Informed an issue with subjects that having

 

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 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 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.

 

The
purpose of clinical research is to develop and establish knowledge to improve
health which valuable to society. Clinical research ethics is about norms,
values, right and wrong, good and bad, and what should and should not be done
in the context of clinical research. 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.

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The
Belmont Report 1979 has introduced 3 fundamental ethical principles that is now
widely accepted. They are 1. Respect for person 2. Beneficence and
non-malfeasance 3. Justice.

1.
Respect for person

Trial
subjects must continue to be treated with respect from the time they are
enrolled, throughout their participation and after their participation ends.
Respecting trial subjects means; the subjects will be informed of all aspects
of the research that are relevant to the subject’s decision to participate
(informed consent);  to protect their
confidentiality and privacy; provide opportunity of early withdrawal without
penalty; monitor subject’s well-being during and after trails; inform subject
of new information and re-consent if necessary; inform subject of study
results; compensate subject for research injury; all clinical trial information
should be properly recorded, handled and stored; medical records and study data
of subjects must confidentially protected. 

2. Beneficence
and non-malfeasance

Experiments need to be started and
continued only if the benefits are expected to justify the risk. The assessment
of risks and benefits of the research lies on the responsibility of International
Review Board (IRB) Independent Ethics Committee (IEC) and investigator before
embarking on a research. In order to gain interest of science and society, they
must important things are to consider on the rights, safety and well – being of
the trial subject. 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, there must be adequate
preclinical and clinical information, research conducted following and IRB
approved protocols and the investigational product must be manufactured and
used according to 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 of the study
and not vulnerability, privilege, efficiency or other factors unrelated to
research purposes. Groups of trial subjects must be targeted especially for
risky research or research without benefits, just because they are convenient
or vulnerable. 

 

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