Obtaining inform consent is a necessaryprocess for the researcher to proceed withtheir research study. Informed consent is an ethical and legal requirement foran individual who is participating in a research study.
It is the action whereall participants are provided sufficient information on the study, adequateopportunity for the participant to ask questions and answered. The languagesthat use in informed consent must be written in terms that they can understand. Inform consent is usually in the form of document signed by the subject andrelevant research information, such as the purpose of the study, expectedduration of study, experimental procedure to be undertake, benefits andpotential risks of participation, also important for the participant to makedecision and confirms for individual willingness to involve in peculiarclinical trial and significance of the study for advancement of medicalknowledge and social welfare. The subject must be given enough time to considerparticipation. The informed consent document should be altered when theshortage is noted or when additional information will improve the consentprocess. However, obtaining informed consent maysound simple enough, but there are some challenges and little attention hasbeen paid to these issues while preparing the consent on human subjects. The first challenge is a language barrier.
Some of the participant thatsinging the consent form may or may not have a full understanding orunderstanding in the wrong way of what isstated on the consent forms given. Furthermore, some of the individual signsthe consent form without giving full attention to what they are singing. Nonetheless, it is quite impossible to identify every person’s angle ofunderstanding since there is no special formula formeasuring the individual understanding level. This misunderstanding can occurby reason of inadequate or incorrect language translations. This problem notonly affects the future participants to use up the information but also mayaffect decision they are going to make.
The second challenge that researcher mayface to obtaining informed consent is when a study involves children. Theresearch study that requires theparticipation of children who are under 18 years old, permission or consentmust be obtained from their parents or guardian. If the child is more than 7 years old, it ismandatory for “ child assent”. Which is children are capable of becomingpartners in research and that they have right to get information. The majorchallenge that arises when parents or guardian agrees and gives theirpermission to everything while child refuses to participate. There are so many different ways ofperception.
The patient’s perception also can consider as one of the challenges to the researcher. Some individuals believe that trial is a good forfinding new things while some will put an extra burden on them. They are afraidof the risk or side effect of the procedure. Obtaining an informed consent fromsuch person is most difficult and challenge for the researcher. The informed consent is purposed todistribute to every participant the feel free to decide whether “ do” or “ donot” to be involved in a research study. Some of individual’s decision towardto participating in a research study may influence by the religious. Understandings of these ethical principlesare crucial for researchers because they need to follow the predetermined rulesthat set a guide to conduct theirresearch.
Besides that, researchers use these ethic principles to support theiroutcomes regarding how to treat their research participants and the informationthat they collect from them. According to Lund Research Ltd (2012), there are four major ethical principles that used to conducting researchincluding beneficence, informed consent, anonymity and confidentiality, andavoiding deceptive practices. BeneficenceBeneficence is indicated to the requirementof the researcher to maximizing benefits forevery participant and at the same time minimizing harm to every participant.
There are some examples ofbenefits and harm that the participants can be experienced. The major benefitsto participants are a pleasure becausethey are able to express their feeling by talkingabout their problem without bias and feeling satisfiedthat the information that they provide may help the study while the majorpotential harm to participants is bodily harm, mental distress, and psychological discomfort. Therefore, thefirst principle focus on the essentialfor researchers to work of free from biases, prejudices, and researchers needto understand clearly that their work is might cause the effect onthe someone’s lives. Informed Consent Beforetaking the informed consent, participants must understand that they are one ofthe parts of the research and should knowwhat researchers need from them.
In the inform consent, they must write that information regarding the purpose ofthe study, the method that they used to conduct the research, the possibleresult, and conclusion of the study. Furthermore, in the informed consent also need to include the contain detailssuch as demands in the studies, the uneasinessof participants, risk, and difficultythat the participants may experience. Anonymity and confidentiality Definition of anonymity is protecting theparticipants. Even though the researchers that conducting the study also cannotmake assumptions about whom the informers according to information provided. While confidentiality means prevention and protection from leakage ofinformation regarding a participant’s identity to other than authorizedindividuals. Based on Data Protection Act (1998), as an ethical principle, eachindividual is privileged to be given privacy and confidentiality protection byprotecting their personal identity and secret data. Besides that, they are alsogiven the opportunity to decide on a timeand how the information is being held or shared. Avoiding deceptive practices Toavoid deception in research, researchers need to practice justice andcomprehensive in their works.
In this point, justice refers to fairness andintegrity for every participant in research. Justice is shown through the method of the procedure that honest, clear astransparent and reasonable and most significant is the process must beindependent according to research protocols. Justice also determines benefitsand obstruction of the research. It is essential to conduct the study carefullyand must be free from biased that harm to the research.
This principle is aimedat ensuring that no deviation anddiscrimination against participants.?
