• 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.

• Journal of Preventive Medicine and Public Health
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• v.40 no.2
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• pp.122-129
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• 2007

During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised important ethical concerns including genetic privacy, confidentiality, discrimination, and informed consent. Informed consent for biobank poses an important question: whether true informed consent is possible in population-based genomic cohort research where the nature of future studies is unforeseeable when consent is obtained. Due to the sensitive character of genetic information, protecting privacy and keeping confidentiality become important topics. To minimize ethical problems and achieve scientific goals to its maximum degree, each country strives to build population-based genomic cohort research project, by organizing public consultation, trying public and expert consensus in research, and providing safeguards to protect privacy and confidentiality.

• 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.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.111-140
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• 2019

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

• The Korean Society of Law and Medicine
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• v.10 no.2
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• pp.11-36
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• 2009

This thesis introduces the trends of korean courts' ruling on damages in medical malpractice cases for past 10 years. First of all, Korean courts' ruling have had a tendency to pay only non-economic damages for not taking the informed consent. If a doctor cannot get the informed consent from a patient, he compensate only non-economic damages for the infringement of self-determination rights of patient. It's enough for the plaintiff to prove the infringement of self-determination rights, if the plaintiff just want to get non-economic damages. The Korean Supreme court have ruled that if plaintiffs want to get economic damages for the infringement of self-determination rights or informed consent, plaintiffs must prove that the infringement of self-determination rights is the proximate cause of the economic damages of patient. There is another tendency for the Korean Supreme court to limit the damages in medical malpractice cases on the ground of patient's diseases' dangerousness or patient's idiosyncrasy. In the past courts often limit the damages only to 70~80% of total damages, but now a days courts mostly limit the damages to 20~30%. This thesis also introduce the Korean courts' trends about Valuing damages in personal injury actions awarded for gratuitously rendered nursing and medical care.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.249-293
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• 2012

Inter-hospital transfer, depending on its medical and legal appropriateness, affect the prognosis of patients and can even lead to legal disputes. As Emergency Medical Service Act, any physician shall, in case where deemed that pertinent medical service is unavailable for such patient with the capacities of the relevant medical institution, transfer without delay such patient to another medical institution where a pertinent medical service is available. For medico-legally appropriate inter-hospital transfer, the head of a medical institution shall, in case where he transfers an emergency patient provide medical instruments and manpower required for a safe transfer of the emergency patient, and furnish the medical records necessary for a medical examination at the medical institution in receipt of such patient. And transfer process must comply with the requirements prescribed by executive rule such as attachment of the referral, provision of ambulance, fellow riders and informed consent of transfer. Those engaged in emergency medical service shall explain an emergency medical service to an emergency patient and secure his consent. In addition to the duty to inform about emergency medical service to the patient and his or her legally representative, there is also a duty for doctors to sufficiently explain to the patient and his or her legally representative during inter-hospital transfer that the need for the transfer, the medical conditions of the patient to be transferred and emergency treatment that will be provided by the hospital from which the patient is going to transferred. Likewise, the hospital to which the patient is transferred must be thoroughly informed about matters such as the patient's conditions, the treatment the patient was given and reasons for transfer by transferring doctors.

• 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.

• 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.11 no.1
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• pp.397-445
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• 2010

This thesis introduces the trends of korean courts' ruling on damages in medical malpractice cases for past 10 years. First of all, Korean courts' ruling have had a tendency to pay only non-economic damages for not taking the informed consent. If a doctor cannot get the informed consent from a patient, he compensate only non-economic damages for the infringement of self-determination rights of patient. It's enough for the plaintiff to prove the infringement of self-determination rights, if the plaintiff just want to get non-economic damages. The Korean Supreme court have ruled that if plaintiffs want to get economic damages for the infringement of self-determination rights or informed consent, plaintiffs must prove that the infringement of self-determination rights is the proximate cause of the economic damages of patient. There is another tendency for the Korean Supreme court to limit the damages in medical malpractice cases on the ground of patient's diseases' dangerousness or patient's idiosyncrasy. In the past courts often limit the damages only to 70~80% of total damages, but now a days courts mostly limit the damages to 20~30%. This thesis also introduce the Korean courts' trends about Valuing damages in personal injury actions awarded for gratuitously rendered nursing and medical care.