Adequacy of Informed Consent in Elective Surgical Procedures: A Study in a Navi Mumbai Tertiary Care Centre.

Background Informed consent (IC) is a voluntary authorisation given by a patient or research subject after fully comprehending the risks involved in various procedures and treatments. Though a patient may fulfill all the aspects of consent by completing an informed consent form (ICF), research indicates poor execution of the IC process by ill-informed patients with little comprehension. The present study was done on patients to assess their understanding and involvement in the consenting process, thereby providing insight into the adequacy and sufficiency of the IC process. Materials and methodology Patients undergoing elective surgical procedures were surveyed using a questionnaire to study whether the written informed consent (IC) process was adequately used in elective surgeries and to assess the patient's understanding of the IC and whether the informed consent forms (ICF) used met the ethical and legal standards for this purpose. The questionnaire was administered to the patients by two surveyors. As per the inclusion/exclusion criteria, data was collected from 221 admitted patients who were planned to undergo or recently underwent various elective surgical/operative procedures. Descriptive analysis using frequency and percentages of the positive and negative responses was used to analyse the data. Results In 219 (99%) of the cases, informed consent was taken. Two hundred-eight patients (94.1%) understood the knowledgeable consent information, while 13 (5.9%) did not. Of the total 221 patients, more than 90% of patients were informed about the nature and indication of the surgery. The expected benefits were told to 83.25% of patients, while possible complications of the procedure were reported to 91 patients (41.2%). Of the total, 58.37 % of patients knew the type of anaesthesia used for elective surgery. Two hundred and sixteen (97.73%) patients favoured the informed consent process, and 213 (96.38%) were satisfied with the information provided in the consent form. The education status of the patient varied, with nearly 15.5% being illiterate while 35.3% being educated till high school. Patients undergoing surgical procedures must be explained the nature and indication of the proposed surgical treatment, including its benefits and risks. About 208 (94.1%) of the patients stated that they understood all the information provided in the ICF, and 213 patients (96.3%) were satisfied with it. Most patients (88.7%) exercised autonomy in deciding to undergo surgery. Ninety-seven percent of patients favoured the IC process, of which 38.46% believed informed consent has a medicolegal significance. Conclusion The present study revealed that a better understanding of the informed consent by the patients is a vital component of the process as it helps exercise autonomy in the decision-making process. However, the lack of information in the informed consent forms critically affects the quality and adequacy of the IC, thus posing ethical and legal challenges to genuinely informed consent.