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...
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.
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)
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.
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.
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.
Barsha completed her MA 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 email@example.com.