Documented informed consent must before any clinical, diagnostic, therapeutic or operative procedure

Written by Barsha Misra Published On 2022-07-02T15:48:27+05:30 | Updated On 2 July 2022 3:48 PM IST

Documented informed consent must before any clinical, diagnostic, therapeutic or operative procedure

New Delhi: Reiterating the importance of "Informed Consent", the National Medical Commission (NMC) in its recent Draft RMP Regulations 2022 has stated that the doctors should obtain documented informed consent before performing any clinical, diagnostic, therapeutic or operative procedure.

Listing down the duties of the Registered medical practitioners regarding maintaining informed consent, the Ethics and Medical Registration Board (EMRB) of NMC has also made it clear that, for undergoing in-vitro fertilization, or artificial insemination, informed consent of the female patient, her spouse and also the donor is mandatory.

The Professional Conduct of the registered medical practitioners have specified in the Chapter 2 of the Draft Regulations. Section 19 of the Draft Registered Medical Practitioners (Professional Conduct) Regulations, 2022 referred to the importance of obtaining Informed Consent before initiating any procedure.

"(A). Before performing any clinical procedure, diagnostic or therapeutic, or operation, the RMP should obtain the documented informed consent of the patient. In case the patient is unable to give consent, the consent of the legal guardian or family member must be taken. The name of the operating surgeon must be mentioned in the medical records. In an operation that may result in sterility, the consent of both husband and wife is required," the Draft read in this regard.

However, in case of emergencies, the Draft specifies, "In case of an emergency, the doctor should try to obtain consent, but if this is not possible, he must act in the best interest of the patient. The medical records should describe the basis of decisions taken in an emergency."

"No act of in-vitro fertilization or artificial insemination shall be undertaken without the informed written consent of the female patient and her spouse as well as the donor. (Consent Guidelines) (L4)," it further mentioned.

NMC has clarified that any violation of these rules would be treated as Level 4 (L4) violation, resulting in the suspension of the license to practice for a period ranging from 3 months to 3 years.

Also Read: Doctor can refuse to treat patient if pre-indicated fees not paid: NMC draft guidelines

Apart from these, the other Rules regarding Informed Consent are as follows:

"(B). A RMP shall not publish photographs or case reports of patients without their permission in any medical or another journal in a manner by which their identity could be revealed. (L1)

(C). Clinical drug trials or other research involving patients or volunteers must comply with ICMR guidelines and the New Drugs and Clinical Trials Rules, 2018. Consent taken from the patient or participants for the trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct. (Research Guidelines) (L2 - L4)."

While in the first case (publishing photographs or case reports) has been specified to be Level 1 violation, the clinical drug trials and other research without consent can be treated as Level 2 to Level 4 violation, NMC has specified.

Guideline 4 of the Regulations mentions that when the State Medical Council or EMRB or NMC investigates a case, the disciplinary action will be awarded while keeping in mind the severity of the act of commission of omission.

These Regulations have graded the disciplinary actions at five levels. As per the Regulations Level 2 penalty may be awarded even when the role of the doctor in causing direct harm was not conclusively proved but the doctor was found to have breached any of the codes listed above.

In this case, "The maximum action is a suspension of the license to practice for up to one month (30days)."

However, Level 4 penalty may be awarded when the role of the doctor in causing direct harm was conclusively proved and the doctor was found to have breached relevant regulations.

"The maximum action is a suspension of the license to practice for a period ranging from 3 months to 3 years," NMC mentioned while defining Level 4 penalty.

"At each of Levels 2, 3, and 4, the extent of action recommended may range from reformation alone to a maximum of suspension for the period indicated at the level, depending on the quantum of responsibility of the RMP for the harm/injury caused," the Regulations further stated.

Apart from this, Guideline-5 of the Draft has specified the Guidelines on Informed Consent in Clinical Practice, where NMC has referred to all clinical interventions that require documentation of consent. The Guideline has thoroughly discussed about the types of consent, types of information that the doctor needs to share with the patient before obtaining consent, the concept of blanket consent, the details regarding standard consent, etc.

Further, it has specified the need for obtaining video consent before transplant surgeries, it has also mentioned about the rules for getting consent at the time of emergencies, in case of special situations, rules for medical students examining patients for learning purposes, in case of processes resulting in sterilization, patients' rights of refusing treatment, and the rules regarding the usage of personal data.

Some of the important points raised in the Guideline-5 of the Draft are as follows:

Surgery

Consent must be taken for all operative procedures minor or major.

The concept of blanket consent when the patient is admitted or before surgery cannot be defended legally or morally.

The consent must be procedure-specific. Pre-printed procedure-specific informed consent can be made available after prior approval from the SMC or EMRB. However, the responsibility of administering the informed consent is on the primary physician

The primary surgeon/surgeon's name should be on the consent form in all surgical procedures.

The standard consent form for surgery under anesthesia used by RMPs and hospitals should include specific risks and information related to each case where necessary and the patient's consent documented for the same.

A patient undergoing two separate elective procedures (example: cholecystectomy and appendicectomy) needs to give consent for each operations. Similarly, fresh consent must be taken for every new procedure planned for the patient. Consent must be taken separately for surgery and anesthesia because the nature of these procedures as well as the complications, is different.

In major surgeries, it is in the interest of the patient to execute an advanced directive nominating a legal representative who can give consent on their behalf if required for further procedures during surgery when the patient is incapacitated Since 2013, it has been a legal requirement to document video recording of consent for transplant surgeries.

Emergencies:

In emergencies, consent for treatment should be taken from patients whenever possible or from legal representatives (wherever available) when the patient is unable to give consent. However, the consent process should not interfere with emergency care and response in the best interest of the patients.

When a patient is brought unconscious and without identification, all efforts should be made to identify the next of kin even while emergency treatment is being provided. The doctor can document the absence of surrogate decision-makers and proceed in the best interest of the patient.

Special situations

In the case of minors, the parents or guardians must provide consent, although assent may also be needed from children above 8 years of age.

In case of vulnerable groups, it is safer to have a witness during the informed consent procedure, and take the signature of the witness as well.

Informed consent process should never be curtailed or neglected for the reason that the patient is unable to "fully understand".

The elderly, marginalized, illiterate and other vulnerable patients may require additional time and efforts at communication prior to consent.

In the case of extended treatments or complicated cases, consent may need to be an ongoing process. Patients who are indisposed should be encouraged to assign surrogates who will take decision and give consent on their behalf, should the need arise.

This should be documented in the patient's records.

Medical Students and consent:

In examining patients by medical students for teaching/learning purposes, students must be educated about the process and importance of consent.

Medical students should take verbal permission from their patients before examining them and the patient's decision must be respected, including refusal to be examined by the medical student.

Patients do not need to give any reason for this refusal and clinical care of the patient must not be adversely affected in such cases.

Sterilization :

In the case of operative procedures which may result in permanent sterilization, it is prudent to take informed consent from both the patient and the spouse unless denial of consent could put the life of patients in danger. RMP should encourage honest disclosure by the patient in their best interests.

Particular care must be taken with consent in infertility treatments like in-vitro fertilisation, embryo transfer or artificial insemination to protect the rights of patients and donors.

Refusal of consent :

Patients have the right to refuse treatment, and this right should be respected. RMP should communicate all possible outcomes of the refusal to be treated especially in emergency and acute conditions. It is important to document the patient's refusal to be treated and the reasons given for the refusal. Use of clinical data Personal data that can reveal the identity of the patient should not be disclosed under any circumstances. However, for the use of patient's data in academic teaching or clinical case discussions, patient's consent is required. Under no circumstances will the patient's data be posted on social media.

Also Read: Doctors need to maintain patient record for 3 years: NMC Draft

Medical Dialogues had earlier reported that while releasing the draft NMC RMP guidelines, the apex medical regulator had invited suggestions from various stakeholders and the deadline for the same was June 22.

Hence, the NMC received responses ranging from comments on the use of prefix Med Dr, to CPD credit hours and learning, generic prescriptions, online consultations, guidelines on social media for doctors and many more.

Also Read:From Rights of Doctors, to use of Med Dr Prefix: Medical Fraternity points out Lacunas in the draft NMC guidelines

Registered Medical PractitionerRegistered Medical Practitioner (Professional Conduct) Regulations 2022national medical commissionNMCEthics and Medical Registration BoardEMRBInformed Consent

Barsha Misra

Barsha completed her Master's in English from the University of Burdwan, West Bengal in 2018. Having a knack for Journalism she joined Medical Dialogues back in 2020. She mainly covers news about medico legal cases, NMC/DCI updates, medical education issues including the latest updates about medical and dental colleges in India. She can be contacted at editorial@medicaldialogues.in.