Informed consent in the research is the voluntary agreement
of the participant before they are been included and joining the research that
been conducted.  The aim of this informed
consent is to ensure the participants is provided with the sufficient knowledge
and information before decising to enrol in the study.  In the informed consent, the participant are
explained about their rights, the purpose and the benefits of study that they
been agreed enrolled in. They are also been explained and understanding about
the risks that they may be faced in when agreed in the study. The informed
consent is not just the papers that need the participant’s signatures, it is a
process that include the study’s purpose, duration, experimental procedures,
alternatives, risks and benefits. All the details and explanations in the
informed consent should be written in the understandable language by the
participants. The participants are allowed not to agree and withdraw from the
study before sign the informed consent.

The issue that always occurred relating to the informed
consent on human objects is language barrier. The candidate of participants are
assumed fully understanding with the study that been conducted due the signs of
them in the informed consent. This understanding cannot be proved to there are
no methods that have been established to measure the level of understanding of
the participants. As the consequence, the participants tend to withdraw in
ongoing the study because not well understanding the study although had sign
the informed consent.

The false expectations from the participants also one of the
issues developed in the informed consent’s matters. The misunderstanding can
occurred due the participants are expecting something different from the
outcome of the study. A few may fear that they will become and treated like an
experimental model for the studies while others may be influenced by history of
clinical trial that been fraud for them. Their expectations of the study are
hindering them from fully understanding the study.

In the study that need the children who is under age of 18
to be part of the participants, the issue is occurred relating the informed
consent when the children need their parent consent in agree to be part of the
research. It is an arguable situation where the children are able to be part of
the research because they have the rights to understand and refuse for the
participation if they want to. The difficulty is occurred when the parents are
given consent although the children are not willing to do so.

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For the vulnerable groups that need to include in the
research, the issue relating consent may occurred due to they will may not
fully understanding of the research that will be conducted. The vulnerable
group is the person that absolutely not capable of protecting their interest
such as person with learning disabilities. Hence, taking the consent from this
group will be difficult and need of special care in order to ensure the
appropriate strategies can be developed.

 

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