the meaning of informed consent, and identify issues relating to it in research
on human subjects.
is a fundamental ethical requirement for research with human subjects. It is
when a 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). The informed consent process is 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 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
understands 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
which in the end caused the participant to withdraw from the
ongoing studies (Nijhawan, 2013). Many
researchers come out with inform consent in multilingual form as solution, but
it is still difficult to evaluate individual’s viewpoint on a study as there are
no verified method established to measure the level of participant’s understanding.
For example, there was one study by Appelbaum et al. (2002), found that 69% of participants
misunderstood the meaning of the word ‘randomization’.
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).
In addition 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. In this case, disclosing information to them might scare them
away. Therefore, it is recommended that researchers ensure all the elements of
informed consent is described clearly and identified then documented in the
consent form. For example, in self-report types of questionnaires a statement
like “RETURN OF THIS QUESTIONAIRE WILL INDICATE YOUR CONSENT TO PARTICIPATE IN
THIS STUDY” must be included.
The elements of informed consent play an important part in the informed
consent process (Nieswiadomy, 2014). The major elements
include presentation of researcher’s identification and credentialed; it also describe
the selection process of participants, study purposes, study procedures,
potential risk and benefits. Besides, it also discuss about any compensation if
applicable and disclose alternative procedures involved. Another element is
assurance of participant’s anonymity and confidentiality.
the major ethical principles that guide researchers in their works.
individual 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 individuals’ right need to be respected and they can
make their own decision whether to participate in the research or they will
refuse to be the participant.
second requirements in the principle of autonomy is people with diminished
autonomy should be protected. This is to ensure 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 decisions.
is the act that is done for the benefit of others or a duty to ensure the
welfare of the persons concerned. This principal states that the research
should do no harm and maximize benefits for participants and minimize risks for
participants. Participant must be safe and feel protected by the researcher
whenever they sign he consent and agree to participate. Full explanations and
information must be detailed to participants.
To use easy words and simple language for details so that they will
fully understand and to avoid miss understand of the concepts.
purpose of the research is to discover new information that would be helpful
for the society in future. It should never cause harm or injured 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. Never take for granted that the participant will
understand the researcher language used. 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. Never exposed the participants’
details to public or other researcher in any way. Participants’ personal
matters must be well kept in the separate location and data are recorded and
subjects’ name are only can be access by the researcher or members of the
to answer All Questions Is made. Potential subjects must always be given the
opportunity to ask any questions they may have about the research. It is almost impossible for the researcher to
include every aspect of the study in a verbal or written explanation. Participants frequently have questions about
the study and an opportunity should be presented for these questions during the
verbal explanations of the research. The
researcher is obligated to be available (by phone/email/letter) if the
questions arise at a time of if participants have questions when reading the
written explanation of research.
or Confidentiality is assured. Anonymity
occurs when no one, including the researcher, can link to the participants’
data they provide. If participants can
be linked to data, the researcher has the obligation to address
confidentiality. Confidentiality involve protections of the participants’
identity by the researchers. In many
studies, it is not possible to maintain anonymity. The researcher will usually come face to face
with the participants in an experimental research. To assure anonymity or confidentiality,
participants and the site where the conclusion of the study was conduction
should be described in general terms in the description of the sample and the
to refuse to participate or to withdraw from research without penalty is
assured. All participant in nursing
research must be voluntary. Even if a random sampling procedure is used to
obtain participants, these people must be given the opportunity to decide if
they which to participate. No form of
coercion should be involved. There must
be no penalty for nonparticipation.
Potential research participants must be informed that they may withdraw
from a study at any time and for any reason.
This is particularly important in experimental studies in which a
treatment is involved. Participants may
withdraw for any reason