Describe the meaning of informed consent, and identify issues relating to it in research onhuman subjects.Informed consent is a fundamental ethical requirements for research with human subjectswhere subject voluntarily agrees to participate in a research study in which he or she has fullunderstanding of the study before the study begins (Nieswiadomy, 2014). It is the process where theparticipant is informed regarding 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 toconfirms his or her willingness to participate in a particular clinical trial and significance of theresearch for advancement of medical knowledge and social welfare (Nijhawan et al., 2013) Theprocess might create or result several ethical issues if it is not being done properly.
Misunderstandings between the researchers and the participants will result due tocommunication barriers such as language differences and religious dogma. The individual whosigned the informed consent is assumed to have fully understand the information that is stated in theconsent form but it is difficult to evaluate the level of understanding in the individual’s point ofview. Therefore, there might some degree of misunderstanding that might occur. Moreover, theparticipants might get involved 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 the research might be affect the process of obtainingthe informed consent because they aware of the consequences of the research on them and thismight scare them away.In order to prevent issues related to informed consent to occur when doing research, themajor element of informed consent need to be included which are researcher is identified andcredentials presented; subject selection process is described; purpose of study is described; studyprocedures are discussed; potential risks are described; potential benefits are described;compensation, if any, is discussed; alternative procedures are disclosed, if any; anonymity orconfidentiality is assured; right to refuse to participate or to withdraw from study without penalty isassured; 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 ofMedical Sciences (2015) which are respect for persons or autonomy, beneficence and justice. Theprinciple of respect for person or autonomy consists of two requirements which is first, theindividuals should be treated as autonomous which means that the individual capable of makingtheir own decision about important personal matters.
The individual should only be involved inresearch if they have voluntarily give their consent and been fully informed about the nature,purpose and consequences of the research. The participants’ right need to be respected so that theycan make their own decision whether to participate in the research. The principle of autonomy ispeople with diminished autonomy should be protected which is the protection needs to be adaptedto individual circumstances, ensuring that the persons concerned are not involved in research whichcould be harmful for them with regard to a research project. This is because some people in societymay 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 ofthe persons concerned. The research should do no harm and maximize benefits for participants andminimize risks for participants. The purpose of the research is to discover new information thatwould be helpful for the society in future.
It shouldn’t cause harm to anyone or find out informationat the expense of other people. There is dilemma arises from the researcher in this case because toavoid the risks, the researcher needs to know what is harmful. The evidence obtained from the studywill show whether it is beneficence or not. In order to identify what can benefit the patients, it maybe necessary to exposed them to risks although the researchers are obligated to do their best tominimize those possible risks and to maximize the benefits for participants.
The other principal is justice which is deals with the concept of fairness that is thedistribution of burdens, risks, chances and benefits. Participants need to be treated with equalrespect and concern where the benefits of the research will be shared, where feasible with all ofthose affected by its results. The participants will not be excluded from research for reasonsunrelated to the research. Researchers will be cognizant of, and works to mitigate, imbalances inpower between themselves and participants, among individual participants, or between participantsand the groups to which they belong.Other than the three previously mentioned fundamental principles of research ethics, thereare also five basic ethical principal (Laerd, 2012) which are minimising the risk of harm, obtaininginformed consent, protecting anonymity and confidentiality, avoiding deceptive practices andproviding the right to withdraw.
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 tofocus on these elements in order to minimising the risk of harm.Obtaining the informed consent from the participant is essential for the researcher for theirstudy. Informed consent is needed to make sure the participants is fully understand that they aretaking part in the research study and what the research requires of them.
All of the elements thatshould be included in the informed consent need to be fully delivered to the participants and theyshould fully understand the consent. The participation of the individuals should be voluntarywithout being influence by any person or subjects. The anonymity and confidentiality of theparticipant need to be protected as previously mentioned in the anonymity principal in thefundamental of research ethics.The fourth principal is to avoid deceptive practices. This can occur when the researcherprovide false or incomplete information to the participants for the purpose of misleading researchsubjects. Dissertation research should avoid any kinds of deceptive practice while in the covertresearch, deception is sometimes a necessary components.
Coverts research reflects research wherethe 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.