Informed consent definition is a
process that the participant is informed about all aspect of the research trial
so that the participant can study all the aspect of the trial before making an
informed decision about whether or not to join in the study and participate in
that particular study. Informed consent makes research on humans is ethical. It
is required as a way for researchers respect individual autonomy, the right to make a decision.
According to Emanuel EJ at al., before
participant is enrolment in a clinical trial, the informed consent of the
subject is ethically required. It is required for most of the human subject
research like therapeutic, diagnostic, interventional, social and behavioural
studies. The elements of informed consent
involves what is the objective of the study, participant’s rights,
procedure that will be taken during clinical trial, what the benefit of the
research and the risk of the research to participation and to the society, the
duration of the study to be undertaken to gain the willingness of the subject
and statement indicating that participation is voluntary and if they refuse to participate, they will not get in any consequences or any loss
of benefits that they should receive.
Informed consent must be clearly written in simple and language easily
understood by the participant, medical terms, scientific and technical must be
defined in simple way, may not include exculpatory language and the subject must
be given enough time to consider their willingness in participation. There are
many types of informed consent such as consent, parental permission, assent, verbal,
short form, information, waiver of documentation of informed consent and waiver
of an element of informed consent.
However, there has some issue and
barrier in informed consent in research
on the human subject. One of the challenges is language. Sometimes, the
participant didn’t understand the content of consent when they sign the consent
because of different level of knowledge and misunderstanding occurs like
limited English proficiency. Escobedo C at al state that many of the
participant just sign the consent form without being fully understand and fully
aware of what they are signing about . Other than that, religious Influence
gives negative effects that might experience due to religious beliefs when
participating in researcher projects like Jehovah Witnesses. This group
believes they can’t receive any blood transfusion and organ donation due to
their belief and can alter the accuracy of research and availability of informed consent associated with medical
treatment among them. False expectations in the participant also lead to
misunderstanding when some of them think they would be an experiment object in
the clinical trial and some of them have the fear due to the past history like
trauma make the informer consent not efficient to the participant and
researcher. This will give the problem to the researcher in their study.
When conducting a research involving
the children below 18 years old, the informed consent must be sign by their
parent and must take permission from them because the child didn’t have the
right and ability to make self-decision, in receive information and accept their
opinion in research study . The problem happens when the parent gives
permission without their children willingness to participate. Vulnerable groups like disabilities people can lead to
the problem in get the informed consent because of potentially they didn’t
understand what the research’s about due to disability such as learning
disability, delay development and others disabilities that required another
Ethical principles are means the researches need be taken into account
when performing the research. The example of basic principles in research is
the researches need to obtain informed consent from participants, minimizing
the risk of harm, protect anonymity and confidentiality, avoiding deceptive
practices and providing the right withdraw.
MINIMISING THE RISK OF HARM
The researches cannot harm the participants or make them in discomfort
positions. The type of means harm to the participants include physical harm to
participants, psychological distress and discomfort, social disadvantage, harm
to participant’s financial and also disturbs the participant’s privacy.
OBTAINING INFORMED CONSENT
When invite the participants in research, the informed consent must be
apply to them. The researchers must be explained to the participants whom they
are taking part in research, about the purpose and what the research required.
Other that the participant must be explains about the purpose of the research
and the methods being used also the possible outcomes of the research. So, from
this can get the respond from participants either can looks there are not
comfortable or agreeable to involve. The participants must be volunteers also taking
part without having been coerced and deceived.
PROTECTING ANONYMITY AND CONFIDENTIALITY
The information by participants must be protect anonymity and
confidentially. The participants only are willing to volunteer information
especially about private and sensitive nature which the researchers agree to
hold in confidence. It’s required to remove identifiers for example names and
geographical cues or provide proxies when writing up.
AVOIDING DECEPTIVE PRACTICES
The identity of the observer and the purpose of the research are not
known to participants where it’s not feasible to let everyone in a particular
research setting know what you are doing. The researchers will involve
observation rather than direct contact with the participants.
PROVIDING THE RIGHT TO WITHDRAW
In the principles of providing the right to withdraw, research
participants should always have the rights to withdraw from research process. That’s
mean they have the right to withdraw at any stage in the research process. If
the participants chooses to withdraw from the researches process, they should not
be pressured or coerced in any way to try stop them from withdrawing because
they have right to withdraw anytime.