• 대한간호학회지
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• 제45권3호
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• pp.315-322
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• 2015

Purpose: This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. Methods: General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. Results: The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Conclusion: Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1998년도 제50차 추계 학술대회 연제집
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• pp.214-215
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• 1998

• International Journal of Advanced Culture Technology
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• 제8권4호
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• pp.8-17
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• 2020

This study aims to draw up comprehensive ethical management practices so that companies can be reborn as high-quality companies not only at the level of management efficiency but also at the level of corporate integrity. -The main focus of in this study is as follows: To curb corrupt practices in the corporate sector, it is necessary to strengthen the monitoring function and accountability system of audits (internal audits, full-time audits, audit committees, external audits). In order for these system improvements to be made reliably, it is necessary to periodically measure and evaluate employee satisfaction with the overall personnel system.

• Journal of Yeungnam Medical Science
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• 제30권2호
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• pp.73-78
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• 2013

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

• BMB Reports
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• 제46권7호
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• pp.335-337
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• 2013

Scientists planning research that involves the use of animals are required by international and/or national law to examine the possibilities for the implementation of Replacement, Reduction and/or Refinement (the Three Rs principles of Russell and Burch) in experiments for research, testing, and education. There are two Korean laws legislating humane use of animals and ethical review prior to animal experiments. This report reviews current practice of the literature search by the researchers and protocol review by the Institutional Animal Care and Use Committees on the Replacement, Reduction and Refinement alternatives in Korea. The promotion and protection of the laboratory animals are one of the core competencies of investigators exploring the ethical conduct of research and good science.

• Journal of Hospice and Palliative Care
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• 제25권1호
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• pp.1-11
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• 2022

The Act on Decisions on Life-Sustaining Treatment has been in effect since 2018 for end-of-life patients. However, only 20~25% of deaths of terminally ill patients comply with the law, while the remaining 75~80% do not. There is significant confusion in how the law distinguishes between those in the terminal stage and those in the dying process. These 2 stages can be hard to distinguish, and they should be understood as a single unified "terminal stage." The number of medical institutions eligible for life-sustaining treatment decisions should be legally expanded to properly reflect patients' wishes. To prevent unnecessary suffering resulting from futile life-sustaining treatment, life-sustaining treatment decisions for terminal patients without the needed familial relationships should be permitted and made by hospital ethics committees. Adult patients should be permitted to assign a legal representative appointed in advance to represent them. Medical records can be substituted for a patient's judgment letter (No. 9) and an implementation letter (No. 13) for the decision to suspend life-sustaining treatment. Forms 1, 10, 11, and 12 should be combined into a single form. The purpose of the Life-sustaining Medical Decisions Act is to respect patients' right to self-determination and protect their best interests. Issues related to the act that have emerged in the 3 years since its implementation must be analyzed, and a plan should be devised to improve upon its shortcomings.

• Journal of Veterinary Science
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• 제23권4호
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• pp.59.1-59.5
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• 2022

Korean Institutional Animal Care and Use Committee (IACUC) is currently facing some operational pressing issues. 1) Review of the animal protocol containing controversial technology. 2) Review of the multi-institution animal protocol. 3) Review of veterinary clinical trials for client-owned animals. 4) Delay in the review process in large institutions with a single IACUC. Here, the following three solutions are proposed to address the above issues. 1) Establishment of public IACUC. 2) Establishment of the Veterinary Clinical Study Committee as an advisory body to the IACUC. 3) Operating multiple committees rather than increasing the number of committee members on a single committee.

• Journal of Hospice and Palliative Care
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• 제22권2호
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• pp.49-66
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• 2019

의료기술 발달 및 경제개발 수준 상승 등으로 호스피스 완화의료(hospice & palliative care) 서비스를 받는 말기 환자들이 점점 늘어나고 있다. 이와 더불어 최근 호스피스 완화의료 분야 임상전문가들은 환자나 가족 대상 호스피스 완화의료 서비스의 질을 향상시킬 목적으로 하는 연구에도 많은 관심을 보이고 있다. 한편 정부의 연구대상자 보호 정책이 강화되면서 IRB(생명윤리심의위원회)에서도 호스피스 완화의료 연구의 연구계획서를 심의할 때 환자의 취약성과 관련된 다양한 윤리적 사안들을 더 엄밀하게 점검하고 있다. 그러나 말기 환자들의 삶의 질 향상 및 유지를 위해서는 질적으로 보장된 호스피스 완화의료 서비스가 제공되어야 한다. 이를 위해서 윤리적으로 안전한 호스피스 완화의료 연구의 시도가 지지되어야 한다. 이에 필자는 호스피스 완화의료 연구의 윤리지침을 종설 논문 형식으로 제안했다. 이는 윤리적으로 안전하고 과학적으로 가치가 있는 연구계획서를 준비해야 하는 연구자 및 그 연구계획서를 심의하는 IRB가 적절하게 참조할 수 있도록 해주기 위함이다.

• 대한한방내과학회지
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• 제45권1호
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• 의료법학
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• 제24권4호
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• pp.103-128
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• 2023

현행 연명의료결정법에 따르면 연명의료를 시행하지 않거나 중단하는 결정은 임종과정에 있는 환자의 의사가 우선적으로 적용된다. 이러한 환자를 대상으로 하는 연명의료의 의사결정은 환자가 의식이 있는 경우에는 환자 본인이 연명의료에 대한 의사를 직접 서면이나 구두로 표시하거나 사전연명의료의향서와 연명의료계획서를 작성하는 것으로 자기결정을 행사할 수 있다. 반면에, 환자가 사전연명의료의향서나 연명의료계획서를 작성하지 않은 경우에는 환자 가족의 진술로 환자의 의사를 확인하거나 환자가족 전원의 동의로 연명의료중단등결정을 할 수 있다. 그러나 가족이 없거나 가족을 알 수 없는 무연고 환자인 경우에는 입원하기 전에 사전연명의료의향서와 연명의료계획서를 작성하지 않은 상태에서 의사표현을 할 수 없는 의학적 상태로 되면 환자의 의사를 알 수가 없어 환자에 대한 연명의료를 지속해야 할지 중단해야 할지에 대한 결정을 해야 하는 상황이 발생한다. 본 연구는 무연고환자의 경우에 연명의료결정을 위한 정책적 방안을 제시하고자 현행법상 무연고 환자에 대한 논의와 방안 검토했다. 첫째로, 성년후견인제도의 적용을 살펴보았지만, 성년후견인은 신체를 침해하는 의료행위에 대한 동의를 대신할 수 있지만 의료행위의 직접적인 결과로 사망할 수 있는 경우에는 가정법원의 허가를 필요로 하기 때문에 임종과정에 있는 급박한 환자에게는 적절한 방안이라고 할 수 없다. 둘째로, 연명의료결정법 제14조에 따라 의료기관윤리위원회에서 무연고 환자에 대한 연명의료중단등결정에 관한 심의에 대해 살펴보았다. 현행법상에서는 의료기관윤리위원회에서 무연고 환자에 대한 연명의료중단등결정을 할 수 없기 때문에, 개정을 통하여 무연고 환자에 대한 연명의료중단등결정에 대한 사항을 동법 제14조에 반영하거나 무연고 환자에 대한 규정을 따로 신설하여 개정하는 것이 필요하다. 또한 의료기관윤리위원회에서 무연고 환자에 대한 결정해야 하지만, 그런 결정을 하는 것에 대해서 해당 의료기관에서 할 수 없다면, 공용윤리위원회에서 무연고환자의 연명의료중단등결정을 할 수 있도록 법률을 개정할 필요가 있다.