A ‘battery’ action is an action for a "touching" to which the patient did not agree i.e. touching without permission. So, even if the procedure was technically successful, the doctor may still be liable for a claim of battery.

In negligent non-disclosure, the patient says that he gave permission i.e. he signed the consent form, but the doctor did not give him the complete information about the proposed procedure and the risks and benefits. The four elements of medical negligence must however be shown by the patient: Duty, breach of duty (failure to meet the minimal standard of care), injury and a causal association between the breach of duty and the injury occurred, which is shown when the patient reasonably declares that he would have refused to undergo the procedure had he or she known the true nature of the risks. If all four are proven, the physician is then liable for the tort of negligent nondisclosure.

Informed consent is therefore the legal and ethical responsibility of every doctor. This means provision of adequate information to the patients so that they can process the information and make the right decision regarding their treatment.

For a consent to be valid, it should fulfill the three required components: voluntary, competence and capacity.

No procedure, be it therapeutic or diagnostic, can be undertaken without the consent of the patient. A doctors should disclose all material facts that will help the patient to reach to an appropriate decision such as diagnosis, proposed treatment, risks and benefits of the treatment, alternative treatments along with their associated risks and benefits and also the risks of refusal.

If asked, the doctor must answer truthfully about the number of similar procedures or cases performed, and also disclose success rates. But, if not asked, he is not bound to disclose such information. However, any financial conflict of interest must be disclosed even if not enquired by the patient.

The patient should know each member of the team including residents, students and equipment representatives involved in his care, including their roles and responsibilities.

The informed consent must be taken in the language which the patients and/or their family members can comprehend. Interpreters may be used if required. Avoid use of medical term when taking informed consent. Educational materials can be used to better explain the various aspects of the disease concerned.

The patient and their family members should be informed beforehand of any additional procedure/s that may need to be done for a successful outcome. “Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment” as held in the Samira Kohli vs Dr Prabha Manchanda & Anr, AIR 2008 SC 1385 by the Supreme Court of India.

A consent stands ineffective or invalid and therefore non-existent if the doctors fails to provide the required information in the manner as described above.

Dr KK Aggarwal

Padma Shri Awardee

Vice President CMAAO

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA