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 intervention. ETHICAL PRINCIPLES 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 HARMThe 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 CONSENTWhen 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 CONFIDENTIALITYThe 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 PRACTICESThe 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 WITHDRAWIn 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.