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Informedconsent is a formed signed by a participant as voluntary agreement toparticipate in research. As essential in ethical codes and rules in research,it purpose is to protect confidentiality of someone whom willing to taking partin a study. The principles of informed consent is known as autonomy,beneficence and justice. There is some issues related to informed consent onhuman research subject. The biggest problem is language barriers.
As we know, Informedconsent is required before someone volunteer to take part in a research. Itshould be present directly in a simple language. The purpose is to ensure it iseasily understood and not mistaken during the interpretation or translation.More than just an agreement that need to be signed, it is actually content informationin which someone has to understand the process of the research and its potentialrisks. All participant was assumed tounderstand the informed consent once it was signed but misunderstanding stillcan occur because incorrect or inadequate information. Most of the subject orparticipant signing the informed consent without being fully aware or not fullyunderstand what it is all about.
Poor translation is one of the factor. So,researcher must performed informed consent in more than one language.Asmention in The Belmont Report and the Nuremberg Code, voluntary informedconsent is a fundamental for the ethical conduct of human subject research. Therefore,some elements should be included in an informed consent. The elements shouldinclude is all this component for all human subject research such astherapeutic studies, interventional studies, diagnostic studies, social studiesand behavioral studies. A good informed consent also provide information to thesubject about his rights, the purpose and objective of the study, the flow ofthe procedures, and explanation regarding the potential risks and benefits ofparticipation.
Not only physical injury but also possible psychological,social, or economic harm, discomfort, or inconvenience Subjects feel free toparticipate or not. Statement regarding the subjects’ right to confidentialityand right to withdraw from the study at any time without any consequences. Personto contact for answers regarding any question related to research or studyshould be clearly mentioned.Anothercommon issues is religious influence. Aparticipant’s decision making sometimes influenced by their religious belief.Hence, not all subject willing to taking part in research voluntarily.
Informed consent is important tool in researchand no any research activity will be carried out until it is complete.Another issues related to human subjects is false expectations and false perceptions. Although explanation andinformation was clearly provide and given, most of participant-to-be fear of being as experimental model or hadrumors known to them regarding the misconduct or failure of the study.
Vulnerable people and groups includethe person who is absolutely or relatively incapable of protecting theirinterests. As the example prisoners, children under age, pregnant ladies,geriatric or disable people .To obtain informed consent is difficult to getfrom them. So that they are creating many problem because their misunderstandingregarding the research purpose, their role in the research and the process ofthe research. Hence, special approach must to be taken to develop theappropriate strategies to communicate properly with them and to make sure thatthe message is delivered clearly. 2) Discussthe major ethical principles that guide researchers in the works.Researchis usually done using human beings with feelings and experiences.
Method ofdata in some studies also touched confidential, emotional, rights, personalthings, and the truth of the subjects. Respondents have secret or confidentialinformation, which cannot be known by others. When disclosed or announced willhave a negative impact on certain parties, researchers need to know the ethicsof research before planning and conducting research.Ethicsis derived from the Greek word meaning “ethos” which means the commonsense that is commonly matched by systematic studies of the concept of ‘good’,’bad’, ‘right’ and ‘wrong’. Ethical issues are the dilemmas and conflicts thatmay arise on a ‘suitable’ method for conducting research. Ethics determine whatcan be done by a researcher and things cannot be done by the researchers.
Basedon ethics in research, a researcher must:a) ResearchParticipant Protectionb) Confidentialityof Research Participant Informationc) PowerOptions for Engagement in Research / Issue Coerciond) InitialExplanation About Research / Informed Consente) AvoidingDeceptive Practices a) ResearchParticipant ProtectionDuringresearch, participating participants should be protected against any negativeeffects that may be either physically or mentally. Allow sufficient time forthe respondent to answer questions and not ask questions that embarrass, orcause emotional turmoil unpleasant experiences. Hence, the researcher mustfully inform the subject of any possible occurrence during the research. b) Confidentialityof Research Participant InformationAnyparticipant’s information should be protected from the general publicinformation unless the participants have given written consent that allows theresearcher to disclose such information to the public. For example, in surveysurveys, respondents’ names need not be stated. Researchers should neverdisclose information about the sample of the study until it can interfere withthe safety or dignity of the respondents.
Personal rights must be protected andcannot be known c) PowerOptions for Engagement in Research / IssueParticipant has the right to be involvedin or not in research, without compulsion. Although elected, the participant isentitled to withdraw from involvement in the research at any time, with orwithout any reason. d) InitialExplanation About Research / Informed ConsentAninitial explanation should be given to the participants about the research theywill participate in so they can choose whether to engage or not in theresearch. One of the measures to ensure ethics in research is through the useof an informed consent form.
The form must be read and signed by theparticipant or guardian/parent (if it involves a child). e) Avoidingdeceptive practicesResearchers must clearlydisclose the data and findings, explaining the procedure of the investigationand publishing status with honesty. Researchers absolutely cannot falsify dataor attempt to deceive colleagues or involved agencies and the general publicabout them. It is unethical if a researcher only refers to and reports theliterature that is in agreement with the problem and avoids any other study.For example, if a researcher enters financial aid for his study it is likelythat it will exaggerate the importance of his research and wilfully does notrefer to a study that does not support his request.
(Gay & Diehl, 1992:96;Forcese & Richer, 1973:5) Good researchfeatures include scientific and ethical perspectives. Issues become morepronounced in social research where the subject is a human who has feelings,intellect and is influenced by social and religious values. Research such asweapons is neutral but human beings determine whether it is used to advancesociety or destroy it.