• 제목/요약/키워드: IRB (Institutional Review Board)

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최근 일본의 의학계 연구규율의 특색 (The Characteristic of Research Regulation in Recent Japanese Medical World)

  • 송영민
    • 의료법학
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    • 제20권2호
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    • pp.173-206
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    • 2019
  • 본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구·치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

The relationship between radiological features and clinical manifestation and dental expenses of keratocystic odontogenic tumor

  • Min, Jung-Hyun;Huh, Kyung-Hoe;Heo, Min-Suk;Choi, Soon-Chul;Yi, Won-Jin;Lee, Sam-Sun;Bae, Kwang-Hak;Choi, Jin-Woo
    • Imaging Science in Dentistry
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    • 제43권2호
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    • pp.91-98
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    • 2013
  • Purpose: This study was performed to identify correlations between keratocystic odontogenic tumor (KCOT) data from CT sections, and data on the KCOT clinical manifestation and resulting dental expenses. Materials and Methods: Following local Institutional Review Board (IRB) approval, a seven-years of retrospective study was performed regarding patients with KCOTs treated at the Seoul National University Dental Hospital. A total of 180 KCOT were included in this study. The following information was collected: age, gender, location and size of the lesion, radiological features, surgical treatment provided and dental expenses. Results: There was no significant association between the size of the KCOT and age, gender, and presenting preoperative symptoms. In both jaws, it was unusual to find KCOTs under 10 mm. The correlation between the number of teeth removed and the size of the KCOT in the tooth bearing area was statistically significant in the mandible, whereas in the maxilla, no significant relationship was found. Dental expenses compared with the size of the KCOT were found to be significant in both jaws. Conclusion: The size of KCOT was associated with a significant increase in dental expenses for both jaws and the number of teeth removed from the mandible. These findings emphasize the importance of routine examinations and early detection of lesions, which in turn helps preserving anatomical structures and reducing dental expenses.

우리나라 다빈도 섭취 과일의 당 함량 및 혈당지수에 관한 연구 (Sugar composition and glycemic indices of frequently consumed fruits in Korea)

  • 유지현;임정은;석완희;이한송이;안혜진;김영설;박천석;조여원
    • Journal of Nutrition and Health
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    • 제45권2호
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    • pp.192-200
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    • 2012
  • Fruits are generally recommended for a balanced meal, as they are good sources of vitamins, minerals, and fiber, which may improve blood glucose control. However, fruits have simple sugars with a wide glycemic index (GI) range. The purpose of this study was to analyze the sugar content and composition and to determine the glycemic indices of the most frequently consumed fruits in Korea, including apple, tangerine, pear, water melon, persimmon, grape, oriental melon, and peach. The sugar content and composition of the fruits were analyzed by high performance anion-exchange chromatography (Dinonex model DX-600). The GI of the fruits was measured in 13 healthy subjects (seven females and six males) after permission was received from the University Hospital institutional review board (KHU-IRB 1114-06). The subjects consumed 50 g of glucose as a reference and carbohydrate portions of eight fruits. Blood samples were collected at 0, 30, 60, 90, and 120 min after consuming the fruits. The GI values for the fruits were calculated by expressing the increase in the area under the blood glucose response curve for each subject. As a result, the total sugar contents of 100 g fruits were: grape (13.9 g), apple (12.3 g), persimmon (11.9 g), oriental melon (11.2 g), watermelon (9.3 g), tangerine (8.9 g), peach (8.6 g), and pear (8.3 g). The GI values of the fruits were as follows: GI value of peach ($56.5{\pm}14.17$), watermelon ($53.5{\pm}18.07$), oriental melon ($51.2{\pm}18.14$), tangerine ($50.4{\pm}15.16$), grape ($48.1{\pm}14.05$), persimmon ($42.9{\pm}18.92$), pear ($35.7{\pm}14.38$), and apple ($33.5{\pm}11.92$). These findings will help individuals choose fruit for controlling blood sugar.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • 제23권6호
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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최근 5년간 교통사고 후유증의 한의학적 치료에 대한 국내 연구 동향 (The Domestic Trends of Korean Medicine Treatments on Traffic Accident for Recent 5 Years)

  • 최영일;김민영;최희승;정윤규;노해린;김세준;신동재
    • 척추신경추나의학회지
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    • 제8권1호
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    • pp.27-38
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    • 2013
  • Objectives : The purpose of this study is to investigate the latest trends of korean Medicine treatments on traffic accident for recent 5 years. Methods : We investigated the studies on korean Medicine treatments for traffic accident via searching 6 Korean web databases. As a result, 65 research papers were found to be analyzed according to their published year, the titles of journals, the types of study, the number of cases, the sites of injury, the types of treatments the instruments for assessment and ethics approvals. Results : 65 articles were published since 2008. The studies on korean Medicine treatments about traffic accident were mainly published in Journal of Oriental Rehabilitation Medicine. 10 case studies, 14 case series, 11 non randomized controlled trials, 21 randomized controlled trials and 9 systemic reviews had been under research. The most frequently occurred symptoms were neck pain and low back pain. In most studies, various korean Medicine treatments were used to treat the symptoms. Visual analogue scale(VAS) and neck disability index(NDI) were used as primary assessments. In most clinical studies, there were no mention about approval of institutional review board(IRB). Conclusion : In this study, we analyzed the trends of korean Medicine treatments on traffic accident from 2008 to 2012. Reviewing the domestic trends of studies on korean Medicine treatments for traffic accident and examining the strong and weak points of those treatments are essential for the future studies. It is needed to adopt the qualitative methods of evaluation in order to develop a level of evidence.

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주관적인 치아에 대한 인식 및 만족도와 자아존중감과의 관련성 (Relationships between subjective teeth awareness and satisfaction on self-esteem)

  • 정은서;이경희
    • 디지털융복합연구
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    • 제14권2호
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    • pp.315-324
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    • 2016
  • 본 연구는 치아가 외모에 미치는 영향에 대한 인식 및 자신의 치아 만족도, 주관적인 치아에 대한 인식과 자아존중감에 대해 살펴보고, 이들의 관련성에 대해 조사함으로써 향후 치아 미용 관련 환자의 진료에 필요한 기초자료를 제공하고자 하였다. 2015년 5월부터 8월까지 서울 및 경기지역에 거주하는 일반인 320명의 자료를 수집하여 이중 응답이 미흡한 18부를 제외한 302(94.38%)부를 분석하여 다음과 같은 결과를 얻었다. 적합된 회귀모형은 통계적으로 유의하였으며(p<0.001), 모형 설명력은 23.4%로 나타났으며, 선정된 독립변수 중 학력(대졸 이상)과 치아가 외모에 미치는 영향에 대한 인식, 주관적인 치아에 대한 인식은 자아존중감에 통계적으로 유의한 영향을 미치는 것으로 나타났다. 이상의 연구결과 주관적인 치아에 대한 인식이 증가할수록 자아존중감을 향상되는 것으로 나타나 치과를 내원하는 환자들의 구강건강을 향상시킬 수 있도록 이와 관련된 구강보건교육을 시행하고, 치아의 색이나 배열 등을 개선할 수 있는 적극적인 의료서비스를 제공하여 자신감과 만족감을 더 고취시킬 수 있어야 할 것으로 사료된다.

Effects of Acupuncture Stimulation on the Radial artery's Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

  • Shin, Jae-Young;Ku, Boncho;Kim, Tae-Hun;Bae, Jang Han;Jun, Min-Ho;Lee, Jun-Hwan;Kim, Jaeuk U.
    • 대한약침학회지
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    • 제19권3호
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    • pp.197-206
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    • 2016
  • Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

고주파 저스트레인 골자극 인가용 진동 시스템 개발 (Development of the High_frequency and Low_strain Vibration Stimulation System for Stimulating Bone)

  • 유주연;박근철;전아영;김윤진;노정훈;전계록
    • 대한의용생체공학회:의공학회지
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    • 제32권2호
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    • pp.177-184
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    • 2011
  • In this study, the system for application of the bone stimulation was implemented using high frequency and low strain method. The whole system consists of the high frequency and low strain vibration stimulation system 177 for stimulating bone, LVDT sensor, and wireless sensor based on tri-axial accelerometer. To evaluate the usefulness of the system, the frequencies and accelerations from function generator were applied to the vibration stimulation system. The range of frequency was 17 Hz, 30 Hz, 45 Hz, 50 Hz and the range of acceleration was set 0.3 g, 0.6 g, 1g, and 2 g. The measured frequencies and acceleration using LVDT (linear variable difference transformer) sensor and 3-axial accelerometer were estimated and compared. The range of frequencies average difference was from 0.0 to 0.004 Hz. As the standard deviation of frequencies estimated by LVDT sensor and accelerometer was below 0.03 Hz and the output frequencies of function generator were similar: Also the results of t-test were satisfied with conditions of p > 0.05. And the acquired frequencies and acceleration from vibration measuring device module were estimated and analyzed. As the mean of accelerations was similar to the acceleration applied from function generator. And the standard deviation of acceleration estimated from vibration measuring device module was ranged from 0.019 g to 0.038 g. Also the results of t-test were satisfied with conditions of p > 0.05. Therefore, these results were airy similar to the acceleration applied from function generator. As a result, the usefulness of the system was confirmed. n a further study, clinical experiment will be carried out with the authorization of IRB (institutional review board) so that appropriate frequency and strain would be investigated in clinical field.

초음파방식으로 측정된 골밀도와 신체조성 및 배근력의 관계 (Relationship of Bone Mineral Density Measured by Ultrasound Bone Densitometry and Body Composition or Backmuscle Strength)

  • 이원정
    • 한국방사선학회논문지
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    • 제13권5호
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    • pp.721-728
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    • 2019
  • 본 연구에서는 20대 초반의 남, 여를 대상으로 초음파 방식으로 측정된 골밀도와 신체조성 및 배근력의 관계에 대해 알아보았다. D대학에 재학 중인 61명의 학생에 대해 IRB 승인과 참여자 동의 후 설문조사, 초음파방식 골밀도 및 신체조성, 배근력을 측정하였다. 골밀도는 주로 사용하는 측 종골을 측정하여 T-값을 두 그룹($T-score{\geq}-1.0$; T-score<-1.0)으로 나누었다. 생체전기 저항법을 이용하여 신체조성을 측정하였고, 배근력은 2회 측정하여 평균값을 구하였다. 모든 통계분석은 SPSS ver. 22.0 을 사용하여 실시하였다. 신체활동 또는 체질량지수가 증가할수록 골밀도 및 신체조성의 근육량도 증가하였다. T-값이 높은 그룹이 낮은 그룹 보다 신체조성의 근육량 및 골격근량, 신체발달이 높았지만 통계학적인 유의성은 없었다(p>0.05). 배근력에서도 T-값이 높은 그룹이 낮은 그룹 보다 높았다(101.1 vs. 92.1, p=0.308). 남, 여그룹에서 골밀도 T-값과 신체조성의 골격근과 근육량은 보통 수준의 유의한 양의 상관성을 보였고(p<0.05), 배근력은 신체조성의 골격근과 근육량, 신체발달에서 골밀도 보다 높은 유의한 양의 상관성을 보였다(p<0.001). 여자그룹이 남자그룹 보다 골밀도 T-값과 신체조성의 골격근과 신체발달에서 높은 상관성을 보였다. 남자 그룹에서 배근력과 골밀도의 T-값과는 유의한 상관성을 보이지 않았지만(r=0.176, p=0.319), 여자 그룹에서는 보통 수준의 유의한 상관성을 보였다(r=0.591, p=0.001). 이상과 같이 초음파 방식으로 측정된 골밀도와 신체조성, 배근력은 상호 유의한 관련성을 보였다.

Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권4호
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.