Informed consent can be defined as a legal document required for acertain procedure or treatment in hospital. It also brings a definition as avoluntary agreement made by a well-advice and mentally competent patient to betreated or randomized into a research study. Italso carries a specific purpose according to the field that it been usedwhether in medical field, or when conduct a research study. In research study,informed consent is an important especially when involving a human subject.There is an act that have been carried from the past that must not be violenceby the researcher. However, when human subject was involved, there will usuallyhave some ethical implication.
Several issues with informed consent when humansubject was involved had been recognizes. It based on these three basicprinciples for protection in human rights. First is autonomy. Autonomy is theability to make your own decisions about what to do rather than beinginfluenced by someone else or told what to do. In this case, it is applied toall participant that they must be given the respect from the researcher.
Theyalso must be given the suitable time especially when making a decision. Theresearcher must be explained detail regarding information of the study in orderfor participant to decide the need to do or not doing the study. All decisionmaking must be free from any persuasion, threatening and pressure toparticipate. Second is beneficence.
It brings the meaning ofthe fact or quality of being kind or doing good. In ethical issues forprotecting human right, beneficence is important in applying at allparticipant. Researcher must be maximized the benefits to participant andminimized the possible harmful effects of participant. Some of the potentialrisk are include psychological or physical harm, loss of confidentiality ofparticipant, and also financial cost.
All of the possibility harm that mightoccur in the study must be explain clearly to the participant prior to sign theconsent. Justice is the last basic principle in order toprotecting the human right. Justice is fairness in the way that people aretreated. Researcher must be fair in selecting the participant and in theprocess of recruiting the participant to participate the study. There must alsobe fair in distribution of benefits of participation in research. Theresearcher must particularly ensure there is no exploitation of participant inthe 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 warrant that researchers can be heldaccountable to the public, in terms of human right, social responsibility andpublic health and safety. Researchers should always be reminded that anyethical breaks in research can significantly harm the subjects and result to alow-quality research study.