• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• 통상정보연구
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• 제9권4호
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• pp.141-158
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• 2007

The purpose of this paper is to examine the validity or effectiveness of the Arbitration Clause such as Model Clause I, and to confirm how other issues such as arbitrable "investment", appointment of arbitrators and law governing the agreement be reflected in the agreement. However, the parties should be sure that the arbitration clause is valid if they have checked whether, for their particular situation, the ICSID Centre has jurisdiction. For the validity of the Arbitration Clause, first the host country and the country which the investor belong to must be "contracting states" to the ICSID Convention. Second, the specific consent to arbitrate must be expressed in writing in the investment contract or in a national investment law or in an investment protection treaty. The issue of "nationality" of an other contracting state is determined by the place of incorporation or the location of the head office. In case the parties have doubts about a valid consent to arbitrate, Art. 41 of the ICSID Convention provides, regarding ICSID jurisdiction, that the tribunal shall be the judge of its own competence. It follows that ICSID Arbitration has an autonomous and exclusive character. As a consequence, domestic courts may not interfere with the question of ICSID's jurisdiction, which is called as "rule of abstention".

• 한국중재학회지:중재연구
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• 제24권3호
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• pp.1-31
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• 2014

The foundation of the arbitration jurisdiction is the arbitration agreement entered into by the parties to a contract. Usually, only the signatory parties to a contract and the disputes arising from a contract that includes an arbitration clause or to which the arbitration clause relates are the ones that can be submitted to arbitration. This article discusses some of the arguments for extending the arbitration clause in complex arbitrations, that is, in those cases where there are more than two parties, more than two contracts or more than two parties and contracts. Particularly, this paper addresses multiple contract arbitration when the contracts are related. One of the arguments used by the arbitral tribunal for the extension of jurisdiction is the existence of a link between the contracts. Additional arguments include implied consent, participation in the negotiation and performance of a contract and good faith. The article also discusses some of the typical cases of linked contracts in many civil law countries, such as subcontracts, third party beneficiaries and standard terms of contracts, from which arbitral jurisdictions problems may arise. Finally, special attention is given to Article 14 of the 2008 Peruvian Arbitration Law as the first provision in an arbitration law in Latin America that extends the arbitration agreement to non-signatory parties using for this a mixed approach.

• 성인간호학회지
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• 제20권1호
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• pp.176-186
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• 2008

Purpose: The purpose of this study was to analyze the published articles in the Journal of Korean Academy of Adult Nursing from 2004 through 2006. Methods: Two hundreds and ten articles were analyzed focusing on research methodology and key words using descriptive statistics. Results: The proportion of quantitative research was 88.1%, while the proportion of qualitative research was 5.2%. The majority of the qualitative research design was survey(67.1%). Seventy-four percent of the research had verbal consent and 8% had written consent from the participants. Eight percent of the research provided conceptual framework. The prevailing data collection settings were hospitals(50.5%) and community(37.1%). For the data analysis, 95% used parametric analysis methods; descriptive statistics(26.2%), chi-square test(18.3%), t-test(18%) and ANOVA(17.4%). Key words were categorized into four nursing domain: human, health, nursing, and environment. The most frequently used domain was health. Conclusion: The number of the published articles in the Journal of Korean Academy of Adult Nursing has been increased and quality has been improved compared with the articles published before the 2000 year. Varied research methodology and data analysis methods were utilized.

• 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.

• 농촌의학ㆍ지역보건
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• 제31권1호
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• pp.35-46
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• 2006

명동의, 실습기록에 관한 취급과 지도실태를 파악, 검토하여 앞으로 환자실습 시에 도움이 되는 자료를 얻고자 한국과 일본의 전국간호교육기관의 성인간호학, 아동간호학 및 정신간호학을 담당하는 교수를 대상으로 우편조사를 실시한 결과, 30.9%(한국), 45.2%(일본)의 응답율을 보였다. 조사내용은 일반적 특성 4문항, 학생실습에 관한 환자 설명동의 내용으로 구성된 29문항, 교수의 실습기록에 대한 지도와 관리에 관한 15문항 및 병동의 간호기록에 대한 학생의 기록에 대한 3문항으로 총 54문항으로 구성하였다. 분석방법으로 일반적 실태는 백분율을 보았으며, 영역별로는 ${\chi}^2-test$ 및 프리드만 검정을 하였으며, 개방식질문(자유기술)에 대해서는 응답자의 내용을 카드화하고 KJ법에 기초하여 관심내용을 추출하였다. 조사결과는 다음과 같다. 간호대학생의 임상실습 시에 "환자를 정해서 실습한다"고 응답한 비율은 50.0%(한국), 99.0%(일본)였으며, 주로 "수간호사"가 환자에게 설명하였는데, 분야별로는 성인, 아동, 정신간호학의 순으로 통계적으로도 유의한 차이를 보였다. 환자의 승인을 얻는 방법으로는 "구두승인"이 대부분이었으며, 실제로 동의서를 받는 경우는 두나라 모두 없는 것으로 조사되었다. 환자배정 시 설명에서는 한국과 일본 모두 "학생이 실습으로 맡게 된다" 49.0%, 100.0%로 가장 높았고, 반대로 가장 낮은 비율은 "실습기록을 보이면서 설명한다" 7.8%(한국), "환자는 실습기록을 볼 수 있다" 0.7%(일본)로 거의 비슷한 상황이었다. 환자실습 시 설명동의에 관한 교수의견에서 일본은 "환자에 대한 설명방법의 현상", "설명동의에 관한 사고와 설명동의의 바람직한 모습", "설명동의서를 받는 것과 관련된 불안과 딜렘마", "설명동의의 도입과 교육적 기대", "설명동의에 필요한 환경", 및 "과제"의 6개로 분류되었다. 한국에서는 "환자에 대한 설명방법의 현상", "설명동의서를 받는 것과 관련된 어려움" 및 "과제"의 3개로 분류되었다. 간호대학생이 실습 시 간호기록지에 기록은 "기재한다"가 한국이 46.1%로 일본의 17.7%보다 2.6배 높게 나타났다. 환자 개인정보가 기재되고 있는 학생의 실습기록의 취급에 관한 것으로 병원 밖으로 "가지고 나간다"가 한 일 각각 50.0%, 89.7%로 유의한 차이가 있었다. 실습기록의 지도에서는 두 나라 모두 "비밀을 지킬 것을 지도하고 있다"는 것이 가장 높아 한국과 일본이 각각 92.2%, 98.3%이었으며, 가장 낮은 항목은 한국이 "실습기록에 워드프로세스를 사용하지 않도록 지도한다" 17.6% 인 반면 일본은 "실습기록에 워드프로세스를 허용하는 경우, 규칙을 정하고 있다" 6.3%로 나타났다. 학생이 병동의 간호기록지에 기재하는 것에 대한 교수의 의견을 개방식으로 질문한 결과를 범주화하여 분류한 결과, "학생이 간호기록에 기재하지 않는 것이 좋다", "과제이다", "기재하고 있다. 기재할 수 있다", "기재하는 것은 의미가 있다", "상황에 따라 판단한다", "현재는 판단하기 어렵다"의 6개 범주로 구분할 수 있었다. 결론적으로 간호대학생의 임상실습 시 환자의 설명동의는 절대적으로 필요하며 실습기록의 관리지도도 교육과 학습의 목적뿐만 아니라 환자의 개인정보의 보호라는 맥락에서 고려되어야 할 것이다. 임상현장에서는 교육적 관점에서만 해결할 수 없는 문제도 있으므로 실습기관과의 대화를 통한 실습기록과 교육의 개선을 시도할 필요가 있음을 제언한다.

• 한국심리학회지ㆍ건강
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• 제14권3호
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• pp.579-596
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• 2009

본 연구는 한국형 치료동의 능력평가도구를 개발하여 이 도구의 신뢰도와 타당도를 검증하고 각 하위능력별 능력, 무능력을 구별할 수 있는 최적의 절단점을 알아보기 위해서 이루어졌다. 본 연구 참여자는 정신의료기관에 입원해 있는 정신질환자, 지역사회정신보건센터 및 사회복귀시설 프로그램에 참여하고 있는 정신질환자 중 본 연구의 참여에 동의한 사람으로, 정신분열증 160명, 기분장애 32명, 기타(강박장애, 알코올) 1명으로 총 193명이었다. 이해능력(understanding), 적용능력(appreciation), 표현능력(expression of a choice), 추론능력(reasoning) 등 총 14문항으로 구성되어 있는 본 치료 동의능력 평가도구와 타당도를 알아보기 위해서 K-MMSE, 지능, 통찰력검사, BPRS를 실시하였다. 그 결과 이 도구의 평정자간의 일치도가 .80~.98로 매우 높고 내적 일관성계수 역시 .56~.83으로 신뢰할만한 수준이었다. 본 도구의 구성개념 타당화를 확인적 요인분석으로 알아본 결과 타당한 것으로 나타났고, 준거관련 타당화를 위해 MMSE, BPRS, IQ, 병식을 검사한 결과 IQ, MMSE는 동의능력 중 이해, 적용, 선택의 표현, 추론 능력 모두와 의미 있는 상관관계를 가지는 것으로 나타났다. ROC 분석 결과 본 척도의 절단점으로 전체점수 18.5점, 하위 영역들의 절단점은 이해능력 4.5, 적용능력 8.5, 의사 표현 0.5, 추론 3.5점이 제안되었다. 이런 결과는 본 연구자들이 개발한 척도가 신뢰롭고 타당하며 진단성 효용성을 지님을 나타낸다. 마지막으로 본 연구의 시사점과 제한점에 대하여 논의하였다.