Informed consent

Informed Consent
o It is both a process and paperwork
o Informed consent begins after the doctor has gathered all necessary
information and has determined the necessary intervention
o The doctor must give the information he or she knows that may play a role in
the patients decision about his or her health or health care choices
Although informed consent for clinical treatment has become a vital part of
contemporary medical practice, it means different things in different contexts is
variably practised and rarely achieves the theoretical ideal. In this review, we focus on
the clinical practice of informed consent.

Although we had hoped to identify high-quality studies that would provide a strong
quantitative base of evidence for recommendations around informed consent, much
of the quantitative literature on this topic is descriptive in nature. Informed consent is
primarily a legal and ethical concept; although often informed by data, the standards
of scholarship in law and ethics focus on the strength of analytical argument rather
than the weight of empirical data. Therefore, we sought to synthesize the available
knowledge on this subject, referencing empirical data when possible, summarizing
relevant arguments that are particularly prevalent, persuasive or insightful.
What is the purpose of informed consent?
Informed consent has become the primary paradigm for protecting the legal rights of
patients and guiding the ethical practice of medicine. It may be used for different
purposes in different contexts: legal, ethical or administrative (Figure ). Although these
purposes overlap, they are not identical, thus leading to different standards and
criteria for what constitutes “adequate” informed consent.
• Prospective Subject Will ..
 Understand nature of research
 Be informed of purpose, risks, and benefits, and alternative therapies
 Make a Voluntary Decision about Participation
Legal
 Although the concept of consent is rooted in ancient legal and philosophical
precepts, the modern legal precedent for “simple” consent was written in
1914, establishing a patient’s “right to determine what shall be done with his
body.”
 The further obligation for physicians to disclose details about treatment in a
process of informed consent did not emerge until the 1950s, when courts first
required physicians to disclose information customarily disclosed by

experienced clinicians (e.g., the reasonable physician standard). It was not until
1975 that American courts articulated the reasonable person standard, which
required that physicians disclose the information that a “reasonable person”
would want to know in a similar situation.
 Regardless of the standard used, informed consent is further predicated on the
patient’s or surrogate’s capacity to make decisions — not only should the
decision-maker understand the relevant information, he or she should also be
able to appreciate the information’s importance and use it to weigh treatment
options in light of their values.
 Legally, simple consent protects patients against assault and battery in the form
of unwanted medical interventions. The higher standard of informed consent
further safeguards patients’ rights to autonomy, self-determination and
inviolability.However, the legal standards that apply to obtaining informed
consent vary across jurisdictions, and their interpretation continues to evolve.
 Some jurisdictions use the reasonable person standard, whereas others
continue to use the older standard of the reasonable physician.
 Therefore, it is important for clinicians to determine the precise standard used
in their jurisdiction and to adapt their practice accordingly.
 The Canadian Medical Protective Association provides detailed information on
Canadian standards (www.cmpa-acpm.ca). Even when the standard is clear,
interpretation is required to apply the standard to a particular case; thus, most
litigation regarding informed consent focuses on precisely what information
satisfies the applicable standard.
 Fortunately, in most cases, legal interpretation is pragmatic; evidence of a
good-faith effort to inform is usually found to be adequate.
Ethical
The ethical purpose of informed consent is somewhat more abstract and ideological,
seeking to respect patient autonomy by ensuring that treatment is directed toward

the ends desired and is chosen by the patient. In this context, informed consent is
intended to shift the ethical paradigm for decision-making away from physician-
centred models to more patient-centred approaches. The ethics literature regarding
informed consent also emphasizes that it is not an event, but a process that precedes
the “signing” of the document and continues for as long as the choice remains
relevant. Thus, the consent to undergo dialysis or continue with chemotherapy is
continually re-evaluated (and may change). The consent form should not be confused
with the consent process; the form merely documents that the process has occurred.
Importantly, other parts of the patient record (e.g., clinic and/or operative notes)
should corroborate details of the process.
Administrative
For the sake of compliance, the informed consent document serves the administrative
purpose of a systems-level check to ensure that a consent process has occurred.
Patients simply do not advance to the operating room, for example, without a signed
consent form. Unfortunately, pressures for efficient workflow may shift the focus of the
informed consent process from robust conversation to the mere requirement of
getting a signature.
Although legal and ethical debate persists, most stakeholders in the informed consent
process agree on at least four basic elements for discussions of informed consent: the
decision-maker (i.e., the patient or a surrogate) should have the capacity to make
decisions; the physician should disclose sufficient details for the decision-maker to
make an informed choice; the decision-maker should show his or her understanding
of the disclosed information; and the decision-maker should freely authorize the
treatment plan.
In current clinical practice, these four elements translate into five components that
should be included in a discussion seeking to obtain informed consent: the diagnosis,
the proposed treatment, the attendant risks and benefits of the treatment, alternative

treatments and their risks and benefits, and the risks and benefits of declining
treatment.

INFORMED CONSENT ELEMENTS
There are 5 important elements of the informed consent process:
1. Diagnosis/Clinical Impression Patient wants to know:
“What is wrong with me?” This must be given in understandable terms
2. Treatment/Intervention
The patient wants to know
3. Risks or complications associated with the treatment or with the diagnosis
In some states, you are required to explain in writing
For example, you must give lifting restrictions to a patient with an acute disc
herniation
4. Alternative treatments, concurrent treatments, or additional diagnostic procedures
This is the time to tell the patient if more treatments or tests are needed (either within
or outside of your office)
5. Successes and Failures
The patient wants to know: “What is my prognosis?”
This information is based upon personal experiences of the doctor, literature,
research, classroom knowledge

TWO RULES
Additionally, there are two rules associated with informed consent that you should be
aware of:
 The Doctor’s Rule
 The Patient’s Rule
The Doctor’s Rule
In ALL states, the Doctor’s Rule applies: The doctor determines what information is
important to deliver to the patient. Example: Kidney stone
The Patient’s Rule
In SOME states, the Patient’s Rule applies:
 The doctor must give any and all information to the patient in order for him or
her to make an informed decision about his or her health care options
 Example: Kidney stone
 It is not a rule that the patient must tell the doctor everything about the
complaint

Conclusion
Having emerged from multiple disciplines,research concerning informed consent
does not afford sufficient clarity or consensus regarding the purposes this process
serves or the standards by which it should be judged. Our pragmatic suggestions
aim to facilitate — and document — a good-faith effort to involve patients in
medical decisions to whatever degree they are interested and able. Such practice
complies with the ethical spirit of informed consent and should minimize legal
conflict by fostering a deep and nuanced respect for patients.
Key points
Informed consent means different things in different contexts, is variably practised
and rarely achieves the theoretical ideal.
Simple consent entails that a patient (or surrogate) with decision-making capacity
freely authorizes a treatment plan aimed at a mutually acknowledged treatment
goal.

The authorization is “informed” when the physician discloses and the patient
understands the diagnosis, the relevant options for treatment (including no
treatment) and any respective risks and benefits.
The informed consent process should be documented thoroughly, using an
electronic medical record, procedure-specific consent forms, patient education
materials and other options whenever possible.

Patient Consent
CONSENT
 Consent refers to the provision of approval or agreement, particularly and
especially after thoughtful consideration and understanding
 As per jurisprudence prior provision of consent signifies a possible defense
(justification) against civil or criminal liability by the doctor.
 Practitioners who use this defense claim that they should not be held liable
for a tort or a crime, as the consequence in question occurred with the
prior consent and permission of the patient without realising whether it is a
commission or an omission and the extent of negligence.
MEDICAL CONSENT
 Consent is one of the critical issues in the area of medical treatment.
 The earliest expression of this fundamental principle, based on autonomy, is
found in the Nuremberg Code of 1947.
 The Nuremberg Code was adopted immediately after World War II in response
to medical and experimental atrocities committed by the German Nazi regime
 The code makes it mandatory to obtain voluntary and informed consent of
human subjects.
 Medical Council of India (MCI) has laid down guidelines that are issued as
regulations in which consent is required to be taken in writing before
performing an operation.
 The MCI guidelines are applicableto operations and not cover to the extent
other treatments or procedures
 These are covered under Implied and expressed consent

 Consent is perhaps the only principle that runs through all aspects of health
care provisions today.
 It also represents the legal and ethical expression of the basic right to have
ones autonomy and self-determination.
 If a medical practitioner attempts to treat a person without valid consent, then
he will be liable under both tort and criminal law
 Patient must give valid consent to medical treatment; and it is his prerogative
to refuse treatment even if the said treatment will save his or her life.
LAW AND MEDICAL CONSENT
 The rights (autonomy) of the patient have deeply eroded the old model of
doctor-patient relationship.“Doctorsare no more Gods.
 There have been significant changes in the doctor patient relationship with the
advancement of technology in day-to-day practice.
 More and more patients are becoming aware of their rights and are keen to
make free choice and decision on their treatment.
 This helps them to choose the treatment of their choice from the options
available and to select a physician of their choice
 Informed consent was practically non-existent till the time COPRA (Consumer
Protection Act) came into existence.
 This is seen as more of a legal requirement than an ethical moral obligation on
part of the doctor towards his patient.
 The patient has now the ability to select or dismiss their doctors and to choose
the treatment of their choice from the options available.
 Important aspect of several Medical Consumer litigations is improper consent .
CONSENT AND MEDICAL PRACTICE

 There exists a duty to obtain prior consent (with respect to living patients) for
the purpose of diagnosis, treatment, organ transplant, research purposes,
disclosure of medical records, and teaching and medico-legal purposes.
 With respect to the dead with regard to pathologicalautopsy, organ transplant
(for legal heirs), and for disclosure of medical record, it is important that prior
informed consent of the patient, or relative is obtained after death.
 The HippocraticOath prevalent for centuries has granted doctors the right to
decide in the best interest of the Patient. But the same has been conflicted with
the trend of twentieth century right of “freedom to control health aswell as
avoiding non-consensual medical treatment.”
 Clinical ethics teaches physicians, a wide range ofspecific ethical issues.
o Informed consent, truth telling,
o End-of-life decisions,
o Advance directives (substitute decision making for incompetent patients)
o Emergency consent

1.INFORMED CONSENT:
 It is defined as voluntary acceptance after full understanding, by a competent
patient , of a plan for medical care after physician adequately discloses the
proposed plan, its risks and benefits, and alternative approaches.
 The decision-making capacity is free from coercion or manipulation by the
patient/doctor
COMPONENTS :
Informed consent must contain four vital components:-
 Mental capacity of the patient to enter into a contract (This also includes his
ability to understand information given)
 Complete Information to be provided by doctor
 Voluntary acceptance of the procedure by the patient
 Should be person and the procedure specific
CONTENTS OF THE CONSENT:
 Condition (Disease) of the patient
 Purpose and Nature of intervention
 Consequences of such intervention
 Any alternatives available
 Risks involved
 Prognosis in the absence of intervention
 The immediate and future cost
The knowledge regarding the intervention should bein an understandable language
and format so that decision in the form of authorization by patient can be made.
ELIGIBILITY FOR CONSENT:
 Age,

 Soundness of mind,
 Ability to understand
 Remember the information given,
 Ability to deliberate and decide the treatment choices,
 Believes that the information applies to the said patient and specific purpose.
2. EXPRESSED CONSENT:
 It may be oral or in writing.
 Though both these categories of consents are of equal value, written
consent can be considered as superior because of its evidential value.
Oral;
 Oral consent should be taken in the presence of uninterested third party
 Mainly in cases where intimate examination of female is required.
 Tests necessitating removal of body fluids, radiological examination can be
done after securing oral consent.
Written:
 It is advisable to take written consent in the presence of disinterested third
party (this third party is only to attest the signature of the patient).
 Consent should be taken in the patients own language.
 Written consent is mandatory in every invasive diagnostic/ therapeutic
procedures or any medico legal examination.
3. IMPLIED CONSENT:
 Implied consent may be implied by patients conduct.
 So it is basicallythe conduct of the patient when he comes tothe doctor
for examination / treatment.
 Doctor should remember that this is only for routine examination as well
as treatment.

 This does not extend to the performance of intimate examination or
diagnostic procedures.
 If there is slightest chance of any complication express consent should
be taken
4. TACIT CONSENT:
Tacit consent means implied consent understood without being stated.
Usually the way a patient present him self for treatment imply consent.
5.SURROGATE CONSENT:
 This consent is given by family members for minors or dead.
 Generally, courts have held that consent of family members with the written
approval of 2 physicians sufficiently protects a patients interest.
6. ADVANCE CONSENT :
 It is the consent given by patient in advance before death
7. PROXY CONSENT :
 It indicates consent given by an authorized person before or after death.
 If an unconscious patient brought by police from road and operation
essential to save life 2 or 3 doctors to give consent by signing on consent
form, preferably along with police.
 Informed consent obtained after explaining all possible risks and side
effects is superior to all other forms of consent and legally defensive.

WHO CAN GIVE CONSENT
 Simple medical examination the minimum age of consent is 12 years.
 For consenting to have any major diagnostic or therapeutic procedure or
surgery the age is above 18 years (I.P.C. Sections 87-93).
 The patient should be mentally sound and he/she should not be under any fear
or threat or any false conception.
 The patient should not be intoxicated or sedated.
 Incomplete information about the patients diagnosis, therapeutic plan etc. is a
commission than misconception of omission.
CONSENT REQUIRED

i) Some body else other than the “patient” wants him to be medically
examined and a medical certificate to be issued (employers,),
ii) Consent of the concerned person must be obtained otherwise the doctor
runs the risk of liability to pay damages. Such as:-
a. Issuing certificate involving complicated process of examination or
infertility in women.
b. When the process is likely to affect the physical ormental well being of
the patient e.g financial loss,
c. damage to reputation, social status (STD, HIV etc.).
d. Procedures violating rights of spouse is in cases such as Sterilisation,
artificial insemination.
Even after the consent is taken the examination should be done in presence of third
person (nurse ,Female attendant) while examining a female patient.

Informed consent

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