Informed consent is an ethical and legal requirement for research involving human participants. “Informing” is the transmission of essential ideas and content from the investigator to the prospective subject. “Consent” is the prospective subject’s agreement to participate in a study as a subject. Informed consent includes four elements which are disclosure of essential study information to the subject, comprehension of this information by the subject, competence of the subject to give consent and voluntary consent of the subject to participate in the study.
Humans should be treated as autonomous agents, who have the freedom to conduct lives as they choose without external 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).
The concept of informed consent is embedded in the principles of The Declaration of Helsinki, The Belmont Report and Nuremberg Code. Informed consent is a requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, procedures to be undertaken, potential risks and benefits of participation, the purpose of the study, extent of 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 several issues related to informed consent in research on human subjects. There is an issue with a persons 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.