Humansshould be treated as autonomous agents, who have the freedom to conduct lives asthey choose without others to controls. Subjects are treated as autonomousagents in a study if the researcher has informed them about the study, allowthem to choose whether to participate, and allowed them to withdraw from thestudy at any time without penalty (Levine, 1986). Informedconsent is a requirement prior to every research involving human being assubjects for study. Obtaining consent involves informing the subject about hisor her rights, procedures to be undertaken, potential risks and benefits ofparticipation, the purpose of the study, extent of confidentiality of personalidentification, expected duration of study and demographic data, so that theparticipation of subjects in the study is entirely voluntary. There areseveral issues related to informed consent in research on human subjects.
Thereis an issue with a persons who have diminished autonomy when they arevulnerable 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 informedconsent. In addition, these people are vulnerable to coercion which happen whenone person intentionally present an overt threat of harm or an excessive rewardto another to obtain compliance.
When research involves children (under theage of 18), consent/permission has to be obtained from parents. Often achild’s competence to give consent is operationalized by age, with incompetencebeing irrefutable up to age 7 (Broome, 1999). The U.S Department of Health andHuman Services (DHHS) regulation require “soliciting the assent of the children(when capable) and the permission of their parents or guardians.
Assent means achild’s affirmative agreement to participate in research. During a study, thechildren needs to be given an option to ask questions and to withdraw fromstudy if he or she desires. Languagebarrier is another issue in informed consent. Misunderstandings and misinterpret the information can occurbecause of incorrect or inadequate language translations.
According toU.S Department of Health and Human Services regulations, to protection the humansubjects, 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 speakEnglish should be presented with a consent document written in a languageunderstandable to them. informed consent is a process through which participant agreeand understand for a study or research. The informed consent process need to fulfill two main purposes which are the ethical and moral right of autonomyand freedom of choice and the legal authorisation for a study.
it is not only a legal and ethical obligation but acore factor in decisional process.