1. religous dogma. The individual whosigned the

1. 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 subjects. Itis when a 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). The informed consentprocess is where the participant is informed regarding all aspects of the trial, which are importantfor the participant to make a decision and after studying all aspects of the trial, the participantvoluntarily confirms his or her willingness to participate in a particular clinical trial and significanceof 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 doneproperly. Misunderstandings between the researchers and the participants will result due tocommunication barriers such as language differences and religous 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. Besides that, otherissue is the participants may have a false expectation regarding the research. 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). In addition the participant’s perception regarding the research might affect the process ofobtaining the informed consent because they afraid of the consequences of the research on them. Inthis case, disclosing information to them might scare them away.2. Discuss the major ethical principles that guide researchers in their works.Principles of research ethics• respect for persons (autonomy) – entails two requirements: firstly, individuals should betreated as autonomous agents, capable of deciding for themselves about important personalmatters. Accordingly, subjects should only be involved in research if they have given theirvoluntary consent and been fully informed about the nature, purpose and consequences ofthe study. Secondly, individuals whose autonomy is diminished as a result of externalcircumstances, or their physical or mental condition, require special protection. With regardto a research project, this protection needs to be adapted to individual circumstances,ensuring that the persons concerned are not involved in research which could be harmful forthem.• Beneficence – is the duty to ensure the welfare of the persons concerned. This means anobligation firstly to avoid harm and secondly to maximise possible benefits. But here adilemma arises: to avoid risks, one needs to know what is harmful. This knowledge, in turn,depends on evidence obtained from studies. Thus, in order to discover what is actuallybeneficial for patients, it may be necessary to expose them to risks.• Justice – is concerned with the distribution of burdens, risks, chances and benefits todifferent persons and groups, and with the question of what exactly is “owed” to anindividual. The first element raises the question, for example, who should receive thebenefits of research and who should bear its burdens. The second asks, for example, to whatextent people whose condition may differ markedly should be recognised as equals andtreated accordingly.The elements of informed consent plays an important role in the informed consen

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