• Users Online: 128
  • Print this page
  • Email this page

EDITORIAL Table of Contents  
Ahead of print publication
Consent and pain practice


1 Director Department of Pain and Palliative Medicine Cytecare Cancer Hospitals, Bengaluru, Karnataka, India
2 Apollo Hospitals, Hyderabad, Telangana, India
3 Director Vishakha Pain Spine Center, Gopalapatanam, Vishakhapatnam, Andhrapradesh, India
4 Department of Pain and Palliative Medicine, Cytecare Cancer Hospitals, Bengaluru, Karnataka, India
5 IPSC India Chain of Single Speciality Hospitals, Dwarka, New Delhi, India

Click here for correspondence address and email

Date of Submission01-Dec-2020
Date of Acceptance10-Dec-2020
Date of Web Publication15-Nov-2021
 


How to cite this URL:
Bhat S, Bichal PK, S Prasad K S, Jyotinagar HP, Surange PN. Consent and pain practice. J Recent Adv Pain [Epub ahead of print] [cited 2022 Jul 5]. Available from: http://www.jorapain.com/preprintarticle.asp?id=330488




The word consent has been defined by Cambridge Dictionary as permission or agreement to do something. This is defined in medical terms as informed consent, express consent, real consent, and so on in different countries. We are concerned with the governing laws in our country and the implications it has both for the medical practitioners and the patients. As the health care becomes more organized and the legal framework becomes a part of the system, more streamlining of documentation becomes mandatory toward better process control and compliance of protocols in health care.

According to the Indian Contracts Act 1872, consent as per section 13 lays down that two or more persons are said to consent when they agree upon the same thing in the same sense (meeting of the minds).[1] According to the law of contracts, consent is said to be free when it is not caused by (1) coercion, (2) undue influence, (3) fraud, (4) misrepresentation, or (5) mistake. Consent is said to be made when it would not have been given but for the existence of such coercion, undue influence, fraud misrepresentation, or mistake. Coercion as per Indian Penal Code (IPC) is the committing or threatening to commit any act forbidden by IPC. Coercion is not of much importance to the doctors fraternity and so we shall delve into misrepresentation which happens often. It means and includes (1) the positive assertion, in a manner not warranted by the information of the person making it, of that which is not true, though he believes it to be true, (2) any breach of duty which, without an intent to deceive, gains an advantage to the person committing it, or anyone claiming under him, by misleading another to his prejudice, or to the prejudice of anyone claiming under him; (3) causing, however innocently, a party to an agreement, to make a mistake as to the substance of the thing which is the subject of the agreement. Unwarranted statements need more explanation here. They are when a person positively asserts that a fact to be true when his information does not warrant to be so, although he believes it to be true, this is misrepresentation. Any breach of duty which brings an advantage to the person committing it by misleading the other to his prejudice is misrepresentation. For instance, a female patient was told that her sterilization would be irreversible but was not told that there was a minute risk (<1%) of failure and of pregnancy. She conceived again and delivered a child and sued the gynecologist for breach of contract. (Thake vs. Maurice 1986, failed sterilization case All ER 497 CA).[2] Suppression of vital facts also constitutes a misrepresentation. Sometimes, patients do not disclose preexisting illnesses, drugs used by them and this might hamper the quality of treatment of which the doctor might not be aware of. Hence, the history taking by the patient to be correlated to the initial response to medication whether the outcomes are in alignment with the theoretical outcomes.

In so far as the Medical Council of India is concerned, consent as defined in Chapter 7 Code of Ethics Regulation 2002, says that “before performing and operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.”[3]

It is worth mentioning that, mere expression of opinion by a doctor or any of the associate doctors should not be regarded as a misrepresentation of facts even if the opinion turns out to be wrong.


  Types of Consent Top


  1. Implied consent
  2. Express consent.


Implied consent

Implied consent is when consent is deemed to be granted to the doctor, even before the procedure is performed. This is implied in the sense that the patient while taking a conscious decision to enter the premises of the doctor, has agreed himself to be subject to physical examination and answering questions pertaining to his case history, etc. Hence, this is implied consent. Consent may be inferred from the general submission by a patient to orders given by a doctor during clinical diagnosis.[4] For example when a patient enters a cardiology clinic his consent for chest auscultation is implied.

Express consent

It is consent which is stated in clear terms in distinct language, explicitly and in writing or oral in some situations. Although both forms of express consent are of equal value, written consent is regarded as superior because of the evidential value.[5] The doctors shall strive to obtain express consent at all times as a good industry practice which will save them from unwarranted situations at a later date. Furthermore, medical records shall be preserved for posterity including the consent forms.

The patient is supreme and in the world of consumerism and consumer rights pro society, the role of medical care professionals has become very delicate as being synonymous with health-care providers and relates to service industry. Hence, the chances of medical cases against lapses whether unintentional or accidental are bound to bring legal situations for the doctors at large.[6] Hence, one such twin concept of true and informed consent needs to be deliberated here.


  True Consent Top


In the case of Sidway versus Board of Governors of Royal Bethleham Hospital (1985) 2 WLR 840, a patient complained of back pain was operated upon and became paralysed due to spinal cord injury. A case was filed as the doctor did not inform the patient of the risk associated with the procedure. The court held that the doctor informed the patient of the risk which was stated to be <1%, and therefore, the patient did not understand it. Hence, the case was decided in favor of the doctor. The takeaway of this case is that the consent has to be clearly obtained in writing and preferably signed off by the patient himself so that it protects and indemnifies although not fully but substantially the medical professional.[7] It only proves that adequate documentation has been completed and flow of information occurred before a procedure was performed.

In Blythe versus Boolmsbury Health Authority (1993) 4 Med L. Rev 15 1, the patient complained that doctor had not disclosed all the risks of Depo Provera. The court held that the doctor is not obliged to explain all possible risks of treatment in response to a general inquiry from a patient. This approach is more doctor oriented.[8]

Samira Kohli versus Dr. Prabha Manchanda case:[9] In this case, the verdict was held in favour of the patient. The patient Samira Kohli 44 years of age approached Dr. Manchanda, with complaint of prolonged bleeding. The patient was subjected to laparotomy and it was opined by the attending doctor Lata Rangarajan that hysterectomy will have to be performed and the consent of the mother was obtained. After the consent, the patient was operated for hysterectomy by Dr. Manchanda. On January 1996, Samira filed a case before the National Consumer Disputes Commission claiming a compensation of Rs. 25 lakhs. The National Commission dismissed the case and the case was filed in Supreme Court. The Supreme Court opined that while an additional surgery was required, the physician performed an unauthorized abdominal hysterectomy without obtaining specific consent of the patient. Although the physician received consent from the patient's mother, it is not considered valid since it amounts to trespass of the bodily integrity of the patient and deficiency in service.

While the Indian and British courts follow the concept of true consent, the American and Canadian Courts follow the concept of informed consent.

[TAG:2]Informed Consent[3][/TAG:2]

This is a mandate on the doctors to explain all information in comprehensive, nonmedical terminology preferably in patient's own language, all relevant, pertinent information relating to the nature and type of illness; proposed treatment; available alternatives for a rational decision by the patient and his attendants; potential risks of the procedure; danger of not undergoing the procedure; possible direct costs; subsequent costs and additional treatments to be taken at a later date; efficacy of the treatment and its possible recurrence statistically; cost of medicines; frequency of follow-up medical consultations in future post the treatment.[10],[11],[12] In Arato vs Aveon (1994) 6 Med L Rev 230, the Supreme Court of California held that the concept of informed consent required disclosure of all medical facts. In Roger versus Whitaker (1992) Australia, the court held the doctor guilty for not disclosing risk of sympathetic opthalmitis in the normal eye after surgery on the diseased eye. Therefore, world over there is a growing leaning in favor of informed consent by the courts. Under these circumstances, it is desirable to adopt protocols in favor of informed consent in patient case documentation


  Difficulties in Obtaining Fully Informed Consent Top


  1. Patient by virtue of the disease has lost his or her ability to discriminate and decide for himself or herself
  2. The sheer complexity of medical terminology and procedures and its lack of understanding or comprehension thereof by the patient
  3. The complexity and impossibility of explaining the para (b) above in the patients' native language
  4. Lack of predictive ability about the intensity of pain and postoperative complications given the patients' pain threshold, age, and mental/psychological condition
  5. Modern medicine and prognosis of various diseases are based on probabilities. This does not go well with a patient if the outcomes are in the narrow range of outliers statistically. An impossible outcome can become possible, and therefore, the consent status becomes questioned and cross examined in the courts.


Notwithstanding the above, in the case of Dr. Thomas versus Smt Elisa, AIR 1987, the court held that the doctor was guilty of negligence by not operating a patient with life-threatening peritonitis following a perforated appendix only because the patient was not in a condition to give consent. Hence, lack of consent is not always a constraint.

Pain management therefore becomes an integral part of quality health care and it cannot be left behind in protocols toward providing holistic patient care. Awareness of the patients has become more handy due to the electronic gadgets and hand held internet services. Therefore, patients are well aware of the consequences of treatment and the options available before them. Hence, there is a growing pressure upon doctors to handle with empathy the patient related issues: comfort, counseling, and patient empathy.

In view of the above, based on the available literature, a flow chart is shown here [Figure 1] which if followed will avoid the unavoidable legal battles [Figure 2].
Figure 1: Flow chart of the decision-making process by the physician while taking consent

Click here to view
Figure 2: Uniform consent form for Interventional pain procedures : Indian Journal of pain[12]

Click here to view



  Conclusion Top


The above review of the literature therefore necessitates dissemination of knowledge relating to types of consent and the landmark cases in several courts in India and overseas to enable the doctors to understand the importance of consent and yet be undeterred in their pursuit of profession without fear. Therefore, consent should as far as possible be documented clearly in writing from the patient and his/her spouse or blood relatives, friends in that order. If a written consent is not possible, then a verbal consent preferably on audio recording or video recording and adequate storing of the same in the digital format for posterity.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Law of Contracts and Specific Relief by Sh Avtar Singh.6th edition.  Back to cited text no. 1
    
2.
Thake vs. Maurice 1986, FAILED Sterilization case All ER 497 CA.  Back to cited text no. 2
    
3.
Indian Medical Council, Professional Conduct, Etiquette and Ethics Regulations 2002, published in Part III, Section 4 of Gazette of India, dated 6th Aril 2002, pages 3 to 5.  Back to cited text no. 3
    
4.
Indian J Urology 2009;25:343-7.  Back to cited text no. 4
    
5.
Indian J Urology 2009;25:372-8.  Back to cited text no. 5
    
6.
Real consent and not informed consent applicable in India by R K Aggrawal. Indian J Clin Pract 2014;25.  Back to cited text no. 6
    
7.
Consent and Medical Treatment: The Legal Paradigm in in India by Om Praksah v Nandimath PMC. 2009;25:343-7. doi: 10.4103/0970-1591.56202.  Back to cited text no. 7
    
8.
Informed consent in medical decision making in India by Rateesh Saree, Akanksha Dutt. J Coun Fam Ther 2019;1:30-7.  Back to cited text no. 8
    
9.
Consent in clinical practice. In Blythe vs Boolmsbury Health Authority 4 Med L Rev 1993;15:40.  Back to cited text no. 9
    
10.
Subramani S. Patient autonomy within real or valid consent: Samira Kohli's case. Indian J Med Ethics 2017;2:184-9.  Back to cited text no. 10
    
11.
Kumar A, Mullick P, Prakash S. Consent and the Indian medical practitioner by - Indian J Anaesth 2015;59:695-700.  Back to cited text no. 11
    
12.
Uniform consent form for Interventional Pain Procedures: Indian Journal of Pain. Document number ISSP/Consent/2018 page nos 1-5.  Back to cited text no. 12
    

Top
Correspondence Address:
Pankaj N Surange,
IPSC India Chain of Single Speciality Hospitals, Dwarka, New Delhi 110 045
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jrap.jrap_14_20



    Figures

  [Figure 1], [Figure 2]



 

Top
 
  Search
 
   Ahead Of Print
  
 Article in PDF
     Search Pubmed for
 
    -  Bhat S
    -  Bichal PK
    -  S Prasad K S
    -  Jyotinagar HP
    -  Surange PN


Types of Consent
True Consent
Informed Consent...
Difficulties in ...
Conclusion
Informed Consent...
References
Article Figures

 Article Access Statistics
    Viewed411    
    PDF Downloaded11    

Recommend this journal