• The Journal of Korean Medicine
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• v.41 no.3
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• pp.66-80
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• 2020

Objectives: We investigated the current status of the consent form for bee-venom pharmacopuncture therapy, which is using in Korean medicine hospitals. We suggest the development of a standard informed consent form. Method: Through the questionnaire survey, status of using informed consent form was identified at 24 Korean medicine hospitals. We analyze different types of informed consent form, which was developed by each hospitals. We investigated the types of informed consent forms for various medical procedures through electronic searches. A standard informed consent form for bee-venom pharmacopuncture therapy was developed based on the medical law and the standard informed consent form for medical procedures developed by Korea Fair Trade Mediation Agency. Result: In our survey, 65% of the hospitals do not use consent well, only 35% of the hospitals use informed consent form, and the most hospitals use self-developed informed consent form. As a result of analyzing the contents of informed consent form used in each hospitals, the explanation of diagnosis, treatment precautions, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change was insufficient. 48% of hospitals manage consent in recording on a chart, 39% in scanned documents, and 13% in digital electronic consent form. Conclusion: A standard informed consent form for Bee-venom pharmacopuncture therapy include diagnosis, effectivness, necessity, indications, method, skin reaction test, hypersensitivity questionnaire, treatment precautions, possible hypersensitivity reactions and countermeasures, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change and the name of doctor.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• Journal of Physiology & Pathology in Korean Medicine
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• v.26 no.2
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• pp.248-252
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• 2012

This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.

• The Journal of Korean Medicine
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• v.45 no.1
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• pp.182-201
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• 2024

Objectives: This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine. Methods: The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert. Results: Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed. Conclusions: The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

• The Journal of the Korea Contents Association
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• v.19 no.12
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• pp.376-388
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• 2019

One important online marketing practice to emerge in recent years is online behavioral advertising. Online behavioral advertising entails a range of issues, including the following: personal information collection and usage agreements (three conditions: no agreement, agreement, or agreement with a reward), consumers' levels of perceived personalization (low vs. high), and consumers' level of online privacy concerns (low vs. high). The effects of all these is what this study is designed to examine, as it evaluates online behavioral advertising. Study findings suggest that types of information collection and usage agreement play a pivotal role in the evaluation of online behavioral ads. Individuals who provided the informed consent form with the possible reward had a more favorable attitude toward the brand than individuals who provided the informed consent form without a possible reward. In terms of personalization, the level of perceived personalization of the advertising message impacted consumers' attitudes toward the online behavioral ad and toward the brand. Finally, online privacy concerns appear to impact consumers' attitudes toward the online behavioral ad and toward the brand. Theoretical and practical implications are also discussed.

• Journal of Dental Anesthesia and Pain Medicine
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• v.17 no.2
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• pp.91-103
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• 2017

General anesthesia is commonly used to facilitate dental treatment in patients with anxiety or challenging behavior, many of whom are children or patients with special needs. When performing procedures under general anesthesia, dental surgeons must perform a thorough pre-operative assessment, as well as ensure that the patients are aware of the potential risks and that informed consent has been obtained. Such precautions ensure optimal patient management and reduce the frequency of morbidities associated with this form of sedation. Most guidelines address the management of pediatric patients under general anesthesia. However, little has been published regarding this method in patients with special needs. This article constitutes a review of the current literature regarding management of patients with special needs under general anesthesia.

• Journal of Sasang Constitutional Medicine
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• v.17 no.1
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• pp.45-55
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• 2005

1. Objectives In this study, we analysed the up-to-the-present data in the SCIB and the chart of Iksan Wonkwang Oriental Medical Clinic, to develop the system and factors of data for the SCIB(Sasang constitution Information Bank). 2. Methods SCIB data is composed of analyses about the QSCC II(Questionnaire for the Sasang Constitution Classification II), Cold-hot questionaire, Ban-chi constitution questionnaire, Body composition, Body measurement, 24-hour food intake & Activity examination, MBTI & MMTIC, Informed consent & Blood sampling, and data presented by committee of Sasang constitution diagnosis expert. And the chart data of Iksan Wonkwang Oriental Medical Clinic is composed of analyses about Inspection, Ausculfation and olfaction, Inquiry, Pulse feeling and palpitation, and treatment field. 3. Results and Conclusions Almost data in the SCIB are lack of regular forms because they are based on mainly the QSCC II and additionally other examinations. Conclusionly important matters of the SCIB data are as follows: (1) the standard form including 4 whole diagnostic factors (2) the standard form including symptoms, pattern identifications, treatment processes and treatment results (3) objectivity and practicality to collect data.

• The Korean Society of Law and Medicine
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• v.10 no.2
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• pp.455-492
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• 2009

(Background) Recent biotechnological breakthroughs are shedding new lights on various ethical and legal issues about human biological material. Since Rudolph Virchow, a German pathologist, had founded the medical discipline of cellular pathology, issues centering around human biological materials began to draw attention. The issues involving human biological materials were revisited with more attention along with series concerns when the human genome map was finally completed. Recently, with researches on human genes and bioengineering reaping enormous commercial values in the form of material patent, such changes require a society to reassess the present and future status of human tissue within the legal system. This in turn gave rise to a heated debate over how to protect the rights of material donors: property rule vs. no property rule. (Debate and Cases) Property rule recognizes the donors' property rights on human biological materials. Thus, donors can claim real action if there were any bleach of informed consent or a donation contract. Donors can also claim damages to the responsible party when there is an infringement of property rights. Some even uphold the concept of material patents overtaking. From the viewpoint of no property rule, human biological materials are objects separated from donors. Thus, a recipient or a third party will be held liable if there were any infringement of donor's human rights. Human biological materials should not be commercially traded and a patent based on a human biological materials research does not belong to the donor of the tissues used during the course of research. In the US, two courts, Moore v. Regents of the University of California, and Greenberg v. Miami Children's Hospital Research Institute, Inc., have already decided that research participants retain no ownership of the biological specimens they contribute to medical research. Significantly, both Moore and Greenberg cases found that the researcher had parted with all ownership rights in the tissue samples when they donated them to the institutions, even though there was no provision in the informed consent forms stating either that the participants donated their tissue or waived their rights to ownership of the tissue. These rulings were led to huge controversy over property rights on human tissues. This research supports no property rule on the ground that it can protect the human dignity and prevent humans from objectification and commercialization. Human biological materials are already parted from human bodies and should be treated differently from the engineering and researches of those materials. Donors do not retain any ownership. (Suggestions) No property rule requires a legal breakthrough in the US in terms of donors' rights protection due to the absence of punitive damages provisions. The Donor rights issue on human biological material can be addressed through prospective legislation or tax policies, price control over patent products, and wider coverage of medical insurance. (Conclusions) Amid growing awareness over commercial values of human biological materials, no property rule should be adopted in order to protect human dignity but not without revamping legal provisions. The donors' rights issue in material patents requires prospective legislation based on current uncertainties. Also should be sought are solutions in the social context and all these discussions should be based on sound medical ethics of both medical staffs and researchers.

• The Journal of the Korean life insurance medical association
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• v.12
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• pp.50-55
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• 1993

After a short historical resume, screening is discussed on the basis of the current philosophy of Life insurance compaines in leading countries. This is followed by considerations with regard to the future in areas of major bearing on Life insurance screening which have emerged as important within the last decade. HIV-antibody testing is dealt with from the screening point of view followed by aspects regarding the applicability of tumour marker use in Life insurance medicine. Last but not least genetic testing will be addressed, taking into account prospects for the future, as well as the resulting responsibility in medical and underwriting terms. The major considerations and suggested guidelines can be summarized as follows: 1) Screening in Life insurance is a prerequisite for underwriting and is a well-functioning selection instrument. 2) Screening technologies are medically well defined and have to follow general clinical rules, also in the future. 3) Screening parameters should follow the patterns of diseases according to age and risk groups. 4) Screening parameters for prognostic use are legitimate as long as they are considered in conjuction with clinical medical observations and rules. 5) Screening technologies of a sensitive nature require very special rules for handling in the sense of "consequential ethies". 6) Screening parameters like HIV-antibody testing require ongoing scientific feedback in their new testing dimensions. 7) Screening in the form of genetic testing is as yet not used in Life insurance; its potential future role in Life insurfance medicine must, however, be discussed responsibly and in time. 8) Screening enables the insurance industry to rule out possible antiselection and provide for equal knowledge on the part of the insurance applicant and the insurer about impairements which shorten life expectancy. 9) Screening, informed consent, counselling and confidentiality must go hand in hand both now and to an even greater extent in the future.

• The Korean Journal of Community Living Science
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• v.25 no.4
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• pp.487-494
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• 2014

This study investigates thermoregulatory behaviors of obese children for their thermal comfort. Nine normal-weight children (NWC) and nine obese children (OC) participated in the study. All subjects were fourth-graders and sixth-graders in elementary school. An informed consent form was obtained from each child and his or her mother. The questionnaire method was used, and the experiment was conducted to determine the preferred amount of clothing at $17^{\circ}C$ and the preferred temperature at $33^{\circ}C$. According to the results, OC were more susceptible to heat than NWC, whereas there was no significant difference in their susceptibility to cold. There were no significant differences of the oral temperature and the mean skin temperature between the two groups, but changes in forearm blood flow were less in OC than in NWC. There was no significant difference in the preferred amount of clothing between OC and NWC, and the preferred temperature was higher in NWC than in OC. The results based on the questionnaire are consistent with those based on the experiment. A compositive study of physical exercise, eating behavior, and wearing behavior should be useful for developing programs for preventing and treating obese children.