• The Journal of Korean Medicine
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• v.43 no.1
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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.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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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.

• Journal of Korean Academy of Nursing Administration
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• v.15 no.3
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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.

• The Korean Society of Law and Medicine
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• v.10 no.1
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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.

• Journal of Research and Publication Ethics
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• v.3 no.2
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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.

• Journal of Korean Clinical Nursing Research
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• v.16 no.3
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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.

• 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.

• 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 agricultural medicine and community health
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• v.31 no.1
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• pp.35-46
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• 2006

Objectives: In recently. the management and protection on individual information in patient's medical & nursing records have been very important, and that need a guideline. The purpose of this study was to investigate the status of using the patient's nursing records of nursing students in clinical practice, to find and discuss the patient's informed consent, and status of education and management concerned to patient's nursing records. Methods: This study used a mailing survey. data collected from September 24th to October 31th in 2002. The subject were 333 professors who are major in adult nursing, pediatric nursing, psychological nursing of 111 university of nursing department and nursing college. And then we received the survey mail from 103 professors that respondent rate was 30.9%. Results: The characteristics of study subjects showed 49.0% of university. 51.0% of college of nursing. 50.0% of the subjects practiced point the patient by oral approval in clinical practice. But when the decision of the patient was very difficult, 21.6% of the subjects take to informed consent from his or her families. During the clinical practice, 49.0% of the subjects were explain to patient about clinical practice and contents of the nursing student, only 7.8% of the subjects were explain to patient with nursing records. 52.0% of the subjects were took out records from the hospital, only 17.6% of the subjects had standard of the patient's informed consent and standard of handling practice records. 17.6%-92.2% of the subjects that educate and manage concern to patient's nursing records.