Informed consent can be define as a legal documentrequired for a certain procedure or treatment in hospital. It also bring adefinition as a voluntary agreement made by a well-advice and mentallycompetent patient to be treated or randomized into a research study. It also carry a specific purpose according to thefield that it been used whether in medical field, or when conduct a researchstudy. In research study, informed consent is an important especially wheninvolving a human subject.
There is an act that have been carried from the pastthat must not be violence by the researcher. However, when human subject wasinvolved, there will usually have some ethical implication. Several issues withinformed consent when human subject was involved had been recognizes. It basedon these three basic principles for protection in human rights.
First isautonomy. Autonomy is the ability to make your own decisions about what to dorather than being influenced by someone else or told what to do. In this case, itis applied to all participant that they must be given the respect from theresearcher. They also must be given the suitable time especially when making adecision.
The researcher must be explain detail regarding information of thestudy in order for participant to decide the need to do or not doing the study.All decision making must be free from any persuasion, threatening and pressureto participate. Second is beneficence.It bring the meaning of the fact or quality of being kind or doing good. Inethical issues for protecting human right, beneficence is important in applyingat all participant. Researcher must be maximized the benefits to participantand minimized the possible harmful effects of participant. Some of thepotential risk are include psychological or physical harm, loss ofconfidentiality of participant, and also financial cost. All of the possibilityharm that might occur in the study must be explain clearly to the participantprior to sign the consent.
Justice is the lastbasic principle in order to protecting the human right. Justice is fairness inthe way that people are treated. Researcher must be fair in selecting theparticipant and in the process of recruiting the participant to participate thestudy. There must also be fair in distribution of benefits of participation inresearch. The researcher must particularly ensure there is no exploitation ofparticipant in the conduct of research. Indoing research, there are five main ethical pillars that must be followed byresearcher. First, minimize the risk of harm to participants. This principlestress on how a research should not harm participants by considering allaspects that could bring harm such as physical harm, psychological distress anddiscomfort, social disadvantage, financial status or an invasion ofparticipant’s privacy and anonymity.
Non-maleficence requires a high level ofsensitivity from the researcher about what constitutes “harm” (FordL., 2009). Discomfort and harm can be physiological, emotional, social and economicin nature (Burns N., 2005). By acknowledging these risk aspects, interventionsto avoid or minimizing the risk of harm could be taken by researcher. Second,attain informed consent from participants.
The idea of informed consent is oneof the foundations of research. Informed consent means the knowing consent of aperson without undue inducement or any element of force, extortion, duress orany other form of constraint or coercion. It is the researcher’s responsibilityto provide sufficient information in comprehensible and simple language on thebenefits and possible risks ahead of the participant’s involvement in theresearch, so that participant can make a well-informed judgement aboutparticipation.
Informed consent is not just a form, but a process, when it wasdone appropriately, 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. Thethird component of research ethics is by ensuring the anonymity andindividuality of research participants. Protecting anonymity of informationfrom participants means that either the researcher does not collect personalinformation of participants such as name, address, email, job, year of servicesor the researcher does not link individual responses with participants’identities. Unless it is necessarily essential to the aimed protocol,participant’s personal details should be keep ‘anonymous’ to protect theparticipant confidentiality. Nonetheless, permission should be obtained beforeany confidential information is used. Forthprinciple of research ethics is to reject any kinds of deceptive practices.
Deceptive may not be seen as an issue if an informed consent has beenperformed, however the question is, how can the participants know what theresearch requires of them if they are being deceived? this question makes theuse of deceptive practices in doubt. Therefore, dissertation research shouldavert any types of deceptive practices. However, deception is sometimes beingallowed in covert research where the identity of the observer and the purposeof the research is not known to participants. This is most likely to be thecase where a research needs an observation rather than through direct contactwith participants, for example; observing what type of customers who likegiving tips in the tip jar.Lastly,allowing the participants to withdraw is one of the principles of researchethics that should be followed by researcher. Participants should have theright to withdraw from the research process at any stage and when the decisionto withdraw was made, the participant should not be pressured or coerced in anyway in order to stop them from withdrawing.
According to Good Clinical Practice(GCP) guidelines, an individual can withdraw from research at any time withoutrevealing the reason of discontinuation. Thesebasic principles of research ethics should be taken into account whenperforming a research as it can help to ensure that researchers can be heldaccountable to the public, in terms of human right, social responsibility andpublic health and safety. Researchers should be reminded that any ethicallapses in research can significantly harm the subjects and result to alow-quality research study.