• Neonatal Medicine
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• v.15 no.2
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• pp.119-122
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• 2008

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.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.3
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• pp.392-398
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• 2012

This research aims to analyze the ethical requirements and to find the problems for the publication guidelines of oriental medicine journals. A total of 13 domestic journals, related to oriental medicine and registered in 'National Research Foundation of Korea' list, were selected for the analysis of ethical requirements. We inquired the revised year of the publication guideline and the status of ethics committee of selected journals. The ethical requirements of publication guidelines were evaluated by categorizing them into Institutional Review Board(IRB), Helsinki Declaration, Informed Consent, confidentiality and anonymity of subjects, and conflict of interest. In the case of revised year of the publication guidelines, the year of the most recently revised journal was 2011. However, the revised year of publication guidelines were not announced for three journals and a few journals haven't revised the publication guidelines since 2002. In the case of ethics committee status, four journals out of 13 journals maintained the ethics committee. In the result of ethical requirement analysis, nine journals included the information for confidentiality and anonymity of subjects, and four journals included the information for Helsinki Declaration and Informed Consent. However, only one journal included the information for IRB and conflict of interest. Recently, the importance of clinical researches has been increased to prove the effect of oriental medicine scientifically and objectively. The clinical researches should be considered in scientific side and ethical side as well, because they have potential risks to human subjects. In this sense, announcing the ethical requirements in the publication guidelines can be one way to secure the morality of researches. Thus, it is required to prepare correct publication guidelines and ethical requirements in oriental medicine journals.

• Journal of Korean society of Dental Hygiene
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• v.14 no.2
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• pp.241-250
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• 2014

Objectives : The purpose of the study was to examine the ethical requirements for the protection of human subjects in the publication guidelines of dental health journals. Methods : The guidelines of 27 dental health journals were reviewed to determine ethical standards alone, with Helsinki Declaration, by an institutional review board (IRB), informed consent, protection of subject privacy and confidentiality, and no conflicts of interest. Results : 1. Dentistry journals listed on National Research Foundation of Korea had a conflict of interest disclosure provisions of the contribution(76.9%) and the IRB approval(61.5%). 2. Half of the dental health journals were not listed on National Research Foundation of Korea Society but they agreed the advance posting provisions. 3. Dental hygiene journals provide 100% of ethics alone and receive 75% of IRB in the papers. 4. Dental health and dental hygiene journals have conflicts of interest disclosure regulations(59.2%) and IRB approval(51.8%). 5. There existed statistically significant differences between the dental health journals whether they were listed on the human subjects and ethical standards for protection in National Research Foundation of Korea or not. Conclusions : While the publication guidelines of dental health journals have followed to a greater extent in recent years, there is still a need for further instructions to ensure that the authors satisfy all ethical requirements in conducting research on human subjects. IRB approval for dental journals must be standardized and reinforced reflecting the characteristics of each journals. The researchers should obey the code of ethics suitable for education and the editors must review the paper continuously.

• Journal of the korean academy of Pediatric Dentistry
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• v.41 no.2
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• pp.187-192
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• 2014

Research ethics is the basic attitude for researchers. Thanks to our predecessors we are able to conduct systematic studies. The current trend of results and the amount of study-oriented assessments make the side effect that researchers conduct SCI (Science Citation Index) studies. Since the Declaration of Helsinki, the importance of the right, safety and welfare for human participants have improved. In the present study, I looked into other countries' standpoints concerning the subject of the responsibilities for research ethics and compared them with Korean's standpoint. Recently, the Ministry of Health and Welfare revised the laws for bioethics and safety. In the point of bioethics, I checked out the function, exemption and process of the Institutional Review Board for the future researcher. It is suggested to use the research note to verify a study procedure and protect oneself from research misconducts.

• Journal of Ginseng Research
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• v.34 no.2
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• pp.89-92
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• 2010

In this study, we determined the glycemic index (GI) of an herbal preparation (Insu $100^{(R)}$; Korean red ginseng, carob, mulberry, and banaba). Ten subjects (men and women) took part in standard glycemic testing during a 4-week study period (with duplicate trials of each treatment). Informed consent was obtained from each subject. No adverse effects resulted from the administration of the herbal preparation. The GI of Insu $100^{(R)}$ was $19.5{\pm}5.1$, indicating that administration of this herbal cocktail may be beneficial to people with metabolic disorders and to those who wish to maintain their overall health. This study complied with the Declaration of Helsinki.

• The Korean Journal of Nuclear Medicine
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• v.38 no.2
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• pp.140-142
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• 2004

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.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.6
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• pp.2777-2783
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• 2014

The purpose of this study was to explore the expression of ATAD2 in ovarian tumor tissue as well as its relationship with degree of malignancy. Tumor tissue from 110 cases of ovarian cancer was collected in accordance with the Declaration of Helsinki for evaluation of ATAD2 expression iimmunohistochemistry, quantitative PCR (qPCR) and Western blotting. The correlation between the ATAD2 expression and and the prognosis of ovarian cancer was evaluated by Cox regression model. In addition, HO-8910 and OVCAR-3 cells were transfected with two siRNAs targeting ATAD2. Cell viability was evaluated with MTT assay, and cell migration by transwell migration assay. ATAD2 was shown to be highly expressed in 65.5% (72/110) of ovarian cancer cases, both at transcriptional and protein levels. Moreover, highly expression was positively correlated with degree of malignancy. Knock-down of ATAD2 in HO-8910 and OVCAR-3 cells was found to reduce cell migration. In addition, follow-up visits of the patients demonstrated that the 5-year survival rate was lower in patients with high expression of ATAD2. Our study suggested that ovarian tumor tissue may have highly expressed ATAD2, which is associated with tumor stage, omentum-metastasis, ascites and CA-125. Increased ATAD2 may play important roles in tumor proliferation and migration. ATAD2 could serve in particular as a prognostic marker and a therapeutic target for ovarian cancer.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.257-285
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• 2011

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.6
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• pp.2961-2966
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• 2012

Extremely low frequency electro magnetic fields (EMFs) have been classified as possibly carcinogenic to humans by the International Agency for Research on Cancer. An increased number of chromosomal alterations in peripheral lymphocytes are correlated with elevated incidence of cancer. The aim of the present study was to assess occupationally induced chromosomal damage in EMF workers exposed to low levels of radiation. We used conventional metaphase chromosome aberration (CA) analysis and the micronucleus (MN) assay as biological indicators of non ionizing radiation exposure. In the present study totally 70 subjects were selected including 50 exposed and 20 controls. Informed written consent was obtained from all participants and the study was performed in accordance with the Declaration of Helsinki and the approval of the local ethical committee. A higher degree of CA and MN was observed in exposed subjects compared to controls, the frequency of CA being significantly enhanced with long years of exposure (P<0.05). Moreover increase in CA and MN with age was noted in both exposed subjects and controls, but was significantly greater in the former. The results of this study demonstrated that a significant induction of cytogenetic damage in peripheral lymphocytes of workers occupationally exposed to EMFs in electric transformer and distribution stations. In conclusion, our findings suggest that EMFs possess genotoxic capability, as measured by CA and MN assays; CA analysis appeared more sensitive than other cytogenetic end-points. It can be concluded that chronic occupational exposure to EMFs may lead to an increased risk of genetic damage among electrical workers.

• Biomolecules & Therapeutics
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• v.11 no.2
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• pp.99-108
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• 2003

Background: There is abundance of studies on the decrease in body fat through limited calorie intake or exercise; however, studies focusing simultaneously on functional foods and exercise are rare. This study was aimed to identify the effects of combination of a functional beverage and exercise on body composition and biochemical metabolic profiles. Method: Eighty-one healthy volunteers (69 females aged 19 to 50 years and 12 males aged 19 to 55 years), who maintained their body weight stable with 23 or higher in BMI (kg/$m^2$) and 25% or higher body fat for the last three months, were recruited in the study through written advertisement. All the subjects gave their informed consent, and the study was conducted in accordance with the Declaration of Helsinki. The study design was a randomized double-blind placebo-controlled parallel group design. All participants were given 12-week programed-exercise, which was performed 3 times a week. One bottle (100 ml) of test (Garcinia cambogia 300 mg, L-carnitine 20 mg, Soy peptide 1,000 mg) or placebo solution was given daily 30 min before each session of programed-exercise. BMI (body mass index), %fat, local fat amount (visceral and mid-thigh), waist circumference, skin fold thickness and some biochemical metabolic parameters like glucose, insulin and free fatty acids, etc in the blood were measured and compared before and after 12-week intervention within groups as well as between groups according to the protocol Results: Twenty six volunteers were dropped out and fifty five volunteers completed the study. At the end of 4, 8, and 12 weeks, approximately 1.98%, 3.00% and 3.50% losses of initial body weight were observed, respectively, in the test group (P<0.01), and 0.29, % ,0.74%, 1.60%, respectively, in the placebo group (P>0.05). BMI changed by 2.40%, 3.41% and 4.46%, respectively, in the test group, and 0.38%, 0.95% and 1.75%, respectively, in the placebo group, at each period of time. The reductions of body weight and BMI were significantly higher in the test group than in the placebo group at each period of time (P<0.05). Conclusions: It is thought that the combination of functional beverage, which contains mostly garcinia cambogia, L-carnitine, and soy peptide, and exercise have synergy effects on reducing body fat.