Informed consent is a relevant aspect of the process where the participant understands and agree for a study . The informed consent process need to fulfill two main objectives which are the ethical and moral right of autonomy, freedom of choice and the legal authorization for a study. It is not only a legal and ethical obligation but a core factor in decisional process. Humans need to be treated as autonomous entities, who are carefree to conduct their lives without other party controlling their life. subjects are treated as autonomous agents in a study if researcher has informed them about the study, giving them choice to choose whether to take part , and allowed them to refuse from taking part in the study at any time with no penalty (Levine, 1986).
Informed consent is an important tool before begin a study using human as their subjects . Taking consent involves notify the subject about important things such as introduction of study process, statement of the study, purpose, selection of research subjects, explanation of procedures, description of risk anddiscomforts, description of benefits, disclosure of alternatives, assurance of anonymity and confidentiality, offer to answer question, voluntary involved in the study, option to retreat and consent to incomplete disclosure for some studies. By doing so, the participation of subjects in the study is voluntary. There are several issues related to informed consent regarding research involving human subjects. There is an issue with subjects who have diminished autonomy where they are vulnerable because of legal or mental incompetence, terminally ill or confinement to an institution such as prisoners (Levigne, 1986). These subjects require additional protection of their right to self –determination because of their inability to give informed consent.
Furthermore, these people are expose to coercion which happen when someone intentionally present an overt threat of harm or an excessive reward to another to obtain compliance. When a study involved younger generation under the age of 18, consent has to be obtained from parents or caretaker. Often a child’s competence to give consent is operationalized by age, with incompetence being irrefutable up to age 7 (Broome, 1999). The U.
S Department of Health and Human Services (DHHS) regulation require “soliciting the assent of the children and the permission of their parents or caretakers. During a study, the children need to be given a choice to ask questions and to withdraw from study if he or she desires. Language barrier is another issue involving informed consent.Misunderstandings and misinterpret of information can happen because of incorrect or inadequate language translations.
According to U.S Department of Health and Human Services regulations, to protect the human rights, it is mandatory that informed consent information bepresented “in language understandable to the subject” and, in most situations, that informed consent be documented in writing. Subjects who cannot speak English must be presented with a consent document, written in a language that they understand.