Moderntechnology and digital lifestyle we had nowadays comes from the innovation donefrom a research.
Research is root word from old French word cerchierwhich means to seek or to search. Research seeks answers in orderly andsystematic way as a method of problem solving. One of the essentials tools inresearch is informed consent. Informedconsent is a formed signed by a participant as voluntary agreement to participatein research. The main purpose is to provide private and to protectconfidentiality of someone whom willing to taking part in a study. The ethicaland principle of informed consent is autonomy, beneficence and justice.
Informedconsent is a mandatory when human become as the subject in research asmentioned in the law and ethical. According to The Belmont Report and theNuremberg Code, voluntary informed consent is a mandatory as endorsed in theethical conduct of human subject research. Therefore, some elements should beincluded in an informed consent. The component should include for all humansubject research such as policies, benefit, participant care, stopping criteriaand feedback.
Agood informed consent also provide information to the subject about his rightstowards the study, the purpose and objective of the study, the procedures, and explanationregarding benefits of participation if available. Unintentional impact toparticipant should be mention as well as the risks. Subjects he had fully controlon to participate or to withdraw.
Statement regarding the private andconfidentiality, stopping criteria from the study at any time without anypenalty should be clearly state. Details for person to contact for answersregarding any question related to research or study should be clearly mentioned.There is some issues related to informed consent onhuman research subject. The biggest problem is language barriers. As we know, Informedconsent is required before someone volunteer to take part in a research.
Itshould use direct words and wtitten in a simple language. The purpose is toensure it is easily understood and not mistaken during the interpretationprocess or when translated by the potential participant. More than just anagreement, it is actually content useful information in which someone has tounderstand the process of the research and the risks that he will facing later.It was assumed that all participant areunderstand the content once it was signed but misunderstanding still can occurbecause of inadequate information. Most of the subject or participant signing theinformed consent without being aware or had low level of understanding what itis all about.
Poor translation is one of the factor. So, informed consent shouldprovide in more than one language depends on sample target. Vulnerable groups include the person who isabsolutely or relatively incapable of protecting their needs. As the example areprisoners, juvenile, pregnant mother, geriatric or disable people .To obtaininformed consent is difficult from them.
They may be creating many problembecause their misunderstanding regarding their role in the research and thewhole process of the research. Hence, special approach must to be taken tocommunicate properly with them and make sure that the message is delivered clearlyas main strategy.Anothercommon issues is religious influence. Aparticipant’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 researchand 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 andinformation was clearly provide and given, most of participant-to-be fear of being just experiment tools or hadrumors known to them regarding the misconduct or failure of the study.