What consent: i. Competence to understand and to decide.

What is consent?

As
written in Miller-Keane Encyclopedia and Dictionary of Medicine, consent is a
voluntary agreement with an action proposed by another. If a person is giving consent,
he must be sufficient in their mental capacity. A person who is a baby, which is
mentally incompetent, or is under influence of drugs, is not in mentally stable
for giving consent.

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What is an informed
consent?

An
informed consent is consent of a client where the principles of autonomy and
privacy are followed. This has become the requirement in decision making for
health care and research Centre.

 There
are 7 criteria in defining an informed consent:

     
i.       
Competence
to understand and to decide.

    
ii.       
Voluntary
decision making.

   
iii.       
Disclosure
of material information.

  
iv.       
Recommendation
of a plan.

   
v.       
Comprehension
of terms (3) and (4).

  
vi.       
Decision
in favor of a plan.

  vii.       
Authorization
of the plan.

A
person who gives an informed consent must meet all of these criteria but if the
person rejects the plan, that person must have an informed refusal.

Informed
consent is defined by permission given by patient to doctor or other medical
team regarding any procedure regardless involving surgical or non-surgical.
Patient explained the purpose, indication, contraindication, side effect and
benefit. Informed consent will be obtain once patient is understood and two way
communication (questioning and answering) done.

Informed
consent is a medico legal issue if it is not perform correctly. It may affect
the patient’s understanding and health if not well delivered. Some patient may
sign the consent blindly without aware the consequences, as all procedure have
its benefit and risk. Misunderstanding may sometimes happen as language barrier
among the informer and receiver might become the issue. Misinterpretation of
language among them might lead to different outcome. Patients have their rights
to accepts, refuse and argue about the decision they are making, but it is the
informer’s responsibility to explained.

 

Ethical principles
for conducting research with human participants.

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 children were 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:

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)
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:

     
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 joint 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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