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1.      Describe
the meaning of informed consent and identify issue relating to it in research
on human subjects

The voluntary informed consent are basic
requirement in for a participation of the subject in the research. To be more
specific, informed consent is a set of voluntary agreement which indicate the
willing of the subject to participate on the study. The subject, or participant
need to know what the research is about and also the risk that they may face
before signing the informed consent. Researcher need to inform clearly to the
subjects about his or her right, the purpose of the study, the procedures that
will be done, and the benefit and the potential risk in participation before
signing an informed consent. The participant need to know the information in
order to make decision whether he or she want to participate in the study or
not. Usually, the informed consent document must be written in the language
that easily understood by the participant so that they will get the information
clearly and not misunderstood. Also, participant need to be given sufficient
time to make decision and considering participation.

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Informed consent is the process which
researcher respect individual autonomy, basic ethical principle. Individual
autonomy is capable of deliberation and personal choice. Responsibility must be
given to an individual to make their own decision and choice according to the
principles of autonomy. Informed consent for human subject not only for safety,
respect, and protection of the subject itself, but also the integrity of the
research also according to Nuremberg Code.

But,
there was some issue related with informed consent such as, failure to
re-consent when new information become available, failure to provide copies of
the form to the subject, using the expired form or non- validated from, missing
consent form, and many more. But there was a way how to overcome it, example
like if using expired form, this type of form need to be thrown immediately copies of expired or outdated
documents should be destroyed, and electronic copies should be moved to archive
folder on computer.

No research can be conducted if
researcher didn’t get any informed consent from the participants. There was few
challenges in informed consent process. One of them is language barrier. We
will assumed that participant who signing up understand about the research.
Many of them sign the informed consent without knowing exactly or not fully
aware on what they are signing and it will give an effect withdrawal from the
study. Thus, it was researcher responsibility to explain in very simple
language to make participant fully understand what they are doing and what
going to happen to them in research.

Another challenges in informed consent
was patient perception. Sometimes, participant feel that trial research will
put a burden to them because they afraid with the new treatment and the unknown
effect for them. To get informed consent from this type of patient was quite
difficult. Another challenges in getting the informed consent is, if the researcher
want the children to be their subject.

If the subject was a children,
researcher or investigator must get the permission from their parent (children
under 18 years old). But, if the children more than 7 years old, “child assent”
is also mandatory. The biggest challenge is, if the parent give the permission
but the children don’t want to participate.

 

 

 

2.      Discuss
the major ethical principles that guide researchers in their works

The major ethical
principles that guide researcher in their works covers some principle. One of
them is autonomy. Informed consent is one of the way which
participant right autonomy was protected. Beauchamp and Childress defined
autonomy as an ability to make decision according to the personal action. It
also protect participant or patient integrity, personal liberty and veracity.
There was several types of ethical principles that guide researchers in their works.
It was, informed consent, protection of participant, confidentiality, and
withdrawal from investigation. For informed consent, researcher or investigator
should obtained informed consent from the participant. Before the study was
conducted, researcher need to explain the whole process of the study, and also
get permission from parents if the subject less than 18 years old. The
information that participant needs to be informed include, purpose of the
study, any risk and discomfort to the participant, procedure in the research,
length of the time that participant need to be participated and the participant
right to withdraw from the research anytime if they cannot continue with the
study.

For protection of participants,
researcher have to make sure during conducting the study with participant, they
must avoid distress to participant. Researcher cannot embarrassed, frighten or
harm the participant. If researcher decided to do the research for the
vulnerable group such as old people, disabled or children, they must give extra
care for them. For example, if researcher used children as a subject,
researcher need to do as brief as they can because children tend to have
limited attention or easy to get tired and limited attention span.

Other than that was
confidentiality. The data gained from the participant must keep it anonymous
unless if their give their full consent. And lastly the withdrawal from an
investigation. If the participant feel uncomfortable, they have a right to
withdraw from the study anytime they want. At the beginning when explaining
about research to the participant, researcher need to tell them also, that they
can withdraw from research with no obligation. Other than that, the basic
principles was beneficence. It is more to balancing the harm and benefit.
Another principles was justice. It more in selecting participant with no bias.

 

 

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