Humans should be treated as autonomous agents, who have the freedom to conduct lives as they choose without others to controls. Subjects are treated as autonomous agents in a study if the researcher has informed them about the study, allow them to choose whether to participate, and allowed them to withdraw from the study at any time without penalty (Levine, 1986).
Informed consent is a requirement prior to every research using human being as a participant for study. Obtaining consent involves informing the subject about their rights, procedures to be done, risks and benefits of participation, the purpose of the study, confidentiality of personal identification, expected duration of study and demographic data, so that the participation of subjects in the study is entirely voluntary.
There are issues related to informed consent regarding research on human subjects. There is an issue with a subjcts who have diminished autonomy when they are vulnerable and less advantaged because of legal or mental incompetence, terminal illness or confinement to an institution such as prisoners ( Levigne, 1986). These persons require additional protection of their right to self –determination because of their decrease ability or inability to give informed consent. In addition, these people are vulnerable to coercion which happen when one person intentionally present an overt threat of harm or an excessive reward to another to obtain compliance.
When research involves children (under the age of 18), consent/permission has to be obtained from parents. 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 (when capable) and the permission of their parents or guardians. Assent means a child’s affirmative agreement to participate in research. During a study, the children needs to be given an option to ask questions and to withdraw from study if he or she desires.
Language barrier is another issue in informed consent. Misunderstandings and misinterpret the information can occur because of incorrect or inadequate language translations. According to U.S Department of Health and Human Services regulations, to protection the human subjects, it is mandatory that informed consent information be presented “in language understandable to the subject” and, in most situations, that informed consent be documented in writing. Subjects who do not speak English should be presented with a consent document written in a language understandable to them.
informed consent is a process through which participant agree and understand for a study or research. The informed consent process need to fulfill two main purposes which are the ethical and moral right of autonomy and freedom of choice and the legal authorisation for a study. it is not only a legal and ethical obligation but a core factor in decisional process.