c h a p t e r

10
INFORMED CONSENT

LEARNING OBJECTIVES

1.  Definition, meaning and important prin-
ciples of informed consent
2.  Types, elements and barriers of informed
consent
3. Contents, purpose and areas requiring
informed consent
4. Criteria of getting informed consent in
conducting research on human subjects
5. Principles involved and the different
forms of informed consent
6.  Role of a nurse in getting the informed
consent

10.1 INTRODUCTION
Informed consent is an important legal document that a patient has to sign before any invasive pro-
cedure is done on the patient. It is the duty of the nurse to inform the patient about the details of the
procedure and the benefits and risks associated with it and then obtain the informed consent. In many
hospitals, nurses order the patient or his/her relatives to sign the informed consent without giving
adequate explanation about the procedure to be done on the patient. The patient will be anxious and
feel insecure about the prognosis of his/her illness. As the fear and anxiety is high, the patient many
not provide full cooperation for the procedure.

10.2 DEFINITION
1. It is defined as a legal document that includes details of invasive procedure to be done on the
patient and the risks and benefits of the procedure and states that the contents of the informed
consent have been read and clearly understood by the patient before obtaining his/her signature
with date and time.

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2. It is a permission obtained from the concerned patient in order to perform specific tests. It is a
legal document that is clearly written and is read and understood by the patient, with the patient’s
signature, date and time along with the signature of a family member or spouse as a witness.
3. It is an agreement by the patient, verbal or written, after being given sufficient details of the
possible risks in having a procedure performed.

10.3  IMPORTANT PRINCIPLES

There are seven important principles that define informed consent:
1. Competence to understand and to decide the matter
2. Voluntary decision-making by the person who gives consent
3. Disclosure of material information that is explained in consent
4. Recommendation of the plan in the consent
5. Comprehensions of terms and conditions in the consent
6. Explain the risk and benefits in the content of the informed consent
7. Explain the risk and benefits in the content of the informed consent
A valid and legal informed consent must meet all these requirements.

10.4  MEANING OF INFORMED CONSENT

1. Informed consent is a legal procedure to ensure that the patient or client knows and understands
all the risks and costs involved in the treatment.
2. Informed consent is a phrase used in law to indicate that the consent a person gives meets cer-
tain minimum standards.
3. Informed consent is more than simply getting patient to sign a written consent form. It is a pro-
cess of communication between a patient and physician that results in the patient’s authorization
or agreement to undergo a specific medical intervention.

10.5  TYPES OF INFORMED CONSENT

Oral: Oral consent follows written consent.
Written: Printed legal document that contains the details of treatment, reason for the treatment, risks
and benefits of the treatment, and the agreement for the treatment by the patient.

10.6  ELEMENTS OF INFORMED CONSENT

The following are the elements of informed consent:
1. Information to the client about the nature of treatment
2. Possible alternative treatments
3. Potential risks involved
4. Benefits of the treatment

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5. Clear understanding by the patient

6. Given by mentally competent adult
7. Written document
8. Consent given by parent if patient is a child
Figure 10.1 shows the elements of informed consent.

Given by
Clear mentally
Information
understanding competent
by patient adult

Benefits of Alternative
Elements
treatment treatment

Consent by Potential
parent if Written
risks document
patient is child

Figure 10.1  Elements of informed consent

10.7  BARRIERS TO EFFECTIVE INFORMED CONSENT

There are many factors that affect or hinder the patient from signing the informed consent. They fol-
lowing are some of the barriers to effective informed consent:
1. Education level of the patient
2. Consciousness of the patient
3. Mental status of the patient (psychological status)
4. Religious beliefs
5. Language
6. Disability of the patient
7. Culture
8. Age
Education Level of the Patient: It is important for the nurse to know the educational status and the
level of knowledge of the patient, since the informed consent is written in a standard language. The
nurse should make sure that the patient has clearly gone through all the details of the informed con-
sent; if not, the nurse has to read it out to the patient and his/her spouse or family members.
Consciousness of the Patient: The nurse may find it difficult to get the informed consent signed in
certain situations. For example, if the patient gets admitted in a coma stage or with a head injury and

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loss of consciousness, he/she will not be able to sign the informed consent. In such cases, the patient’s
spouse or blood relative should be given clear explanation about the procedure and the signature on
the informed consent obtained from him/her.
Mental (Psychological) Status: The nurse needs to analyse the mental status of the patient and find
whether he/she is in a state of fear, anxiety, or depression and whether he/she can understand the
details in the informed consent. The nurse has to handle the situation accordingly; he/she should talk
to or console the patient and get his/her signature.
Religious Beliefs: Any document or paper will be signed only at a “good” time and place, according
to the believers of certain religious customs. The nurse should understand their beliefs, if present, but
should ensure that he/she gets the informed consent signed.
Language: This is a very important barrier as the patient may find it difficult to understand the stand-
ard language of the informed consent. The nurse should understand this problem and read the informed
consent to the patient and explain its contents clearly before getting the signature.
Disability of the Patient: If the patient is not able to see clearly the informed consent or if he/she is
visually impaired, the nurse must read the informed consent clearly and slowly to make sure that the
patient understands it before signing it.
Culture: The nurse should be aware of the different cultural practices in getting the informed consent,
such as prayer or worship of God before signing any legal document. If the presence of a spiritual
leader or priest is required, according to the patient’s religion, a nurse allows it along with neces-
sary religious rituals. The presence of the priest to chant the prayers for the patient’s well-being will
be taken as a token of respect by the patient and his/her family members. Presume of any picot is
required, which will be taken as a token of respect from patients of certain culture.
Age: If the patient is a child, he/she will not be able to understand the contents of the informed consent.
In such cases, the patient’s parent can sign the informed consent. Similarly, old patients may take time
in reading and understanding the language of the informed consent. Therefore, the nurse should antici-
pate all the factors and help the patient to clearly understand the contents of the informed consent.

10.8  CONTENTS OF INFORMED CONSENT

The following are the contents of an informed consent:
1. Identity of the patient—name, age, date, anthropometric measurements, phone and address of
the patients
2. Details about disease present in the body, specifying the parts of the body and describing the
location and site of discomfort
3. Past medical history—a list of illnesses suffered by the patient in the past one year
4. Past surgical history—history of any surgery performed in the past one year with details of the
hospitals and the surgeries
5. List of any allergies to medicines
6. Family history of any medical illness in the patient’s family members
7. Social history—marital status, number of children, habits such as smoking and alcoholism,
employment details and type of work

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8. Review of the system—details of head-to-foot physical examination by the physician on the patient
9. Certification by the doctor
10. Certification and declaration by the patient that he/she has understood the details of the proce-
dure and that the information given by the patient is true
11. Details about the proposed treatment or procedure
12. Benefits of the procedure and risks associated with it
13. Alternative treatments available
14. Signature of witness along with date and time

10.9  PURPOSE OF GETTING INFORMED CONSENT

The following are the purposes of getting an informed consent from the patient:
1. It is to provide adequate information about the procedures to be performed on or treatment to
be given to the patient. It is an act of respecting the patient’s right to information and allows the
patient to choose the treatment of his/her choice.
2. It helps to serve as a legal written document for the patient as well as health care providers.
3. Patients can take legal action if the informed consent is not signed or not given to them.
4. It helps to clear the fear and anxiety of the patient about the treatment and prognosis and men-
tally prepare him/her for the treatment.

10.10  AREAS REQUIRING INFORMED CONSENT

Whatever be the place of treatment, informed consent is a must as per law, especially in medico-legal
cases. It can be the outpatient department, inpatient department, or general ward of a hospital, nursing
home, medical college, primary health centre, sub-centre or any health institution. If a patient has to
undergo treatment or procedure that requires informed consent, it is the duty of the concerned health
care providers to get it signed by the patient.
Informed consent is necessary for any invasive procedure to be done on a patient for diagnostic or
therapeutic purposes. The following are the requirements or indications to get the informed consent
in a hospital:

Diagnostic
1. Lumbar fracture—for cerebrospinal fluid analysis
2. Thoracocentesis—for diagnostic and therapeutic purposes
3. Abdominal paracentesis
4. Incision and drainage of any cyst

Therapeutic
Informed consent is obtained before performing any surgery such as lower segment caesarean section
under spinal anaesthesia, explaining the risks of surgery, the side effects of anaesthesia on the mother
and child, the risks after surgery—blood may be required after surgery, and any advanced technique or

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technology that may be used to support the mother’s life. There are many interventions carried out by
use of advanced technology equipments such as heart and lung machines and ventilators. There may
arise a need for blood transfusion during or after surgery, which should be anticipated and informed
to the patient and his/her family in order to make arrangements to get the necessary blood pints.
Maintaining a therapeutic relationship with the patient and explaining the details of informed consent
are more important to avoid conflicts and confusion. Thus, therapeutic relationship has become an
important aspect in treating the patient.

10.11  INFORMED CONSENT IN RESEARCH

It is very important for all the researchers to inform the participants or subjects of their research
about the research, the benefits of the study, and the risks, if any, associated with it. The subject must
participate in the research with full willingness and must not be forced to do it. Informed consent is
a legal document that ensures that the subject signing it understands the details of the research before
agreeing to participate in the study.
Its contents include the following:
1. Information about the researcher—institution, designation, etc.
2. Details of the study—statement of the problem and the title and purpose of the study
3. Place of study, number of participants, and the benefits and possible risks to the participants
during the study
4. Details of interventions used in the study
5. Measures to overcome the risk, if any, to the participants during the study
6. Freedom of the participant to withdraw from the study at any time
7. Timeframe of the study—start time and end time
8. Details about provisions of confidentiality and privacy of the participant and it can be respect
for his/her dignity
9. Signature of researcher with date and time
10. Signature of the participant with date and time indicating willingness to participate in the study

10.12 CRITERIA TO GET INFORMED CONSENT FOR CONDUCTING

RESEARCH ON HUMAN SUBJECTS
The following are the criteria to get informed consent before conducting research on human subjects:
1. Get a formal written approval from the ethical committee of the health institution where the
researcher conducts the research before starting any research.
2. Get the approval of the ethical committee review board for any information that is later included/
updated in the informed consent.
3. Researcher should not force the subjects to provide the informed consent.
4. Complete details of the researcher and the role of the participants should be clearly provided
before getting the signature in the informed consent.

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5. The language used in the informed consent should be simple, clear, and easy to understand and
should be printed legibly so that the participant can clearly understand it before signing the
informed consent.
6. The researcher should provide adequate time for the participant to think about participation in
the research and give opportunity to check and clarify any doubts before deciding whether or
not to participate in the research.
7. If the participant is uneducated or is visually or hearing impaired, an impartial witness should be
arranged to explain the contents of the informed consent to the participant. It should be ensured that
the witness understands the details of the study clearly and assures the participant about the involve-
ment in the study. The informed consent must include the signature of the witness with date and time.
8. Brief explanation about the expected benefits, advantages, demerits, and risks involved should
be provided before getting the consent signed.
9. The participants are free to withdraw from the study at any time or at any stage of the study.
10. The patients should be informed that the results of the study will be communicated to them.
They should be given assurance on the confidentiality of their details and on their privacy and
respect of their dignity, before getting the informed consent signed.
The health team members who are involved in the provision of informed consent in research are
shown in Fig. 10.2. They are as follows:

Researcher Participant in Witness

Ethical the research
committee co-researcher
review board
members

Figure 10.2  Health team members involved in provision of informed consent in research

Members of Ethical Committee Review Board: These are the members who check the framework of
the informed consent, provide corrections, check the advantages and errors, and help the researcher to
frame a good valid informed consent.
Research and Co-researchers: These are the ones who conduct the research. To prepare the standard
informed consent, they should acquire knowledge by going through relevant literature.
Participants: These are the subjects who read the informed consent, understand its contents, and
decide to participate or refuse to participate in the study.
Witness: Witness is required if the participant has any disability such as visual or hearing impairment
or is ill and requires another person to read and understand the details of the research.
The following are the members involved in getting the informed consent in a hospital (see Fig. 10.3):
1. Patient/client
2. Nurse
3. Doctor
4. Witness—spouse or a close blood relative of the patient

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Doctor

Members involved in
Patient informed consent in the Nurse
hospital

Witness/spouse
/family
member

Figure 10.3  Members involved in getting informed consent in hospital

Patient: The patient/client is the most important person who should read and understand the contents of
the informed consent. He/she should have the opportunity to accept or refuse the treatment and should
be provided with all needed information by the nurse and the doctor before beginning any procedure.
Doctor: The medical authority should sign the declaration that all information regarding the disease
condition and treatment is correct. The consent should clearly state in simple language the advantages,
benefits, and risks associated with the procedure and the requirements fulfilled by the patient and his/
her family. The doctor should promise not to disclose the details of the consent to others and pledge that
the information given is true to his/her knowledge; if not, any legal attain can be taken by the patient.
Nurse: The nurse is the person who gets the informed consent signed by the patient. A patient feels
free to talk with the nurse rather than the doctor. The nurse should explain in a simple language the
details about the purpose of the informed consent, advantages of the treatment, and the risks involved.
Witness: A witness is mandatory in the case of a patient who is a minor or an orphan, or has visual or
hearing impairment. Even for normal patients, a witness is required for legal purposes. The following
patients are not capable of giving the consent:
Unconscious Patient: For example, a patient in the coma stage because of cerebrovascular accident.
Child: Patients below 18 years of age cannot understand the reason for the surgery. Hence, it is man-
datory to get the parent’s or guardian’s signature, especially for newborns, toddlers, preschoolers and
children in school-going age.
Mentally Upset Patient: A patient who is diagnosed with any neurotic or psychiatric illness cannot
understand the seriousness of the informed consent.
Confused Geriatric Patients:  Old patients who have been diagnosed with degenerative disorders of
brain such as Alzheimer’s disease, multiple sclerosis, myasthenia gravis, and dementia will not have
their insight, memory, and cognition skills intact. Therefore, they require witness signature for treat-
ment. Anyone of the following can serve as a witness and sign the informed consent:
(a) Parent of the child—mother or father; in case the child is an orphan, it can be the guardian
(b) Spouse of the patient—husband or wife
(c) Blood relative—son/daughter/grandfather/grandmother/father/mother/uncle/aunt

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10.13 PRINCIPLES INVOLVED IN FRAMING THE INFORMED

CONSENT
The following are the principles involved in framing the informed consent:
1. Informed consent should be specific and unique for each procedure; it should not be taken as a
common informed consent.
2. Any procedure that involves invasive or beyond-routine physical examination such as surgery,
blood transfusion, and collection of blood requires expressed consent by the patient.
3. Expressed consent is taken in advance for invasive procedures.
4. Separate specific consent should be taken for the administration of general anaesthesia used for
any surgery.
5. The nature of surgery should be clear, concise and precise.
6. The doctor who takes the informed consent should inform the patient about the reason for the
informed consent and also that the findings of the treatment will be included in the medical
report.
7. The nature of the informed consent should be clear, simple, direct, concise, free from ambiguous
contents, intelligently framed, and easy to understand for the patient.
8. In medico-legal cases such as criminal cases, rape, miscarriage or abortion, the patient should
not be examined without a written informed consent.
9. Only if the patient is above 18 years of age is he/she allowed to give the written consent to take
the risk of the operation, that is, the patient can give valid consent to suffer any harm that results
out of an act that is not intended to cause harm or death. For example, a patient suffering from
a disease that shortens the life can give consent to take the risk of the operation.
10. A patient below 12 years of age is not eligible to give valid consent to suffer from any harm that
may result from an act done in a good faith or for the patient’s benefit. In such a situation, the
parents or the guardian of the child should give the informed consent
11. A consent given by a patient who is mentally upset or diagnosed to be mentally ill will not be a
valid informed consent.
12. Any detail regarding the patient or the treatment should be not disclosed to third parties or
­others without the consent of the patient.
13. Joint informed consent is needed for certain procedures such as family planning. For example,
the signatures of both husband and wife are needed to perform tubectomy.
14. Consent given for committing a crime or an illegal act, such as criminal abortion, is not regarded
as valid.
15. The consent of one spouse is not necessary for an operation or treatment of the other. A husband
has no right to refuse consent to any operation, including a gynaecological operation, which is
required to safeguard the health of his wife. The consent of the wife is enough. It is advisable to
take the consent of the spouse whenever practicable, especially if the operation involves danger
to life, may destroy or limit sex functions, or may result in the death of an unborn child.
16. If the patient is an adult, he/she has the right to get discharged against the medical advice. This
is known as leaving against medical advice (LAMA). In such cases, the consent of the patient
is recorded and his/her signature is obtained.

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17. In the case of organ transplantation, the donor should give consent to donate the organ, for
example, kidney, to be grafted to the recipient. The donor must be informed about the procedure
and the risks involved must be explained.
18. If a person has donated his eyes to be used for therapeutic purpose after his death, the eyes can
be removed only after getting the consent of the concerned person’s spouse, family members, or
guardian.
19. In the case of organ transplantation, the anonymity of the donor and the recipient should be
maintained.
20. If any person has donated his body to be used for therapeutic or research purposes after his
death, the organs should not be removed without the consent of the person’s spouse, guardian,
or parent.
21. Informed consent for children in case of emergency situations where parents or guardians are
not available, for example, if the child is badly hurt during a school picnic, the school teacher
can give the informed consent. In residential schools, the headmaster can give the consent to
treat the child.
22. Adequate time should be given to the patient to give the consent. It should not be hurried nor
should it be delayed.

10.14  DIFFERENT FORMS OF INFORMED CONSENT

The following are the different forms of informed consent:
1. Informed consent for ordinary treatment or any procedure such as physical examination is taken
just before the procedure.
2. Expressed consent for specific invasive procedures such as surgery wherein the patient’s choice
to accept or reject the treatment is included is taken in advance.
3. For medico-legal cases, such as criminal cases, rape, sexual abuse of a child or adolescent
or abortion, a specific unique informed consent is obtained from the affected person or the
patient’s parent or guardian before starting any treatment on the patient.
4. Informed consent is taken for any specific procedure that might be of risk to the patient’s
life, such as general anaesthesia. The drug used to give anaesthesia might affect the life of
the patient; therefore, a separate consent is taken if the surgery involves the use of general
anaesthesia.
5. Informed consent for minor patients (children below 12 years of age) is given by the child’s
parent or guardian.
6. Informed consent for disabled patients, such as deaf, dumb, blind, unconscious, coma, or men-
tally ill, is given by the concerned patient’s spouse, parent or guardian.
7. Informed consent for geriatric clients with degenerative disease of the brain, such as myasthenia
gravis or dementia, is given by the patient’s spouse, parent or blood relative.
8. Informed consent for organ donation such as kidney and eye needs proper consent from the
donor as well as the donor’s parent or spouse.
9. Joint informed consent of the husband and wife is needed in the case of family planning proce-
dures such as tubectomy.

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10. Spouse’s consent is not necessary if the life of the patient is at risk; the patient’s consent alone
is enough. Spouse’s consent is taken if the procedure involves danger to life or affects or limits
sex function.
11. Situational informed consent in emergency in the case of minors below 12 years of age (school
children) is taken from school teachers. For example, school teachers can give the consent if
there is an emergency during situations such as a school picnic where the child has met with
an accident and needs treatment. In the case of residential schools, the headmaster can give the
consent to provide treatment to the child if there is an emergency.

10.15  ROLE OF NURSE IN GETTING INFORMED CONSENT SIGNED

A nurse is the first and most important contact for a patient and he/she plays different roles in getting
the informed consent signed by the patient as follows:
1. A nurse should recognize the purpose and need of the treatment and get the signature accordingly.
2. A nurse should read clearly the contents of the informed consent and explain it to the patient in
simple language.
3. If the patient has any doubts, a nurse should clear them by explaining the risks and benefits of
the treatment.
4. A nurse should explain the contents of the informed consent to the patient’s spouse, parent or
guardian to get the signature.
The different roles played by a nurse in getting the informed consent signed are shown in Fig. 10.4.

Caregiver role
Communicator Resource
role person role

Nurse-informed consent-
patient
Advocate role
Mediator role

Counsellor role Comforter role

Figure 10.4  Roles played by a nurse in getting informed consent signed by the patient

The following are the responsibilities of a nurse in getting the informed consent signed by the
patient:
1. Use good communication skills, maintain good interpersonal relationship, and introduce, ori-
ent, and explain the details of the consent form to the patient.
2. Get the sign of the witness with date and time.
3. Never barrier or neglect any questions asked by the patient.
4. Use his/her skill in handling the medico-legal cases carefully, for example, rape cases, where the
patients are very sensitive and finds it difficult to answer the questions in the form.

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5. Keep the details of the informed consent confidentially and never disclose them to anyone with-
out the consent of the patient.
6. Act as a mediator between the doctor and the patient. A nurse clarifies all the patient’s doubts
and bridges the gap between the doctor and the patient, thus helping to get the informed consent
signed smoothly.

CONCLUSION
Informed consent is a mandatory and most important legal document used in different medical set-
tings. It is a written document that is framed to respect the rights of the patients for whom care is pro-
vided, whether it is a hospital or a research institution. The patients or participants should be informed
about the details of the procedure to be done or treatment to be given and their signature is obtained
in the informed consent before starting the procedure or treatment. This in an act that shows respect
to humans; giving treatment to patients without getting their consent is similar to treating them like
animals. As a nurse plays a vital role in getting the informed consent signed, he/she should be aware
of the different types of informed consent, the rationale for getting consent and its importance.

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December 14, 2003.
5. Sieber J. E (Ed.), “The Ethics of Social Research: Surveys and Experiments”, New York,
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Nazi Doctors and the Nuremberg Code, Annas G. J. and Grodin M. A. (Eds.), Oxford University
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REVIEW QUESTIONS
1. Define informed consent. Explain the meaning and the types of informed consent.
2. Describe the elements of informed consent.
3. Explain the factors affecting informed consent.
4. Enumerate the contents of informed consent.

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5. Discuss the purposes of informed consent.

6. Explain the importance of informed consent in nursing research.
7. Describe the criteria of getting informed consent.
8. Enumerate and explain the principles involved in informed consent.
9. Discuss and describe the different forms of informed consent.
10. Explain the role of a nurse in informed consent.

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