UNIT: IV

CONFIDENTIALITY AND
INFORMED CONSENT

By: Farzana Kausar Khattak

Lecturer
KMU-INS
2 OBJECTIVES
At the end of this session learners will be able to:

 Define confidentiality and informed consent

 Discuss the importance of confidentiality & consent
 List ethical and legal elements of informed consent
 Discuss the process informed consent.
 Discuss nurse’s roles and responsibilities in consent process

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INFORMED CONSENT
 It is an agreement by a client to accept a course of a
treatment, procedure or research after being provided
complete information including benefits and risks.
 Obtaining informed consent is the responsibility of the
person performing the procedure or research.

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TYPES OF CONSENT
Types of consent
1- Expressed Consent
2- Implied Consent
 Expressed Consent
• May either be oral or written.
• Written consent is preferred if there are greater risks of a
procedure.
 Implied consent
• Exists when the client’s non-verbal behavior indicates
agreement.
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CONFEDENTIALITY
 Confidentiality means that any information provided by
individuals as part of the informed consent process,
including their personal and medical details, must be
kept confidential and not disclosed to unauthorized
parties.
 Respecting confidentiality is essential to maintain trust
and ensure that individuals are comfortable sharing
information when making informed decisions about
medical treatments, research participation, or other
relevant matters.

Farzana Khattak 02/02/2024

 IMPORTANCE OF
6
CONFIDENTIALITY & CONSENT
CONFIDENTIALITY
 Respect for Privacy: Maintains individuals' privacy and dignity by
safeguarding their personal information.
 Trust Building: Fosters trust between individuals and professionals,
enabling open and honest communication.
 Ethical Responsibility: Upholds the ethical duty to protect sensitive
data and maintain trustworthiness.
 Legal Compliance: Often required by law and regulations to protect
the rights and privacy of individuals.
 Psychological Well-being: Preserves emotional and psychological
well-being by ensuring that personal information is not misused or
disclosed without consent.
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7 IMPORTANCE OF
CONFIDENTIALITY & CONSENT
CONSENT
 Autonomy and Respect: Empowers individuals to make informed
decisions about their own bodies and participation, respecting their
autonomy.
 Ethical Research: In research, it ensures that individuals voluntarily
agree to participate.
 Legal Compliance: Required in many contexts, including healthcare,
research, and business, to comply with laws and regulations.
 Protection from Coercion: Guards against coercion, ensuring that
decisions are made willingly and without undue pressure.
 Clear Communication: Promotes clear communication between
parties,Farzana
reducing
Khattak
misunderstandings and disputes. 02/02/2024
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ETHICAL ELEMENTS OF
INFORMED CONSENT
 Autonomy: Respecting an individual's right to make decisions about their
own body and participation.
 Beneficence: Person providing consent understands the potential benefits and
risks involved and their well being is protected.
 Non-maleficence: Minimizing harm and ensuring that any risks are
reasonable and justifiable.
 Veracity: Providing honest and accurate information to enable informed
decision-making.
 Respect for Privacy: Safeguarding the confidentiality of personal
information shared during the consent process.
 Withdraw Consent: The right to withdraw consent at any point during the
procedure or activity without negative consequences.

Farzana Khattak 02/02/2024

9 LEGAL ELEMENTS OF INFORMED
CONSENT

 Capacity: The individual providing consent must be legally capable of

making decisions, often determined by age or mental competence.
 Voluntariness: Consent should be freely given, without coercion or
pressure.
 Comprehension: The person must fully understand the information
provided about the consent request.
 Disclosure (Information): Complete and clear information must be
provided about the matter at hand.
 Authorization: In some cases, a formal written agreement may be
required, such as a consent form.

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10 INFORMED CONSENT
PROCESS
The process of informed consent typically involves the following steps:
1. Introduction and Information Disclosure:
• The individual is introduced to the situation or procedure, and the relevant information is
disclosed.
• This includes the nature of the procedure, its purpose, potential risks and benefits, and any
available alternatives.

2. Comprehension:
• The individual is given the opportunity to ask questions and seek clarification on any
aspects of the information presented.
• It's essential that they fully understand what they are consenting to.

3. Voluntariness: The person is assured that their consent is entirely voluntary,

and they have the right to decline or withdraw their consent at any time
without facing negative consequences.
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11 INFORMED CONSENT
PROCESS
4. Documentation:
• In many cases, written consent is obtained through a consent form,
which both the individual and the person obtaining consent sign.
• This form may summarize the key information provided.
5. Continued Communication: Throughout the procedure or
activity, there should be ongoing communication to address
any concerns or changes in the individual's consent.
6. Respect for Privacy: Any information disclosed during the
consent process is kept confidential and not shared without
proper authorization.

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12 INFORMED CONSENT
PROCESS
7. Ethical Principles: The process adheres to ethical principles, including:
• Respect for autonomy (the individual's right to make decisions about
their own body)
• Beneficence (ensuring their well-being)
• Non-maleficence (minimizing harm)

 The goal of the informed consent process is to ensure that individuals

make voluntary, informed, and autonomous decisions regarding their
participation in a procedure, research study, or any situation where their
consent is required. It aims to protect their rights and well-being.

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 NURSE’S ROLES AND RESPONSIBILITIES IN
13
CONSENT PROCESS

 The nurse is responsible and accountable for the verification of and

witnessing that the patient or the legal representative has signed the
consent document in their presence.
 The patient, or the legal representative, is of legal age and competent to
provide consent.
 They also confirm that the patient has sufficient knowledge to make a
knowledgeable decision.
 Advocate for the patient's right to make decisions about their care and
ensure their preferences are respected.
 Safeguard the confidentiality of any information shared during the
consent process, respecting the patient's privacy.

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 NURSE’S ROLES AND RESPONSIBILITIES IN
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CONSENT PROCESS

 Consider cultural and linguistic factors that may impact the

patient's comprehension and willingness to provide consent.
 Confirm the patient's identity to prevent errors in the consent
process.
 Address any questions, concerns, or uncertainties the patient may
have regarding the procedure or treatment.
 Accurately document the informed consent process, including the
patient's understanding and agreement, which is often done by
witnessing the patient's signature on the consent form.

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