Informed consent is a fundamental ethical requirements for researchwith human subjects where subject voluntarily agrees to participate in a researchstudy in which he or she has full understanding of the study before the studybegins (Nieswiadomy, 2014). It is the process where the participant is informedregarding all aspects of the trial, which are important for the participant tomake a decision and after studying all aspects of the trial, The participant voluntarily need to confirmshis or her willingness to participate in a particular clinical trial andsignificance of the research for advancement of medical knowledge and socialwelfare (Nijhawan et al., 2013) The informed consent process might createor result several ethical issues if it is not being done properly.
Misunderstandings between the researchers and the participants will result dueto communication barriers such as language differences and religious dogma. Theindividual who signed the informed consent is assumed to have fully understandthe information that is stated in the consent form but it is difficult toevaluate the level of understanding in the individual’s point of view.Therefore, there might some degree of misunderstanding that might occur.
Other issue is theparticipants may have a false expectation regarding the research. Moreover, the participants might getinvolved in research projects that they did not approve of due tomisunderstandings or misinterpretation concerning the experimental procedures(Escobedo et al., 2007). The participant’s perception regarding theresearch might affect the process of obtaining the informed consent becausethey afraid of the consequences of the research on them.
This might scare themaway. In order to preventissues related to informed consent to occur when doing research, the majorelement of informed consent need to be included which are researcher isidentified and credentials presented; subject selection process is described;purpose of study is described; study procedures are discussed; potential risksare described; potential benefits are described; compensation, if any, is discussed;alternative procedures are disclosed, if any; anonymity or confidentiality isassured; right to refuse to participate or to withdraw from study withoutpenalty is assured; offer to answer all question is made; and means ofobtaining study results is presented. 2. Discuss the major ethical principles that guideresearchers in their works. There are three fundamental principles of research ethics accordingto Swiss Academy of Medical Sciences (2015) which are respect for persons or autonomy, beneficence and justice.The principle of respect for person or autonomy consists of two requirementswhich is first, the individuals should be treated as autonomous which means that theindividual capable of making their own decision about important personal matters.
The individual should only be involved in research if they have voluntarilygive their consent and been fully informed about the nature, purpose andconsequences of the research. Therefore the participants’ right need to be respected so thatthey can make their own decision whether to participate in the research. The principle ofautonomy is people with diminished autonomy should be protected which is the protection needs to be adapted to individualcircumstances, ensuring that the persons concerned are not involved in researchwhich could be harmful for them with regard to a research project.
This isbecause some people in society may not have the capacity to make fully informeddecisions. Beneficence is the act that is donefor the benefit of others or a duty to ensure the welfare of the personsconcerned. The research should do no harm and maximize benefits forparticipants and minimize risks for participants. The purpose of the researchis to discover new information that would be helpful for the society in future.It shouldn’t causeharm to anyone or find out information at the expense of other people.
There isdilemma arises from the researcher in this case because to avoid the risks, theresearcher needs to know what is harmful. The evidence obtained from the studywill show whether it is beneficence or not. In order to identify what canbenefit the patients, it may be necessary to exposed them to risks although theresearchers are obligated to do their best to minimize those possible risks andto maximize the benefits for participants. The last fundamental principal isjustice which is deals with the concept of fairness that is the distribution ofburdens, risks, chances and benefits.
Participants need to be treated withequal respect and concern where the benefits of the research will be shared,where feasible withall of those affected by its results. The participants will not beexcluded from research for reasons unrelated to the research. Researchers willbe cognizant of, and works to mitigate, imbalances in power between themselvesand participants, among individual participants, or between participants andthe groups to which they belong. Otherthan the three previously mentioned fundamental principles of research ethics,there are also five basic ethical principal (Laerd, 2012) which are minimisingthe risk of harm, obtaining informed consent, protecting anonymity andconfidentiality, avoiding deceptive practices and providing the right towithdraw. The research that will be conducted must not give harm to theparticipants’ physically, psychologically, socially, financially and/or affecttheir privacy and anonymity. Researchers need to focus on these elements inorder to minimising the risk of harm. Obtaining the informed consent fromthe participant is essential for the researcher for their study. Informedconsent is needed to make sure the participants is fully understand that theyare taking part in the research study and what the research requires of them.
All of the elements that should beincluded in the informed consent need to be fully delivered to the participantsand they should fully understand the consent. The participation of theindividuals should be voluntary without being influence by any person orsubjects. The anonymity and confidentiality of the participant need to beprotected as previously mentioned in the anonymity principal in the fundamentalof research ethics. The fourth principal is to avoiddeceptive practices. This can occur when the researcher provide false orincomplete information to the participants for the purpose of misleadingresearch subjects. Dissertation research should avoid any kinds of deceptivepractice while in the covert research, deception is sometimes a necessarycomponents.
Coverts research reflects research where the identity of theobserver and/or the purpose of the research is not known to participants. The last principal is providing the participants the right towithdraw from the research study. The participants should have the right towithdraw themselves from the research study anytime. They should not bepressured or coerced in any way to try and stop them from withdrawing.