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.1.
in deciding and understanding. 2.
in making the decision 3.
of material information. 4.
of a plan. 5.
of terms 3 and 46.
in favor of a plan.7.
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 want 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 issue. 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:
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.
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.
of Helsinki (1964) developed these ethical principles further by
looking at issues such as informed consent in more detail.
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:
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)
Beneficence: Researchers have an
obligation to protect persons from harm by maximizing the
anticipated benefits and minimizing the risk of harm
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:
The informed consent must be clear.
The participant understood about the explanations and they were given chance to
question any doubt.
The participant joined the research voluntarily without any outside event.
Participant is fully competent to involve in the research.
Participant must authorize their participation in the research study