Informed competent patient to be treated or randomized into

Informed consent can be define as a legal document
required for a certain procedure or treatment in hospital. It also bring a
definition as a voluntary agreement made by a well-advice and mentally
competent patient to be treated or randomized into a research study. It also carry a specific purpose according to the
field that it been used whether in medical field, or when conduct a research
study. In research study, informed consent is an important especially when
involving a human subject. There is an act that have been carried from the past
that must not be violence by the researcher. However, when human subject was
involved, there will usually have some ethical implication.

 

Several issues with
informed consent when human subject was involved had been recognizes. It based
on these three basic principles for protection in human rights. First is
autonomy. Autonomy is the ability to make your own decisions about what to do
rather than being influenced by someone else or told what to do. In this case, it
is applied to all participant that they must be given the respect from the
researcher. They also must be given the suitable time especially when making a
decision. The researcher must be explain detail regarding information of the
study in order for participant to decide the need to do or not doing the study.
All decision making must be free from any persuasion, threatening and pressure
to participate.

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Second is beneficence.
It bring the meaning of the fact or quality of being kind or doing good. In
ethical issues for protecting human right, beneficence is important in applying
at all participant. Researcher must be maximized the benefits to participant
and minimized the possible harmful effects of participant. Some of the
potential risk are include psychological or physical harm, loss of
confidentiality of participant, and also financial cost. All of the possibility
harm that might occur in the study must be explain clearly to the participant
prior to sign the consent.

 

Justice is the last
basic principle in order to protecting the human right. Justice is fairness in
the way that people are treated. Researcher must be fair in selecting the
participant and in the process of recruiting the participant to participate the
study. There must also be fair in distribution of benefits of participation in
research. The researcher must particularly ensure there is no exploitation of
participant in the conduct of research.   

 

In
doing research, there are five main ethical pillars that must be followed by
researcher. First, minimize the risk of harm to participants. This principle
stress on how a research should not harm participants by considering all
aspects that could bring harm such as physical harm, psychological distress and
discomfort, social disadvantage, financial status or an invasion of
participant’s privacy and anonymity. Non-maleficence requires a high level of
sensitivity from the researcher about what constitutes “harm” (Ford
L., 2009). Discomfort and harm can be physiological, emotional, social and economic
in nature (Burns N., 2005). By acknowledging these risk aspects, interventions
to avoid or minimizing the risk of harm could be taken by researcher.

Second,
attain informed consent from participants. The idea of informed consent is one
of the foundations of research. Informed consent means the knowing consent of a
person without undue inducement or any element of force, extortion, duress or
any other form of constraint or coercion. It is the researcher’s responsibility
to provide sufficient information in comprehensible and simple language on the
benefits and possible risks ahead of the participant’s involvement in the
research, so that participant can make a well-informed judgement about
participation. Informed consent is not just a form, but a process, when it was
done appropriately, the process assures that participants are willingly
participating in the research with full knowledge and information of relevant
risks and benefits. In some cases, that involve people with low autonomy such
as young children, very ill people or mentally disables, they could only be
included in research under specific circumstances, as they not able to make
fully informed decisions on their own. They should always be protected. 

The
third component of research ethics is by ensuring the anonymity and
individuality of research participants. Protecting anonymity of information
from participants means that either the researcher does not collect personal
information of participants such as name, address, email, job, year of services
or the researcher does not link individual responses with participants’
identities. Unless it is necessarily essential to the aimed protocol,
participant’s personal details should be keep ‘anonymous’ to protect the
participant confidentiality. Nonetheless, permission should be obtained before
any confidential information is used.

Forth
principle of research ethics is to reject any kinds of deceptive practices.
Deceptive may not be seen as an issue if an informed consent has been
performed, however the question is, how can the participants know what the
research requires of them if they are being deceived? this question makes the
use of deceptive practices in doubt. Therefore, dissertation research should
avert any types of deceptive practices. However, deception is sometimes being
allowed in covert research where the identity of the observer and the purpose
of the research is not known to participants. This is most likely to be the
case where a research needs an observation rather than through direct contact
with participants, for example; observing what type of customers who like
giving tips in the tip jar.

Lastly,
allowing the participants to withdraw is one of the principles of research
ethics that should be followed by researcher. Participants should have the
right to withdraw from the research process at any stage and when the decision
to withdraw was made, the participant should not be pressured or coerced in any
way in order to stop them from withdrawing. According to Good Clinical Practice
(GCP) guidelines, an individual can withdraw from research at any time without
revealing the reason of discontinuation.

These
basic principles of research ethics should be taken into account when
performing a research as it can help to ensure that researchers can be held
accountable to the public, in terms of human right, social responsibility and
public health and safety. Researchers should be reminded that any ethical
lapses in research can significantly harm the subjects and result to a
low-quality research study.  

 

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