THE MEANING OF INFORMED CONSENT AND INDENTIFY ISSUES RELATING TO IT IN RESEARCH
ON HUMAN SUBJECTS.
According to Jessica (2014), informed consent can be defined as a
process for getting permission before conducting any intervention or procedure
on a person, or for disclosing personal information. It means that it’s one of the process in
which the patient or participant are participate in some research project after
being informed of its procedure including the risk and benefits as stated by Bulger
(2002). Nowadays, there are many ethical issues regarding the informed consent
that can be entwined. In rare circumstances, these may or can be ad litem to be
appointed by the court. Having an awareness of these issue’s example as below
is crucial for both researchers and participants. Misunderstandings concerning
the experimental procedures can lead participants to get involved in research
projects that they don’t approve of. So, according to Crisool et. al (2010), these issues are mostly related
to language barriers and false expectations.
Language plays important
role in the communication between second and third party as it could affect
direct healthcare delivery (Crane,1997). From the informed consent taken, it is
assume that the individual who signs the consent form does with full of
understanding for each sentence stated . However , it is difficult to identify
the percentage of patient’s understanding since there is no establish method to
measure the level of understanding towards the information given to the
participant. So, it can be assumed that there is a degree of misunderstanding
that occur. In other word, the participants or individuals merely sign the
consent form without being fully aware of what they are dealing with. According
to Appelbaum et al. (1982), research
subjects systematically misrepresent the risk/benefits ratio of participating
in research as the study found that more than half participants failed to
understand the meaning of randomization. Most probably the consent is written
in the English and those misunderstanding crises increased with patient who
have limited English proficiency.
According to the Gueerro
(2014), he stated that informed consent has to be given in a language that is
understood by the participant or their representative. However the
misunderstanding still occur because of the quality of interpretation is poor.
Research has shown that the use of untrained translator in clinical setting
tend to make frequent errors as consequences in dangerous misinterpretations
Expectation is the outcome
that the participant’s desire to achieved. Even there such perfect in conveying
the information or no other religious impediments to the communication
relationship between researcher and participant, the misunderstanding can still
occur because of the false expectation of the projects or experiment outcome.
Lee et al. (2001) stated that
intermediate and advance stage patients respectively were given the consent
form with general information about the stem cell transplant and their
treatment. They were ask to complete the survey concerning about the
expectations. The physician were asked to complete a survey concerning the
likelihood of the treatment success.
This study found the disagreement between patient and physician
expectation 48%-93% of the survey. Patient mostly found to have higher
expectation about the treatment they are receiving from the physicians. Patient
in higher disease level would also hope for miracle to happen in the treatment.
As the result of the study show the patient hopes and expectations did not
reflect them of fully understand on what they were consenting to before the
procedure although they were aware of
potential treatment-related deaths as well.
2. DISCUSS THE MAJOR ETHICAL PRINCIPLES
THAT GUIDE RESEARCHERS IN THEIR WORKS.
According to Beauchamp
et. al (2001), there are 4 main ethical
principle of study that guided researchers to use these principle in conducting
their research and the data that are gathered. These are:
Respect for autonomy.
Respect for autonomy can be defined as requirement to ensure that
research participants are entirely free to make a choice about their
participation in a research study (Beauchamp et. al, 2001). It means that the
participant must be given an adequate information about the conducted research
and what participation are involves. They also must be free from any influence
or coercion. Duncan (2015) stated that the principle of non-maleficence must be
applied to any researchers which they have an obligation not to inflict any
harm on their study participant. For example, asking a question that can cause
distress or discomfort to the participant. Therefore, these particular care
should be stressed to ensure that these research are properly conducted. In the
beneficence ethical principle, it has two elements which is positive
beneficence and utility beneficence. This is according to Yoshino (2008) which
he stated that positive beneficence are doing positive good in the sense that
research has some value of scientifically and educationally, for example,
address an necessary and important question. Meanwhile, he also stated that
utility beneficence are refers to the researcher’s requirement in ‘balances and
drawback’ to produce or generate the best overall results, for example, make an
assessment whether the benefits of the research are justify the level of
effort, costs, and risk of harm to the participants. Lastly, the ethical
principle of justice can refers as an
equal and fair distribution of resources, analysis based and the burdens of the
decisions (Rich, 2008). It means that treating people equally and fairly to
ensure that they are accorded their full rights.
For example, many participants
are willing to participate in research, and to take on the considerable burden
often associated with clinical research, in the same time they are not exposed
to economic harm by engaging in the research. Therefore, all these ethical
principle that are outlined are well acknowledged and respected by most of the
researchers should pay attention to this issue so that participants can be
better informed and have greater exposure about the informed consent
documents that they are required to sign. Furthermore, researchers should take
all the steps necessary to ensure that participants fully understand what is
being stated in the consent form.