Who Can Give Consent?
A person who has capacity and competence can consent to
his/her treatment. A person is said to have ‘capacity’ when he/she can
understand the necessary information, retain that information, use it for
decision making and communicate the decision by appropriate means(8). It
also depends on what is being consented; more the risk of the treatment
offered, greater the capacity required to understand and comprehend(9).
Various tools and tests of competence to consent have been designed.
MacArthur Competence Assessment Tool-Treatment (MacCAT-T) Scale assesses
patient’s competence in terms of: understanding the information, reasoning
the risks/benefits of their choice, consequences of their choice and
expression of their choice(10). The process of informed consent should be
voluntary, without coercion.
There are fixed guidelines outlining the exact age of
consent for medical or surgical treatment. In India, ‘majority’ is
achieved at an age of 18 years and considered a legal age for giving a
valid consent for treatment as per Indian Majority Act, Guardian and Wards
Act, and Indian Contract Act(11). A child below 12 years (minor) cannot
give consent, and parents/guardian can consent for their medical/surgical
procedures(12). A child between 12-18 years can give consent only for
medical examination but not for any procedure(13).
For children who are orphans or unknown or street
children, the court is appointed as a guardian and any
procedures/treatment requires court per-mission(14). In case of emergency,
when parents/guardians are not available to consent, a person in charge of
the child like principal or school teacher can consent for medical
treatment (loco parentis)(15). A legal age of 18 years has been set
to consent for termination of pregnancy (MTP Act 1971), donation of blood
and donation of organs (Transplantation of Human Organ Act 1994)(11).
Role of Assent in Pediatric Practice
Healthcare of older children and adolescents is complex
as they are in the process of developing competence to participate in
decision making on their health. A child’s agreement to medical procedures
in circumstances where he or she is not legally authorized or lacks
sufficient understanding for giving consent competently is called
‘assent’. Children are considered to "assent" when they have sufficient
competence to understand the nature, risks, and benefits of a procedure,
but not enough competence to give fully informed consent(16).
It is considered by age of seven years, a child
develops competence to distinguish right from wrong and can assent to
treatment/procedure. A child of age 7-14 years is capable of understanding
the outcome of a procedure. However the age of seven has been challenged
by a study that indicated that a child of less than 9 years is not capable
to assent(17). Child’s assent primarily respects the autonomy and
rationality of children on their medical care(18). It involves creating
awareness on the nature of illness, explaining the nature and outcome of
the treatment/diagnosis offered, assessment of understanding and
willingness to accept the proposed treatment(18).
Who Should Obtain the Consent?
Ideally, consent may be obtained by a person who is
capable of communicating all the necessary information required to make a
decision regarding their health care. The physician rendering the care may
obtain the consent himself(19). It remains unclear whether a house
surgeon/intern can obtain an informed consent(20). Staff nurses or other
health care providers are not entitled to obtain the consent although they
can bridge the communication gap between the physician and the patient. In
case where the patient is treated in a hospital, failure to obtain consent
has implication on both the employee (doctor) and employer (hospital)
[theory of respondent superior](21).
Perception of Informed Consent in Society
The process of informed consent is acknowledged by
majority of parents as an essential step toward their child’s,
healthcare(22). Parents consider it a legal document to agreement of
treatment/procedure and a document which would protect the physician
against future litigations, rather than providing with relevant
information about the procedure(23).Majority of patients in a study felt
the informed consent form was meant to remove the responsibility of the
doctor in case of untoward incident(24). 90% of patients had filled the
form in fear, anxiety and insecurity(24). Parents at the time of consent
are distressed with seriousness of their child mixed with a sense of
responsibility towards the child, making them vulnerable to consent(25).
The gap between parents and the physician results from
lack of effective communication skills, empathy, time and patience, and
ignorance about the risks and side effects among the physicians. This
emerges from the lack of training in medical ethics in undergraduate and
postgraduate curriculum(26). In a survey conducted on attitude of doctors
towards medical ethics, it was observed that only one third of the
respondents had knowledge of code of medical ethics(27).
The information conveyed to the parents would depend
upon the intelligence of the parents, educational status,
religious/cultural/beliefs, and family/peer pressures. Majority of the
parents in a study did not understand the nature of
treatment/procedure(28). In another study, parents preferred the decision
to be left to the physician(29). It has been observed that older, less
educated and poor patients have lesser recall of information provided to
them while consenting to treatment(30). This study also outlined the fact
that Indian patients can under-stand the treatment options, if explained
properly and the excuse that the patient was illiterate and could not
understand the process being explained is unethical(30).
Poor patients from the lower socio-economic strata
seeking medical treatment in public hospitals in India face a
unsatisfactory medical environment in the form of non-availability of
beds, lack of quality care, and lack of opportunity to interact with
health professionals, doctor. The resident doctors working in such
hospitals have to work with limited resources and infrastructure, lack of
time, and prolonged working hours. How many doctors are able to obtain a
proper informed consent before initiation of treatment in such a medical
framework remains to be elucidated.
Private centers, on the other hand, rely on effective
communication with the patient regarding the diagnosis and possible
outcome of treatment, due to lesser patient load and more resources. Does
that mean that private doctors take a proper, valid, informed consent? To
the best of our knowledge, there are no Indian studies which outline the
difference in the valid consents taken at government and private
hospitals. However, it is clear that the law applies equally to both of
Legal Implications of Informed Consent
Treating a patient without consent constitutes a
‘battery’, and failure of adequate disclosure amounts to ‘negligence.’
Framework under which patient can obtain redressal for their injuries
resulting from treatment administered in absence of informed consent
include criminal penal code (IPC-Indian Penal Code), Medical Council Act,
and Consumer Protection Act (COPRA). As per the Indian Contract Act, if
one party to the contract is misled or has entered into it in a different
sense to that in which it ought to have been understood, then it would not
be construed as a valid contract. Under the Indian Penal Code (IPC) 1860,
Section 89 stipulates that an act done in good faith for benefit of a
person under 12 years of age by consent, either express or implied, by the
guardian or other person having lawful charge is not an offence by reason
of any harm. This exception is not available if there is an intention to
cause death or grievous hurt(12). In emergency situations, where there are
no guardians/parents from whom it is possible to obtain consent, one can
proceed to save the life of the child (Section 92 IPC)(12).
Medical Council of India (MCI) considers failure to
obtain consent (from the parents/guardian in case of minors) prior to
surgical treatment as "misconduct". The code of misconduct can render
him/her liable for disciplinary action. If the practioner is found guilty,
the Council may award the punishment as necessary and may direct the
removal of their name altogether/temporarily from the register, and this
is widely publicized in local press and in the publications of different
medical association/society/bodies. Main flaw with the clause concerning
consent for medical procedure and treatment is that, there is no provision
for patients to approach the council directly or for claiming any
Of the existing approaches, the most cost-effective,
patient friendly forum is through the COPRA, which aims to settle the
consumer’s dispute in a fast and cheap way(32). COPRA has emerged as
weapon against unlawful medical practices in India and happens to be only
social forum for the patients who are subjected to unethical medical
practices. A main drawback with COPRA is that it has no provision to
punish people who file unnecessary and false cases against the doctors.
Hence, a screening committee was suggested to screen the cases that need
to be heard in the forum. Another disadvantage of the forum is that it
does not consist of any medical professional in the panel. Doctors who are
working in a hospital that is rendering absolutely free of cost treatment
for their patients are excluded from the Act(33).
Dealing With Refusal to Consent
When the parents/guardian refuse to undergo the desired
diagnostic procedure/treatment after a complete and comprehensive
information has been provided, they should be informed in a discreet
professional manner of consequences of refusal, failing which the
physician can be held liable in the court of law. The conflict of ‘best
interest standards’ for treatment of the child versus ‘rational
parent standard’ for the attitude of parents is matter of never ending
In the absence of an emergency, it is generally agreed
that parents have a right to refuse treatment. However, it remains
unsettled as to what should a physician do when a part of medical
treatment is refused. For example, if the parents refuse for a lumbar
puncture in a child with suspected meningitis, but consent to all other
blood investigations and treatment. No court of law can protect the
physician from litigations if he denies treatment on such grounds.
However, in children with life threatening illness or other serious or
chronic medical condition, informed refusal can amount to ‘medical
neglect’, which is included as a form of child maltreatment or child abuse
in USA(35). However, Indian laws are silent on this aspect (36). Informed
refusal must be dealt by the physician with persuasion, education and
removal of obstacles to expression of underlying values. Court
intervention may be sought when parents refuse treatment, which the health
care professionals deem essential; however, post treatment rehabilitation
needs to be offered to improve parent-child relationship(37).
Improving the process of Informed Consent?
Books/illustrations/videos: The contents of
consent form can be augmented with audio-visual interventions like
booklets/illustrations/video clips(38). However, a recent Cochrane review
on role of audio visual interventions in clinical trial participation
revealed that there is no conclusive evidence that it improves the
patient’s understanding /knowledge, at least in the long term(39).
Communication/oral disclosure: Parents expect the
treating physician to speak in a honest, clear, unambiguous manner with
clarity of information and at same time giving plenty of space and
opportunity to answer their questions(40). It may be prudent to record the
nature and content of the conversation with the parents and their response
in the medical record with time and date. Understanding of the ailment and
desired outcome may be ensured before the parents place a signature in the
Making consent forms simple: A consent form in
developed nations is expected to be readable by 8th
grade level, but there are no guidelines developed in India(38). It was
observed that the consent form given to the parents often has plenty of
tough medical terminology and often is not legible and scribbled in a poor
handwriting(26,41). The consent forms need to be comprehensible and
written/typed legibly. It would be advisable to use short sentences with
simple vocabulary and use of non-medical terminology as far as possible.
The consent forms written in patient’s own language might improve the
comprehension and understanding(42). In cases where the same language is
not possible, a good interpreter should be provided. The consent form
should be signed by all parties concerned
(parents/guardian/doctor/witness) to make it a valid document(43).
Third person witness: There is no conclusive
judgment mandating a witness by a uninterested third person while
consenting to medical treatment. However, it is realized that importance
of third person witness improves, especially when the consenting parents
are illiterate and have consented by placing a thumb impression(43).
Anticipatory guidance: Nursing staff that has been
trained in a particular specialty can educate, empathize and prepare the
parents before the anticipated formal meeting of physician and parents.
This may improve the communication between the physician and parents and
remove the fears and barrier pertaining to the desired
Informed consent as process: Obtaining an informed
consent must be considered a process rather than a point which ends once
the patient signs the consent forms. It is a continuous two way
communication and must proceed as frequently as possible during the entire
treatment of the patient. It may also be accomplished by giving a copy of
consent form to the parents so that they can read them carefully at home
and might clarify any further queries in the next visit. It was observed
that problems in competence and understanding reduced markedly in the post
signature phase when further discussion took place(22). In a study
evaluating the process of informed consent in pediatric oncology patients,
it was observed that about 90% of the parents felt the need for a written
Waiver of consent: An attitude of the
parents/guardian, where they wish not to have information that might
unduly distress them, and leave the decision on the physician must be
honored and this is called ‘waiver of consent’. Indian patients who are
poor, underprivileged, with low education levels have blind faith in the
doctors and believe the best of treatment will be offered to their child.
Such waiver of consent should be documented in medical records, and
preferably should be in the form of signed proforma.
It is the physician’s responsibility to decide for the
need of the proposed investigation or treatment and to explain the parents
about it. Four basic elements of an informed consent should include the
nature of the procedure, the risks, the benefits, and the available
alternative treatments. As the doctrine is of recent origin, guidelines
have yet not been developed by the court and are evolving slowly. Explicit
standards that delineate specifically which procedures
require consent may be required to assure more uniform practices.
Therefore, each institute/centre must make its own written consent form
for common procedures and treatment.
Contributors: JK and NA: Literature searches,
writing of the manuscript. MN: conceptualized the idea and approved the
final version. JK would act as the guarantor.
Competing interest: None stated.
• Best interests of the child must be borne to
assess potential harms, benefits while making decisions.
• An informed permission of parents is essential
for an informed consent.
• Assent of child must be taken when possible.
• A copy of the consent form should be given to the parents.
1. Berkowitz KA, Foglia MB, Chanko BL. Informed
consent. Chest 2004; 125: 2367-2368.
2. Kohli S. Medical negligence. Accessed from: http://www.indiastudychannel.com/resources/40644-Samira-Kohli-Medical-Negligence.aspx.
Accessed on 31 January, 2010.
3. Barton A. Consent to medical treatment. In:
Paynejames J, Dean P, Wall J, editor. Medico legal Essentials in
Healthcare. New York: Churchill livingstone; 1996. p. 37-47.
4. Mantous CA. Informed consent. Chest 2004; 125:
5. Jesani A. About student research and blanket consent
from patients. Ind J Med Ethics 2009; 6(4). Accessed from: http://www.issuesinmedicalethics.
org/174ec216.html. Accessed on 05 March, 2010.
6. DMC/DC/14/2/Comp.504/2009. Order. Accessed from
www.delhimedicalcouncil.nic.in/order/order504.doc. Accessed on 31
7. Consent. Accessed from: http//www.lawyerscollective.org/hiv-aidsactivities/advocacyissue.htm.
Accessed on 24 January, 2010.
8. Jacob R, Chowdury AN. Assessment of mental capacity
in patients recruited in clinical trials in psychiatry and its
relationship to informed consent. Indian J Med Ethics 2009; Jan-Mar; 6.
Accessed from http://www.issuesinmedicalethics.org/171re43. Accessed on 5
9. Buchanan A. Mental capacity, legal competence and
consent to treatment. J R Soc Med 2004; 97: 415-420.
10. Grisso T, Appelbaum PS. The MacCAT-T: A clinical
tool to assess patients’ capacities to make treatment decisions.
Psychiatric Services 1997; 48: 1415-1419.
11. Yadav M. Age of consent in medical profession: A
food for thought. J Indian Academy Forensic Med 2007; 29. Accessed from:
Accessed on 5 March, 2010.
12. Indian Penal Code Section. Accessed from:
http://www. Vakilno1.com/bareacts/Indian penal code. Accessed on 1
13. Sharma RK. Consent. In: Sharma RK, editor. Legal
aspects of patient care. New Delhi: Modern publishers; 2000: 3-6.
14. Guardians and Ward Act 1890. Accessed from:
http://www. Vakilno1.com/bareacts/guardians and ward act/guardianwardsact.htm.
Accessed on 1 December, 2009.
15. Sobti PC, Biswas G, Sobti BS. Medicolegal issues in
adolescent health care. In: Bhave SY. Bhave’s Textbook of Adolescent
Medicine. Jaypee Brothers. New Delhi 2006. p. 42-59.
16. Foreman DM. The family rule: a framework for
obtaining ethical consent for medical interventions from children. J Med
Ethics 1999; 25: 491-496.
17. Ondrusek N, Abramovitch R, Pencharz P, Koren G.
Empirical examination of the ability of children to consent to clinical
research. J Med Ethics 1998; 24: 158-165.
18. Committee on Bioethics. Informed Consent, Parental
Permission, and Assent in Pediatric Practice. Pediatrics 1995; 95:
19. Bianco EA, Hirsh HL. Consent to and refusal to
medical treatment. In: Sanbar SS, Firestone MH, Fiscina S, Leblang TR,
Wecht CH, Zaremski MJ. Eds. Legal Medicine. American College of Legal
Medicine Textbook Committee. Philadelphia: Elsevier publications; 2007. P.
20. Singh D. Informed vs valid consent:
legislation and responsibilities. Ind J Neurotrauma 2008; 2: 105-108.
21. BS Yadwad, H Gouda. Consent - Its medico legal
aspects. J Assoc Physcians India 2005; 53: 891-894.
22. Allmark P, Mason S. Improving the quality of
consent to randomised controlled trials by using continuous consent and
clinician training in the consent process. J Med Ethics 2006; 32: 439–443.
23. Bottrell MM, Alpert H, Fischbach RL, Emanuel LL.
Hospital informed consent for procedure forms. Arch Surg 2000; 135: 26-33.
24. Sachdeva A. Gupta S, Soni A, Kumar R, Gupta D,
Raina A, and Pruthi PK. Evaluation of Informed Consent (IC). Presented at
SIOP XXXIV meeting Medical and Pediatric Oncology 2002; 39: 262.
25. Shilling B, Young B. How do parents experience
being asked to enter a child in a randomised controlled trial? BMC
Medical Ethics 2009, 10: 1.
26. Kalantri SP. Informed consent in public hospitals.
Ind J Med Ethics 2000; 8: 21-27. Accessed from: http://www.issuesinmedicalethics.org/084
di116.html. Accessed on 5 March, 2010.
27. Knowledge and attitudes of doctors on medical
ethics in a teaching hospital, Manipur. Indian J Med Ethics. 2009; 6.
Accessed from: http://www.issuesinmedicalethics.org/174ar194.html.
Accessed on 31 January, 2010.
28. Cassileth BR, Zupkis RV, Sutton-smith K, March V.
Informed consent- why are goals imperfectly realized. N Engl J Med 1980;
29. Patrick JD, Dawes BS. Informed consent: what
patients want to know? J Roy Soc Med 1994; 87: 149.
30. Sanwal AK, Kumar S, Sahni P, Nundy S. Informed
consent in Indian patients. J R Soc Med 1996; 89: 196-198.
31. Code of medical ethics, professional conduct,
etiquettes, ethics regulation. Medical Council of India Act 1992.
32. Pandit MS, Pandit S. Medical negligence: criminal
prosecution of medical professionals, importance of medical evidence: some
guidelines for medical practioners. Indian J Urol 2009; 25: 379-383.
33. Bhat R. Regulating the private health sector: the
case of the Indian consumer protection act. Health Policy and Planning
34. Cooper R, Koch KA. Neonatal and pediatric critical
care: ethical decision making. Crit Care Clin 1996; 12:149-164.
35. Sirotnak AP, Krugman RD. Child abuse and neglect.
In: Hay WW, Levin MJ, Sondheimer JM, Deterding RR (eds). Current
Pediatric Diagnosis and Treatment. 18th
edn. Philadelphia: Lange publication; 2003. P. 219-224.
36. Mehta MN. Child abuse and neglect. In:
Parthasarathy A. IAP Textbook of Pediatrics. New Delhi: Jaypee
Publication; 2006. p 952-959.
37. Spinetta JJ, Masera G, Jankovic M, Oppenheim D,
Martins AG, Arush MWB, et al. Valid informed consent and
participative decision-making in children with cancer and their parents: A
report of the SIOP Working Committee on Psychosocial Issues in Pediatric
Oncology. Med Pediatr Oncol 2003; 40: 244–246.
38. Woodsong C, Karim QA. A model designed to enhance
informed consent: Experiences from the HIV prevention trials network. Am J
Public Health 2005; 95: 412-419.
39. Ryan R, Prictor M, McLaughlin KJ, Hill S.
Audio-visual presentation of information for informed consent for
participation in clinical trials. Cochrane Database of Systematic Reviews
2008, Issue 1. Art No: CD003717.DOI:10.1002/14651858. CD003717. pub2.
40. Eder ML, Yamokoski AD, Wittmann PW, Kodish ED.
Improving informed consent: Suggestions from parents of children with
leukemia. Pediatrics 2007; 119; e849-e859.
41. Pape T. Legal and ethical considerations of
informed consent. AORN J 1997; 65: 1122-1127.
42. Bastia BK. Consent to treatment: practice
vis-à-vis principle. Indian J Med Ethics 2008; 5. Accessed from:
http://www.issuesinmedicalethics.org/163ar 113.html. Accessed on 31
43. Taylor HA. Barriers to informed consent. Semin
Oncol Nurs 1999; 15: 89-95.
44. Moazam F. Comment on " Consent to treatment:
practice vis-à-vis principle " by BK Bastia. Indian J Med Ethics 2008; 5.
Accessed from: http://www.issuesinmedicalethics.org/issue163.html.
Assessed on 28 January, 2010.