Informed consent because they afraid of the consequences

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Informed consent because they afraid of the consequences

Informed consent is a fundamental ethical requirements for research with human subjects. It is when a subject voluntarily agrees to participate in a research study in which he or she has full understanding of the study before the study begins (Nieswiadomy, 2014). The informed consent process is where the participant is informed regarding all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial, the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare (Nijhawan et al., 2013) The informed consent process might create or result several ethical issues if it is not being done properly. Misunderstandings between the researchers and the participants will result due to communication barriers such as language differences and religous dogma. The individual who signed the informed consent is assumed to have fully understand the information that is stated in the consent form but it is difficult to evaluate the level of understanding in the individual’s point of view. Therefore, there might some degree of misunderstanding that might occur. Besides that, other issue is the participants may have a false expectation regarding the research. Moreover, the participants might get involved in research projects that they did not approve of due to misunderstandings or misinterpretation concerning the experimental procedures (Escobedo et al., 2007). In addition the participant’s perception regarding the research might affect the process of obtaining the informed consent because they afraid of the consequences of the research on them. In this case, disclosing information to them might scare them away. In order to prevent issues related to informed consent to occur when doing research, the major element of informed consent need to be included which are researcher is identified and credentials presented; subject selection process is described; purpose of study is described; study procedures are discussed; potential risks are described; potential benefits are described; compensation, if any, is discussed; alternative procedures are disclosed, if any; anonymity or confidentiality is assured; right to refuse to participate or to withdraw from study without penalty is assured; offer to answer all question is made; and means of obtaining study results is presented.2. Discuss the major ethical principles that guide researchers in their works. There are three fundamental principles of research ethics according to 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 requirements which is first, the individuals should be treated as autonomous which means that the individual capable of making their own decision about important personal matters. The individual should only be involved in research if they have voluntarily give their consent and been fully informed about the nature, purpose and consequences of the research. Therefore the individuals’ right need to be respected so that they can make their own decision whether to participate in the research. The second requirements in the principle of autonomy is people with diminished autonomy should be protected. This protection needs to be adapted to individual circumstances, ensuring that the persons concerned are not involved in research which could be harmful for them with regard to a research project. This is because some people in society may not have the capacity to make fully informed decisions. Beneficence is the act that is done for the benefit of others or a duty to ensure the welfare of the persons concerned. This principal states that the research should do no harm and maximize benefits for participants and minimize risks for participants. The purpose of the research is to discover new information that would be helpful for the society in future. It should never cause harm to anyone or find out information at the expense of other people. There is dilemma arises from the researcher in this case because to avoid the risks, the researcher needs to know what is harmful. The evidence obtained from the study will show whether it is beneficence or not. In order to identify what can benefit the patients, it may be necessary to exposed them to risks although the researchers are obligated to do their best to minimize those possible risks and to maximize the benefits for particpants. The last fundamenrtal principal is justice which is deals with the concept of fairness that is the distribution of burdens, risks, chances and benefits. Several elements need to be considered by the researcher when doing their research. All the participants need to be treated with equal respect and concern where the benefits of the research will be shared, where feasible, with all of those affected by its results. Other than that, the participants also will not be excluded from research for reasons unrelated to the research. Researchers will be cognizant of, and works to mitigate, imbalances in power between themselves and participants, among individual participants , or between participants and the groups to which they belong. Other than the three previously mentioned fundamental principles of research ethics, there are also five basic ethical principal (Laerd, 2012) which are minimising the risk of harm, obtaining informed consent, protecting anonymity and confidentiality, avoiding deceptive practices and providing the right to withdraw. The first principal is minimising the risk of harm. The research that will be conducted must not give harm to the participants’ physically, psychologically, socially, financially and/or affect their privacy and anonymity. Researchers need to focus on these elements in order to minimising the risk of harm. Obtaining the informed consent from the participant is essential for the researcher for their study. Informed consent is needed to make sure the participants is fully understand that they are taking part in the research study and what the research requires of them. All the elements that should be included in the informed consent need to be fully delivered to the participants and they should fully understand the consent. The participation of the individuals should be voluntary without being influence by any person or subjects. The anonymity and confidentiality of the participant need to be protected as previously mentioned in the anonymity principal in the fundamental of research ethics. The fourth principal is to avoid deceptive practices. This can occur when the researcher provide false or incomplete information to the participants for the purpose of misleading research subjects. Dissertation research should avoid any kinds of deceptive practice while in the covert research, deception is sometimes a necessary components. Coverts research reflects research where the identity of the observer and/or the purpose of the research is not known to participants. The last principal is providing the participants the right to withdraw from the research study. The participants should have the right to withdraw themselves from the research study anytime. They should not be pressured or coerced in any way to try and stop them from withdrawing.

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