BackgroundInternational clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians’ attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries.MethodsA questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials.ResultsThe number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH.ConclusionsOur results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.

Prompted by an increased interest of both research participants and the patient advocacy community in obtaining information about research outcomes and on the use of their biological samples; the international community has begun to debate the emergence of an ethical 'duty' to return research results to participants. Furthermore, the use of new technologies (e.g., whole-genome and -exome sequencing) has revealed both genetic data and incidental findings with possible clinical significance. These technologies together with the proliferation of biorepositories, provide a compelling rationale for governments and scientific institutions to adopt prospective policies. Given the scarcity of policies in the context of stem cell research, a discussion on the scientific, ethical and legal implications of disclosing research results for research participants is needed. We present the International Stem Forum Ethics Working Party's Policy Statement and trust that it will stimulate debate and meet the concerns of researchers and research participants alike.

Novel methods and associated tools permitting individual identification in publicly accessible SNP databases have become a debatable issue. There is growing concern that current technical and ethical safeguards to protect the identities of donors could be insufficient. In the context of human embryonic stem cell research, there are no studies focusing on the probability that an hESC line donor could be identified by analyzing published SNP profiles and associated genotypic and phenotypic information. We present the International Stem Cell Forum (ISCF) Ethics Working Party’s Policy Statement on “Publishing SNP Genotypes of Human Embryonic Stem Cell Lines (hESC)”. The Statement prospectively addresses issues surrounding the publication of genotypic data and associated annotations of hESC lines in open access databases. It proposes a balanced approach between the goals of open science and data sharing with the respect for fundamental bioethical principles (autonomy, privacy, beneficence, justice and research merit and integrity).

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The ethical issues related to current stem cell based therapies are examined based upon ethical principles. For the ethical conduct of clinical trials using stem cells, the guidelines for all clinical research should be followed. Because of highly innovative nature of such trials, special attention must be paid to rigorous scientific and ethics review in comparison of currently available treatments, assurance of voluntary informed consent and publication of findings of the clinical trial including negative results and adverse effects. International guidelines and Korean regulations are surveyed for justifiable medical use of unproven stem cell-based interventions. Key features include application of such innovative intervention only to a very small number of seriously ill patients, following a written protocol, approval from an ethics committee, informed consent, safety monitoring, follow-up data collection to evaluate effectiveness and adverse effects and transition to a formal clinical trial in a timely fashion after experiencing a few patients. Keywords: Stem cell; Ethics; Clinical trial; Innovative therapy AbstractThis research was supported

This research aimed to investigate the changes in ethical issues in everyday clinical practice recognized by critical care nurses during two observation periods. We conducted a retrospective analysis of data obtained by prospective questionnaire surveys of nurses in the intensive care units (ICU) of a tertiary university-affiliated hospital in Seoul, Korea. Data were collected prospectively during two different periods, February 2002-January 2003 (Period 1) and August 2011-July 2012 (Period 2). Significantly fewer cases with ethical issues were reported in Period 2 than in Period 1 (89 cases [2.1%] of 4,291 ICU admissions vs. 51 [0.5%] of 9,302 ICU admissions, respectively; P < 0.001). The highest incidence of cases with identified ethical issues in both Periods occurred in MICU. The major source of ethical issues in Periods 1 and 2 was behavior-related. Among behaviorrelated issues, inappropriate healthcare professional behavior was predominant in both periods and mainly involved resident physicians. Ethical issue numbers regarding end-oflife (EOL) care significantly decreased in the proportion with respect to ethical issues during Period 2 (P = 0.044). In conclusion, the decreased incidence of cases with identified ethical issues in Period 2 might be associated with ethical enhancement related with EOL and improvements in the ICU care environment of the studied hospital. However, behaviorrelated issues involving resident physicians represent a considerable proportion of ethical issues encountered by critical care nurses. A systemic approach to solve behavior-related issues of resident physicians seems to be required to enhance an ethical environment in the studied ICU.Graphical Abstract

This paper deals with Pavlov theory in North Korea in the late 1950s, focusing on its role in ideological struggle in medicine and in reinterpretation of traditional medicine. In North Korean Ministry of Health found Pavlov theory to have rich resources which could be used in the construction of the North Korea's socialist medicine. First of all, Pavlov theory provided the North Korean Communist Party with a powerful ideological weapon against capitalist medical thoughts, representing superior socialist medicine based upon Marx-Leninism and dialectical materialism. This paper examines the contents of Pavlov theory introduced in the North Korea from the Soviet Union in the late 1950s. Pavlov theory in the North Korea was not merely a political slogan but a unified medical system of thought, ranging from biological theory on the organism and pathogenesis to clinical theory. Nonetheless, Pavlov theory became Pavlov doctrine in the ideological struggle in healthcare field initiated by Kim Il Sung and the Communist Party. In the process of the ideological struggle, the abducted surgeon Kim Si-Chang was accused and purged of counter-revolutionary and refusal to conform to Pavlov doctrines by the Communist Party in 1959. Interestingly, Pavlov theory was used in reinterpretation of Traditional Medicine in North Korea from unscientific practice to a rich and scientific complementary medicine by connecting the two with common theoretical components such as Pavlov's typology. By the enthusiastic Communist Party members, Pavlov doctrine was introduced, transformed and exploited to build monolithic ideology system in medicine in North Korea in the late 1950s.

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