Informed agree for participate in a study. The informed

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 exposed to coercion which 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 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.

The
aim of clinical study is to gain and develop knowledge in order to improve
health for society. Ethics of clinical study in the contact of clinical
research are all about values, norms, correct and wrong, good and bad and which
is must be done and must not be done. Investigators are responsible for
research ethics to ensure that there is no potential for exploitation and or
abuse of human research subjects. Two significant events that have contributed
to the development of research ethics; a. Nazi experiments and Nuremberg Trial
1946, b. Tuskegee Syphilis study.

The
Belmont Report (1979), had come out with three important ethical principles
that had been accepted and used by worldwide. These 3 fundamental ethical
principles are; Respect for person, beneficence and non-malfeasance and lastly
is justice.

 

1.
Respect for person

Starting
from the participation, in the middle of the participation and until the
participation have ended, the person should be treated with respect and
equally. Respect for person who involve in the research means; the researcher
should inform the participants regarding all of the aspects related to the
study and participant’s decision to participate which means taking consent from
the participants. Other than that, researcher must protect participant’s
confidentiality and privacy and provide opportunity of early withdrawal without
penalty. Besides that, participants need to be monitored during and after the
trails, participants need to be informed regarding new information and details
and to re-take the consent if necessary. At the end of the study, the
participants should be informed the result of the study, compensate
participants to research injury, all of the information regarding clinical
trial should be recorded, handled and keep properly. The researcher must make
sure the medical records and data of subjects must be keep confidentially.

 

2. Beneficence
and non-malfeasance

Experiments need to be started and only can
be continued if the advantages are expected to justify the risk. An
assessment of risks and benefits of the research lies on the responsibility of
International Review Board (IRB) Independent Ethics Committee and before the
researcher embarking on that particular research.  In order to gain interest of science and
society, there are some important things to consider which are on the correct,
safety and well-being of the participants. Medical physicians or qualified medical
personnel should hold the responsibilities in giving medical care and medical
decisions made on behalf on the trial subjects. All trials must have
scientifically protocols to ensure research outcomes are accurate and
reproducible, researcher should provide adequate information regarding pre –
clinical and clinical, research conducted following and IRB approved protocols
and the products of investigational should be manufactured and used based on
Good Manufacturing Practice (GMP).

 

3. Justice

Trial
subjects should be fairly selected. The selection of subject must be consider
of inclusion and exclusion criteria, target group as well as how to approach
them. Furthermore, the selection requires a clear scientific objectives
regarding the study, and not vulnerability, privilege, efficiency or other
factors unrelated to research purposes. Groups of trial subjects should be
aimed especially for risky study or study without advantages, which they are
convenient or vulnerable. 

 

Conclusion

By
having an insight and awareness regarding these type of issues involve in human
subjects, it is so important to both parties, subjects and researcher. Any
misunderstanding of information eventually will end up with subjects to involve
in the study that they not approve of and the three major ethical principles
are the great tool use on the best ethical practices that involved in research
and to bring ethical awareness to their thinking and decision – making.  Researcher need to instill
in their mind and heart to treat the subjects accordingly.

 

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