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.
There are three fundamental principles of research ethics that can be used by the researchersin their work which are respect for persons or autonomy, beneficence and justice. The principle ofrespect for person or autonomy consists of two requirements which is first, the individuals shouldbe treated as autonomous which means that the individual capable of making their own decisionabout important personal matters. The individual should only be involved in research if they havevoluntarily give their consent and been fully informed about the nature, purpose and consequencesof the research. Therefore the individuals’ right need to be respected so that they can make their owndecision whether to participate in the research.
The second requirements in the principle ofautonomy is people with diminished autonomy should be protected. This protection needs to beadapted to individual circumstances, ensuring that the persons concerned are not involved inresearch which could be harmful for them with regard to a research project. This is because somepeople 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 ofthe persons concerned.
This principal states that the research should do no harm and maximizebenefits for participants and minimize risks for participants. The purpose of the research is todiscover new information that would be helpful for the society in future. It should never cause harmto anyone or find out information at the expense of other people. There is dilemma arises from theresearcher in this case because to avoid the risks, the researcher needs to know what is harmful. Theevidence obtained from the study will show whether it is beneficence or not.
In order to identifywhat can benefit the patients, it may be necessary to exposed them to risks although the researchersare obligated to do their best to minimize those possible risks and to maximize the benefits forparticpants.The last principal is justice which is deals with the concept of fairness that is the distributionof burdens, risks, chances and benefits. Several elements need to be considered by the researcherwhen doing their research. All the participants need to be treated with equal respect and concernwhere the benefits of the research will be shared, where feasible, with all of those affected by itsresults. Other than that, the participants also 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 pariticpants , or between participantsand the groups to which they belong.