• 대한한의학회지
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• 제41권3호
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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.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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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.

• 동의생리병리학회지
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• 제26권2호
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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.

• 대한한의학회지
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• 제45권1호
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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.

• 한국콘텐츠학회논문지
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• 제19권12호
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• pp.376-388
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• 2019

최근 온라인 마케팅에서 가장 중요한 분야로 온라인 맞춤형 광고가 떠오르고 있다. 온라인 맞춤형 광고는 개인정보 수집 및 동의, 소비자의 인지된 개인화 및 소비자의 온라인 사생활 침해 걱정 등과 같은 이슈들을 만들었다. 본 연구는 이러한 세 가지 이슈들이 온라인 맞춤형 광고에 미치는 영향들이 무엇인지를 알아보고자 한다. 연구결과, 정보 수집과 사용동의 구분은 온라인 맞춤형 광고 평가에 주요한 역할을 하고 있다는 것이 밝혀졌다. 개인정보 수집에서 향후 온라인 맞춤형 광고 노출 시 리워드를 받을 수 있을 거라고 고지된 사람들은 그렇지 않은 사람들보다 브랜드 태도가 더 긍정적이었다. 광고 메시지의 인지된 개인화 정도는 온라인 맞춤형 광고 태도 및 브랜드 태도에 영향을 미치는 것으로 나타났다. 마지막으로, 온라인 사생활 침해 걱정 역시 온라인 맞춤형 광고 태도 및 브랜드 태도에 영향을 미치는 것으로 나타났다. 이론적 및 실무적 시사점은 토의에서 더 자세히 살펴보았다.

• Journal of Dental Anesthesia and Pain Medicine
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• 제17권2호
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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.

• 사상체질의학회지
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• 제17권1호
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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.

• 의료법학
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• 제10권2호
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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.

• 보험의학회지
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• 제12권
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• pp.50-55
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• 1993

1) 생명보험(生命保險)에서의 Screening은 사정조건(査定條件)이며 충분(充分)한 기능(機能)을 갖인 기구(器具)이다. 2) Screening 기술(技術)은 의학적(醫學的)으로 충분(充分)히 명시(明示)되여 있으며 장래(將來)에도 일반적(一般的)인 임상적(臨床的)인 Rule에 따라야 한다. 3) Screening Parameter는 연령(年齡)이나 Risk-Group에 의(依)한 질병(疾病)의 Pattern에 따라야 한다. 4) Screening Parameter에서의 예후(豫後)의 추론(推論)은 임상의학적관찰(臨床醫學的觀察)과 Rule를 모두 고처(考處)하는 한(限)에서는 합법적(合法的)이다. 5) 민감(敏感)한 성격(性格)의 Screening 기술(技術)은 일관성(一貫性)있게 취급(取扱)하기 의(依)해서는 대단(大端)히 특별(特別)한 Rule를 필요(必要)로 한다. 6) HIV-항체시험(抗體試驗)과 같은 Screening-Parameter는 그들의 새로운 시험범위내(試驗範圍內)에서는 계속적(繼續的)인 과학적(科學的) Feedback를 필요(必要)로 한다. 7) 유전의학적시험(遺傳醫學的試驗은 생명보험(生命保險) Screening에서는 아직 사용(使用)하고 있지 않지만 생명보험의학(生命保險醫學)에서는 장래(將來)의 역할(役割)과 가능성(可能性)에 대(對)해서 검토(檢討)해야 될 것이다. 8) 보험업계(保險業界)의 Screening은 가능한(可能限) 역선택(逆選擇)을 배제(排除)하고 보험청약자(保險請約者)나 보험자(保險者)의 쌍방(雙方)에서 평균여명(平均餘命)을 짧게하는 어떠한 결함(缺陷)에도 같은 지식(知識)으로 대비(對備)해야 한다. 9) Screening에서의 Informed Consent, Counselling과 Confidentiality는 현재나 더욱 발전된 장래에서도 알맞게 취급하지 않으면 않된다.

• 한국지역사회생활과학회지
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• 제25권4호
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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.