Describe research study in which he or she

the meaning of informed consent, and identify issues relating to it in research
on human subjects.


Informed consent 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.

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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 ‘randomiation’.

Besides that, 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.


the major ethical principles that guide researchers in their works.

An 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.

The 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

Beneficence 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.

The 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

Offer 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.

Anonymity 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

Right 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 non-participation.  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