It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.
Bioethics ; Computer Security ; Consent Forms ; Ethics ; Ethics Committees, Research ; Humans ; Informed Consent ; Jurisprudence ; Korea ; Personally Identifiable Information ; Privacy ; Publications ; Republic of Korea ; Retrospective Studies

BACKGROUND/OBJECTIVES: This study aimed to compare student consumption of school meals by school level, to identify the influencing factors of school meal consumption, and to assess improvement needs of school food service among students. SUBJECTS/METHODS: A total of 1,441 elementary, middle, and high school students attending 58 schools in Gyeonggi-do, South Korea participated in the survey in 2015. A questionnaire and informed consent forms for students and legal guardians were sent home and completed responses were returned to the researcher. RESULTS: Approximately 58% of the students perceived the portion sizes of school meals as appropriate and 76.1% consumed almost all or all of the meals served. More elementary and middle school students than high school students consumed almost all or all of the meals (P < 0.001). A regression analysis revealed that the students with a higher dietary behavior score (P < 0.001), higher satisfaction with food service (P < 0.001), a higher environmental protection practice score (P < 0.05), and more positive attitudes toward school meals (P < 0.01) consumed significantly more meals. The provision of foods that taste good and reflecting student opinions on menus were the most important factors for increasing school meal consumption. CONCLUSIONS: To increase consumption of school meals, food service staff should provide students with quality meals and engage students in school food service. Nutrition education that emphasizes healthy eating behaviors and cafeteria environment modification that applies strategies based on behavioral economics can encourage students to consume more school meals.
Consent Forms ; Conservation of Natural Resources ; Economics, Behavioral ; Education ; Feeding Behavior ; Food Habits ; Food Services ; Gyeonggi-do ; Humans ; Korea ; Legal Guardians ; Meals ; Portion Size

The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus (HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE's genetic experiments. China's guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE's human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist's self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.
CRISPR-Cas Systems ; China ; Consent Forms/ethics* ; Ethics, Medical ; Female ; Gene Editing/legislation & jurisprudence* ; Gene Knockout Techniques/ethics* ; HIV Infections/prevention & control* ; Human Experimentation/legislation & jurisprudence* ; Humans ; Infant, Newborn ; Pregnancy ; Professional Misconduct/ethics* ; Receptors, CCR5/genetics*

PURPOSE: There are few reports from Asian countries about the long-term results of aromatase inhibitor adjuvant treatment for breast cancer. This observational study aimed to evaluate the long-term effects of letrozole in postmenopausal Korean women with operable breast cancer. METHODS: Self-reported quality of life (QoL) scores were serially assessed for 3 years during adjuvant letrozole treatment using the Korean version of the Functional Assessment of Cancer Therapy-Breast questionnaires (version 3). Changes in bone mineral density (BMD) and serum cholesterol levels were also examined. RESULTS: All 897 patients received the documented informed consent form and completed a baseline questionnaire before treatment. Adjuvant chemotherapy was administered to 684 (76.3%) subjects, and 410 (45.7%) and 396 (44.1%) patients had stage I and II breast cancer, respectively. Each patient completed questionnaires at 3, 6, 12, 18, 24, 30, and 36 months after enrollment. Of 897 patients, 749 (83.5%) completed the study. The dropout rate was 16.5%. The serial trial outcome index, the sum of the physical and functional well-being subscales, increased gradually and significantly from baseline during letrozole treatment (p<0.001). The mean serum cholesterol level increased significantly from 199 to 205 after 36 months (p=0.042). The mean BMD significantly decreased from −0.39 at baseline to −0.87 after 36 months (p<0.001). CONCLUSION: QoL gradually improved during letrozole treatment. BMD and serum cholesterol level changes were similar to those in Western countries, indicating that adjuvant letrozole treatment is well tolerated in Korean women, with minimal ethnic variation.
Aromatase ; Asian Continental Ancestry Group ; Bone Density ; Breast Neoplasms* ; Breast* ; Chemotherapy, Adjuvant ; Cholesterol ; Consent Forms ; Female ; Humans ; Observational Study ; Quality of Life*

OBJECTIVE: Burr hole craniostomy and closed-system drainage (BCD) is a common surgical procedure in the field of neurosurgery. However, complications following BCD have seldom been reported. The purpose of this study was to report our experiences regarding complications following BCD for subdural lesions. METHODS: A retrospective study of all consecutive patients who underwent BCD for presumed subdural lesions at one institute since the opening of the hospital was performed. RESULTS: Of the 395 patients who underwent BCD for presumed subdural lesions, 117 experienced surgical or nonsurgical complications. Acute intracranial hemorrhagic complications developed in 14 patients (3.5%). Among these, 1 patient died and 5 patients had major morbidities. Malposition of the drainage catheter in the brain parenchyma occurred in 4 patients, and opposite-side surgery occurred in 2 patients. Newly developed seizures after BCD occurred in 8 patients (2.0%), five of whom developed the seizures in relation to new brain lesions. Eighty-eight patients (22.3%) suffered from nonsurgical complications after BCD. Pulmonary problems (7.3%) were the most common nonsurgical complications, followed by urinary problems (5.8%), psychologic problems (4.3%), and cognitive impairments (3.8%). CONCLUSION: The incidence of complications after BCD for subdural lesions is higher than previously believed. In particular, catastrophic complications such as acute intracranial hematomas and surgical or management errors occur at rates that cannot be ignored, possibly causing medico-legal problems. Great caution must be taken during surgery and the postoperative period, and these complications should be listed on the informed consent form before surgery.
Brain ; Catheters ; Cognition Disorders ; Consent Forms ; Drainage* ; Hematoma ; Hematoma, Subdural, Chronic ; Humans ; Incidence ; Neurosurgery ; Postoperative Complications ; Postoperative Period ; Retrospective Studies ; Seizures ; Trephining

OBJECTIVE: Whether to perform cardiopulmonary resuscitation (CPR) or do-not-resuscitate (DNR) is not only a medical problem but also a decision that should be made carefully with self-autonomy in accordance with life values. We conducted a retrospective observational study to identify the characteristics of current CPR and DNR at a practical level. METHODS: We retrospectively analyzed data from medical records with regard to the clinical status of DNR decision in 356 patients with cancer who expired between October 2014 and September 2015 in Soonchunhyang University Bucheon Hospital. RESULTS: DNR was decided significantly more frequently in patients with solid cancers than in patients with hematological cancer (87.7% vs. 71.4%, P=0.003). No other significant factor influenced the DNR decision in this study. The main persons who signed the DNR consent form were mostly sons or daughters (60.7%), never the patients themselves. The median time from the DNR order to death was longer in the ward than in the intensive care unit (ICU; 3.0 days vs. 1.0 days). The mean time from the DNR order to death was 6.6 days (median, 2 days). Among the patients with a DNR order, 110 (36.7%) were hospitalized in the ICU and 73 (24.3%) were treated with ventilator support. CONCLUSION: Most patients expired 6.6 days after DNR permission was given and could not decide their treatment plan by themselves. For better end-of-life care, the sensitive DNR decision with consideration of the individualized environment of the patient for life-sustaining treatment should be settled in Korea.
Cardiopulmonary Resuscitation* ; Consent Forms ; Gyeonggi-do ; Humans ; Intensive Care Units ; Korea ; Medical Records ; Nuclear Family ; Observational Study ; Resuscitation Orders ; Retrospective Studies* ; Terminal Care ; Ventilators, Mechanical

PURPOSE: This study was done to analyze nursing students' attitudes to life-sustaining treatment by measuring their awareness of biomedical ethics and resulting attitude toward withdrawal of life-sustaining treatment. METHODS: This study was a descriptive research to assess the level of nursing students' awareness of biomedical ethics, attitude toward withdrawal of life-sustaining treatment, and correlations between these variables. After the nursing students signed a consent form they were assessed. Data collection was done from September 1 to October 25, 2016, and analyzed using SPSS 23.0 WIM Program. RESULTS: There was a negative correlation and significant difference between nursing students' awareness of biomedical ethics and attitude toward withdrawal of life-sustaining treatment. There was a significant correlation among attitude toward withdrawal of life-sustaining treatment and medical ethics, mortality ethics. CONCLUSION: The findings in the study indicate that it is necessary to provide nursing students with easy access to continuous education to help them establish an acceptable view of withdrawal of life-sustaining treatment.
Bioethics* ; Consent Forms ; Data Collection ; Education ; Ethics ; Ethics, Medical ; Humans ; Life Support Care ; Mortality ; Nursing* ; Students, Nursing

BACKGROUND: Many physicians hesitate to discuss do-not-resuscitate (DNR) orders with patients or family members in critical situations. In the intensive care unit (ICU), delayed DNR decisions could cause unintentional cardiopulmonary resuscitation, patient distress, and substantial cost. We investigated whether the timing of DNR designation affects patient outcome in the medical ICU. METHODS: We enrolled retrospective patients with written DNR orders in a medical ICU (13 bed) from June 1, 2014 to May 31, 2015. The patients were divided into two groups: early DNR patients for whom DNR orders were implemented within 48 h of ICU admission, and late DNR patients for whom DNR orders were implemented more than 48 h after ICU admission. RESULTS: Herein, 354 patients were admitted to the medical ICU and among them, 80 (22.6%) patients had requested DNR orders. Of these patients, 37 (46.3%) had designated DNR orders within 48 hours of ICU admission and 43 (53.7%) patients had designated DNR orders more than 48 hours after ICU admission. Compared with early DNR patients, late DNR patients tended to withhold or withdraw life-sustaining management (18.9% vs. 37.2%, p = 0.072). DNR consent forms were signed by family members instead of the patients. Septic shock was the most common cause of medical ICU admission in both the early and late DNR patients (54.1% vs. 37.2%, p = 0.131). There was no difference in in-hospital mortality (83.8% vs. 81.4%, p = 0.779). Late DNR patients had longer ICU stays than early DNR patients (7.4 ± 8.1 vs. 19.7 ± 19.2, p < 0.001). CONCLUSIONS: Clinical outcomes are not influenced by the time of DNR designation in the medical ICU. The late DNR group is associated with a longer length of ICU stay and a tendency of withholding or withdrawing life-sustaining treatment. However, further studies are needed to clarify the guideline for end-of-life care in critically ill patients.
Advance Directives ; Cardiopulmonary Resuscitation ; Consent Forms ; Critical Illness* ; Hospital Mortality ; Humans ; Intensive Care Units ; Resuscitation Orders* ; Retrospective Studies ; Shock, Septic

BACKGROUND: The decision on whether or not to transfuse should be based on agreement from the patient's own understanding and free will. In Korea, the transfusion guideline first developed in 2009 specified that informed consent should be obtained before transfusion. The standard consent form has also been distributed since 2010. The purpose of this study was to evaluate the degree of improvement in obtaining informed consent for blood transfusion. METHODS: Prior to the development of the transfusion guideline in 2008, an e-mail survey was conducted on 105 clinicians. In 2015, questionnaires were sent to 1,179 clinicians, 32 academic societies, and 6 institutions. RESULTS: Forty-three and 374 answers were received in 2008 and 2015, respectively (response rate, 41.0% and 30.7%). Compared with 2008, the use of explanatory materials increased from 20.9% to 70.5%, and consent acquisitions using a written form increased from 27.9% to 81.7%. The number of respondents who answered that informed consent for transfusions is absolutely necessary also increased from 51.2% to 71.3%. Among the reasons why obtaining informed consent for transfusion can be difficult, the response that standardized consent form is unavailable decreased from 51.2% to 26.9%. CONCLUSION: The transfusion guideline and the standard consent form have contributed greatly to the improvement of obtaining informed consent before blood transfusion at medical institutions in Korea.
Blood Transfusion* ; Consent Forms ; Electronic Mail ; Informed Consent* ; Korea ; Personal Autonomy ; Surveys and Questionnaires

PURPOSE: This study was designed to explore nursing students' knowledge, attitudes and intention to report cases of child abuse. METHODS: A descriptive research design was used with a convenience sample of 202 nursing students. After explaining the purpose of the study, participants who signed the consent form were asked to complete a self-descriptive questionnaire, which included the Child Abuse Intension Scale (CARIS). RESULTS: The number of correct answers for knowledge of child abuse and the law was 7.0/13. The mean scores were, for attitude toward childrearing belief and discipline, 17.1±5.2, for punishment and culpability of offender or victim, 24.6±4.1, for professional responsibility, 30.5±5.1, and for perceived behavioral control, 25.3±5.0. The intended reporting behavior differed significantly by severity of abuse. Factors influencing the intention to report child abuse were attitude towards punishment of parents, professional responsibility, and perceived behavioral control (R2=.133). CONCLUSION: On the basis of our finding, developing education programs to help nursing students detect child abuse and improve reporting rates is important. Thus, we suggests that nursing students be provided with educational protocol for detection and reporting of child abuse.
Behavior Control* ; Child ; Child Abuse* ; Child* ; Consent Forms ; Criminals ; Education ; Humans ; Intention* ; Jurisprudence ; Nursing* ; Parents ; Punishment ; Research Design ; Students, Nursing