Informed consent can be describedas a protected document required for a certain procedure or treatment inhospital. It also brings a definition as a voluntary agreement made by awell-advice and mentally competent patient to be treated or randomized into a researchstudy. It also carries aspecific purpose according to the field that it been used whether in medicalfield, or when conduct a research study. In research study, informed consent isimportant especially when involving a human subject.
There is an act that havebeen agreed from the past that must not be violence by the researcher. However,when human subject was involved, there will usually have some ethical inference.Severalissues with informed consent when human subject was involved had beenrecognizes. It based on these three basic principles for protection in humanrights.
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First is autonomy. Autonomy is the ability to make your own decisionsabout what to do rather than being influenced by someone else or told what todo. In this case, it is applied to all participant that they must be given therespect from the researcher. They also must be given the suitable timeespecially when making a decision.
The researcher must be explained detailregarding information of the study in order for participant to decide the needto do or not doing the study. All decision making must be free from anypersuasion, threatening and pressure to participate. Secondis beneficence. It brings the meaning of the fact or quality of being kind ordoing good. In ethical issues for protecting human right, beneficence isimportant in applying at all participant.
Researcher must be maximized thebenefits to participant and minimized the possible harmful effects ofparticipant. Some of the potential risk are include psychological or physicalharm, loss of confidentiality of participant, and also financial cost. All ofthe possibility harm that might occur in the study must be explain clearly tothe participant ahead of their agreement to join the research. Justiceis the last basic principle in order to protect the human right.
Justice isfairness in the way that people are treated. Researcher must be fair inselecting the participant and in the process of recruiting the participant toparticipate the study. There must also be fair in distribution of benefits ofparticipation in research. The researcher must ensure that the participants arenot being exploited for the sake of the research study. In doing research, there are five main ethicalpillars that must be followed by researcher. First, minimize the risk of harmto participants.
This ethical pillar stress on how a research should not harmparticipants by considering all aspects that could bring harm such as physicalharm, psychological distress and discomfort, social disadvantage, financialstatus or an invasion of participant’s privacy and anonymity. Non-maleficencerequires a high level of sensitivity from the researcher about what create”harm” (Ford L., 2009).
Discomfort and harm can be physiological,emotional, social and economic in nature (Burns N., 2005). By acknowledgingthese risk aspects, interventions to avoid or minimizing the risk of harm couldbe taken by researcher. Second, attain informed consent fromparticipants. The idea of informed consent is one of the foundations ofresearch. Informed consent means the knowing consent of a person without undueinducement or any element of force, extortion, duress or any other form ofconstraint or coercion. It is the researcher’s responsibility to providesufficient information in comprehensible and simple language on the benefitsand possible risks ahead of the participant’s involvement in the research, sothat participant can make a well-informed judgement about participation.Informed consent is not just a form, but a process, when it was doneappropriately, the process assures that participants are willinglyparticipating in the research with full knowledge and information of relevantrisks and benefits.
In some cases, that involve people with low autonomy suchas young children, very ill people or mentally disables, they could only beincluded in research under specific circumstances, as they not able to makefully informed decisions on their own. They should always be protected. The third component of research ethics is byensuring the anonymity and individuality of research participants. Protectinganonymity of information from participants means that either the researcherdoes not collect personal information of participants such as name, address,email, job, year of services or the researcher does not link individualresponses with participants’ identities. Unless it is necessarily essential tothe aimed protocol, participant’s personal details should be keep ‘anonymous’to protect the participant confidentiality. Nonetheless, permission should beobtained before any confidential information is used.
Forth principle of research ethics is to rejectany kinds of deceptive practices. Deceptive may not be seen as an issue if aninformed consent has been performed, however the question is, how can theparticipants know what the research requires of them if they are beingdeceived? this question makes the use of deceptive practices in doubt.Therefore, dissertation research should avert any types of deceptive practices.However, deception is sometimes being allowed in covert research where theidentity of the observer and the purpose of the research is not known toparticipants. This is most likely to be the case where a research needs anobservation rather than through direct contact with participants, for example;observing what type of customers who like giving tips in the tip jar.Lastly, allowing the participants to withdrawis one of the principles of research ethics that should be followed byresearcher.
Participants should have the right to withdraw from the researchprocess at any stage and when the decision to withdraw was made, theparticipant should not be pressured or coerced in any way in order to stop themfrom withdrawing. As stated in Good Clinical Practice protocol, an individualcan withdraw from research at any time without revealing the reason of suspension.These basic principles of research ethicsshould be taken into account by researcher when performing a research as it canhelp to ensure that researchers feel accountable to the public, in terms ofhuman right, social responsibility and public health and safety. Researchersshould be reminded that any ethical lapses in research can significantly harmthe subjects and result to a low-quality research study.