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 their willingness to participate in a clinical trial and significance
of the research for advancement of medical knowledge and social welfare.

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).

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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.

Nurses who critique published
studies, review research for conduct in their agencies, or assist with data
collection for a study have an ethical responsibilities 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 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. 

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