Patient Informed Consent Compliance 5 Day Series: Day 3

11 January, 2018


The same may either be obtained in writing from the individual or obtained by getting the individual to sign on a pre-printed form. There are certain details that must be added in the same as per the guidelines/statute/practice/judicial pronouncements, generally prevalent domestically as well as internationally to make a consent form legally valid and informative in the interest of the patient. They are:
  1. Name/ Age/Sex and Address of the Patient should be provided;
  2. Name of the patient/guardian giving consent in the case of the minor;
  3. In case of guardian the space should be provided for mentioning the details of the guardian including the relationship with the patient;
  4. Name and address of the Doctor/Hospital;
  5. Registration number, qualification and specialization of the doctor;
  6. Date of the consent given by the patient;
  7. The present condition/disorder/disease that the Patient is suffering from;
  8. Name of the procedure(s) to be followed;
  9. Statement that the relevant side-effects, risks and benefits have been explained;
  10. Reasonable alternatives to the proposed intervention and supporting information regarding those alternatives;
  11. Consequences of non-treatment including the effect on the prognosis and the material risks associated with no treatment;
  12. The expected outcome of the treatment administered;
  13. Should stipulate any measures/treatment/surgery that may have to be administered on an immediate basis in case the treatment/surgery for which the consent form is being issued is unsuccessful;
  14. Approximate duration and cost of treatment;
  15. Statement of the Patient that he got an opportunity to decide and take a second opinion;
  16. Statement of the Patient that the procedure was explained to the Patient or guardian and he/ she in his/ her capacity/ competence has voluntarily consented for the treatment on the basis of adequate information concerning the nature of the treatment;
  17. Signed declaration by the patient that all the information given by the patient are true to the best his knowledge and he will be liable for any misinformation and consequences ensuing from such misinformation;
  18. Signature of doctor who explained the procedure to the patient or guardian
  1. Doctrine of Emergency In medical emergencies consent need not be obtained if circumstances are such that it is impossible for that person to give consent. Under section 92 of Indian Penal Code (IPC) treating without consent of patient is permissible if patient is unconscious, mentally ill or gravely sick. When the time required for disclosure would create a substantial risk of harm to the patient or third parties, full disclosure requirements may not apply. It is implied that the procedure / surgery is done to save the life or limb of the patient. If possible, surrogate/proxy consent should be taken.
  2. Therapeutic Privilege If doctor suspects that passing full information could have detrimental effect on the health of the patient, then he need not follow the doctrine of full disclosure and can be excused of obtaining consent from the patient. However, to take the privilege of the doctrine, he should disclose full information to the competent relative of the patient.
  3. Incompetence Incompetent patients may not, as a matter of law, give an informed consent as they do not possess the capacity to fully understand and comprehend the situation so as to enable them to make a reasonable decision. State law generally provides alternative mechanisms by which consent can be obtained, and requires disclosure to a substitute decision-maker. Procedure requires that when a person is incapable of giving expressed consent a substituted consent can be taken from the next of kin. Generally accepted order is spouse, adult child, parents, siblings, and lawful guardian.
  4. Involuntary treatment Psychiatric treatment is allowed to be carried on without patients’ informed consent. This occurs most commonly when patients’ refusals of treatment are specifically overridden following clinical, administrative, or judicial review.
Read Day 2 Here

Read Day 1 Here