1. DESCRIBETHE MEANING OF INFORMED CONSENT AND INDENTIFY ISSUES RELATING TO IT IN RESEARCHON HUMAN SUBJECTS. According to Jessica (2014), informed consent can be defined as aprocess for getting permission before conducting any intervention or procedureon a person, or for disclosing personal information. It means that it’s one of the process inwhich the patient or participant are participate in some research project afterbeing informed of its procedure including the risk and benefits as stated by Bulger(2002).
Nowadays, there are many ethical issues regarding the informed consentthat can be entwined. In rare circumstances, these may or can be ad litem to beappointed by the court. Having an awareness of these issue’s example as belowis crucial for both researchers and participants. Misunderstandings concerningthe experimental procedures can lead participants to get involved in researchprojects that they don’t approve of. So, according to Crisool et.
al (2010), these issues are mostly relatedto language barriers and false expectations. Language plays importantrole in the communication between second and third party as it could affectdirect healthcare delivery (Crane,1997). From the informed consent taken, it isassume that the individual who signs the consent form does with full ofunderstanding for each sentence stated . However , it is difficult to identifythe percentage of patient’s understanding since there is no establish method tomeasure the level of understanding towards the information given to theparticipant.
So, it can be assumed that there is a degree of misunderstandingthat occur. In other word, the participants or individuals merely sign theconsent form without being fully aware of what they are dealing with. Accordingto Appelbaum et al.
(1982), researchsubjects systematically misrepresent the risk/benefits ratio of participatingin research as the study found that more than half participants failed tounderstand the meaning of randomization. Most probably the consent is writtenin the English and those misunderstanding crises increased with patient whohave limited English proficiency. According to the Gueerro(2014), he stated that informed consent has to be given in a language that isunderstood by the participant or their representative.
However themisunderstanding still occur because of the quality of interpretation is poor.Research has shown that the use of untrained translator in clinical settingtend to make frequent errors as consequences in dangerous misinterpretations(Vasquez, 1991).Expectation is the outcomethat the participant’s desire to achieved. Even there such perfect in conveyingthe information or no other religious impediments to the communicationrelationship between researcher and participant, the misunderstanding can stilloccur because of the false expectation of the projects or experiment outcome.Lee et al.
(2001) stated thatintermediate and advance stage patients respectively were given the consentform with general information about the stem cell transplant and theirtreatment. They were ask to complete the survey concerning about theexpectations. The physician were asked to complete a survey concerning thelikelihood of the treatment success.
This study found the disagreement between patient and physicianexpectation 48%-93% of the survey. Patient mostly found to have higherexpectation about the treatment they are receiving from the physicians. Patientin higher disease level would also hope for miracle to happen in the treatment.
As the result of the study show the patient hopes and expectations did notreflect them of fully understand on what they were consenting to before theprocedure although they were aware ofpotential treatment-related deaths as well. 2. DISCUSS THE MAJOR ETHICAL PRINCIPLESTHAT GUIDE RESEARCHERS IN THEIR WORKS. According to Beauchampet.
al (2001), there are 4 main ethicalprinciple of study that guided researchers to use these principle in conductingtheir research and the data that are gathered. These are:· Respect for autonomy.· Non-maleficence.· Beneficence.· Justice. Respect for autonomy can be defined as requirement to ensure thatresearch participants are entirely free to make a choice about theirparticipation in a research study (Beauchamp et. al, 2001).
It means that theparticipant must be given an adequate information about the conducted researchand what participation are involves. They also must be free from any influenceor coercion. Duncan (2015) stated that the principle of non-maleficence must beapplied to any researchers which they have an obligation not to inflict anyharm on their study participant. For example, asking a question that can causedistress or discomfort to the participant. Therefore, these particular careshould be stressed to ensure that these research are properly conducted.
In thebeneficence ethical principle, it has two elements which is positivebeneficence and utility beneficence. This is according to Yoshino (2008) whichhe stated that positive beneficence are doing positive good in the sense thatresearch has some value of scientifically and educationally, for example,address an necessary and important question. Meanwhile, he also stated thatutility beneficence are refers to the researcher’s requirement in ‘balances anddrawback’ to produce or generate the best overall results, for example, make anassessment whether the benefits of the research are justify the level ofeffort, costs, and risk of harm to the participants. Lastly, the ethicalprinciple of justice can refers as anequal and fair distribution of resources, analysis based and the burdens of thedecisions (Rich, 2008).
It means that treating people equally and fairly toensure that they are accorded their full rights. For example, many participantsare willing to participate in research, and to take on the considerable burdenoften associated with clinical research, in the same time they are not exposedto economic harm by engaging in the research. Therefore, all these ethicalprinciple that are outlined are well acknowledged and respected by most of theresearcher. Thus,researchers should pay attention to this issue so that participants can bebetter informed and have greater exposure about the informed consentdocuments that they are required to sign. Furthermore, researchers should takeall the steps necessary to ensure that participants fully understand what isbeing stated in the consent form.