Role of electronic devices in obtaining informed consent for critically ill COVID-19 patients: Where do we stand?

Dear Editor,

Informed consent (IC) is defined as a process of voluntary willingness for therapeutic or diagnostic intervention, after being informed of all aspects of it. Traditionally it is documented as a written, dual signed (the subject and the person taking), and dated form. IC of the patient or next of kin or legally authorized representative (LAR) is a key ethical and medico-legal requirement. The consent procedures are evolving in this ongoing pandemic of coronavirus disease-2019 (COVID-19).[1]

Deviation from standard treatment due to limited resources, increased risk of nosocomial infection, increased risk of infection in health care personnel due to aerosolization, and poor prognosis in critically-ill COVID-19 raises serious legal, ethical concerns.[2] In view of optimal utilization of resources, highly infectious, unpredictable clinical outcome in nature informed written consent in the context of COVID-19 has emerged as a burning dilemma. The risk of infection transmission from the signed hard copy has shifted the paradigm towards an increased reliance on virtual services. Since 2018 the electronic consent has been used for research participants (NHS Health Research Authority, 2018) and currently adopted by some NHS trusts for treatment. An electronic consent regarding the unpredictable course of the disease, the probability of intubation can be taken form the patient on admission either by sending a secure electronic link to their phone or recording the conversation with the patient’s permission. It ensures discussion on all important points, adequate time to perceive before signing auditing, and quality improvement.[3] With restricted visitor policy in the current scenario, remote consent has become a suitable alternative. It was initially started for improving enrolment in the stroke trials. While the EXTEND-IA trial reported about verbal phone consent from a LAR, the DAWN trial used smart phone-based electronic consent.[4] Similarly, in the current scenario for debilitating patients, their family or LAR can be informed over the phone and the electronic consent can be procured by email, text, or video recording with permission.

USA, UK, Singapore, South Africa, China, and other countries have come forward with new legislatures in response to the unprecedented crisis of COVID-19 pandemic.[5] Patient autonomy and IC have come out from the shade of the paternalistic umbrella of the traditional medical practice in India. Any invasive intervention without consent can be tried for battery under civil as well as criminal law. It seems more to be a legal requirement rather than an ethical obligation with the incorporation of the healthcare system under the Consumer Protection Act and expanding patient awareness. However, the honorable Supreme Court of India held that the absence of valid consent is not a constraint for treatment in life-threatening situations.[6] “Article 21” of the Indian Constitution, deals with the “right to life and personal liberty” is of extensive amplitude and covers a wide variety of rights. However, the absence of unambiguous legal provisions regarding the consequences if a COVID-19 patient, suspected of having COVID-19, or who has been in contact with a COVID-19 patient refuses medical examination, admission to health care or a quarantine site, and prophylaxis and treatment make a dedicated legislation for COVID-19 is the need of the hour.

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