Obtaining inform consent is a necessary process for theresearcher to proceed in their research study.
Informed consent is an ethicaland legal requirement for an individual who is participating in a researchstudy. It is the action where all participants are provided sufficientinformation on the study, adequate opportunity for the participant to askquestions and answered. The languages that use in informed consent must bewritten in terms that they can understand.
Inform consent is usually in the formof document signed by the subject and relevant research information, such asthe purpose of the study, expected duration of study, experimental procedure tobe undertake, benefits and potential risks of participation, also important forthe participant to make decision and confirms for individual willingness toinvolve in peculiar clinical trial and significance of the study foradvancement of medical knowledge and social welfare. The subject must be givenenough time to consider participation. The informed consent document should bealtered when the shortage is noted or when additional information will improvethe consent process. However, obtaining informed consent may sound simple enough,but there are some challenges and little attention has been paid to theseissues while preparing the consent on human subjects.
The first challenge is language barrier. Some of theparticipant that singing the consent form may or may not have a fullunderstanding or understanding in wrong way of what is stated on the consentforms given. Furthermore, some of the individual signs the consent form withoutgiving full attention to what they are singing. Nonetheless, it is quiteimpossible to identify every person’s angle of understanding since there is nospecial formula to measuring the individual understanding level. Thismisunderstanding can occur by reason of inadequate or incorrect languagetranslations. This problem not only affects the future participants to use upthe information but also may affect decision they are going to make. The second challenge that researcher may face to obtaininginformed consent is when a study involves children.
The research study thatrequire the participation of children who are under 18 years old, permission orconsent must 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 of perception. Thepatient’s perception also can consider as one of the challenge to researcher.Some individuals believe that trial is a good for finding new things while somewill put an extra burden on them. They are afraid of the risk or side effect ofthe procedure. Obtaining an informed consent from such person is most difficultand challenge for researcher.
The informed consent is purposed to distribute to everyparticipant the feel free to decide whether “do” or “do not” to be involved ina research study. Some of individual’s decision toward to participating in aresearch study may influence by the religious. IntroductionUnderstandings of these ethical principles are crucial forresearchers because they need to follow the predetermined rules that set asguide to conduct their research. Besides that, researchers use these ethicprinciples to support their outcomes regarding how to treat their researchparticipants and the information that they collect from them.According to Lund Research Ltd (2012), there are four majorethical principles that used to conducting research including beneficence,informed consent, anonymity and confidentiality, and avoiding deceptivepractices.
BeneficenceBeneficence is indicated to the requirement of theresearcher to maximizing benefits for the every participant and at the sametime minimizing harm to the every participant. There are some examples ofbenefits and harm that the participants can be experienced. The major benefitsto participants are pleasure because they are able to express their feeling bytalk about their problem without bias and feeling satisfaction that theinformation that they provide may help the study while the major potential harmto participants are body harm, mental distress and psychological discomfort.Therefore, the first principle focus to the essential for researchers to workof free from biases, prejudices, and researchers need to understand clearlythat their work is might cause effect to the someone’s lives. Informed Consent Beforetaking the informed consent, participants must understand that they are one ofthe parts in the research and should know what researchers need from them. Inthe inform consent, they must written 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 alsoneed to include the contain details such as demands in the studies, uneasinessof participants, risk and difficulty that the participants may experience.Anonymity and confidentiality Definition of anonymity is protecting the participants.
Eventhough the researchers that conducting the study also cannot make assumptionsabout whom the informers according to information provided. Whileconfidentiality means prevention and protection from leakage of informationregarding a participant’s identity to other than authorized individuals. Basedon Data Protection Act (1998), as an ethical principle, each individual isprivileged to be given privacy and confidentiality protection by protectingtheir personal identity and secret data. Besides that, they are also given theopportunity to decide on time and 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 method ofthe procedure that honest, clear as transparent and reasonable and mostsignificant is the process must be independent according to research protocols.Justice also determines of benefits and obstruction of the research. It isessential to conduct the study carefully and must be free from biased that harmto the research.
This principle is aimed to ensuring that no deviation anddiscrimination against participants.