Obtaining inform consent is a necessary process for the
researcher to proceed in their research study. Informed consent is an ethical
and legal requirement for an individual who is participating in a research
study. It is the action where all participants are provided sufficient
information on the study, adequate opportunity for the participant to ask
questions and answered. The languages that use in informed consent must be
written in terms that they can understand. Inform consent is usually in the form
of document signed by the subject and relevant research information, such as
the purpose of the study, expected duration of study, experimental procedure to
be undertake, benefits and potential risks of participation, also important for
the participant to make decision and confirms for individual willingness to
involve in peculiar clinical trial and significance of the study for
advancement of medical knowledge and social welfare. The subject must be given
enough time to consider participation. The informed consent document should be
altered when the shortage is noted or when additional information will improve
the consent process.
However, obtaining informed consent may sound simple enough,
but there are some challenges and little attention has been paid to these
issues while preparing the consent on human subjects.
The first challenge is language barrier. Some of the
participant that singing the consent form may or may not have a full
understanding or understanding in wrong way of what is stated on the consent
forms given. Furthermore, some of the individual signs the consent form without
giving full attention to what they are singing. Nonetheless, it is quite
impossible to identify every person’s angle of understanding since there is no
special formula to measuring the individual understanding level. This
misunderstanding can occur by reason of inadequate or incorrect language
translations. This problem not only affects the future participants to use up
the information but also may affect decision they are going to make.
The second challenge that researcher may face to obtaining
informed consent is when a study involves children. The research study that
require the participation of children who are under 18 years old, permission or
consent must be obtained from their parents or guardian. If the child is more than 7 years old, it is
mandatory for “child assent”. Which is children are capable of becoming
partners in research and that they have right to get information. The major
challenge that arises when parents or guardian agrees and gives their
permission to everything while child refuses to participate.
There are so many different ways of perception. The
patient’s perception also can consider as one of the challenge to researcher.
Some individuals believe that trial is a good for finding new things while some
will put an extra burden on them. They are afraid of the risk or side effect of
the procedure. Obtaining an informed consent from such person is most difficult
and challenge for researcher.
The informed consent is purposed to distribute to every
participant the feel free to decide whether “do” or “do not” to be involved in
a research study. Some of individual’s decision toward to participating in a
research study may influence by the religious.
Understandings of these ethical principles are crucial for
researchers because they need to follow the predetermined rules that set as
guide to conduct their research. Besides that, researchers use these ethic
principles to support their outcomes regarding how to treat their research
participants and the information that they collect from them.
According to Lund Research Ltd (2012), there are four major
ethical principles that used to conducting research including beneficence,
informed consent, anonymity and confidentiality, and avoiding deceptive
Beneficence is indicated to the requirement of the
researcher to maximizing benefits for the every participant and at the same
time minimizing harm to the every participant. There are some examples of
benefits and harm that the participants can be experienced. The major benefits
to participants are pleasure because they are able to express their feeling by
talk about their problem without bias and feeling satisfaction that the
information that they provide may help the study while the major potential harm
to participants are body harm, mental distress and psychological discomfort.
Therefore, the first principle focus to the essential for researchers to work
of free from biases, prejudices, and researchers need to understand clearly
that their work is might cause effect to the someone’s lives.
taking the informed consent, participants must understand that they are one of
the parts in the research and should know what researchers need from them. In
the inform consent, they must written that information regarding the purpose of
the study, the method that they used to conduct the research, the possible
result and conclusion of the study. Furthermore, in the informed consent also
need to include the contain details such as demands in the studies, uneasiness
of participants, risk and difficulty that the participants may experience.
Anonymity and confidentiality
Definition of anonymity is protecting the participants. Even
though the researchers that conducting the study also cannot make assumptions
about whom the informers according to information provided. While
confidentiality means prevention and protection from leakage of information
regarding a participant’s identity to other than authorized individuals. Based
on Data Protection Act (1998), as an ethical principle, each individual is
privileged to be given privacy and confidentiality protection by protecting
their personal identity and secret data. Besides that, they are also given the
opportunity to decide on time and how the information is being held or shared.
Avoiding deceptive practices
avoid deception in research, researchers need to practice justice and
comprehensive in their works. In this point, justice refers to fairness and
integrity for every participant in research. Justice is shown through method of
the procedure that honest, clear as transparent and reasonable and most
significant is the process must be independent according to research protocols.
Justice also determines of benefits and obstruction of the research. It is
essential to conduct the study carefully and must be free from biased that harm
to the research. This principle is aimed to ensuring that no deviation and
discrimination against participants.