Informed consent can be defined as
a legal document required for a certain procedure or treatment in hospital. It
also brings 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 carries 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
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 explained 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.
is beneficence. It brings 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 ahead of their agreement to join the research.
is the last basic principle in order to protect 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 ensure that the participants are
not being exploited for the sake of the research study.
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
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.