WHAT IS A CONSENT?
Consent is an agreement with a voluntary
action proposed by another person. If a person was giving a consent, that
person must be sufficient in their own mental capacity. The person who is a mentally
incompetent, or is under an influence of drugs, he or she is not in mentally
stable for being consented as written in Miller-Keane Encyclopedia and
Dictionary of Medicine
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
to understand and to decide.
of material information.
of a plan.
of terms (3) and (4).
in favor of a plan.
of the plan.
A person who give an informed
consent must follow all of the criteria but if the person rejects the plan,
that person must have an informed refusal.
THAT RELATE TO THE INFORMED CONSENT ON HUMAN SUBJECT RESEARCH.
Informed consent defined a permission
who given by patient to a doctor or other medical team regarding any procedure involving
surgical or non-surgical procedure. Patient 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 patient has understood
and two-way communication (questioning and answering) was achieved.
Informed consent is a medico legal subject
which if it is not performed correctly, it may affect the patient’s
understanding and health. Some patient 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. Misinterpretation of language among them might
lead to different outcome. Patients also have their rights to accepts, refuse
and argue about the decision that has been made by them, but it is also the
informer’s responsibility to explained about the details.
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
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
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.
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:
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
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.
Belmont Report also includes that to ensure informed consent to be ethically valid; it must include
components such as:
informed consent must be clear.
participant understood about the explanations and they were given chance to
question any doubt.
participant joined the research voluntarily without any outside event.
is fully competent to involve in the research.
must authorize their participation in the research study