In a research, informed consentdefines as human subjects are well informed about the study. According to Armiger:”it means that a person knowingly, voluntarily and intelligently, and in aclear and manifest way, gives his consent” It is an ethical and legalrequirement in research on human subjects. The process to obtain consentincluding the potential subjects are well informed about their rights, thereason why the study is conduct, all theprocedures process, possible risks and advantages of participation, expected periodof study, extent of privileged of self-identification and demographic data,hence the participation of potential subjects in the study are entirelywilling.
The aim of the informed consent process is to deliver adequate informationto potential subjects, in easy to understand language so that the subjects can makevoluntary decision about taking part in the study. To get a signature on a consentdocument is essential, but it is one step in the constant process of informedconsent and not just about signing a form. With signing informed consent, itshow subjects having and understanding of the potential risks and advantages totheir participation and entirely knowing that they do not have to willing andcan quit at any time.
It is important that consent forms must be written inplain language so that subjects easily understand. The consent form must be alwaysreviewed and if there any changes in the study that can affect the subjects,hence additional information will improve the consent process. There are a few issues in informedconsent process. With assuming individual who signs the consent form does sowith full comprehension of what is present on the consent form. However, levelof understanding one person to another person is different and no other methodto measure it, hence misunderstanding of information given can occur.
It isbecause might be inaccurate or insufficient language translations. The responsibleof researcher become more when a study is carry out in multilingual subjects.The informed consent processintend to give every human subjects the right to choose whether to participateor not in the study. Sometimes the decision for participating in researchprojects is influenced by the religious belief. It is because sometimes methodologyof the research comes into conflict with the regulation of behavior set by asubject’s religion. Subject’s false expectationof the research outcome is another of issues in informed consent process due tomisunderstanding.
Some subject’s worry of being treated as ‘experimental model’for the study while others decline to participate because of misconduct knownto them. Subject perception whenparticipate in research will put extra burden on them and believed will give extrawork to answer questionnaire and so on. To get informed consent from them ismost difficult. As a conclusion, although surroundby obstacle, informed consent is an important step in research. Informedconsent must completely sought otherwise no research activity involving humansubjects can be carry out and continued.