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Rinsho Byori. The Japanese Journal Of Clinical Pathology[JOURNAL]

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[Infection Control from the Viewpoint of Medical Safety by Our Clinical Laboratory in TMDU Hospital].

Tohda S

Rinsho Byori · 2016 Mar · PMID 27363226

Infection control based on appropriate bacteriological examinations and information is important for medical safety. I present the activities performed by our clinical laboratory in Tokyo Medical and Dental University (T... Infection control based on appropriate bacteriological examinations and information is important for medical safety. I present the activities performed by our clinical laboratory in Tokyo Medical and Dental University (TMDU) Hospital. We detected and reported the first Japanese case of KPC-2 carbapenemase-producing Klebsiella pneumoniae, of which infection will be a serious problem in the near future in Japan. We examine the antigen and toxins of Clostridium difficile with an immunochromatographic method using not only stool specimens but also the colonies in order to improve the detection rate of the toxins. We perform PCR-based open reading frame typing of methicillin-resistant Staphylococcus aureus for molecular epidemiology. We also contribute to infection control through presenting information such as antibiograms and giving lectures to residents and medical staff.

[Review of Safety Management from Infection Control Perspectives--Chairmen's Introductory Remarks].

Yoshida H, Koshiba M

Rinsho Byori · 2016 Mar · PMID 27363225

The Japanese Society of Laboratory Medicine has been running its own Medical Safety Committee, and holding a symposium on medical safety during the annual meeting every year. Adopting a team approach to medicine plays a... The Japanese Society of Laboratory Medicine has been running its own Medical Safety Committee, and holding a symposium on medical safety during the annual meeting every year. Adopting a team approach to medicine plays a critical role in the development of medical safety culture and advancing medical safety in clinical practice. The infection control team plays a major role in team medical care. This time, the review of safety management from infection control perspective was discussed in the medical safety symposium, which is hoped will help advance medical and patient safety, leading to improvements in the quality of medical care.

[Relationship between Coronary Plaque Stability Evaluated by Intravascular Ultrasound and Laboratory Parameters].

Kawasaki M, Iwasa M, Kanamori H … +7 more , Yamada Y, Tanaka T, Ushikoshi H, Ohno Y, Mikami A, Nishigaki K, Minatoguchi S

Rinsho Byori · 2016 Mar · PMID 27363224

Tissue characteristics of coronary plaque have been reported to be associated with cardiovascular events. The stabilization of vulnerable tissue components such as the lipid pool rather than regression of the plaque volu... Tissue characteristics of coronary plaque have been reported to be associated with cardiovascular events. The stabilization of vulnerable tissue components such as the lipid pool rather than regression of the plaque volume is considered to be of major benefit in the reduction of cardiovascular events. Conventional echocardiography, especially intravascular ultrasound imaging (IVUS), is widely used to determine calcification and the three layers of the arterial wall. However, differentiation of the lipid pool from fibrous tissue using the echo intensity is difficult. Recently, an integrated backscatter (IB) ultrasound technique was developed. The ultrasound IB power ratio is a function of the difference in acoustic characteristic impedance between the medium and target tissue, and the acoustic characteristic impedance is determined by the density of tissue multiplied by the speed of sound. For more comprehensive plaque analysis using IB-IVUS, three-dimensional IB-IVUS offers the potential for the quantitative volumetric tissue characterization of coronary atherosclerosis. Several large clinical trials demonstrated that lipid-lowering therapy with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) reduces cardiovascular events. The IB techniques provide useful clinical information on the effects of statins and other medications. The presence of lipid-rich plaque is associated with the incidence of atherosclerotic diseases; therefore, ultrasound IB techniques are useful to detect coronary atherosclerotic lesions.

[Utilization of Big Data in Medicine and Future Outlook].

Kinosada Y, Uematsu M, Fujiwara T

Rinsho Byori · 2016 Mar · PMID 27363223

"Big data" is a new buzzword. The point is not to be dazzled by the volume of data, but rather to analyze it, and convert it into insights, innovations, and business value. There are also real differences between convent... "Big data" is a new buzzword. The point is not to be dazzled by the volume of data, but rather to analyze it, and convert it into insights, innovations, and business value. There are also real differences between conventional analytics and big data. In this article, we show some results of big data analysis using open DPC (Diagnosis Procedure Combination) data in areas of the central part of JAPAN: Toyama, Ishikawa, Fukui, Nagano, Gifu, Aichi, Shizuoka, and Mie Prefectures. These 8 prefectures contain 51 medical administration areas called the second medical area. By applying big data analysis techniques such as k-means, hierarchical clustering, and self-organizing maps to DPC data, we can visualize the disease structure and detect similarities or variations among the 51 second medical areas. The combination of a big data analysis technique and open DPC data is a very powerful method to depict real figures on patient distribution in Japan.

[Possibility of New Circulating Atherosclerosis-Related Lipid Markers Measurement in Medical and Complete Medical Checkups: Small Dense Low-Density Lipoprotein Cholesterol and Lipoprotein Lipase].

Sumino H, Nakajima K, Murakami M

Rinsho Byori · 2016 Mar · PMID 27363222

Small dense low-density lipoprotein cholesterol (sdLDL-C) concentrations correlate more strongly with cardiovascular disease (CVD) than other LDL-C and large LDL particle concentrations. Lipoprotein lipase (LPL) plays a... Small dense low-density lipoprotein cholesterol (sdLDL-C) concentrations correlate more strongly with cardiovascular disease (CVD) than other LDL-C and large LDL particle concentrations. Lipoprotein lipase (LPL) plays a central role in triglyceride-rich lipoprotein metabolism by catalyzing the hydrolysis of triglycerides in chylomicrons and very low-density lipoprotein particles and is a useful biomarker in diagnosing Type I, Type IV, and Type V hyperlipidemia. Therefore, the measurement of circulating sdLDL-C and LPL concentrations contributes to the assessment of circulating atherosclerosis-related lipid markers. However, the measurement of these lipids has not been fully adopted in medical and complete medical checkups. Recently, novel automated homogenous assay for measuring sdLDL-C and latex particle-enhanced turbidimetric immunoassay (LTIA) for measuring LPL have been developed, respectively. Using these new assays, sdLDL-C values showed excellent agreement with those obtained by isolation of the d = 1.044 - 1.063 g/mL plasma fraction by sequential ultracentrifugation, and LPL values measured with and without heparin injection were highly correlated with the values measured by the LPL-enzyme-linked immunosorbent assay (ELISA). These assays may be superior to the previous assays for the measurement of sdLDL-C and LPL concentrations due their simplicity and reproducibility. The measurements of sdLDL-C and LPL concentrations may be useful as lipid markers in the assessment of the development and progression of atherosclerosis and the detection of pathological conditions and diseases if these markers are measured in medical and complete medical checkups. We have introduced the possibility of the novel measurement of circulating atherosclerosis-related lipid markers such as sdLDL-C and LPL in medical and complete medical checkups. Further studies are needed to clarify whether sdLDL-C and LPL concentrations are related to the development and progression of atherosclerosis and CVD events.

[How to Define Significant Changes in Laboratory Test Results in Health Screening].

Kawano R, Ichihara K, Wada T

Rinsho Byori · 2016 Mar · PMID 27363221

It is necessary to judge the significance of changes in laboratory test results, especially in health screening. For this purpose, the reference change value (RCV) was proposed, which is the (1- α) 100% confidence limit... It is necessary to judge the significance of changes in laboratory test results, especially in health screening. For this purpose, the reference change value (RCV) was proposed, which is the (1- α) 100% confidence limit of differences between any two measurements: RCV = √2 z(α) x CV(I), where CV(I) represents intra-individual CV and α = 0.05. However, RCV is not commonly employed because: (1) it assumes constant CV(I) regardless of test levels, and (2) it often results in conservative judgements about the changes due to the blind use of 95% as its confidence probability (CP). Recently, we evaluated the level dependency of CV(I) in common laboratory tests and sought an appropriate CP for computing RCV through systematic analysis of a large long-term health-screening database. The dataset used contained data from approximately 14,000 individuals who underwent annual health-checks repeatedly. None of them were taking any medications or showed unnatural changes in BMI. The level of dependency of CV(I) was clearly observed for test items which showed skewed, logarithmic normal distributions but not for those with normal distributions, indicating the need to compute RCV according to the test level for the former items. To assess the choice of practical CP for RCV, we introduced a metabolic syndrome score (sMS) derived by logistic regression analysis. AsMS was used as an external criterion of changes in the nutritional status of individuals in relation to changes in laboratory tests. We evaluated the sensitivity and specificity of RCV at various CPs for detecting significant changes in ΔsMS. The analysis revealed that CP of 80-90% for computing RCV markedly enhanced the sensitivity of detecting ΔsMS without compromising the specificity. We provide a table listing appropriate RCVs for typical levels of common screening tests obtained from the analysis.

[The Reliability of Measurement Methods for Medical Examinations and Health Screening].

Hosogaya S

Rinsho Byori · 2016 Mar · PMID 27363220

Clinical laboratory data used in medical examinations and health screening need to have a guaranteed analytical reliability. To ensure the reliability of measurement data, each constituent is required to be compatible wi... Clinical laboratory data used in medical examinations and health screening need to have a guaranteed analytical reliability. To ensure the reliability of measurement data, each constituent is required to be compatible with its traceability chain, and any constituent whose traceability chain has yet to be established is required to be appropriately harmonized in the current measurement system. The inter-laboratory reproducibility of standardized measurement values obtained from the external quality assessments conducted by the Japan Medical Association and Japanese Association of Medical Technologists was estimated to evaluate the analytical reliability of clinical tests in Japan. The estimated inter-laboratory reproducibility was then compared with the permissible error limits which have been reported domestically and internationally based on inter- and intra-individual biological variations of healthy subjects. The results showed that most of the measurement uncertainties were sufficiently lower than the permissible limits. This study proposes that the measurement uncertainty of the standardized measurement method has the potential to be a new assessment standard for analytical reliability.

[Reference Intervals of Standard Test Items in Ningen Dock Examination].

Yamakado M

Rinsho Byori · 2016 Mar · PMID 27363219

OBJECTIVE: Reference intervals (RIs) were derived from records of 1,499,288 individuals who underwent ningen dock examination in 188 institutes which belong to Japan Society of Ningen Dock in 2012. METHODS: Targets were... OBJECTIVE: Reference intervals (RIs) were derived from records of 1,499,288 individuals who underwent ningen dock examination in 188 institutes which belong to Japan Society of Ningen Dock in 2012. METHODS: Targets were 27 basic laboratory tests, including the body mass index (BMI) and systolic and diastolic blood pressures (SBP, DBP). Individuals fulfilling strict criteria were chosen: SBP < 130, DBP < 85 mmHg, BMI < 25 Kg/m2, non-smoking, ethanol consumption < 20 g/day, under no medication, with no remarkable current/past illness. The latent abnormal values exclusion (LAVE) method was applied to ensure normal results. RLs were derived using a parametric method with modified Box-Cox power transformation. RESULTS: Among all attendees, 23% fulfilled the criteria. Application of the LAVE method further reduced the dataset by 40-50%. RIs without distinction of the sex and age were SBP, DBP, TP, TB, MCV, WBC, and Plt. Sex-specific RIs were BMI, CRE, UA, TG, HDL-C, ALT, GGT, Glu, RBC, Hb, and Ht. Age-specific RIs in either sex were Alb, AST, HbA1c, TC, LDL-C, FW-LDL-C, nonHDL-C, and ALP. An age-specific RI without distinction of the sex was eGFR. Comparison of derived RIs with clinical decision limits (CDLs) revealed that the upper limits of RIs differed from CDLs according to the sex and age. CONCLUSION: Implementation of sex- and age-related RIs derived from individuals with fully normal ningen dock results will enable the appropriate interpretation of test results in health screening, and promote the effective application of CDLs for therapeutic intervention, taking into account the sex, age, and other health attributes.

[Analysis of the Squamous Cell Carcinoma Antigen (SCCA) Which Has a Significant Difference in Values between CLIA and FEIA--Case Report of Extra Glycosylation in SCCA].

Maruyama K, Aoki Y, Yamanaka M … +3 more , Ono M, Hotta T, Kang D

Rinsho Byori · 2016 Mar · PMID 27363218

Squamous cell carcinoma antigen (SCCA) is a glycoprotein that belongs to the serine protease inhibitor family. Clinically, it has been utilized as a tumor marker for squamous cell carcinoma. In clinical laboratories, SCC... Squamous cell carcinoma antigen (SCCA) is a glycoprotein that belongs to the serine protease inhibitor family. Clinically, it has been utilized as a tumor marker for squamous cell carcinoma. In clinical laboratories, SCCA is measured by several immunoassays. Recently, a number of studies have been reported that there is a significant difference in values between the immunoassays, attributing to SCCA-immunoglobulin complex. We found a case with significant difference in the SCCA value between CLIA and FEIA. In this case, SCCA-Immunoglobulin complex was not confirmed by gel filtration analysis. Interestingly, 5 to 10 kDa slightly-high molecular weight SCCA compared to control was detected by immunoblotting assay. It may be suspected that the aberrant glycosyl modification of SCCA influenced the reactivity to immunoassays.

[Relationship between Clostridium difficile ITS-PCR Type and Pathogenicity].

Takemori Y, Senda Y, Munesue T … +6 more , Horita H, Nagahara M, Iwata Y, Wada T, Sakai Y, Wada T

Rinsho Byori · 2016 Mar · PMID 27363217

Clostridium difficile (C. difficile) causes antibiotic-associated diarrhea and nosocomial infection. The PCR of internal transcribed spacer regions (ITS) is easily conductible in a relatively short time. The purpose of t... Clostridium difficile (C. difficile) causes antibiotic-associated diarrhea and nosocomial infection. The PCR of internal transcribed spacer regions (ITS) is easily conductible in a relatively short time. The purpose of the current study is to classify C. difficile by PCR electrophoresis pattern of ITS (ITS-PCR type) and estimate the relationship of the ITS-PCR type of C. difficile with its pathogenicity. We examined 77 strains which were obtained in our hospital from March 2012 to August 2013. Toxin genes were detected by PCR using toxin gene specific primers. Antimicrobial sensitivities were measured by E-test. Pseudomembrane formation and severity of the illness in clinical patients were investigated based on the medical records. The strains were classified into the 33 ITS-PCR types. Among them, most of strains in 18 PCR types were not associated with any toxin genes. Strains with toxin A(+)/B(+)genes were classified into 14PCR types. The 3 strains with toxin B (+) strains and the two strains with toxin A(+)/B(+)/binary toxin(+) genes were classified into 1 PCR type, type 17, and type 16, respectively. 6 strains in 13 strains of type 33, and 5 strains in 11 strains of type 2 were detected from the same ward, presuming nosocomial infection. Minimum inhibitory concentrations (MICs) of vancomycin and metronidazole were ≤ 2 μg/mL, distribution of MICs were not correlated with ITS-PCR type. The pseudomembrane forming and severity of the illness were not obviously related to ITS-PCR pattern. Thus, the typing of C. difficile by ITS-PCR pattern is considered to be useful for early detection of nosocomial infection, and assessment of toxigenicity.

[Diagnostic Ability of Natriuretic Peptides for Heart Failure According to eGFR Level: Comparison between Brain Natriuretic Peptide and Amino-Terminal Probrain Natriuretic Peptide].

Arakawa K, Ando Y, Matsunaga S … +1 more , Nishiura A

Rinsho Byori · 2016 Mar · PMID 27363216

Although the influence of reduced kidney function on natriuretic peptides (B-type natriuretic peptide [BNP] and amino terminal probrain natriuretic peptide [NT]) is clear, effect of kidney function on the difference of d... Although the influence of reduced kidney function on natriuretic peptides (B-type natriuretic peptide [BNP] and amino terminal probrain natriuretic peptide [NT]) is clear, effect of kidney function on the difference of diagnostic ability for heart failure by these peptides is not obvious. The aim of this study was to examine the relationship between natriuretic peptide concentrations and echocardiographic findings according to eGFR level of the patients. In addition, we compared diagnostic ability of BNP with that of NT according to eGFR level. The eGFR levels were classified by based on CKD stage (≥ 60, 45-59, 30-44, 15-29, < 15 and on maintenance HD). Patients who underwent the measurements of BNP, NT and serum creatinine concentrations, as well as echocardiography between March and October in 2011 were enrolled (n = 1,297). The left ventricular mass index was greater in patients with eGFR < 60 than in those with eGFR ≥ 60, but EF (%) was not different among eGFR level (except eGFR30-44). The percentage of patients with heart failure in those with eGFR < 60 (16.0%) was more than eGFR ≥ 60 (5.8%). Median BNP and NT concentrations were elevated in association with decreasing eGFR level. Using receiver-operator characteristic (ROC) analysis, the area under the ROC curve for BNP and NT that stratified subjects with or without heart failure was not different among eGFR level. In conclusion, BNP and NT levels are elevated depend on decreasing eGFR level, BNP and NT are comparable in the accuracy for diagnosing heart failure at every eGFR level. The cut-off value of BNP and NT should be established according to the eGFR level.

[Associations with Clinical Trials].

Higashikage A, Aoe S

Rinsho Byori · 2016 Jul · PMID 30695479

Since the necessity of confirming records to ensure appropriate accuracy management for clinical laborato- ry tests was initially specified in the Good Clinical Practice (GCP) in 2011, it has been mandatory for clinical... Since the necessity of confirming records to ensure appropriate accuracy management for clinical laborato- ry tests was initially specified in the Good Clinical Practice (GCP) in 2011, it has been mandatory for clinical trial sponsors to confirm such management in the relevant medical institutions. In 2007, the Department of Clinical Laboratory and the Department of Blood Transfusion at Okayama Uni- versity Hospital acquired the ISO 15189 certification as the international standard for clinical laboratory tests. In 2015, they, including the Physiological Test Room, renewed this certification. Record documents to ensure appropriate accuracy management are stored in the Department of Clinical Laboratory for a fixed period. Subsequently, to be inspected by regulatory authorities, such as the PMDA, they are continuously stored in the Department of Clinical Research of New Drugs and Therapeutics for a long period. [Review].

[ISO 15189 So Far and in the Future -Effects of Quality Assurance and Management System Using ISO 15189-].

Kanno K, Nishimiya T, Oosawa H

Rinsho Byori · 2016 Jul · PMID 30695478

Clinical examinations are also influenced by medical globalization. Samples from patients for some special tests, including genetic analyses, are transported across the world. International standardization should be appl... Clinical examinations are also influenced by medical globalization. Samples from patients for some special tests, including genetic analyses, are transported across the world. International standardization should be applied to clinical examinations as a part of medical care. The quality of techniques and management in clini- cal laboratories are evaluated by organizations for ISO 15189 authorization. This process helps detect issues overlooked on a daily basis and establish a system to maintain the high quality of laboratory examinations. In Ehime University Hospital Clinical Laboratory, we went through examinations from ISO 15189 authorization acquisition to the 3rd periodical surveillance. When the incongruent rate was assessed in each in- spection process under the quality management system (QMS), that of the process before the inspection ac- counted for 47% of the total. Therefore, the management of early processes including sample extraction, inspection, reception, and processing appears to be particularly important. [Review].

[Present Status of Quality Assurance for Laboratory Medicine in Japan].

Takagi Y

Rinsho Byori · 2016 Jul · PMID 30695477

Standardization of the clinical laboratory and compatible clinical data is needed for accurate diagnosis in routine medical practice or medical care. We have many megaEQSPs in Japan, and they suggest the mark- edly favor... Standardization of the clinical laboratory and compatible clinical data is needed for accurate diagnosis in routine medical practice or medical care. We have many megaEQSPs in Japan, and they suggest the mark- edly favorable present status of quality assurance, but they have problems, such as the examination sample (matrix and spike materials in abnormal specimens) and valuation basis. Improved proposals for EQSP have been developed: EQSP with fresh blood, combination of open with blind surveys, and control Serum using donated blood (MacRM). [Review].

[Team Medical Care Involving Biomedical Laboratory Scientists].

Maruta H, Shimoda K, Miyajima Y

Rinsho Byori · 2016 Jul · PMID 30695476

As medical care becomes'more advanced and complex, increasing importance is being attached to the im- plementation of team medical care that provides appropriate care while making use of the advances, mutually cooperatin... As medical care becomes'more advanced and complex, increasing importance is being attached to the im- plementation of team medical care that provides appropriate care while making use of the advances, mutually cooperating, and supplementing the high-level specializations of various branches of medicine in order to provide safe care with peace of mind. Planned team medical care is demanded in this era, and the Japanese Association of Medical Technologists is developing various projects as well as promoting the participation of biomedical laboratory scientists in team medical care. [Review].

[Audiologists and Team Medical Care -Strategies for Team Medical Care and Expectations of the Clinical Laboratory Department-].

Sasaki S

Rinsho Byori · 2016 Jul · PMID 30695475

To improve the quality of medical care, it is necessary to create joint medical teams with members from various disciplines. A team medical care approach can be best achieved through information-sharing and communication... To improve the quality of medical care, it is necessary to create joint medical teams with members from various disciplines. A team medical care approach can be best achieved through information-sharing and communication be- tween cooperative medical staff. It is beneficial to share audiology test results with the ENT department as well as share professional tech- nical knowledge with specialists in other fields. It is recommended that clinical laboratory departments participate more positively so as to contribute to team medical care. [Review].

[Roles of and Team Medical Care Involving Clinical Engineers in Blood Purification Therapy].

Abe T, Ishimori I, Murakami J … +8 more , Kaneko I, Miura H, Kimata N, Hanafusa N, Mineshima M, Kawashima M, Nitta K, Tsuchiya K

Rinsho Byori · 2016 Jul · PMID 30695474

Progress in medical care strongly depends on the development of pharmaceutical and medical technologies. Multi-disciplinary care by a medical team is required for the diversity of medical care. "Clinical engineering tech... Progress in medical care strongly depends on the development of pharmaceutical and medical technologies. Multi-disciplinary care by a medical team is required for the diversity of medical care. "Clinical engineering technician (CET) " is one of the national medical licenses in Japan. Many CETs are engaged in blood purification therapies. Team medical care, involving medical doctors, nurses, CETs, etc., in the hemodialysis field is useful for the early detection of complications in dialysis patients and provision of appropriate treatments. In some medical facilities, for example, progressive approaches such as appropriate nutritional guidance by a dietitian or exercise therapy by a physical therapist are practiced in advance. Clinical laboratory technologists (CLTs), furthermore, play an important role in team medical care for dial- ysis therapy. They can use ultrasonic equipment for vascular access management. Based on the results of the ABI and SPP measurements by CLTs, medical doctors can diagnose PAD in dialysis patients. [Review].

[Medical Social Worker and Team Approach to Medicine].

Kitasumi Y, Katase H, Yao M … +2 more , Horiguchi Y, Miyake C

Rinsho Byori · 2016 Jul · PMID 30695473

Our hospital is an independent-type emergency critical care center. Because the majority of our patients are critically ill, we post nurses at the regional medical liaison office as medical social workers (MSWs). Inside... Our hospital is an independent-type emergency critical care center. Because the majority of our patients are critically ill, we post nurses at the regional medical liaison office as medical social workers (MSWs). Inside the hospital, we, as the MSWs, contact the patients' families immediately after their arrival, attend doctors' conferences and meetings of the bed-management team, and join doctors' rounds to collect infor- mation. We also meet patients and their families to solve their problems, making use of knowledge as social workers and psychiatric social workers. Outside the hospital, we work with and share information with oth- er hospitals, clinics, comprehensive support centers, social welfare councils, and public assistance sections in our district, to facilitate the return of patients to their previous activities independently. We will continue supporting patients to live meaningful, individual lives in our district. [Review].

[Clinical Research Ethics in Seirei General Hospital -Introduction to the Actual Environment in Clinical Research Ethics in a Private Community Hospital-].

Yonekawa O

Rinsho Byori · 2016 Jul · PMID 30695472

Seirei General Hospital is a community hospital with 744 beds located in Hamamatsu City, one of the ordi- nance-designated cities. Since the introduction of the mandatory residency program, marked changes have occurred i... Seirei General Hospital is a community hospital with 744 beds located in Hamamatsu City, one of the ordi- nance-designated cities. Since the introduction of the mandatory residency program, marked changes have occurred in the medical field. Most young residents have chosen to stay for training in community hospitals even after the initial mandatory program, not moving to university hospitals. Considering the changes in medical situations, the role of community hospitals has to change. Nowadays, different from the previous situation, even a community hospital has to concentrate on and devote efforts for the education of young staff and clinical research. To perform clinical research with ethics is essential for education of young staff and progress in clinical medicine. Our hospital is private and has a strict code of clinical ethics. To start clinical research in our hospital, we should maintain ethics in clinical research. We have to obey the Helsinki Decla- ration and ethics guidance put forward by the government. In addition, all researchers have to'take a series of lectures on clinical ethics. Using a specimens for clinical research, we need a general rule on how to treat and use such specimens. The general rule should not be decided by government bureaucrats, but by the staff of clinical laboratories. Active performance of clinical research with ethics in a community hospital may contribute to progress in clinical medicine. It will definitely promote the interest of medical students and young staff in community hospitals. Community hospitals will be highly evaluated. [Review].

[Research Ethics -The Case of Juntendo University Hospital-].

Tabe Y

Rinsho Byori · 2016 Jul · PMID 30695471

The "Ethical Guidelines for Medical and Health Research Involving Human Subjects" were enforced in 2015, which integrated two former government guidelines: "Ethical Guidelines for Epidemiological Research" and "Ethical G... The "Ethical Guidelines for Medical and Health Research Involving Human Subjects" were enforced in 2015, which integrated two former government guidelines: "Ethical Guidelines for Epidemiological Research" and "Ethical Guidelines for Clinical Studies". Under the new guidelines, the role of the ethics review boards is of growing significance for vetting the ethical conduct of biomedical research in institutions. This review describes the system and activity of the ethics committee at Juntendo University Hospital. [Review].
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