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
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).
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 entirely voluntary.
There are issues related to
informed consent regarding research involving human subjects. There is an issue
with subjects who have diminished autonomy where 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 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 involves 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 needs
to be given a choice to ask questions and to withdraw from study if he or she
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 protection 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
understandable to them.