• Journal of Korean Academy of Nursing
• /
• v.45 no.3
• /
• pp.315-322
• /
• 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
• /
• 1998.10b
• /
• pp.214-215
• /
• 1998

• International Journal of Advanced Culture Technology
• /
• v.8 no.4
• /
• pp.8-17
• /
• 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
• /
• v.30 no.2
• /
• pp.73-78
• /
• 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
• /
• v.46 no.7
• /
• pp.335-337
• /
• 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
• /
• v.25 no.1
• /
• pp.1-11
• /
• 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
• /
• v.23 no.4
• /
• pp.59.1-59.5
• /
• 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
• /
• v.22 no.2
• /
• pp.49-66
• /
• 2019

Along with the advances in medical technology and the economic development, more terminally ill patients are receiving hospice and palliative care services. Moreover, hospice and palliative care clinicians have been showing considerable interest in studies that aim to improve the quality of said care for patients and their families. Meanwhile, after the government has strengthened its policy to protect research participants, the institutional review boards (IRBs) are more closely examining various ethical issues related to patients' vulnerability when reviewing protocols for hospice and palliative care research. However, terminally ill patients should be provided with guaranteed qualities of hospice and palliative care to improve and maintain their quality of life. To that end, support should be provided for efforts to conduct ethical and safe studies with hospice and palliative care patients. Thus, this review paper proposes ethical guidelines for hospice and palliative care research. The guidelines could be appropriately used as a reference for researchers who should prepare for ethically safe and scientifically valued research protocols and the IRBs that will review the protocols.

• The Journal of Internal Korean Medicine
• /
• v.45 no.1
• /
• pp.1-10
• /
• 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)

• The Korean Society of Law and Medicine
• /
• v.24 no.4
• /
• pp.103-128
• /
• 2023

According to the current act of Decision-Marking in Life-Sustaining Medicine, the decision to withhold or discontinue life-sustaining treatment is primarily based on the wishes of a patient in the dying process. Decision-making regarding life-sustaining treatment for these patients is made by the patient, if he or she is conscious, directly expressing his/her intention for life-sustaining treatment in writing or verbally or by writing an advance medical directive and physician orders for life-sustaining treatment. It can be exercised. On the other hand, if the patient has not written an advance medical directive or physician orders for life-sustaining treatment, the patient's intention can be confirmed with a statement from the patient's family, or a decision to discontinue life-sustaining treatment can be made with the consent of all members of the patient's family. However, in the case of an unrelated patient who has no family or whose family is unknown, if an advance medical directive or physician orders for life-sustaining treatment are not written before hospitalization and a medical condition prevents the patient from expressing his or her opinion, the patient's will cannot be known and the patient cannot be informed. A situation arises where a decision must be made as to whether to continue or discontinue life-sustaining treatment. This study reviewed discussions and measures for unbefriended patients under the current law in order to suggest policy measures for deciding on life-sustaining treatment in the case of unbefriended patients. First, we looked at the application of the adult guardian system, but although an adult guardian can replace consent for medical treatment that infringes on the body, permission from the family court is required in cases where death may occur as a direct result of medical treatment. It cannot be said to be an appropriate solution for patients in the process of dying. Second, in accordance with Article 14 of the Life-Sustaining Treatment Decision Act, we looked at the deliberation of medical institution ethics committees on decisions to discontinue life-sustaining treatment for patients without family ties.Under the current law, the medical institution ethics committee cannot make decisions on discontinuation of life-sustaining treatment for unbefriended patients, so through revision, matters regarding decisions on discontinuation of life-sustaining treatment for unbefriended patients are reflected in Article 14 of the same Act or separate provisions for unbefriended patients are made. It is necessary to establish and amend new provisions. In addition, the medical institution ethics committee must make a decision on unbefriended patients, but if the medical institution cannot make such a decision, there is a need to revise the law so that the public ethics committee can make decisions, such as discontinuing life-sustaining treatment for unbefriended patients.