Obtaining consent document should be altered when the

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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


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.

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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


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.


Astra Nova . (2016). Retrieved from 5 COMMON CHALLENGES WHEN

5 Common Challenges When Obtaining Informed Consent in Clinical Research

Escobedo, C., Guerrero, J., Lujan, G.,
Ramirez, A., & Diana. (n.d.). Retrieved from Ethical Issues with Informed
Nijhawan, L. P., Janodia, M. D.,
Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., et al. (2013).
Retrieved from Informed consent: Issues and challenges:
Shahnazarian, D., Hagemann, J., Aburto,
M., & Rose, S. (n.d.). Retrieved from Office for the Protection of
Research Subjects (OPRS):

Categories: Languages


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