172 CMAAO CORONA FACTS and MYTH COVID Informed Consent
Dr K Aggarwal
With inputs from Dr Monica Vasudev
1034: Round Table Expert Zoom Meeting on “Consent in Covid era - Need for Change”
1st August, 2020
Dr KK Aggarwal
Dr AK Agarwal
Prof Mahesh Verma
Dr Ashok Gupta
Dr Shashank Joshi
Dr JA Jayalal
Dr Jayakrishnan Alapet
Dr Anil Kumar
Mrs Upasana Arora
Dr KK Kalra
Ms Ira Gupta
Dr Sanchita Sharma
Key points from the discussion
- Covid-19 has changed the scenario today. There is an inherent risk due to the changing nature of the virus.
- The requirements of presurgical patients are different; patients require more ICU stay.
- Institutes and hospitals have to come out with new consent formats.
- Introducing the subject, Dr Kalra shared modified formats of consent from American Society of Plastic Surgeons and one published in the Indian Journal of Surgery.
- Time has come to revisit consent. Consent should now be “fully” informed consent and not just informed consent. Include informed refusal.
- Blanket immunity may not work.
- There is now a need to shift from written informed consent to video; record consent in audio-visual format.
- There should be transparency in information provided to the patient. Include all points as can be imagined so there will be no counterpoints. Make it “foolproof”.
- The regular consent form in a preprinted format is outdated. In a recent order in July, the National Consumer Disputes Redressal Commission (NCDRC) has held that the use of preprinted consents forms is not valid.
- Consent should be in the patient’s language, which he/she can understand. Consent will change in every counseling session.
- MCI Code of ethics regulations specify that consent should be given by the patient or the spouse. In the Covid era, both husband and wife may be infected and may be hospitalized. So, now the “next of kin” should be identified for consent. Also, identify someone who will pay (guarantor).
- For a patient under isolation, the routinely taken consent may not be valid; it can be challenged on the grounds that the patient was under mental stress etc.
- Shift from consent to agreement; now a detailed consent will be required and every step should be recorded.
- The landmark Samira Kohli judgement took into consideration the Bolam’s rule under which complications that occur <1% need not be informed to the patient/family. But now the definition of consent will change from this.
- Include the words “as on today” in the consent when giving information to the patient; as new information about Covid is emerging almost every day.
- We need to define guidelines; they are not mandatory; treatment may change from the guidelines based on the professional competence of the treating doctor. This needs to be included in the consent. Guidelines inflict on professional autonomy.
- Define “off-label”; every treatment in Covid is off-label use.
- Declare death when brain death occurs; do not wait for the heart to stop – follow organ transplantation guidelines for this. Extended CPR not allowed. Define the hours or how long will the body be kept in the hospital. Include such information in the consent.
- Include a clause for DNR.
- Put in a clause for compensation; write down your in-house redressal mechanism in case of a dispute.
- Include clause of good faith.
- Clearly define isolation rooms in the consent; in the western literature, isolation rooms mean negative pressure rooms.
- Define presymptomatic cases in consent as sometimes patient brought in negative for Covid-19, but may become positive during hospitalization. This may become a dispute.
- Be transparent about charges (ethical); whether insurance will cover or not.