Informed in a study if researcher has informed them

Informed consent is a process
where the participant understands and agree for a study or research. The
informed consent process need to fulfill two main objectives which are the
ethical and moral right of autonomy, freedom of choice and the legal
authorization for a study. It is not only a legal and ethical obligation but a
core factor in decisional process.

 Humans need to be treated as autonomous
entities, who are carefree to conduct their lives as they choose without others
to controls. Participants are treated as autonomous agents in a study if
researcher has informed them about the study, giving them choice to choose
whether to participate, and allowed them to refuse participating in the study
at any time with no penalty (Levine, 1986).  

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Informed consent is an
important tool prior to every study using human as subjects for study.
Obtaining consent involves notify the subject about important things such as
introduction of study activities, statement of the study purpose, selection of
research subjects, explanation of procedures, description of risk and
discomforts, description of benefits, disclosure of alternatives, assurance of
anonymity 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, the participation of subjects in the study is voluntary.
There are several issues related to informed consent regarding research
involving human subjects.

There is an issue with
subjects who have 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 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 a study involved children
under the age of 18, consent 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 and
the permission of their parents or caretakers. Assent is defined as a child’s
affirmative agreement to be a part of study. 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 U.S Department of Health and Human Services
regulations, 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.