Obtaining study. Informed consent is an ethical and

Obtaining inform
consent is a necessary process for the researcher to proceed in their research
study. Informed consent is an ethical and legal requirement for an individual
who is participating in a research study. It is the action where all
participants are provided sufficient information on the study, adequate
opportunity for the participant to ask questions and answered. The languages
that use in informed consent must be written in terms that they can understand.
Inform consent is usually in the form of document signed by the subject and
relevant research information, such as the purpose of the study, expected duration
of study, experimental procedure to be undertake, benefits and potential risks
of participation, also important for the participant to make decision and confirms
for individual willingness to involve in peculiar clinical trial and
significance of the study for advancement of medical knowledge and social
welfare. The subject must be given enough time to consider participation. The informed
consent document should be altered when the shortage
is noted or when additional information will improve the consent process.

 

However, obtaining
informed consent may sound simple enough, but there are some challenges and
little attention has been paid to these issues while preparing the consent on
human subjects.

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The first challenge
is language barrier. Some of the participant that singing the consent form may
or may not have a full understanding or understanding in wrong way of what is
stated on the consent forms given. Furthermore, some of the individual signs
the consent form without giving full attention to what they are singing. Nonetheless, it is quite impossible to identify every
person’s angle of understanding since there is no special formula to measuring
the individual understanding level. This misunderstanding can occur by reason
of inadequate or incorrect language translations. This problem not only affects
the future participants to use up the information but also may affect decision
they are going to make.

 

The second challenge
that researcher may face to obtaining informed consent is when a study involves
children. The research study that require
the participation of children who are under 18 years old, permission or consent
must be obtained from their parents or guardian.  If the child is more than 7 years old, it is
mandatory for “child assent”. Which is children are capable of becoming partners in research and that they
have right to get information. The major challenge that arises when parents or
guardian agrees and gives their permission to everything while child refuses to
participate.  

 

There are so many different
ways of perception. The patient’s
perception also can consider as one of the challenge to researcher. Some individuals believe that trial is a good for
finding new things while some will put an extra
burden on them. They are afraid of the risk or side effect of the
procedure. Obtaining an informed consent from such person is most difficult and
challenge for researcher.

 

The informed consent
is purposed to distribute to every
participant the feel free to decide whether “do” or “do not” to be involved in a research study. Some of individual’s decision toward to
participating in a research study may influence by the religious.

 

Introduction

Understandings of
these ethical principles are crucial for researchers because they need to
follow the predetermined rules that set as guide to conduct their research.
Besides that, researchers use these ethic principles to support their outcomes
regarding how to treat their research participants and the information that
they collect from them.

According to Lund
Research Ltd (2012), there are four major ethical principles that used to
conducting research including beneficence, informed consent, anonymity and
confidentiality, and avoiding deceptive practices.

 

Beneficence

Beneficence is
indicated to the requirement of the researcher to maximizing benefits for the
every participant and at the same time minimizing harm to the every
participant. There are some examples of benefits and harm that the participants
can be experienced. The major benefits to participants are pleasure because
they are able to express their feeling by talk about their problem without bias
and feeling satisfaction that the information that they provide may help the
study while the major potential harm to participants are body harm, mental
distress and psychological discomfort. Therefore, the first principle focus to
the essential for researchers to work of free from biases, prejudices, and
researchers need to understand clearly that their work is might cause effect to
the someone’s lives.

 

Informed Consent

            Before taking the informed consent,
participants must understand that they are one of the parts in the research and
should know what researchers need from them. In the inform consent, they must
written that information regarding the purpose of the study, the method that
they used to conduct the research, the possible result and conclusion of the
study. Furthermore, in the informed consent also need to include the contain
details such as demands in the studies, uneasiness of participants, risk and
difficulty that the participants may experience.

 

Anonymity and
confidentiality

Definition of
anonymity is protecting the participants. Even though the researchers that
conducting the study also cannot make assumptions about whom the informers
according to information provided. While confidentiality means prevention and
protection from leakage of information regarding a participant’s identity to
other than authorized individuals. Based on Data Protection Act (1998), as an
ethical principle, each individual is privileged to be given privacy and
confidentiality protection by protecting their personal identity and secret
data. Besides that, they are also given the opportunity to decide on time and
how the information is being held or shared.

 

Avoiding deceptive
practices

            To avoid deception in research,
researchers need to practice justice and comprehensive in their works. In this
point, justice refers to fairness and integrity for every participant in
research. Justice is shown through method of the procedure that honest, clear
as transparent and reasonable and most significant is the process must be
independent according to research protocols. Justice also determines of
benefits and obstruction of the research. It is essential to conduct the study
carefully and must be free from biased that harm to the research. This
principle is aimed to ensuring that no deviation and discrimination against
participants.

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