technology and comfortable lifestyle we had nowadays comes from the innovation
done from a research. Research derived from old French word cerchier
meaning to seek or to search. Research seeks answers in orderly and
systematic way. It’s a method of problem solving. One of the essentials tools
in research is informed consent.
consent is a formed signed by a participant as voluntary agreement to participate
in research purposely is to provide private and to protect confidentiality of
someone whom willing to taking part in a study. The ethical consideration and
prinsiples of informed consent is autonomy, beneficence and justice. Informed
consent is a mandatory when human become as the subject in research as
mentioned in the law and ethical. According to The Belmont Report and the
Nuremberg Code, voluntary informed consent is a mandatory as per state in the
ethical conduct of human subject research. Therefore, some elements should be
included in an informed consent. The component should include for all human
subject research such as policies, benefit, participant care, stopping criteria
good informed consent also provide information to the subject about his rights
towards the study, the purpose and objective of the study, the flow of the
procedures, and explanation regarding the potential risks and benefits of
participation if available. Unintentional impact to participant should be also
be clearly state. Subjects had the rights to participate or to withdraw.
Statement regarding the private and confidentiality, stopping criteria from the
study at any time without any consequences should be clearly state. Details for
person to contact for answers regarding any question related to research or
study should be clearly mentioned.
There is some issues related to informed consent on
human research subject. The biggest problem is language barriers. As we know, Informed
consent is required before someone volunteer to take part in a research. It
should be present directly in a simple language. The purpose is to ensure it is
easily understood and not mistaken during the interpretation process or when translated
by the potential participant. More than just an agreement, it is actually
content useful information in which someone has to understand the process of
the research and the risks that he will facing later. It was assumed that all participant are understand the content once it
was signed but misunderstanding still can occur because of inadequate
information. Most of the subject or participant signing the informed consent
without being aware or had low level of understanding what it is all about.
Poor translation is one of the factor. So, informed consent should provide in
more than one language depends on sample target.
Vulnerable groups include the person who is
absolutely or relatively incapable of protecting their needs. As the example are
prisoners, juvenile, pregnant mother, geriatric or disable people .To obtain
informed consent is difficult from them. They may be creating many problem
because their misunderstanding regarding their role in the research and the
whole process of the research. Hence, special approach must to be taken to
communicate properly with them and make sure that the message is delivered clearly
as main strategy.
common issues is religious influence. A
participant’s decision making sometimes influenced by their religious belief.
Hence, not all subject willing to taking part in research voluntarily. Informed consent is important tool in research
and no any research activity will be carried out until it is complete.
Another issues related to human subjects is false expectations and false perceptions. Although explanation and
information was clearly provide and given, most of participant-to-be fear of being just experiment tools or had
rumors known to them regarding the misconduct or failure of the study.