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Informed Consent

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Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare.

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 Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving a human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of the study, the extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary.

Human rights are claims and demand that have been justified in the eyes of an individual or by the consensus of a group of people. Nurses who critique published studies, review research for conduct in their agencies, or assist with data collection for a study have an ethical responsibility to determine whether the rights of the research subjects are protected. The human rights that require protection in research are the rights to self- determination, privacy, anonymity and confidentiality, fair treatment and protection from discomfort and harm.

There are several issues related to informed consent in research on human subjects. There is an issue with 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 decreased 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 need to be given an option to ask questions and to withdraw from the study if he or she desires.

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