Informed consent 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 enroll in the study and participate in that particular study. Informed consent makes research involving humans is ethical. It is required as a way for researchers respect individual autonomy, the fundamental ethical principle.
According to Emanuel EJ at al., before 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 behavioral studies. The elements of informed consent involves the purpose of the study, subject rights, procedure that will be taken, 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 voluntary of the subject and statement indicating that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the subject is otherwise entitled to 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 lay terms, may not include exculpatory language and the subject must be given sufficient time to consider their 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 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 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 people and groups like disabilities people can lead to the problem in obtained 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 intervention.