Experimental studies involve intervention and manipulation of study elements such as randomization of the participating groups. In general, experimental studies involving human are riskier than observational studies, demanding robust ethical vigilance and compliance among such stakeholders as investigators, sponsors, IRBs and health authorities. Social values of research should be counted as a primary ethical consideration in experimental research. It is unethical to put human subjects into uncertain and risky conditions if the study does not pursue valuable knowledge. Sound scientific design is prerequisite for good ethics. Risk-benefit ratio of the study must be carefully evaluated study. Not only risks from physical harms but also socio-economical and psychological harms from the study should be considered as risk of the study. Risks from the design of the study such as randomization and placebo must be carefully examined. Voluntary informed consent is essential in experimental studies involving human. Human subjects, before they decide to participate in the study, must be informed the followings: risks, benefits, experimental procedures, alternative treatment, compensation for injury, and participants' voluntariness and right to withdraw at anytime. Experimental studies are usually required written consent documentation and full institutional review board (IRB) review. Other elements of experimental research ethics includes special protection for high risk groups and various vulnerable groups, and protection of privacy and confidentiality.
Bioethics* ; Compensation and Redress ; Compliance ; Confidentiality ; Consent Forms ; Ethics ; Ethics Committees, Research ; Ethics, Research ; Humans ; Informed Consent ; Privacy ; Random Allocation ; Research Personnel ; Social Values

PURPOSE: The purposes of this study were to investigate factors related to the depression of the elderly dwelling in a big city, and to explore the influence of physical health, cognitive symptom and nutritional status on the elders' depression. METHODS: After the approval of the Institutional Review Board (IRB) and obtaining the participants' consent form, a face-to-face and private interview was conducted with each participant from May, 2007 to Aug, 2007 by trained graduate level students. A total of 201 elders aged over 65 years participated in the study. The questionnaire consisted of K-GDS, PHQ-15 and Nutritional Screening Initiative (NSI). Collected data were analyzed with the SPSS 13.0 program, which was used for frequency, percentage, mean, standard deviation, Pearson correlation coefficients, and multiple regression. RESULTS: The major findings of this study were as follows. 1) 28.4% of the subjects belonged to the depression group, 78.1% had one or more diseases, 85.6% had experienced somatic symptoms, and 49.7% belonged to the nutritional risk group. 2) Older age, lower educational level, more pocket money, a larger number of diseases, more severe cognitive symptoms and poorer nutritional status were significantly related to a higher depression score. 3) Significant factors influencing depression were nutritional status, cognitive symptoms and the number of diseases, which explained 38.1% of the variance of elderly depression, and nutritional status was the most influencing factor. CONCLUSION: The finding of this study gives useful information for developing assessment tools and interventions for elders' depression.
Aged* ; Consent Forms ; Depression* ; Ethics Committees, Research ; Humans ; Mass Screening ; Neurobehavioral Manifestations* ; Nutritional Status* ; Surveys and Questionnaires

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

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

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: To assess the toxicity and tumor response induced by DCVac/IR(R) dendritic cell (DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. MATERIALS AND METHODS: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of 6x10(6) DCs were packed into a vial (DCVac/IR(R), 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses (3x10(6) to 12x10(6) DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. RESULTS: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The 12x10(6) DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. CONCLUSION: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The DCVac/IR(R) immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.
Appointments and Schedules ; Colorectal Neoplasms ; Consent Forms ; Dendritic Cells ; Ethics Committees, Research ; Humans ; Immunization ; Immunotherapy ; Liver ; National Cancer Institute (U.S.) ; Needles ; Neoplasm Metastasis ; Radiation Dosage ; Vaccination

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