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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 in making 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 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. However, it is
difficult to evaluate the level of understanding of participants as different
individual may have different point of view. Therefore, some degree of misunderstanding
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 is
no verified method established to measure the level of participant’s understanding.

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.

The ethical aspects of a study take precedence over
any other areas of the study (Nieswiadomy, 2014). Participants’
rights must be protected in all proposed research studies. Ethics on the other
hand, concerned with rules and principle of human behaviour which is known to
be complex that makes it difficult to formulate rules to govern the actions of
human being. The present ethical standards used in research are based on
guideline developed after the World War II where Nuremberg Code was established
in 1947, followed by Declaration of Helsinki in 1964. In 1978, the ethical
principal and guideline were reviewed. A draft was prepared and reported in The
Belmont Report published in 1979 presenting three basic principles:

Respect for persons (autonomy)



Respect for persons (autonomy) entails two
requirements: firstly, individuals should be treated as autonomous agents,
capable of deciding for themselves about important personal matters.
Accordingly, subjects should only be involved in research if they have given
their voluntary consent and been fully informed about the nature, purpose and
consequences of the study. Secondly, individuals whose autonomy is diminished
as a result of external circumstances, or their physical or mental condition,
require special protection. With regard to a research project, this protection
needs to be adapted to individual circumstances, ensuring that the persons
concerned are not involved in research which could be harmful for them. Therefore, their right must be
respected and they are free to decide whether to participate or not. This is
because some people in society may not have the capacity to make fully informed

Beneficence is the duty to ensure the welfare of the persons concerned.
This means an obligation firstly to avoid harm and secondly to maximise
possible benefits (Beauchamp
& Childres, 2001). But here a dilemma arises: to avoid risks, one needs
to know what is harmful. This knowledge, in turn, depends on evidence obtained
from studies. Thus, in order to discover what is actually beneficial for
patients, it may be necessary to expose them to risks although the researchers are obligated to do their best to
minimize those possible risks and to maximize the benefits for participants.

Justice is concerned with the distribution of burdens,
risks, chances and benefits to different persons and groups, and with the
question of what exactly is “owed” to an individual. The first element raises
the question, for example, who should receive the benefits of research and who
should bear its burdens. The second question, for example, to what extent
people whose condition may differ markedly should be recognised as equals and
treated accordingly.


Potential subjects
must always be given the opportunity to ask any questions they may have about
the research.  Although it is almost
impossible for the researcher to include every aspect of the study in a verbal
or written explanation, offer to answer all questions should be made.  Participants may 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) to answer any
questions arise.

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 participation in research must be
voluntary. Even if a random sampling procedure is used to obtain participants, they
must be given the opportunity to decide if they are willing to participate
without any form of coercion involved. 
There must be no penalty for not participating.  Potential research participants must be
informed that they may withdraw from a study at any time and for any reason
without penalty.  

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