• Korean Parent-Child Health Journal
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• v.6 no.1
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• pp.18-30
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• 2003

Congenital heart disease is the most frequently shown congenital disease among children, most of them can be corrected with operation. However, Patients and their parents need nursing intervention when they face this risky incident of operation. Therefore, parents' experiences are absolutely needed to plan nursing intervention to give practical help to the patients and their parents. The purpose of this study is to provide basic resources to develop a feasible intervention program for the parents by understanding the experiences related to the informed consent of cardiac surgery of their child. From January to June 2003, 10 parents of children patients with congenital heart disease were interviewed who filled out Operation Agreement before the primary operation after they are diagnosed as congenital heart disease in pediatric chest surgery of A hospital in Seoul. They were asked to give opinion regarding pre-operation needs and the interviewed information was analyzed. The results of this study are as follows : Firstly, they were asked what they felt before they were told about the operation of their children from the doctor before filling out the informed consent of operation. They felt 1) vague, 2) confusion of choose, 3) risky, 4) resented, 5) uneasy, 6) guilty, and 7) the burden of operation. Secondly, they were asked what they felt after they filled out the informed consent of operation and the doctor gave them detailed information on the operation of their children. They felt 1) confused, 2) responsible, 3) rejected, 4) angry, 5) plain, 6) to have hope, 7) trying to trust medical people, 8) that consolation is needed, and 9) conditional reduction of the burden of operation. Thirdly, followings are the categories of congenital parents' demand before operation based on the analysis of experiences related to the preparation of the informed consent of operation. 1) Information Demand (1) Anticipatory information (2) Concrete and precise information (3) Individual information 2) Support (1) Empathy (2) Parental supporting (3) Support of parents in the same situation 3) Education and consulting (1) Children-oriented Education (2) Consultation Considering the results of this study, parents of the child with congenital heart disease seem to have various emotional experiences related to filling out the informed consent and they need concrete and practical helps before cardiac surgery. This study proposes that systematic nursing intervention is needed according to the needs of the parents who have the child with congenital heart disease before operation in the field of child health nursing.

• Korean Journal of Medical Ethics
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• v.21 no.4
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• pp.344-359
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• 2018

The purpose of this study was to identify how patients with chronic kidney disease understand informed consent and related factors for clinical trials. Data from a paper-based survey was collected from July 1, 2017 to April 30, 2018. The subjects for this study were 85 adult patients with chronic kidney disease who were participating in clinical trials. Surveys were conducted by a tool modified from QuIC as designated by Joffe in 2001. The QuIC consists of two parts: objective and subjective cognition. These tools were modified for this study. The average score for the objective understanding (OU) of informed consent for clinical trials was 69.56; the average score for the subjective understanding (SU) of informed consent for clinical trials was 3.28. It was found that health literacy predicted OU (F=27.709, p<.001) while SU was predicted by additional information (F=-3.095, p<.003), question (F=13.603, p<.001), and informed consent (F=-4.833, p<.001). In conclusion, the results of this study indicate that the understanding of informed consent for clinical trials among patients with chronic kidney disease is relatively low. Accordingly, alternative methods that consider each patient's health literacy levels and related factors need to be considered in order to improve their understanding of informed consents during the clinical trial process.

• The Journal of Society for e-Business Studies
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• v.17 no.3
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• pp.43-60
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• 2012

This study reviews the life cycle models considering legal and technical characteristics of personal data respectively. Based on the reviews, this research proposes 'consent and management based model of personal data' which is applicable to the domestic IT companies. The model suggested in this paper has characteristics that 'Consent' and 'Management' factors are ㅁpositively considered, which is overlooked in the other models. The validity of the model is examined by two methods, validation of the model of excellence by contrast of the other models, and 'consent' and 'management' factors cover all the life cycle processes. Using this model, IT companies will be contributed to the analysis of the personal data utilization and the development of IT system protection.

• Journal of Arbitration Studies
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• v.30 no.4
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• pp.51-70
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• 2020

The Mediation-Arbitration hybrid is becoming more popular since it makes an amicable relationship and thorough statement possible. The Mediation-Arbitration hybrid has been used to take advantage of both dispute resolution methods. In a Med-Arb process, negotiating a resolution to disputes is attempted with a mediator's help. If the mediation ends in an impasse or issues remain unresolved, parties can move on to arbitration. Med-Arb can also be cost-effective when disputants hire one person to serve as mediator and arbitrator (Med-Arb-Pure). However, it can disturb the fairness and neutrality of arbitrators, and awards can be annulled. Indeed, "Award by Consent" is different from the "Med-Arb-Pure" process. Arbitrators easily confuse them. Only the parties settle on the arbitral proceedings' course, and the arbitrator can help them (award by consent). The role and skill of a mediator are different from an arbitrator's. Disputants have the right to use a mediator who specializes in mediation. Moreover, mediation communication confidentiality is the essential value of mediation, and this should be protected. Therefore, in the process of "Med-Arb," separation between mediating and arbitrating is a better choice to specialize in each expertise. In this process, "Med-Arb" can be an affordable, expeditious, proper, and effective method of resolving international commercial disputes and continuing ADR prime time.

• Development and Reproduction
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• v.27 no.1
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• pp.47-56
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• 2023

Despite the commercialization of Next generation sequencing (NGS) gene testing, only a few studies have addressed the various ethical and legal problems associated with NGS testing in Korea Here, we reviewed the normative issues that emerged at each stage of the wet analysis and bioinformatics analysis of NGS gene testing. In particular, it was in mind to apply various international guidelines and the principles of bioethics to actual clinical practice. Considering the characteristics of NGS testing, wet analysis of additional testing can be justified if presumptive consent is recognized. Furthermore, the medical relationship between diseases needs to be established and it should be clear that the patient would have given consent if the patient had been aware of the correlation between genes. At the stage of bioinformatics analysis, the question of unsolicited findings arises. In case of unsolicited and relevant findings, according to American College of Medical Genetics and Genomics (ACMG), a recognized relationship between genes and diseases needs to be established. In case of unsolicited and not-relevant findings, it is almost impossible to determine whether knowing or not knowing the findings is more beneficial to the patient. However, it seems to be certain that the psychological harm an individual may suffer from such information is likely to be greater if the disease is severe and if there is no cure. The list of genes for which the ACMG guidelines impose reporting obligations is a good reference for judgment.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.2
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• pp.248-252
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• 2012

This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.

• Korean Journal of Clinical Pharmacy
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• v.24 no.4
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• pp.265-271
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• 2014

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public's perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

• Clinical and Experimental Pediatrics
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• v.52 no.1
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• pp.1-5
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• 2009

Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Finally, criteria for the protection of children in clinical trials therefore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.

• Journal of Korean Academy of Nursing Administration
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• v.4 no.2
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• pp.475-487
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• 1998

This is a study to search for the ethical basis for valid informed consent of organ donors. It is an admirable action that a person give his own body part or organ as a gift to another person. The organ for transplantation can be removed only when the donor consents voluntarily to donation. It is recently proposed as the need for organ transplantation is increased that organs can be harvested although the consent of deceased cannot be obtained. This may raise many moral issues because human beings all have an unalienable right to control their own bodies. The principle of autonomy is usually regarded as an ethical basis for informed consent. However, some people criticize that the principle of autonomy requires a person and his decision to be autonomous (but there are many patients who aren't autonomous due to their confusion or unconscious condition in a clinical situation). or this principle can foster indifference to patients needing help: thus respect for principles of care and beneficence is necessary. When we consider the complexity of making a decision about organ donation. the principle of autonomy should be replaced by the principle of respect for individual autonomy. as expressed by Childress (1990). This principle requires the care givers to respect the client's individual decisions. The elements of informed consent are threshold elements: competence to understand and decide. voluntariness in deciding: information elements: disclosure of material information. recommendation of a plan. understanding of disclosure and recommendation: and consent elements: decision in favor of a plan. authorization of the chosen plan. In cases of living donors. the elements of competence and voluntariness are more important than the others. So only an adult can give a recipient his own body part. but it should be forbidden to harvest from minors or protected adults (i.e. developmentally disabled person However. when organs are removed from a cadaver donor. we ought to respect the donor's decision. So we ought to try to seek donor cards or any documents expressing the donor's opinion about organ transplant. All health care givers ought to disclose donor information about organ transplantation clearly enough for the donor to understand it and to be able to weigh the harms and benefits. We are going to propose 'the subjective standard' as the ethical standard of disclosure. This standard will assure that patients have enough information to be able to decide autonomously from their own position. Care givers have to consider the method of disclosure because donors can be influenced by it positively or negatively, Establishment of the Hospital Committee is recommended. because medical professionals will have a chance to discuss the procedure of decision and the validity of harvesting a organ from a person.

• The Korean Society of Law and Medicine
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• v.13 no.2
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.