Informed consent is a fundamental ethical requirements for research
with human subjects where subject voluntarily agrees to participate in a research
study in which he or she has full understanding of the study before the study
begins (Nieswiadomy, 2014). It is the process where the participant is informed
regarding all aspects of the trial, which are important for the participant to
make a decision and after studying all aspects of the trial, The participant voluntarily need to confirms
his or her willingness to participate in a particular clinical trial and
significance of the research for advancement of medical knowledge and social
welfare (Nijhawan et al., 2013) The informed consent process might create
or result several ethical issues if it is not being done properly.
Misunderstandings between the researchers and the participants will result due
to communication barriers such as language differences and religious dogma. The
individual who signed the informed consent is assumed to have fully understand
the information that is stated in the consent form but it is difficult to
evaluate the level of understanding in the individual’s point of view.
Therefore, there might some degree of misunderstanding that might occur. Other issue is the
participants may have a false expectation regarding the research. Moreover, the participants might get
involved in research projects that they did not approve of due to
misunderstandings or misinterpretation concerning the experimental procedures
(Escobedo et al., 2007). The participant’s perception regarding the
research might affect the process of obtaining the informed consent because
they afraid of the consequences of the research on them. This might scare them
In order to prevent
issues related to informed consent to occur when doing research, the major
element of informed consent need to be included which are researcher is
identified and credentials presented; subject selection process is described;
purpose of study is described; study procedures are discussed; potential risks
are described; potential benefits are described; compensation, if any, is discussed;
alternative procedures are disclosed, if any; anonymity or confidentiality is
assured; right to refuse to participate or to withdraw from study without
penalty is assured; offer to answer all question is made; and means of
obtaining study results is presented.
2. Discuss the major ethical principles that guide
researchers in their works.
There are three fundamental principles of research ethics according
to Swiss Academy of Medical Sciences (2015) which are respect for persons or autonomy, beneficence and justice.
The principle of respect for person or autonomy consists of two requirements
which is first, the individuals should be treated as autonomous which means that the
individual capable of making their own decision about important personal matters.
The individual should only be involved in research if they have voluntarily
give their consent and been fully informed about the nature, purpose and
consequences of the research. Therefore the participants’ right need to be respected so that
they can make their own decision whether to participate in the research. The principle of
autonomy is people with diminished autonomy should be protected which is the protection needs to be adapted to individual
circumstances, ensuring that the persons concerned are not involved in research
which could be harmful for them with regard to a research project. This is
because some people in society may not have the capacity to make fully informed
Beneficence is the act that is done
for the benefit of others or a duty to ensure the welfare of the persons
concerned. The research should do no harm and maximize benefits for
participants and minimize risks for participants. The purpose of the research
is to discover new information that would be helpful for the society in future.
It shouldn’t cause
harm to anyone or find out information at the expense of other people. There is
dilemma arises from the researcher in this case because to avoid the risks, the
researcher needs to know what is harmful. The evidence obtained from the study
will show whether it is beneficence or not. In order to identify what can
benefit the patients, it may be necessary to exposed them to risks although the
researchers are obligated to do their best to minimize those possible risks and
to maximize the benefits for participants.
The last fundamental principal is
justice which is deals with the concept of fairness that is the distribution of
burdens, risks, chances and benefits. Participants need to be treated with
equal respect and concern where the benefits of the research will be shared,
where feasible with
all of those affected by its results. The participants will not be
excluded from research for reasons unrelated to the research. Researchers will
be cognizant of, and works to mitigate, imbalances in power between themselves
and participants, among individual participants, or between participants and
the groups to which they belong.
than the three previously mentioned fundamental principles of research ethics,
there are also five basic ethical principal (Laerd, 2012) which are minimising
the risk of harm, obtaining informed consent, protecting anonymity and
confidentiality, avoiding deceptive practices and providing the right to
The research that will be conducted must not give harm to the
participants’ physically, psychologically, socially, financially and/or affect
their privacy and anonymity. Researchers need to focus on these elements in
order to minimising the risk of harm.
Obtaining the informed consent from
the participant is essential for the researcher for their study. Informed
consent is needed to make sure the participants is fully understand that they
are taking part in the research study and what the research requires of them.
All of the elements that should be
included in the informed consent need to be fully delivered to the participants
and they should fully understand the consent. The participation of the
individuals should be voluntary without being influence by any person or
subjects. The anonymity and confidentiality of the participant need to be
protected as previously mentioned in the anonymity principal in the fundamental
of research ethics.
The fourth principal is to avoid
deceptive practices. This can occur when the researcher provide false or
incomplete information to the participants for the purpose of misleading
research subjects. Dissertation research should avoid any kinds of deceptive
practice while in the covert research, deception is sometimes a necessary
components. Coverts research reflects research where the identity of the
observer and/or the purpose of the research is not known to participants.
The last principal is providing the participants the right to
withdraw from the research study. The participants should have the right to
withdraw themselves from the research study anytime. They should not be
pressured or coerced in any way to try and stop them from withdrawing.