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. The purpose is to protect confidentiality of someone whom willingto taking part in a study. The principles of informed consent is known as autonomy,beneficence and justice. Informed consent is essential in any research thatwill be conduct.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 ortranslated by 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 taken. All participant was assumed to understand the informed consent once itwas signed but misunderstanding still can occur because of inadequateinformation. Most of the subject or participant signing the informed consentwithout being fully aware or not fully understand what it is all about. Poortranslation is one of the factor.
So, informed consent should provide in morethan one language depends on sample target.Accordingto The Belmont Report and the Nuremberg Code, voluntary informed consent is vitalas per state in the ethical conduct of human subject research. Therefore, someelements should be included in an informed consent. The component shouldinclude 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 people and groups includethe person who is absolutely or relatively incapable of protecting theirinterests. As the example are prisoners, juvenile, pregnant mother, geriatricor disable people .
To obtain informed consent is difficult from them. They maybe creating many problem because their misunderstanding regarding their role inthe research and the whole process of the research. Hence, special approachmust to be taken to communicate properly with them and make sure that themessage is delivered clearly as main strategy.
