Clinical trials are the flower of clinical research. Recently such clinical trials occur increasingly on a global scale. Korea is also one of the countries newly involved in global clinical trials, with resulting scientific, economic, industrial, and ethical implications. The sweeping and meticulous precautions must be introduced to these global clinical trials promoting patient protection through the public, national and international surveillance. These many guidelines in clinical trials are based on the Declaration of Helsinki of the World Medical Association (WMA). Fortunately, we were proud to be able to host the WMA 2008 meeting in Seoul, where the sixth edition of this declaration was announced. Thus, KMA insists that all clinical trials in Korea maintain strict standards and that all our member physicians follow the Declaration of Helsinki and be observers.
Flowers ; Helsinki Declaration ; Humans ; Internationality ; Korea

All medical researches concentrate primarily on advances of medical knowledge and strategies for prevention, diagnosis and treatment of diseases. However, since most of the medical researches are being carried out on human subjects, they often pose ethical problems. Clinical investigations from which the human subjects involved may not derive any personal benefits include studies of physiological function in health or disease, investigations of new drugs, and the trial of new procedures. This paper discusses the ethical problems associated with medical researches, especially clinical investigations involving human subjects directly or indirectly. One general principle that has been wildly accepted is that patients or volunteers involved in the clinical investigations should be fully informed about the experiment in which they participate. However, ethical problems in those clinical investigations should be evaluated by the three major biomedical ethical principles, or the principle of autonomy, the principle of beneficence, and the principle of justice. This paper also presents the 'Helsinki Declaration' advocated by the World Medical Association in 1964 and revised thereafter several times as a practical guideline for the ethics of medical research.
Beneficence ; Diagnosis ; Ethics* ; Helsinki Declaration ; Humans ; Social Justice ; Volunteers

Publication bias has a negative impact on the ability of healthcare providers and consumers to make unbiased healthcare decisions. The demand for greater transparency of clinical trials has increased and a prospective registry has been suggested by the International Committee of Medical Journal Editors. By 2008, prospective registration was considered as an ethical requirement within the Declaration of Helsinki. In Korea, the clinical research registry named 'Clinical Research Information Service (CRIS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. This means that CRIS conforms to the WHO registry criteria and that registering trials with the CRIS satisfies the trial registration policies of many medical journals. To improve the comprehensiveness and completeness of registered clinical research data, it is necessary to communicate and raise awareness of the need to register clinical trials, as well as to establish national policies on clinical trial registration.
Delivery of Health Care ; Health Personnel ; Helsinki Declaration ; Humans ; Information Services ; Korea ; Publication Bias ; World Health Organization

The aim of this report is to show that treadmill running exercise under well-controlled conditions is to improve of regeneration in rat gastrocnemius muscles after physical injury. For this, rats were submitted to bouts of exercise on a treadmill up a 10 degrees decline for 60 min and gastrocnemius muscles were analysed at different exercise periods by immunohistochemistry in comparison with injured nonexercised muscles. Rats were used with guidelines for experimental procedures as set forth in the Declaration of Helsinki. We analysed the regenerative processes by detection of immunoreactivity for the two intermediate filaments, desmin and vimentin. Desmin and vimentin are specific components of the cytoskeleton of striated muscle fibers and of mononuclear cells of mesenchymal origin including myoblasts, respectively. We found that non-exercised rats had more desmin-and vimentin-positive myofibers than that of exercised rats at 9th, 16th, 23th, 30th day after physical injury. At 30th day, non-exercised rats had several desmin-and vimentinpositive myofibers, but exercised rats had numerous normal myofibers. These results show that exercise is able to improve regeneration processes in physical injured gastrocnemius muscles of rats.
Animals ; Cytoskeleton ; Desmin ; Helsinki Declaration ; Immunohistochemistry ; Intermediate Filaments ; Lower Extremity* ; Muscle, Skeletal ; Muscle, Striated ; Muscles ; Myoblasts ; Rats* ; Regeneration ; Running ; Vimentin

Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society.
Beneficence ; Compliance ; Dietary Sucrose ; Helsinki Declaration ; Human Rights ; Humans ; Infant, Newborn ; Research Personnel ; Social Justice ; Vulnerable Populations

PURPOSE: There is increasing concern about ethical conduct of human research in the field of medicine. The purpose of this study was to assess the ethical review process by institutional review boards for human research articles published in the journal of Korean Society of Emergency Medicine. METHODS: We reviewed human research papers published in the journal of Korean Society of Emergency Medicine from the 1st edition, 1990 to the 6th edition, 2006. A checklist was used to review the articles. RESULTS: The total number of prospective clinical research paper was 250. Among them, there were 63 papers (25.2%) in which the obtaining of informed consent was described in the article. Only two studies (0.8%) published in the journal were noted to have IRB approval. Invasive techniques were employed in 134 studies (53.6%). Among the 134, only 22 (16.4%) mentioned that informed consent taken was given during the study. Studies which may have involved discrimination totaled 21 (8.4%), and the number of studies that may have violated the patients' right to privacy was 20 (8%). The number of studies that may have a conflict of interest but was not declared was 12 (4.8%). CONCLUSION: There should be greater concern about the ethical conduct of research in studies with human research subjects in the journal of the Korean Society of Emergency Medicine.
Bioethics ; Checklist ; Conflict of Interest ; Discrimination (Psychology) ; Emergencies ; Emergency Medicine ; Ethical Review ; Ethics Committees, Research ; Helsinki Declaration ; Humans ; Informed Consent ; Patient Rights ; Privacy ; Research Subjects

As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. For clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.
Animal Care Committees ; Animal Experimentation ; Ethics ; Ethics Committees, Research ; Helsinki Declaration ; Humans ; Korea ; Ligands ; Molecular Imaging* ; Nuclear Medicine ; United States Food and Drug Administration

Antineoplastic Agents ; administration & dosage ; therapeutic use ; Case-Control Studies ; Controlled Clinical Trials as Topic ; methods ; Ethics, Medical ; Helsinki Declaration ; Humans ; Neoplasms ; drug therapy ; Placebos ; Randomized Controlled Trials as Topic ; methods ; Therapeutic Equivalency