Informed consent is a relevant
aspect of the process where the
participant understands and agree for a study . The
informed consentprocess 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
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 anddiscomforts ,
selection of research subjects, explanation of procedures, 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, taking
part and involvement of
the 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 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 coercionwhich happen when
someone intentionally present an overt threat of harm or an excessive
reward to another to obtain
compliance. 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 bepresented “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.


I'm Erica!

Would you like to get a custom essay? How about receiving a customized one?

Check it out