Informed consent is a relevantaspect of the process where theparticipant understands and agree for a study . Theinformed consentprocess need to fulfill two main objectiveswhich are the ethical and moral right of autonomy,freedom of choice and the legalauthorization for a study. It is not only a legal and ethicalconcern but a core factor in decisionalprocess. Humans need to be treatedas autonomous entities, who are carefree to conduct their lives without other party controlling their life. subjects are treated as autonomous agents ina study if researcher has informed themabout the study, giving them choice to choose whetherto take part, and allow them to refuse from taking part in the study, any time with no penalty (Levine, 1986). Informed consent isan important tool before begin a study using human as their subjects . Taking consent involvesprocess of notify the subject about important things suchas introduction of study process, statement of the study, purpose, description of risk anddiscomforts ,selection of research subjects, explanation of procedures, description ofbenefits, disclosure of alternatives, assurance ofanonymity and confidentiality, offer to answer question, voluntary involved inthe study, option to retreat and consent to incomplete disclosure for some studies.
By doing so, takingpart and involvement ofthe subjects in the study isvoluntary. There are several issues related toinformed consent regarding research involving humansubjects. There is an issue with subjects that having diminished autonomy where they are vulnerablebecause of legal or mental incompetence, terminally ill orconfinement to an institution such as prisoners (Levigne,1986). These subjects require additional protection of their right to self –determinationbecause of their inability to give informedconsent.
Furthermore, these people are expose to coercionwhich happen whensomeone intentionally present an overt threat of harm or an excessivereward to another to obtaincompliance. When a study involved younger generationunder the age of 18, consent has to be obtained from parents orcaretaker. Often a child’scompetence to give consent is operationalized by age, withincompetence being irrefutable up to age 7 (Broome, 1999). TheU.
S Department of Health and Human Services (DHHS) regulation require”soliciting the assent ofthe children and the permission of theirparents or caretakers. During a study,the children need to be given a choice toask questions and to withdraw from study if he orshe desires. Language barrier is another issue involving informedconsent.
Misunderstandings and misinterpret ofinformation can happen because of incorrect orinadequate language translations. According to Department of Healthand Human Services regulations ofUS, to protect the human rights, itis mandatory that informed consent information bepresented “inlanguage understandable to the subject” and,in most situations, that informed consent be documented in writing. Subjectswho cannot speak English must be presentedwith a consent document, written ina language that they understand.
