technology and digital lifestyle we had nowadays comes from the innovation done
from a research. Research is root word from old French word cerchier
which means to seek or to search. Research seeks answers in orderly and
systematic way as 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. The main purpose is to provide private and to protect
confidentiality of someone whom willing to taking part in a study. The ethical
and principle 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 endorsed 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 procedures, and explanation
regarding benefits of participation if available. Unintentional impact to
participant should be mention as well as the risks. Subjects he had fully control
on to participate or to withdraw. Statement regarding the private and
confidentiality, stopping criteria from the study at any time without any
penalty 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 use direct words and wtitten 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.