• The Journal of KAIRB
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• v.6 no.1
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• pp.1-4
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• 2024

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

• The Korean Society of Law and Medicine
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• v.15 no.1
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• pp.123-164
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• 2014

Under the new system of 'Separation of pharmaceutical prescription and dispensing' in Korea, which was implemented in 2000, physician could not dispense a medicine, and outpatient should have a physician's prescription filled at a drugstore. After pharmacist makes up outpatient's prescription, National Health Insurance Service(NHIS) pay for outpatient's medicine to pharmacist, except an outpatient's own medicine charge. And NHIS only pay for outpatient's prescription fee to physician and, physician doesn't derive profit from dispensing medicine in itself. Nevertheless, if physician writes out a prescription with violation of 'Criteria for the Medical Care Benefits', NHIS clawed back the payment of outpatient's prescription and medicine from the physician or the medical institution which the physician belongs to. In the past, NHIS's confiscation was in accordance with 'the National Health Care Insurance Act, Article 52, Clause 1'. But, since 2006 when the Supreme Court declared that there was no legal basis on the NHIS's confiscation of outpatient's medicine payment, NHIS had put in a claim for illegal prescriptions on the basis 'the Korean Civil law, Article 750(tort)'. So, Many medical institutions filed civil actions against NHIS. The key point of this actions was whether the issuing outpatient prescriptions with violations of Criteria for the Medical Care Benefits constitute of the law of tort. On this point, the first trial and the second trial took different position. Finally the Supreme Court acknowledged the constitution of the law of tort in 2013. In this paper, the author will review critically the decision of the Supreme Court, and consider the relativeness between the legal effect of Criteria for the Medical Care Benefits and the constitution of the issuing outpatient prescriptions with violations of Criteria for the Medical Care Benefits as the law of tort.

• Journal of Korean Neurosurgical Society
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• v.47 no.1
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• pp.30-35
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• 2010

Objective: The purpose of this study is to explain the effect and reciprocal action among tumor necrosis factor (TNF) like weak inducer of apoptosis (TWEAK), fibroblast growth factor-inducible 14 (Fn14), and transforming growth factor-$\beta1$ (TGF-$\beta1$) on degeneration of human intervertebral disc (IVD). Methods: Human intervertebral disc tissues and cells were cultured with Dulbecco's Modified Eagle's Medium/Nutrient F-12 Ham (DMEM/F-12) media in $37^{\circ}C$, 5% $CO_2$ incubator. When IVD tissues were cultured with TWEAK, Fn14 that is an antagonistic receptor for TWEAK and TGF-$\beta1$, the level of sulfated glycosaminoglycan (sGAG) was estimated by dimethyl methyleneblue (DMMB) assay and sex determining region Y (SRY)-box 9 (Sox9) and versican messenger ribonucleic acid (mRNA) levels were estimated by reverse transcriptase polymerase chain reaction (RT-PCR). Results: When human IVD tissue was cultured for nine days, the sGAG content was elevated in proportion to culture duration. The sGAG was decreased significantly by TWEAK 100 ng/mL, however, Fn14 500 ng/mL did not change the sGAG production of IVD tissue. The Fn14 increased versican and Sox9 mRNA levels decreased with TWEAK in IVD tissue TGF-$\beta1$ 20 ng/mL elevated the sGAG concentration 40% more than control. The sGAG amount decreased with TWEAK was increased with Fn14 or TGF-$\beta1$ but the result was insignificant statistically. TGF-$\beta1$ increased the Sox9 mRNA expression to 180% compared to control group in IVD tissue. Sox9 and versican mRNA levels decreased by TWEAK were increased with TGF-$\beta1$ in primary cultured IVD cells, however, Fn14 did not show increasing effect on Sox9 and versican. Conclusion: This study suggests that TWEAK would act a role in intervertebral disc degeneration through decreasing sGAG and the mRNA level of versican and Sox9.

• Molecules and Cells
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• v.38 no.10
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• pp.886-894
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• 2015

Macrophages are divided into two subpopulations: classically activated macrophages (M1) and alternatively activated macrophages (M2). BCG (Bacilli Calmette-$Gu{\acute{e}}rin$) activates disabled $na{\ddot{i}}ve$ macrophages to M1 macrophages, which act as inflammatory, microbicidal and tumoricidal cells through cell-cell contact and/or the release of soluble factors. Various transcription factors and signaling pathways are involved in the regulation of macrophage activation and polarization. We discovered that BCG-activated macrophages (BAM) expressed a new molecule, and we named it Novel Macrophage Activated Associated Protein 1 (NMAAP1). 1 The current study found that the overexpression of NMAAP1 in macrophages results in M1 polarization with increased expression levels of M1 genes, such as inducible nitric oxide synthase (iNOS), tumor necrosis factor alpha (TNF-${\alpha}$), Interleukin 6 (IL-6), Interleukin 12 (IL-12), Monocyte chemoattractant protein-1 (MCP-1) and Interleukin-1 beta (IL-$1{\beta}$), and decreased expression of some M2 genes, such as Kruppel-like factor 4 (KLF4) and suppressor of cytokine signaling 1 (SOCS1), but not other M2 genes, including arginase-1 (Arg-1), Interleukin (IL-10), transforming growth factor beta (TGF-${\beta}$) and found in inflammatory zone 1 (Fizz1). Moreover, NMAAP1 overexpression in the RAW264.7 cell line increased cytotoxicity against MCA207 tumor cells, which depends on increased inflammatory cytokines rather than cell-cell contact. NMAAP1 also substantially enhanced the phagocytic ability of macrophages, which implies that NMAAP1 promoted macrophage adhesive and clearance activities. Our results indicate that NMAAP1 is an essential molecule that modulates macrophages phenotype and plays an important role in macrophage tumoricidal functions.

• Health Policy and Management
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• v.29 no.2
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• pp.105-111
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• 2019

On December 31, 2018, an incident occurred where a doctor was attacked and killed by a patient carrying a lethal weapon in the outpatients' clinic of the psychiatric department of a tertiary general hospital. The suspect was diagnosed with bipolar affective disorder (manic depressive disorder) and has been hospitalized and cared for in the psychiatric ward of this hospital. This incident illustrates the necessity of more active cures and therapeutic intervention for mental patients with intellectual developmental disorders who require treatment considering the fact that a radical outcome has been caused by such a patient. However, on the other hand, there is also a need for an approach and analysis from the perspective of crime prevention for all medical departments. The reason for this is that even a tertiary general hospital equipped with the largest human resources, medical devices, facilities, and so forth, is susceptible to violence. As for illegal actions perpetrated against health and medical service personnel in medical institutions, such as verbal abuse, assault, injury, etc. there have neither been understanding shown for the current extent of damage in detail, nor discussions of active institutional improvement related to the seriousness of the act. It can be said that violence in the field of medical treatment is a realm requiring serious discussion and appropriate remedial actions. This is because when such incidents take place, if a patient who is supposed to get treatment from the damaged health care provider is in an urgent situation or on the waiting list of serious cases, he or she could suffer serious damage caused by deprivation of treatment opportunity, or secondary damage might be caused to the patient and/or a guardian who can hardly have an opportunity to take action. Accordingly, in this review, we would like to help create the necessary conditions for both health and medical service personnel and patients/guardians, respectively, to provide and receive medical treatment in a more secure environment. Therefore, objective assessment of the institution and issues relating to this aforementioned incident and general cases of violence occurring in medical institutions, and by suggesting legal and institutional improvements and solutions.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.79-117
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• 2023

Among the healthcare-related judgments handed down in 2002, there was a significant ruling on the timing of the duty of explanation, stating that, in order to ensure the exercise of the patient's right to self-determination, the patient must be given time to consider and decide on the risks and side effects of a medical procedure in specific circumstances. In addition, in a case where an insurance company claimed unjust enrichment against a medical institution on behalf of its insureds, the court provided a clear standard by distinguishing between active and passive requirements regarding the need to preserve the right of subrogation of creditors. In the area of medical administration, there was a ruling that clarified that a medical institution's business suspension under the National Health Insurance Act is directed against the medical institution, a ruling that broadly recognized causation in a case of compensation for side effects of corona vaccination, and a ruling on the scope of a medical practitioner's license, such as the use of ultrasound devices by an oriental medicine practitioner. In a case involving a patient's claim for eviction from a medical institution, the court reviewed a ruling on just cause for termination of a hospitalization contract in relation to Article 15(1) of the Medical law.

• Korean Journal of Clinical Laboratory Science
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• v.48 no.2
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• pp.158-167
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• 2016

The requirements for medical laboratories ISO 15189 is examined in organization and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Medical services are provided from the areas of resource management, and pre-examination, examination and post-examination processes. The main goal of ISO 15189 accreditation is to improve the quality of laboratory services provided for patients and clinical users not only through compliance with consensually developed and harmonized requirements but also by adopting the philosophy of continual improvement using the Plan-Do-Check-Act cycle. Laboratory quality should be evaluated and improved in all steps of the testing process as the state-of-the art indicates that the pre- and post-analytical phases are more vulnerable to errors than the intra-analytical phase. The Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation body, provides medical laboratory accreditations for appropriate approaches to evaluating the competence of a medical laboratory in providing effective services to its customers and clinical users. Adoption of ISO 15189 in 2010s as a government policy has been delayed, and only 5 laboratories have been accredited to date in Korea. The medical laboratories should seek the adoption of ISO 15189 with a positive attitude for quality improvement and strengthening of international competitiveness.

• The Korean Journal of Pain
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• v.29 no.3
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• pp.164-171
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• 2016

Background: Nefopam has been known as an inhibitor of the reuptake of monoamines, and the noradrenergic and/or serotonergic system has been focused on as a mechanism of its analgesic action. Here we investigated the role of the spinal dopaminergic neurotransmission in the antinociceptive effect of nefopam administered intravenously or intrathecally. Methods: The effects of intravenously and intrathecally administered nefopam were examined using the rat formalin test. Then we performed a microdialysis study to confirm the change of extracellular dopamine concentration in the spinal dorsal horn by nefopam. To determine whether the changes of dopamine level are associated with the nefopam analgesia, its mechanism was investigated pharmacologically via pretreatment with sulpiride, a dopaminergic D2 receptor antagonist. Results: When nefopam was administered intravenously the flinching responses in phase I of the formalin test were decreased, but not those in phase II of the formalin test were decreased. Intrathecally injected nefopam reduced the flinching responses in both phases of the formalin test in a dose dependent manner. Microdialysis study revealed a significant increase of the level of dopamine in the spinal cord by intrathecally administered nefopam (about 3.8 fold the baseline value) but not by that administered intravenously. The analgesic effects of intrathecally injected nefopam were not affected by pretreatment with sulpiride, and neither were those of the intravenous nefopam. Conclusions: Both the intravenously and intrathecally administered nefopam effectively relieved inflammatory pain in rats. Nefopam may act as an inhibitor of dopamine reuptake when delivered into the spinal cord. However, the analgesic mechanism of nefopam may not involve the dopaminergic transmission at the spinal level.

• The Korean Society of Law and Medicine
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• v.18 no.2
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• pp.75-103
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• 2017

There are three types of benefits in the National Health Insurance Act of Korea. Those are the treatment benefit, statutory uninsured medical benefits and arbitrary uninsured medical benefits. Recently the Korea Supreme Court changed its past legal theory and permitted the arbitrary uninsured medical benefits under the strictly exceptional conditions. According to the Supreme Court's decision, the existence of procedural difficulty, the medical necessity and the patient's consent are necessarily required in order to allow the legal exceptions in arbitrary uninsured medical benefits. Among the three requirements, the doctor's explanation and the patient's fully informed consent are the most important essentials in this legal conflict. The requirement concerning the doctor's explanation and the patient's consent roles like a hole in the ice as a breathing hole in the arbitrary uninsured medical benefits. The most cases dismissed after Supreme Court Decision 2010DU27639, 27646 Decided June 18, 2012. were due to the defect of three requirements.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.207-229
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• 2019

It is a general recognition that more serious criminal acts in a certain area of society should be given more serious condemation than the same general crimnal act. In particular, considering the purpose of the medical treatment and the trust relationship between the doctor and the patient, the sexual violence by doctor in medical field can not be placed on the same line as that of the general public. But the special legislation to solve this through criminal legal sanctions is not desirable. The basic principle of criminal law ist ultima ratio, so the principle of supplementality. It means to try to solve by all possible means and finally to enter with punishment. A flat and hasty Reaction without the considering of the speciality of medical treatment will cause serious cracking in that area. In addition, it will not be able to expect desirable results in legal practice by breaking down the legal system. Rather, administrative regulation is more efficient than punishment sanctions. But the best way is autonomous control by members of the medical area. Penalties in criminal law must make an enterance at the last, and administrative regulation should be timely intervene in specific situations through diversification. In conclusion, state interventions should be farthest in order to proceed to autonomous control of medical area.