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Consent is a consistency voluntary action to say ‘yes’ that
has been proposed by another person. If a person was giving consent, that
person must have an adequate level in their own mental capacity. The person who
is a mentally incompetent, or under an influence of drugs, he or she was not in
mentally stable for being consented as written in Miller-Keane Encyclopedia and
Dictionary of Medicine.

Informed consent is where the concepts of the clients were
ascendancy and privacy has been followed. This has become the requirement in
decision making for health care and research Centre.

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1.            Capability
in deciding and understanding.

2.            Voluntary
in making the decision

3.            Disclosure
of material information.

4.            Recommendation
of a plan.

5.            Comprehension
of terms 3 and 4

6.            Decision
in favor of a plan.

7.            Authorized
the plan.

The person who gives an informed consent must follow all of
the criteria and if the person rejects the plan, that person must have an
informed refusal.

Informed consent defined a permission who given by client to
a person who wants to do any procedure that involved the client itself. Client
will be explained the purpose of the procedure, indication, contraindication,
side effect and the risk of the procedure. Informed consent will be obtained
once the client has understood and two-way communication (questioning and answering)
was achieved.

Informed consent is a medico legal procedure which if it is
not performed correctly, it may affect the client’s understanding. Some client
may sign the consent blindly without aware of the consequences, as all
procedure have its benefit and risk. Misunderstanding may sometimes happen
among the informer and receiver when language barrier is one of the issues.
Language barrier among them might lead to a different outcome. The clients will
also have their rights to accepts, refuse and argue about the decision that has
been made by them, but it is also the in-charge’s responsibility to explained
about the details

Medical research involving human beings have created a lot
of potential pitfalls that led to tragedies in the last century.

In 1963 in Brooklyn; Jewish Chronic Diseases Hospital, a
cancer cells were injected into debilitated elderly patients just to see if
they would immunologically reject the cells and in 1972, Willow Brook State
Hospital in New York; a retarded child was deliberately infected with viral
hepatitis to study its natural history. So, it is clear that various cultures
such as Persia, Ancient and Greece have attempted to regulate medicine and
protect patient rights. Due to all of these cases, they were trying to avoid mistakes
made in the past and to provide guidance for the future.

These are the resulted in a series of International
Declarations and Conventions which underpin all research involving human
participants:

•             The
Nuremberg Code (1947) set out ten key points for responsible research with
human participants, including the need to obtain informed consent, the
importance of proper planning and conduct, and the need for beneficence towards
participants.

•             The
Council of Europe (CoE) was created in 1949 and established the European
Convention on Human Rights in 1953, which is now also embedded in Member
States’ legislation.

•             The
Declaration of Helsinki (1964) developed these ethical principles further by
looking at issues such as informed consent in more detail.

A further Convention which specifically addresses human
rights and biomedicine was produced in 1997 in the light of new advances in
research.

According to The US Belmont Report, they have the most
concise summary of rights and obligations in terms of research and, as such,
provide the foundation for research ethics guidance in several places around
the globe. The Belmont Report includes three ‘basic ethical principles’ for
judging the ethical treatment of human participants:

i.              Respect
for persons: The personal dignity and autonomy of individuals must be
recognized and there must be special protections for persons with ‘diminished
autonomy’ (e.g. children and prisoners)

ii.             Beneficence:
Researchers have an obligation to protect persons from harm by maximizing the
anticipated benefits and minimizing the risk of harm

iii.            Justice:
The benefits and burdens of research must be distributed fairly.

The Belmont Report also includes that to ensure informed
consent to be ethically valid; it must include components such as:

I.             Disclosure:
The informed consent must be clear.

II.            Understanding:
The participant understood about the explanations and they were given chance to
question any doubt.

III.           Voluntariness:
The participant joined the research voluntarily without any outside event.

IV.          Competence:
Participant is fully competent to involve in the research.

V.            Consent:
Participant must authorize their participation in the research study

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