfusing blood, administering contrast and the admission & registration counter are responsible for explaining the procedure and taking consent.
- In case the patient is minor (below the age of 18yrs) or is in unconscious condition or not in a stable mind or not in a position to take any decision the Surrogate Decision Maker/ representative can give the consent. The priority order of surrogate decision-maker is the Spouse, adult children, parents, adult brothers or sisters, adult grandchildren. In case these relatives are not available, a close friend or any other person who accompanied the patient can also give consent.
- In case the patient requires an emergency procedure or intervention, but is unconscious or not in a state to give consent and is not accompanied by a legal representative, two of the senior consultants shall give a written authorization stating that emergency procedure or intervention is required in order to save the patient’s life.
- Communication in advanced Disease” is taken for terminally ill patients to activate and manage End of Life Care
- All the entries in the consent form shall be filled compulsorily.
- It is the responsibility of the person obtaining the consent to ensure that the consent form shall be properly filled prior to signing.
- The date and time of signing shall be clearly indicated.
- If any sign is not found on the consent form during Surgery Safe Checklist, the patient should not be taken in OT till the sign is obtained or the procedure shall be postponed or cancelled.
- The decision regarding the patient’s ability to make an informed consent shall be the responsibility of the Consultant.
- A patient or the surrogate decision-maker may revoke the consent for the procedure at any time before it is carried out. In such an event, the Duty Doctor / Consultant shall discuss the procedure again and if the patient or the decision-maker still wishes to revoke the consent, then the procedure shall not be carried out. The patient or decision-maker shall sign a note to the effect on the signed consent form. The Consultant shall document this in the progress notes.
- Only the person performing the procedure or intervention explains the informed consent & gets it signed. It is not acceptable that he/ she only explain & nurse gets the consent signed.
- It’s acceptable if a team member (Peer) who is also involved in the procedure obtains it. (Like Anesthetist team member or surgical team member can take on behalf of their colleague if they too are part of performing team).
- In a life-threatening emergency where the patient is unconscious or unaccompanied, consent shall be implied; therefore the patient’s signature is not required. In such situations, the Consultant shall document in the patient’s medical record both the nature of the emergency and the inability of the patient or surrogate decision-maker to consent.
The hospital has laid down a policy, which describes as to who can give consent in case a patient is incapable of independent decision-making, i.e. Surrogate Decision Maker.
The order of preference for “surrogate” is as follows:
|Type of Patient||Authorized Person|
|Adult Patient (above 18 years)||The patient himself (if capable physically)
If Incapable or otherwise
a. Parents ( Father or mother )
b. Brother or Sister depending upon seniority in the family and their availability at the time of obtaining consent (if father or mother is not available or has expired) or the relative available.
a. Spouse or the husband (as the case may be)
b. Parents (father or mother)
c. Brother or Sister – satisfying the conditions stated above.
( Under 18 years)
|a. Parents ( Father or mother )
b. Brother or Sister (if either parent is not available and if the person has crossed 18 years).For more than one eligible brother or sister available at the time of consent, consent will be obtained from the willing persons depending upon their seniority and availability.
|In case neither of the above-mentioned relatives of the patients is present, consent would be taken from the relative available at the hospital premises.|
Informed consent process adheres to statutory norms.
- It is taken beforehand, in the presence of a witness, the witness also with sign in the consent.
- A fresh one is taken when the procedure is changed midway
- In case the patient has to undergo a procedure repeatedly for a long time informed consent is taken at the first instance. Such consent will a defined validity period but not more than 6 months.
- Patient endorses the consent at each repeat treatment. However, if there is a change in the treatment modality or an addition of another modality then fresh consent shall be obtained.
Staff is aware of the informed consent procedure. Training on the list of consents & who has to take it – doctors, admin, nurses etc is imparted during induction and department level training.