• 대한한의학회지
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• 제43권1호
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• pp.6-17
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• 2022

Objectives: This study describes the implementation of a training course that aimed to increase the competency of undergraduate students of Korean medicine at a single college to obtain informed consent and perform bee venom acupuncture using an objective structured clinical examination (OSCE). Methods: We developed and implemented a short training course for 111 fourth-year students of Korean medicine during their clinical rotation at the Department of Acupuncture and Moxibustion Medicine. Lectures were conducted on the effects of and hypersensitivity reactions to bee venom acupuncture, obtaining informed consent, performing skin test and bee venom acupuncture. Due to the COVID-19 pandemic, some students were offered online lectures, and some could not experience the performance of OSCE in person. A survey with 16 closed and three open questions was used to investigate self-efficacy, opinions about the online lectures, and the OSCE. Results: Out of 111 questionnaires, 104 were completed (94%). Students were generally satisfied with the online lectures and OSCE. For the subjective questionnaire about what was helpful in the training of bee venom acupuncture techniques and OSCE, the authenticity of the teaching method was recorded the highest. Conclusions: This study showed that online lectures were effective in teaching clinical skills of Korean Medicine. It is necessary to produce standard educational materials for clinical skills of Korean Medicine, and studies to analyze the reliability and validity of OSCE are needed.

• 의료법학
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• 제24권2호
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• pp.147-196
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• 2023

오늘날에는 기술의 발전으로 인간의 뇌에 직접 자극을 가하여 질병을 치료하거나 뇌파를 통해 직접 기계를 조정하는 것이 가능해졌다. 이러한 뇌신경과학기술은 비침습적으로 이루어질 수도 있으나 적어도 현재까지는 뇌에 직접 전극이나 마이크로칩을 이식하는 침습적 방법이 필요한 자극을 더 정확하게 가하거나 뇌파를 더 정밀하게 측정할 수 있다. 뇌심부자극술(DBS)의 경우 파킨슨병, 본태성진전증에 대해 안정적인 치료방법으로 인정받고 있으며, 그 외 알츠하이머나 우울증 등에도 활용할 수 있는지 연구가 진행중이다. 뇌-컴퓨터 인터페이스(BCI)의 경우 임상단계이지만 신경이 손상되어 신체를 움직이지 못하는 사람들의 신체기능을 대체하거나 재활치료를 지원하는 역할을 할 것으로 기대되고 있다. 문제는 이러한 침습적 뇌신경과학기술을 필요로 하는 사람들의 상당수는 질병 또는 신경 손상으로 인해 판단능력이 손상되어 있거나 의사표시를 제대로 할 수 없는 사람들인데 반해, 이 기술들을 이용한 시술은 고도의 침습적인 시술이어서 반드시 환자 본인의 동의를 필요로 한다는 것이다. 특히 뇌신경과학기술이 아직 임상시험단계에 머물러 있는 영역에서는 위험은 그만큼 커지고 이익은 불확실하기 때문에 이를 고려하여 수술을 받을지 여부를 판단할 수 있도록 더 충분한 설명이 이루어져야 한다. 환자에게 성년후견이 개시되어 있다면 성년후견인이 - 경우에 따라서는 법원의 허가를 받아 - 이 시술에 대한 동의를 대신할 수 있을 것이다. 성년후견이 개시되어 있지 않은 경우 환자의 판단능력이 손상되어 있거나 의사표시를 할 수 없는 경우가 문제이다. 우리 의료 실무에서는 환자가 동의할 수 없는 경우 환자의 보호자에게 동의를 받는 경향이 있지만, 환자의 보호자라는 개념은 우리법상 근거를 찾기 어려운 개념이어서 문제가 있다. 장기적으로는 환자의 배우자나 근친이 보충적으로 환자의 의료행위 동의대행권을 갖도록 법률상 규정하는 편이 타당할 것이다. 뇌신경과학시술을 받은 환자에게 부작용 등 손해가 발생한 경우도 검토를 요한다. 만일 환자에게 수술에 수반되는 위험에 대해 제대로 설명이 되지 않았다면 위자료 청구가 가능하다. 의료과실과 부작용 사이에 인과관계가 있다면 그 부작용에 대해서도 손해배상청구를 할 수 있다. 또한 BCI나 DBS 모두 뇌에 전극이나 마이크로칩등을 이식하고 이를 외부의 컴퓨터를 통해 제어하기 때문에 인체의식형 의료기기가 사용된다. 인체이식형 의료기기에는 제조물책임법이 적용되므로 그 결함으로 인해 부작용이 발생했다고 인정된다면 제조자에 대해서 손해배상을 청구할 수 있다. 최근 우리 의료기기법에는 인체이식형 의료기기 책임보험제도가 시행되어 피해자가 구제를 받을 가능성이 더 강하게 보장된다.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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• pp.265-269
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• 1994

A brief review is presented of the strengths and weaknesses of historical controls, data banks, and randomized trials in the evaluation of clinical treatment. Use of pre randomized versus postrandomized informed consent is discussed. Recommendations are made for the development of an appropriate clinical research strategy.

• 간호행정학회지
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• 제15권3호
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• pp.336-345
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• 2009

Purpose: The purpose of this study was to examine job status and job satisfaction among clinical research coordinators. Method: Subjects were 91 clinical research coordinators participating in clinical trials at hospitals in Korea. Data were collected from July to August, 2008 using a structured questionnaire that include informed consent, and question as pertaining to, general characteristics, job related characteristics, and job satisfaction. The collected data were analyzed using SPSS 12.0 version. Result: Almost half of the subjects were called as nurse researcher. Major tasks included participant screening (100%), participant scheduling (100%), and obtaining informed consent from participants (98.9%). The most difficult aspect of work was salary (28.6%). The mean score on the job satisfaction was 80.21 (range: 54.00-109.00). Item related to promotion ranked lowest in job satisfaction. There were significant differences in job satisfaction according to the type of hospital (t=-3.640, p<.001), title (t=7.894, p=.001), and route for information of CRC (t=4.970, p=.001). Conclusions: Subjects feel poorly compensated, unrecognized, and perceive a limited career path. These factors are likely to diminish job satisfaction over time. Attention to these aspects through education program and criteria for clinical research coordinators could be helpful.

• 의료법학
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• 제10권1호
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• pp.389-420
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• 2009

Main Issue of Supreme Court Decision 2005Da16713 Delivered on June 24, 2005 is about the duty of medical care in the interhospital transfer of patients. According to the above Supreme Court Decision, in the interhospital transfer of patients, the decision to transfer should make from the aspect of medical treatment. The hospitals and doctors keep the duty of medical care. In addition to the duty for hospitals/doctors to check the capacity and availability of the hospital to which the patient is transferred, there are also duties to inform about emergency medical service and to sufficiently explain the need for the transfer, the medical conditions of the patient to be transferred and the hospital from which the patient is transferred. 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. including information upon referral, completeness of medical records, patient monitoring and so on. The interhospital transfer requires the consent of doctor belonging to the hospital to which the patient is transferred after the consideration of capacity and availability of the hospital and the informed consent of patients or legal representatives.

• 연구윤리
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• 제3권2호
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• pp.1-5
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• 2022

Purpose: Various ethical issues arise in different stages of management and business marketing research. The current study aims to take look at practices that ensure informed consent, privacy and confidentiality, deception, and legal aspect in data management in procedures involved in marketing research. Research design, data and methodology: Literature content analysis was conducted for this research and the current author has investigated journal articles mostly to guarantee a high degree of content validity and to keep the advantages of qualitative content approach. The current study explores manifest topics regarding the ethical issues of business marketing research. Results: The current study found that ethical consideration needs to be similarly significant and learning from the previous researchers' approach to handling this issue is helpful for future research and is essential to have additional guidelines. Also, four findings (Lack of Informed Consent, Deception, Invasion of Privacy and Confidentiality, and Legal Data Management) indicate that marketing researchers need to consider before undertaking any project. Conclusions: Overall, the study presents practical suggestions though unexhausted. By raising these ethical marketing issues, consumer behavior disciplines will continue to expand and contribute positively towards attaining thoughts, feelings, and decisions that positively contribute to marketing research as the foundation for effective marking practices.

• 임상간호연구
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• 제16권3호
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• pp.73-84
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• 2010

Purpose: The purpose of this study was to investigate the ethical awareness and attitude of patients' families towards Do-Not-Resuscitate(DNR), and thus provide basic information required to develop Korean appropriate DNR instructions and practice informed consent for DNR. Methods: During April 2010, 219 patient family members visiting the hospital were surveyed using a questionnaire. Results: Most of the participants preferred DNR to meaningless treatment for incurable patients. They recognized the necessity of explaining DNR to the patient with a terminal disease. They also requested DNR orders for themselves if they were in the same medical condition. In making a DNR decision, the patient's family agreed and preferred that it reflect the opinion of the patient and the doctor in charge. They also agreed that treatment should be given with the best efforts even if a DNR decision had been made for the patient. Conclusion: To make a decision on DNR for a patient who is terminally ill or for whom survival is not possible, a practice of informed consent and guidelines for executing the DNR reflecting the patient's opinion are required.

• 대한한의학회지
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• 제45권1호
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• pp.182-201
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• 2024

Objectives: This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine. Methods: The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert. Results: Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed. Conclusions: The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

• 의료법학
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• 제13권2호
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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.

• 한국발생생물학회지:발생과생식
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• 제27권1호
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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.