The use of cosmetics in the crowd has the long-term characteristics. The adverse reactions of cosmetics reported in other country in the world suggest that human patch tests and short-term human using test may not be sufficient to evaluate the safety of high-risk new cosmetic raw ingredients, and long-term human using test should be conducted for evaluation. Therefore, this article reviews the key factors that affect long-term human trial trials, such as site of use, single-use amount, frequency of use, duration of use, and subject conditions, providing supportive evidence for standardized safety evaluation standards for long-term human using test of cosmetics.
Humans ; Cosmetics ; Human Experimentation

The use of cosmetics in the crowd has the long-term characteristics. The adverse reactions of cosmetics reported in other country in the world suggest that human patch tests and short-term human using test may not be sufficient to evaluate the safety of high-risk new cosmetic raw ingredients, and long-term human using test should be conducted for evaluation. Therefore, this article reviews the key factors that affect long-term human trial trials, such as site of use, single-use amount, frequency of use, duration of use, and subject conditions, providing supportive evidence for standardized safety evaluation standards for long-term human using test of cosmetics.
Humans ; Cosmetics ; Human Experimentation

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.
Economic Development ; Ethics ; Ethics Committees, Research ; Hospice Care ; Hospices ; Human Experimentation ; Humans ; Palliative Care ; Patient Rights ; Quality of Life ; Terminally Ill

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*

The electrical conductivity is a passive material property primarily determined by concentrations of charge carriers and their mobility. The macroscopic conductivity of a biological tissue at low frequency may exhibit anisotropy related with its structural directionality. When expressed as a tensor and properly quantified, the conductivity tensor can provide diagnostic information of numerous diseases. Imaging conductivity distributions inside the human body requires probing it by externally injecting conduction currents or inducing eddy currents. At low frequency, the Faraday induction is negligible and it has been necessary in most practical cases to inject currents through surface electrodes. Here we report a novel method to reconstruct conductivity tensor images using an MRI scanner without current injection. This electrodeless method of conductivity tensor imaging (CTI) utilizes B1 mapping to recover a high-frequency isotropic conductivity image which is influenced by contents in both extracellular and intracellular spaces. Multi-b diffusion weighted imaging is then utilized to extract the effects of the extracellular space and incorporate its directional structural property. Implementing the novel CTI method in a clinical MRI scanner, we reconstructed in vivo conductivity tensor images of canine brains. Depending on the details of the implementation, it may produce conductivity contrast images for conductivity weighted imaging (CWI). Clinical applications of CTI and CWI may include imaging of tumor, ischemia, inflammation, cirrhosis, and other diseases. CTI can provide patient-specific models for source imaging, transcranial dc stimulation, deep brain stimulation, and electroporation.
Animal Experimentation* ; Animals* ; Anisotropy ; Brain ; Deep Brain Stimulation ; Diffusion ; Electric Conductivity ; Electrodes ; Electroporation ; Extracellular Space ; Fibrosis ; Human Body ; Inflammation ; Intracellular Space ; Ischemia ; Magnetic Resonance Imaging* ; Methods

PURPOSE: Nitrocellulose membrane–based filtration system (NCFS) is widely used for protein concentration. In this study, we applied NCFS for production of virus-like particle (VLP) as a vaccine candidate and evaluated yield property and immunogenicity. MATERIALS AND METHODS: Influenza VLPs were generated by baculovirus-insect cell protein expression system. NCFS and sucrose gradient ultracentrifugation were used for purification of VLP. Immunogenicity of VLP was evaluated by animal experiment. RESULTS: Influenza VLPs expressing hemagglutinin (HA) and neuraminidase proteins derived from highly pathogenic influenza virus (H5N8) were effectively produced and purified by NCFS. HA activity of VLP which correlated with antigenicity was well conserved during multiple purification steps. This NCFS based purified VLPs induced influenza virus–specific antibody responses. CONCLUSION: Our results indicate that the influenza VLP vaccine could be prepared by NCFS without loss of immunogenicity and elicit antigen-specific immune responses.
Animal Experimentation ; Antibody Formation ; Baculoviridae ; Collodion* ; Filtration* ; Hemagglutinins ; Influenza, Human* ; Membranes* ; Neuraminidase ; Orthomyxoviridae ; Sucrose ; Ultracentrifugation ; Vaccines

Patients with heart failure (HF) have structural and functional changes of the gut as a result of microcirculatory disturbances. A disrupted gut epithelial barrier may lead to translocation of microbial products into systemic circulation, possibly aggravating HF by inducing inflammatory responses. Gut microbiota play an essential role in the maintenance of host homeostasis because large quantities of their gene products complement host physiological processes. Emerging evidence has suggested the potential clinical significance of gut microbiota in the pathophysiology of HF. Imbalances of gut microbe-derived metabolites can contribute to cardiac dysfunction and other morbidities in patients with HF. Therapeutic research for HF through targeting microbiota is under way. Thus, the novel concept of a heart-gut axis may lead to breakthroughs in the development of innovative diagnostics and therapeutic approaches for HF.
Complement System Proteins ; Dysbiosis ; Gastrointestinal Microbiome ; Heart Failure* ; Heart* ; Homeostasis ; Humans ; Microbiota ; Physiological Processes ; Therapeutic Human Experimentation

Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.
Clinical Trials as Topic/*ethics ; *Ethics, Research ; Human Experimentation/*ethics ; Publishing/*ethics ; Republic of Korea ; *Research Report ; Research Subjects

Stroke is one of the common causes of death and disability. Despite extensive efforts in stroke research, therapeutic options for improving the functional recovery remain limited in clinical practice. Experimental stroke models using genetically modified mice could aid in unraveling the complex pathophysiology triggered by ischemic brain injury. Here, we optimized the procedure for generating mouse stroke model using an intraluminal suture in the middle cerebral artery and verified the blockage of blood flow using indocyanine green coupled with near infra-red radiation. The first week after the ischemic injury was critical for survivability. The survival rate of 11% in mice without any treatment but increased to 60% on administering prophylactic antibiotics. During this period, mice showed severe functional impairment but recovered spontaneously starting from the second week onward. Among the various behavioral tests, the pole tests and neurological severity score tests remained reliable up to 4 weeks after ischemia, whereas the rotarod and corner tests became less sensitive for assessing the severity of ischemic injury with time. Further, loss of body weight was also observed for up 4 weeks after ischemia induction. In conclusion, we have developed an improved approach which allows us to investigate the role of the cell death-related genes in the disease progression using genetically modified mice and to evaluate the modes of action of candidate drugs.
Animals ; Anti-Bacterial Agents ; Body Weight ; Brain Injuries ; Brain Ischemia ; Cause of Death ; Disease Progression ; Indocyanine Green ; Ischemia ; Mice* ; Middle Cerebral Artery ; Stroke* ; Survival Rate ; Sutures ; Therapeutic Human Experimentation

Whiplash injury in low-speed traffic accidents are not objectively verified by medical equipment, thereby creating scope for misuse, which has resulted in huge social losses worldwide. The aim of this study was to examine the influence of low-speed vehicular rear-impact collisions on middle-aged men, and to analyze the head and neck injury criteria for the symptomatic human volunteers. Data was examined from the results of 50 dynamic sled tests, originally performed by Hong et al. (2012). In the previous tests, 50 men aged 30~50 years were exposed to an impulse equivalent to a bumper-to-bumper rear collision under medical supervision, and no resulting whiplash injury was identified. In this study, for 6 subjects who experienced dull aches over their bodies, head injury criteria (HIC15) and neck injury criteria (N(km)) were calculated according to the accelerations, forces, and moments at the occipital condyle measured by motion capture system. Although there were no changes in magnetic resonance imaging findings in all subjects at the pre-/post-test orthopedic examination, 6 subjects revealed mild aches around the shoulder, back, or lumbar area, and their symptoms disappeared within 2 days. The head and neck injury criteria, HIC15 (3.086 +/- 2.942) and N(km) (0.077 +/- 0.064) were obtained, and the maximum HIC15 and N(km) were found to be significantly lower than the critical injury assessment reference values (HIC15: 700, N(km): 0.3). Moreover, even though 2 subjects were exposed to the same level of change of velocity (7.9 km/h), each N(km) was significantly different (0.179, 0.057). One can therefore conclude that N(km) can vary according to voluntary movements in the human subject.
Acceleration ; Accidents, Traffic ; Aged ; Automobiles ; Craniocerebral Trauma ; Head ; Human Experimentation ; Humans ; Magnetic Resonance Imaging ; Male ; Neck ; Neck Injuries ; Organization and Administration ; Orthopedics ; Reference Values ; Shoulder ; Whiplash Injuries