Year : 2020 | Volume
: 34 | Issue : 2 | Page : 65--70
ISSP consent form for minimally invasive pain and spine interventions
Pankaj N Surange1, Swati Bhat2,
1 Director, IPSC, Sector-7, Dwarka, New Delhi, India
2 Kovai Medical Center and Hospitals Limited, Coimbatore, Tamil Nadu, India
Dr. Pankaj N Surange
Director, IPSC, Sector-7, Dwarka, New Delhi - 110 045
|How to cite this article:|
Surange PN, Bhat S. ISSP consent form for minimally invasive pain and spine interventions.Indian J Pain 2020;34:65-70
|How to cite this URL:|
Surange PN, Bhat S. ISSP consent form for minimally invasive pain and spine interventions. Indian J Pain [serial online] 2020 [cited 2021 Oct 25 ];34:65-70
Available from: https://www.indianjpain.org/text.asp?2020/34/2/65/291547
It is the ethical, moral, and contractual obligation of health-care professionals to give treatment to the patient, and at the same time, it is their legal obligation in obtaining consent from the patient.
Consent in terms of a doctor–patient relationship or agreement means the grant of permission by the patient on his volition for an act to be carried out by the doctor, such as a diagnostic, surgical, or therapeutic procedure and in terms of law, as the autonomous authorization of intervention by individual patients undergoing medical or surgical treatment.
An expressed consent is known as “real consent” in the UK and as “informed consent” in the United States of America.
The development of informed consent is well documented, both in Tort law and common law jurisdictions, and is directly linked with an individual's self-determination. Self-determination is primarily the right to noninterference, where an individual has the right to make decisions concerning one's own life without the control or interference of others. The doctrine of informed consent can be traced to American law, and the emphasis has been on individual autonomy. As a legal doctrine, it was first formulated in the case of Canterbury v. Spence, 1971 in the USA. This case involved a boy who suffered paralysis after back surgery. He claimed that he was not informed adequately about the risks involved in the surgery. The court argued against the physician's standard of disclosure of information and held the patient's standard of informed consent reasonable. The Canterbury Court held that the standard of disclosure of information should take the individual circumstances of a patient into consideration. Thus, this case emphasized the patient's autonomy, which demands that the physician provides information to the patient as a duty. While in the UK, informed consent was recognized initially in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and others, 1985, it was not recognized exactly in the sense in which it is applied in the USA. In this case, the operation performed by the surgeon left the patient paralyzed. The plaintiff alleged that the surgeon was negligent as he failed to disclose or explain the risks inherent in the operation. The judge applied the “Bolam test,” which was first laid down in Bolam v. Friern Hospital Management Committee, 1957. Under the Bolam test, professional standards were set according to peer standards of professional conduct. This implied that it was doctors who decided how much to tell patients about the risks of treatment, and therefore, a doctor could not be sued if he/she failed to inform the patient about the risks when other reasonable doctors would not have informed the patient about risks in a given situation.
Informed Consent in India
In India, laws governing medical negligence are derived from English common law. An individual who has been affected by medical negligence or malpractice can approach the judicial system under the Civil Procedure Code, Criminal Procedure Code (Section 304A, Indian Penal Code), Consumer Protection Act, 1986, and Code of Medical Ethics Regulations, 2002 for disciplinary action. Jurisprudentially, there is no distinction between negligence under the civil code and the criminal code. It is the amount of damages incurred which determines the extent of liability in tort; in the criminal code/law, it is not the damages but the degree of negligence.
According to the Supreme Court in Samira Kohli v. Dr. Prabha Manchanda and Another (2008) 2 SCC 1, consent in the context of a doctor–patient relationship has been defined as the grant of permission by a patient for an act to be carried out by a doctor, such as a diagnostic, surgical, or therapeutic procedure.
The Medical Council of India (MCI) has laid down in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 that, a physician before performing an operation, should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. Otherwise, it shall constitute professional misconduct on the part of the physician rendering him/her liable for disciplinary action by MCI.
In this case, the judgment not only provided details regarding specific consent to additional surgery but also elaborated on the meaning of consent and the nature of the disclosure of information. It also set guidelines to be adopted in the Indian context. The Supreme Court in Samira Kohli (supra) has discussed about the following essential elements of informed consent:
A doctor has to seek and secure the consent of the patient before commencing a “treatment” (the term treatment includes surgery). The consent so obtained should be real and valid, which means that the patient should have the capacity and competence to consent and should be voluntary, and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to
The “adequate information” to be furnished by the doctor (or a member of his team) who treats the patient should enable the patient to make a balanced judgment as to whether she/he should submit themselves to the particular treatment or not. This means that the doctor should disclose:
Nature and procedure of the treatment and its purpose, benefits, and effectAlternatives if any availableAn outline of the substantial risksAdverse consequences of refusing treatment. However, there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment.
A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoiding the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
Consent given only for a diagnostic procedure cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that unauthorized additional surgery is beneficial to the patient or that it would save considerable time and expenses to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defense in an action for negligence
The only exception to this rule is where the additional procedure, though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until the patient regains consciousness and takes a decision.
There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgeryThe nature and extent of information to be furnished by the doctor to the patient to secure the consent need to be of the stringent and high degree mentioned in Canterbury (Canterbury v. Spence, 464 F.2d 772) but should be of the extent which is accepted as normal and proper by a body of medical personal skilled and experienced in the particular field. It will depend on the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the patient.
Chronic Pain Management during Epidemic/pandemic Outbreak
In light of recent COVID-19 pandemic outbreak, health-care providers including pain physicians are changing their care delivery to protect themselves, patients, and staff from infection. Elective and routine cases have stopped to a great extent, and social distancing has become in vogue unless it is an emergency. Denial of treatment for patients with chronic pain can lead to worsening of their condition and reducing chances of spontaneous recovery. In these unprecedented times, chronic pain management would require a special treatment consent form, weighing the risks of infections and declaring benefits of the interventions but at the same time saving us from litigations. ISSP believes that such an unprecedented situation may continue or arise in the future and clinicians should incorporate a special consent form for such circumstances.
In view of the nature of the procedures and category of the patient who suffers from chronic pains, ISSP has developed a uniform consent form, specially designed for minimally invasive pain and spine interventions from the point of view of the legal environment as it exists in India today.
ISSP acknowledges the contribution of SIG Chairman Dr. Gautam Das and the members of the committee of SIG: Dr. Rajeev Harshe; Vice Chairman, members of SIG group on documentations; Dr. Anurag Agarwal, Dr. Gaurav Goyal, Dr. Pavan Kumar Bichal, Dr. Manish Raj, Dr. Nazir Ahmad, Dr. Sweta Salgaonkar, Dr. Rohit Lahori, Dr. Ashish Chakrborty, and Dr. Hammad Usmani, Editor, Indian Journal of Pain.
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