Informed consent is a relevant
aspect of the process where the participant of a study understands and agree
for participate in a study. The informed consent process need to fulfill main objectives
which namely the ethical and moral right of autonomy, freedom of choice and
legal authorization for a study. It is not only a legal and
ethical concern but a core factor in decisional process. Humans need
to be treated as autonomous entities, who are carefree to conduct their
lives without other party controlling their life. Subjects
are treated as autonomous agents in a study if researcher has informed them
about the study, giving them choice to choose whether
to take part, and allow them to refuse from
taking part in the study, any time with no penalty
(Levine, 1986).    

Informed consent is
an important tool before begin a study using human as their
subjects. Taking consent involves process of notify the subject about important things such
as introduction of study process, statement of the study, purpose, description of risk and
discomforts, selection of research subjects, explanation of procedures,
description of benefits, disclosure of alternatives, assurance of ananonymity and confidentiality, offer to answer question, voluntary involved in
the study, option to retreat and consent to incomplete disclosure for some studies.
By doing so, taking part and involvement of
the subjects in the study is voluntary. 

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There are
several issues related to informed consent regarding research involving
human subjects. There is an issue with subjects that having diminished autonomy where
they are vulnerable because of legal or mental incompetence,
terminally ill or confinement to an institution such
as prisoners (Levigne, 1986). These subjects require
additional protection of their right to self
–determination because of their
inability to give informed consent. Furthermore, these
people are expose to coercion which happen when
someone intentionally present an overt threat
of harm or an excessive reward to another to obtain

When a study
involved younger generation under the age of 18, consent has to
be obtained from parents or caretaker. 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 and the permission of their parents or
caretakers. During a study, the children need to be given a choice to
ask questions and to withdraw from study if he or
she desires.

 Language barrier is another
issue involving informed consent. Misunderstandings and misinterpret of
information can happen because of incorrect or inadequate language
translations. According to Department of Health and
Human Services regulations of
US, to protect the human rights, 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 cannot speak English must be presented
with a consent document, written in
a language that they understand.

By having an insight and awareness
regarding these type of issues is so important to both party, subjects and
researcher. Any misunderstanding of information eventually will end up with
subjects to involve in the study that they not approve of. Researcher need to
instill in their mind and heart to treat the subjects accordingly.

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