Inform consent is a
principal means for ensuring the rights of research subject or participants in
studies are protected. It means that subjects agree to participate in studies
about which they have complete understanding of the study before the study begins.
reflects the practical, ethical and legal conceptions (Adams, et.al.,2007). Therefore,
the it is a must for a researcher to document that informed consent was
obtained. Informed consent may be obtained in written or oral form. As for oral
permission informed consent, it must be witnessed by a third person (Nieswiadomy, 2014). If self-report
questionaires are used, a statement like “RETURN OF THIS QUESTIONAIRE WILL
INDICATE YOUR CONSENT TO PARTICIPATE IN THIS STUDY” should be included on the
questionaire. Subjects are well informed and free to make decision whereby they
are allowed to withdraw at any time. Victorian Charter of Human Rights (2006) states that
“must be voluntary and the person concerned must have been
given sufficient information for an informed decision to be made.”
According to Neff (2008), the importance and integrity of informed consent is
based on partnership agreement between researchers and subjects in sharing
their understanding of a study. It is not merely to have a signature on a form
but it is a process that involves exchange of information and communication
between reseacher and subjects in the decision- making process (U.S. Food and
Drug Administration, 2014).
To the general community, informed
consent is an important issue which in many ways defines the commitment of the
health system to genuine consumer engagement beyond diagnostic services while
at a broader level, consent processes help deliver services that are more
closely aligned with the priorities and concerns of the community (Consumers
Health Forum of Australia, 2013).
The concept of informed
consent is embedded in the principles of Nuremberg Code, The Declaration of
Helsinki and The Belmont Report (Nijhawan,
2013). The Belmont
Report indentified three basic principles to be followed by all researchers.
One of it is all human participants are to “be treated as autonomous agents
capable of self-determination”. This implies that all participants must give
informed consent to be involved in a research project, after given adequate
information, understand the researchs protocol, and they are allowed to
withdraw from the project at any point.
Few studies support the position that
improved communication between clinicians and consumers overall contributes to
both increased adherence to treatment regimes (Bull, Hu & Hunkeler, 2002), improved long-term
health outcomes, increased patient satisfaction, faster recovery, reduced
emotional distress, a lower level of pain relief used and in some cases a
reduced length of stay in hospital (Consumers Health Forum of
However, there are still many covert
barriers to understanding the informed consent process that lead to ineffective
communication between the participants and researchers (Escobedo et. al 2007) involving
language barriers and cultural and religious influences.
individuals sign the consent form without being full understanding, which
results in withdrawal of subject at later stages of ongoing clinical studies (Nijhawan, 2013). Although the responsibility of researcher enlarges
when a study is performed in multilingual subjects, it is still very difficult
to evaluate participant’s viewpoint about trial since there is no established
method to measure the level of understanding that a participant has. Appelbaum et al. (2002) reports
that 69% of the participants in their study “research subjects systematically
misrepresent the risk/benefits ratio of participating in research.” failed to
understand the meaning of randomization.
and Religious influences
language, cultural and religious issues will also affect a patient’s
understanding of the consent process and content. In some cases, for example, a
patient’s community or self-identified group may have a relative lack of
background knowledge about a certain disease or risk factor (Fleisher et.al.,
2018). In other cases, the patient may share a set of core beliefs that
essentially rule out a proposed procedure or test for example Jehovah’s
Witnesses believers refuse blood transfusions, including autologous
transfusions in which a person has their own blood stored to be used later in a
medical procedure (British Broadcasting Corporation,
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. 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
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
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.
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.