Moderntechnology and comfortable lifestyle we had nowadays comes from the innovationdone from a research.
Research derived from old French word cerchiermeaning to seek or to search. Research seeks answers in orderly andsystematic way. It’s a method of problem solving. One of the essentials toolsin research is informed consent. Informedconsent is a formed signed by a participant as voluntary agreement to participatein research as the main objective is to provide private and to protectconfidentiality of someone whom willing to taking part in a study. The principlesof informed consent is autonomy, beneficence and justice. Informed consent isessential in any research that will be conduct especially human as the subject.
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 be present directly in a simple language. The purpose is to ensure it iseasily understood and not mistaken during the interpretation process or when translatedby the potential participant. More than just an agreement, it is actuallycontent useful information in which someone has to understand the process ofthe research and the risks that he will facing later. It was assumed that all participant are understand the content once itwas signed but misunderstanding still can occur because of inadequateinformation. Most of the subject or participant signing the informed consentwithout 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 inmore than one language depends on sample target.Accordingto The Belmont Report and the Nuremberg Code, voluntary informed consent is amandatory as per state in the ethical conduct of human subject research.Therefore, some elements should be included in an informed consent. Thecomponent should include for all human subject research such as · Therapeutic Studies, · Interventional Studies, · Diagnostic Studies, · Social Studies And · Behavioral Studies. Agood informed consent also provide information to the subject about his rightstowards the study, the purpose and objective of the study, the flow of theprocedures, and explanation regarding the potential risks and benefits ofparticipation if available. Unintentional impact to participant such as psychological,social, or economic harm, discomfort, or inconvenience should be also bewritten clearly. Subjects feel free to participate or to withdraw.
Statement regardingthe subjects’ private and confidentiality, feel free to withdraw from the studyat any time without any consequences should be clearly state. Details for personto contact for answers regarding any question related to research or studyshould be clearly mentioned.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 as experimental model or hadrumors known to them regarding the misconduct or failure of the study.
Vulnerable groups include the personwho is absolutely or relatively incapable of protecting their interests. As theexample are prisoners, juvenile, pregnant mother, geriatric or disable people .Toobtain informed consent is difficult from them. They may be creating manyproblem because their misunderstanding regarding their role in the research andthe whole 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.