Informed consent in the research is the voluntary agreementof the participant before they are been included and joining the research thatbeen conducted. The aim of this informedconsent is to ensure the participants is provided with the sufficient knowledgeand information before decising to enrol in the study. In the informed consent, the participant areexplained about their rights, the purpose and the benefits of study that theybeen agreed enrolled in.
They are also been explained and understanding aboutthe risks that they may be faced in when agreed in the study. The informedconsent is not just the papers that need the participant’s signatures, it is aprocess that include the study’s purpose, duration, experimental procedures,alternatives, risks and benefits. All the details and explanations in theinformed consent should be written in the understandable language by theparticipants. The participants are allowed not to agree and withdraw from thestudy before sign the informed consent.
The issue that always occurred relating to the informedconsent on human objects is language barrier. The candidate of participants areassumed fully understanding with the study that been conducted due the signs ofthem in the informed consent. This understanding cannot be proved to there areno methods that have been established to measure the level of understanding ofthe participants. As the consequence, the participants tend to withdraw inongoing the study because not well understanding the study although had signthe informed consent.The false expectations from the participants also one of theissues developed in the informed consent’s matters. The misunderstanding canoccurred due the participants are expecting something different from theoutcome of the study. A few may fear that they will become and treated like anexperimental model for the studies while others may be influenced by history ofclinical trial that been fraud for them. Their expectations of the study arehindering them from fully understanding the study.
In the study that need the children who is under age of 18to be part of the participants, the issue is occurred relating the informedconsent when the children need their parent consent in agree to be part of theresearch. It is an arguable situation where the children are able to be part ofthe research because they have the rights to understand and refuse for theparticipation if they want to. The difficulty is occurred when the parents aregiven consent although the children are not willing to do so.For the vulnerable groups that need to include in theresearch, the issue relating consent may occurred due to they will may notfully understanding of the research that will be conducted. The vulnerablegroup is the person that absolutely not capable of protecting their interestsuch as person with learning disabilities.
Hence, taking the consent from thisgroup will be difficult and need of special care in order to ensure theappropriate strategies can be developed.