BACKGROUND/AIMS: Due to a lack of scientific evidence and unstandardized protocols, the correct use of personal protective equipment (PPE) is not always easy for healthcare personnel (HCP). This study aimed to generate experimental evidence to reduce contaminations during PPE doffing. METHODS: With institutional review board approval, 4 standardized HCP were recruited to examine selected PPE protocols based on consultations with 10 invited Korean infection control leaders. Using fluorescent powder and ultraviolet light, each PPE protocol was evaluated for contaminations by comparing methods or steps. Pictures of contaminated areas and videos of HCP practice were evaluated for case analysis by linking all collected data using assigned study experiment codes. RESULTS: A total of 38 simulation experiments were conducted during December 14–20, 2016. No significant difference was found among minor variations in PPE protocols. Rather, after an intensive, 1-minute patient care simulation (e.g., physical assessment), severe powder contaminations on the front and under the sleeves of coveralls were found. Even after the outer-glove surface was wiped clean, partial contaminations still remained, especially between fingers and on fingertips. Moreover, after cleaning glove surface contaminations using wipes, each doffing step caused different contaminations. Among different types of N95 respirators, the foldable N95 type was the most stable during doffing processes, with less possibility of contamination. CONCLUSIONS: Based on this study's findings with visual evidence of contaminations during PPE doffing processes, some meaningful recommendations were feasible, such as the use of disposable long-sleeve aprons over coveralls. Further study is necessary to evaluate these recommendations.
Delivery of Health Care ; Equipment Contamination ; Ethics Committees, Research ; Fingers ; Health Personnel ; Humans ; Infection Control ; Patient Care ; Personal Protective Equipment ; Referral and Consultation ; Ultraviolet Rays ; Ventilators, Mechanical

No abstract available.
Humans ; Peer Review, Research/*ethics ; Periodicals as Topic ; Publishing/*ethics ; Research Personnel

PURPOSE: The purpose of this study was to explore ethical problems that cause moral distress in nurses and affects the quality of care provided by community mental health nurses working in community mental health settings. METHODS: Three focus group interviews were held with 14 nurses working in 3 community mental health centers in Korea. Qualitative descriptive methods and qualitative content analysis were used. RESULTS: Data analysis found 5 domains (decision making, communication, resources, safety, advocacy), 9 categories (personal information sharing issues, ethical insensibility, collisions between principles and practice, institutions unprepared in ethical problems, ethical dilemma in interactions with clients, problems with the evaluation system, problems with the budget structure, problems with the lack of safety measure, and problems with role limitation as a professional) and 11 subcategories. CONCLUSION: Results of this study suggest a) a need for further research on identifying ethical conflicts arising in community mental health fields, and b) on what nurses actually do when they deal with ethical conflicts, c) efforts to develop ethics support programs such as ethics education, training and reflection meetings to enhance nurses' ethical sensitivity, d) consideration of a supportive environment and culture that prioritizes ethical concerns in practitioners as well as administrators.
Administrative Personnel ; Budgets ; Community Mental Health Centers ; Education ; Ethics ; Focus Groups ; Humans ; Information Dissemination ; Korea* ; Mental Health Services ; Mental Health* ; Nursing ; Qualitative Research ; Statistics as Topic

BACKGROUND: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. METHODS: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. RESULTS: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. CONCLUSION: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.
Academies and Institutes ; Certification ; Compliance* ; Ethics Committees, Research ; Germany ; Humans ; Korea ; Research Personnel* ; Social Control, Formal ; Writing

BACKGROUND/AIMS: The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied. METHODS: We included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval. RESULTS: Investigators' decisions on risk level were higher in the IBD group than in the non-IBD group (P<0.05). Results of initial reviews, frequencies of continuing reviews, the numbers of IRB review comments, and durations from submission to approval were not different between the two groups, but IRB decisions on risk level were higher in the IBD group (P<0.05). In subgroup analysis, the number of IRB comments from initial review on informed consent forms and procedures as well were quest of more information were significantly higher in the IBD group than in the non-IBD group (P<0.001 and 0.01, respectively). CONCLUSIONS: In Korea, rare diseases such as IBD require more information for the IRB process due to their distinct characteristics. IBD researchers should develop research protocols more carefully and make their research as subject-friendly as possible.
Consent Forms ; Ethics Committees, Research ; Gastrointestinal Diseases ; Humans ; Inflammatory Bowel Diseases* ; Jurisprudence ; Korea ; Rare Diseases ; Research Design ; Research Personnel ; Retrospective Studies ; Social Control, Formal

Attitude of Health Personnel ; Biomedical Research ; Child ; Ethics, Research ; Humans ; Pediatrics

The purpose of this study was to examine trends in duplicate publication in Korean medical articles indexed in the KoreaMed database from 2004 to 2009, before and after a campaign against scientific misconduct launched by the Korean Association of Medical Journal Editors in 2006. The study covered period from 2007 to 2012; and 5% of the articles indexed in KoreaMed were retrieved by random sampling. Three authors reviewed full texts of the retrieved articles. The pattern of duplicate publication, such as copy, salami slicing (fragmentation), and aggregation (imalas), was also determined. Before the launching ethics campaign, the national duplication rate in medical journals was relatively high: 5.9% in 2004, 6.0% in 2005, and 7.2% in 2006. However, duplication rate steadily declined to 4.5% in 2007, 2.8% in 2008, and 1.2 % in 2009. Of all duplicated articles, 53.4% were classified as copies, 27.8% as salami slicing, and 18.8% as aggregation (imalas). The decline in duplicate publication rate took place as a result of nationwide campaigns and monitoring by KoreaMed and KoreaMed Synapse, starting from 2006.
Databases, Factual ; *Duplicate Publication as Topic ; Humans ; Journalism, Medical ; Publishing/ethics/*statistics & numerical data/trends ; Republic of Korea ; Research Personnel/ethics

No abstract available.
Humans ; Journal Impact Factor ; Publishing/ethics/*standards ; Research ; Research Personnel/ethics

PURPOSE: Generic substitution of brand-name medications can lead to significant cost savings and is an accepted medical practice. This study evaluated clinical and safety outcomes among liver transplant recipients whose mycophenolate mofetil (MMF) was converted from the brand-name formulation (Cellcept) to a generic formulation (My-rept). METHODS: Clinical data from multiple centers were prospectively collected for determination of complications, safety, and quality of life after in 154 clinically stable, adult liver transplant recipients whose MMF was converted to a generic formulation between April 2010 and September 2012. This protocol was approved by Institutional Review Boards of all involved sites. RESULTS: In eight patients (5.19%), nine instances of drug-related complications occurred after medication conversion. Half of these complications were gastrointestinal disorders (n = 4), and most (7 of 9) were mild. No significant differences were noted in mean pre- and postconversion gastrointestinal symptoms via a rating system (8.9 vs. 10.4) or gastrointestinal quality-of-life index scores (125.6 vs. 123.1). More than 90% of patients reported a status of "about the same" when questioned about the brand-name and generic formulation using the Patient Overall Treatment Effect and Investigator Overall Treatment Effect measures. The incidence of serious adverse events was 5.8%. Acute rejection occurred in two patients, with no graft loss or death. CONCLUSION: Clinical experience as well as research data showed that generic MMF was comparable in efficacy to the brand-name drug. Given the lack of adverse events and the safety findings, conversion from brand-name MMF to generic MMF should be encouraged.
Adult ; Cost Savings ; Drug Substitution ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Generic ; Ethics Committees, Research ; Humans ; Incidence ; Liver* ; Prospective Studies ; Quality of Life ; Research Personnel ; Transplantation* ; Transplants

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.
Ethics ; Ethics Committees, Research* ; Humans ; Missions and Missionaries* ; Research Personnel ; Social Control, Formal