As more research work is done on eye disorders, more safety rules and regulations are required to ensure the safety of trial subjects. This is the main function of Research Ethics Committees [also known as Institutional Review Boards (IRBs) and Domain Specific Review Boards (DSRBs)]. Tragedies in research in other fields are wake-up calls, such as the death of a healthy young volunteer subject in New York, the termination of a large study sparked by breach of medical confidentiality in Singapore and the South Korean debacle of its pioneering work in cloning. Many issues are still being debated, such as what statutory changes are required to control trials; whether all trials should be reviewed by IRB; if phase IV trials should be exempted; if compensation should be paid for all trial-related injuries; and whether investigators and IRB members be allowed to hold certain amount of shares in drug or device firms. Recent measures taken to prevent ethical problems include funding organisations not approving a study unless it has been cleared by the IRB, and requiring all investigators and IRB members to pass an ethics course. More measures will need to be taken to ensure the safety of the trial subjects involved in research studies.
Clinical Trials as Topic ; ethics ; Conflict of Interest ; Ethics Committees, Research ; Ethics, Research ; Humans ; Ophthalmology ; Singapore

BACKGROUND: A hospital ethics committee (HEC) handles ethics problems in a hospital and mediates conflicts between patients and caregivers. The role of HEC on treatment withdrawal has increased after Boramae-hospital's case on 1997 in Korea. This study is an analysis of cases referred to the HEC of Asan Medical Center for the discontinuation of patient therapy. METHODS: The conference records of the HEC from January 1998 to December 2003 and the relevant patient charts were reviewed retrospectively. RESULTS: Twenty-seven cases related to treatment withdrawal were referred to the HEC during the study period. Based on the number of admitted ICU patients during the study period, the case request rate was 0.05%. The bimodal distribution of the cases in terms of age was neonate, 13 (48%); infant, 6 (22%); adult, 8 (30%). The major causes of treatment withdrawal were futile management, financial difficulty and patient suffering. The HEC recommended the continuation of treatment in 7 cases (25.9%); treatment withdrawal in 11 (40.7%); treatment withholding in 8 (29.6%); transfer to another hospital in one case (3.8%). Of the seven recommendations for treatment continuation, only three were accepted by their families. These three patients were eventually discharged alive. Treatment was withdrawn within one week in all eleven cases recommended for that by the HEC. Treatment was withheld in seven of those eight such recommended cases. CONCLUSIONS: The case referral rate was low in the studied hospital. In all cases, the patients' families requested the case to the HEC. Although the committee's recommendations to withhold or withdraw the treatment were followed by the families, the recommendation to continue therapy was often refused.
Adult ; Caregivers ; Chungcheongnam-do ; Ethics Committees* ; Ethics Committees, Clinical ; Ethics* ; Financial Management ; Humans ; Infant ; Infant, Newborn ; Korea ; Referral and Consultation ; Retrospective Studies

This year on May 21st, the full panel of the Supreme Court in Korea had first made a judgment on 'withdrawal of life-sustaining management'. In this case, where a 76 -year-old patient was represented by her children, while being in a persistent vegetative status, the Supreme Court ruled that if a patient is in an irreversible condition with imminent death and the discontinuation of treatment can be approved as the patient's self -determination, while such action will not be allowed in any other special circumstances. This judgement presented the general criteria and process of withdrawal of life -sustaining management in Korea for the first time. The Supreme Court also brought about the specific requirements of advance directives and decided that in case where legal proceedings are not taken, the hospital ethic committee constiting of medical specialists should decide whether the patient is in an irreversible condition. However, the judgment vaguely defined the concept of 'irreversible death-imminent condition' and did not clearly examine the relations between the patient's right on self-determination and the duty of the national government to protect the life of the people, and the discretionary power of the doctor.
Advance Directives ; Child ; Ethics Committees, Clinical ; Ethics, Institutional ; Euthanasia ; Federal Government ; Humans ; Judgment ; Korea ; Patient Rights ; Right to Die ; Specialization

PURPOSE: The objective of this study is to analyze systematically the trends of experimental researches in the area of community health nursing. METHODS: This is a study based on literature review, which analyzed 137 experimental research papers in the Journal of Korean Academy of Community Health Nursing, from the first issue in 1989 to those in 2012. RESULTS: 1) The proportion of experimental researches in the total published papers was 14.9%. 2) The mainly used research method was quasi-experiment, which was 60.6% of them, and there was no RCT. 3) Convenient sampling was used in 95.6% of the researches. 4) Only 5.1% were reviewed for keeping the ethical standards for the study objects by the IRB. 5 When classified by the Omaha Classification System, psycho-social researches were most frequent, which were followed by physiological, health-related behavioral, and environmental ones in order of frequency. CONCLUSION: This study found that the proportion of experimental research papers was increasing in the 2000s and ethical standards were required more rigorously. However, it was suggested that the research design be more elaborated and sampling methods be manifested to reduce research bias and errors.
Bias (Epidemiology) ; Classification ; Community Health Nursing* ; Ethics Committees, Research ; Clinical Trial ; Research Design

OBJECTIVE: To assess whether contrast-enhanced ultrasonography (CEUS) with Sonazoid can improve the lesion conspicuity and feasibility of percutaneous biopsies for focal hepatic lesions invisible on fusion imaging of real-time ultrasonography (US) with computed tomography/magnetic resonance images, and evaluate its impact on clinical decision making. MATERIALS AND METHODS: The Institutional Review Board approved this retrospective study. Between June 2013 and January 2015, 711 US-guided percutaneous biopsies were performed for focal hepatic lesions. Biopsies were performed using CEUS for guidance if lesions were invisible on fusion imaging. We retrospectively evaluated the number of target lesions initially invisible on fusion imaging that became visible after applying CEUS, using a 4-point scale. Technical success rates of biopsies were evaluated based on histopathological results. In addition, the occurrence of changes in clinical decision making was assessed. RESULTS: Among 711 patients, 16 patients (2.3%) were included in the study. The median size of target lesions was 1.1 cm (range, 0.5–1.9 cm) in pre-procedural imaging. After CEUS, 15 of 16 (93.8%) focal hepatic lesions were visualized. The conspicuity score was significantly increased after adding CEUS, as compared to that on fusion imaging (p < 0.001). The technical success rate of biopsy was 87.6% (14/16). After biopsy, there were changes in clinical decision making for 11 of 16 patients (68.8%). CONCLUSION: The addition of CEUS could improve the conspicuity of focal hepatic lesions invisible on fusion imaging. This dual guidance using CEUS and fusion imaging may affect patient management via changes in clinical decision-making.
Biopsy* ; Clinical Decision-Making ; Ethics Committees, Research ; Humans ; Liver ; Retrospective Studies ; Ultrasonography*

BACKGROUND/AIMS: Do-Not-Resuscitate (DNR) orders have been one of the critical issues considered in futile medical management, but they have not been legally defined in Korea. The aim of this study was to observe the factors that influence DNR agreement and to determine the current status of DNR orders in the hemato-oncology wards of a university hospital, in which DNR orders were formally implemented through the Hospital Ethics Committee in October 2001. METHODS: We retrospectively analyzed the records of 213 patients who had died in the hemato-oncology department at a university hospital between January 2002 and July 2002. RESULTS: Of the 213 patients, 181 (85%) agreed to a DNR order. Cardiopulmonary resuscitation was done in 1 out of 181 patients. The DNRs were suggested by attending physicians in 83.9% of cases and by family members in 16.1%. The patients with more frequent admission to the hospital (3.7+/-2.6 vs. 2.9+/-1.7, p<0.05) and with higher educational level (p<0.05) were more likely to agree to a DNR order. Patients with gastrointestinal tract cancer were more likely to agree to a DNR order than patients with lung cancer or hematologic malignancy (p<0.05). The levels of care after DNR agreement were: withholding of resuscitation only (17.2%), withholding of additional support (73.9%), and active withdrawal of provided support (8.9%). CONCLUSIONS: The frequency of admission, type of malignancy, and educational level of patients were determining factors for the establishment of DNR orders in patients with malignancy.
Cardiopulmonary Resuscitation ; Ethics Committees, Clinical ; Gastrointestinal Neoplasms ; Hematologic Neoplasms ; Humans ; Korea ; Lung Neoplasms ; Medical Futility ; Resuscitation ; Retrospective Studies

Ethical problems in an emergency department (ED) are much more common than is usually recognized. But these difficult ethical dilemmas have not been dealt with by general medical ethicists. Most medical ethics guidelines tend to concentrate on chronic or at least relatively stable situations rather than on the acute, episodic cases that are typical in the ED. most ethical problems such as abortion, euthanasia, and professionalism can be solved after reflection and deliberation, and after a process of communication that reveals the values and interests of the patient or the patient's family. In contrast, when health care professionals in the ED recognize ethical problems, they often don't have enough time for an ethical consultation such as a Hospital Ethics Committee. Ethical principles such as autonomy, beneficence, nonmaleficence, and justice need to be applied to the unique setting of emergency medicine. Hence, it is necessary to develop ethics guidelines in emergency medicine and ethics education for health care professionals in emergency departments. At first, we collected cases involving ethical problems and reviewed the ethical and legal aspects of those cases. In this article, we summarize the ethical issues in emergency medicine, deal with actions in emergency medical services, and also consider the relationships between ethical issues and act on emergency medical services. We want to present the important factors that should be considered in ethical decision making within an emergency medicine department including patient decision making capacity, legal custody, and ethical principles.
Beneficence ; Decision Making ; Delivery of Health Care ; Emergencies ; Emergency Medical Services ; Emergency Medicine ; Ethicists ; Ethics Committees, Clinical ; Ethics, Medical ; Euthanasia ; Humans ; Jurisprudence ; Social Justice

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.
Appointments and Schedules ; Clinical Trials/legislation & jurisprudence ; Clinical Trials/standards ; Data Collection ; Epidemiologic Studies ; Ethics Committees, Research*/legislation & jurisprudence ; Ethics Committees, Research*/standards ; Ethics Committees, Research*/statistics & numerical data ; Female ; Human ; Human Experimentation/legislation & jurisprudence ; Human Experimentation/standards ; Korea ; Male ; Politics ; Public Policy ; Research Design/standards

PURPOSE: In our previous study, the authors developed high heat-treated mineralized porcine cancellous bone(TS-GBB, TaeSan Green Bone Block) as bone-substitute. So we projected that this experiments about TSGBB would prove its safety about problems after transplants, and its stability in mechanical strength as the human bone-substitute. MATERIALS AND METHODS: Highly heat-treated mineralized porcine cancellous bone was made. The chemical, mechanical, and morphological properties were evaluated through various tests. Animal study Total 31 New Zealand White rabbits were randomly selected. Bony defect on medial side of the proximal tibia was made. TS-GBB was implanted into the defect area in experimental group, while it was not inserted in control group. For stable fixation self-designed plate of stainless steel was used in both groups. At 2, 8, and 24 weeks, radiological evaluation was performed to measure new bone formation. At 4 and 16 weeks, clinical laboratory tests were performed. Mechanical shear tests were performed for control and experimental groups at 2, 8, and 16 weeks after operation. Also, histological observations were performed by H & E staining at 2 and 16 weeks after operation. Clinical experiments With the approval of IRB in Pusan Paik Hospital of Inje University and Hwasoon Hospital of Chunnam National University, the clinical trials were processed. After harvesting iliac bone for auto grafts from the 40 patients, 20 for each hospital, the TS-GBB were inserted to the donor site. ESR, CRP, WBC count were performed at postoperative time immediately, 1 week, 4 weeks, and 12 weeks to examine possible infection. At 12 weeks after operation, additional X-ray and CT observation were performed. RESULTS: Animal study At all laboratory finding, two group did not indicate a significant difference. At radiologic evaluation, we could comfirm that bone defect size was small gradually by new bone formation in the control group but new bone formation degree was more smaller and slower compared to the TS-GBB group. And at result of biological dynamic stiffness experiments, at postoperative 16 weeks, maximum load at breakage of control group showed to approximately 70% in normal tibia's that. But, maximum load at breakage or yield of TS-GBB group showed to more than 95% in normal tibia's that. In histologic examination, at postoperative 16 weeks, we comfirmed that in control group atypical bony tissue existed in defect site. On the other side, in TS-GBB group new bone formation formed in uniform. Clinical experiments In 20 cases of Inje University, absorption rate was slow a little at 1 case, but the others absorbed normally. In 17 cases of Hwasun Hospital of Chunnam National University, we comfirmed in grade 3 about TS-GBB's absorption and new bone formation at 16 case. At only 1 case, degree of TS-GBB's absorption and new bone formation was poor. In clinical chemistry tests to evaluate the safety, 19 of 20 patients who participated in the experiment in Pusan Paik hospital showed no specific abnormality and showed similar result to preoperative laboratory. In 1 case at postoperative 12 weeks, CRP was elevated, at 16 weeks this patient showed in normal value in ESR, CRP, and WBC count. In 20 patients of Hwasun Hospital all showed similar results to preoperative laboratory in clinical chemistry tests. CONCLUSION: We think that TS-GBB is the suitable material for regeneration of bone defect site as xenograft of clinical bone substitute.
Absorption ; Animals ; Bone Substitutes ; Chemistry, Clinical ; Clinical Chemistry Tests ; Ethics Committees, Research ; Humans ; Osteogenesis ; Rabbits ; Reference Values ; Regeneration ; Stainless Steel ; Tibia ; Tissue Donors ; Transplantation, Heterologous ; Transplants

The development of life sustaining treatment technology including artificial ventilation has given us the moral problem, considering the human dignity and futility of medical treatment, until when these treatments could be given to terminally ill patients. In Korea, there were two supreme court decisions a significant impacts on the withdrawal of life sustaining treatment. After these decisions, Korean medical society has developed a guideline for advance directives and has also established a voluntary hospital ethics committee. The patient's right of self- determination right and the paternalistic approach of medicine should be balanced at an optimal level, because benefits of medical advances should be adjusted to take into account the burden of life prolongations. Decision making always has been difficult because related to ethical values, and there a broad spectrum of value-laden attitudes within Korean society. The legalization of end-of-life care should be from the respect of the professional autonomy of medical society. Under these considerations, we should supply alternative methods like hospice care, which can help to manage the withdrawal of life support appropriately, and also make an effort to relieve the economical burden of patients.
Advance Directives ; Decision Making ; Ethics Committees ; Ethics Committees, Clinical ; Hospice Care ; Hospices ; Hospitals, Voluntary ; Humans ; Jurisprudence ; Korea ; Medical Futility ; Patient Rights ; Personal Autonomy ; Personhood ; Professional Autonomy ; Societies, Medical ; Supreme Court Decisions ; Terminally Ill ; Ventilation ; Withholding Treatment