• Title/Summary/Keyword: Consent form

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Usage of informed consent form for Bee-venom pharmacopuncture Therapy at korean medicine hospitals and Proposal for development of a standard informed consent form. (한방병원의 봉약침 시술 동의서의 사용 현황과 표준 시술 동의서 개발에 대한 제안)

  • Kim, Minjeong
    • 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.

Legal issues of obtaining informed consent in pharmaceutical clinical trial as human material research : Focusing on the use of statutory form (인체유래물연구에 해당되는 의약품임상시험에서 동의 획득 기준의 법적 문제: <인체유래물연구동의서> 법정 서식의 사용을 중심으로)

  • Yoo, Sujung;Kim, Eunae
    • 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.

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Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method (한방병원의 침도 시술 동의서의 현황 조사와 델파이 기법을 활용한 표준 시술 동의서 개발)

  • Jihun Kim;Bonhyuk Goo;Hyongjun Kim;Kyoungsuk Seo;Myungjin Oh;Myungseok Ryu;Sang-Hoon Yoon;Kwang Ho Lee;Hyun-Jong Lee;Jungtae Leem;Hyungsun Jun;Jeong Ihn Sook;Sung Woon Choi;Tae Wook Lee;Yeonhak Kim;Yoona Oh;Kunhyung Kim;Gi Young Yang;Eunseok Kim
    • 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.

Study on the Perception of Informed Consent for Elderly Subjects Participated in Oriental Medicine Clinical Trials (한방 임상시험에 참여한 노인 대상자들의 사전 동의에 대한 인식도 조사)

  • Kim, Yun-Young;Kwon, Ji-Hye;Lee, Si-Woo;Kim, Ho-Suk;Yoo, Jong-Hyang
    • 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.

GDPR Compliant Consent Procedure for Personal Information Collection in the IoT Environment (IoT 환경에서 GDPR에 부합하는 개인정보수집 동의 절차)

  • Lee, Goo Yeon;Bang, Junil;Cha, Kyung Jin;Kim, Hwa Jong
    • The Journal of Korean Institute of Information Technology
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    • v.17 no.5
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    • pp.129-136
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    • 2019
  • Many IoT devices like sensors lack screen and input devices, thus making them hard to meet the consent conditions that GDPR requires. This is acting as a legal barrier for further advancement in the business field. In this paper, we designed the process for consent of personal information collection that meets the legal conditions. In this design, user's personal data is received in an encrypted form by data collecting server first. The encrypted personal data can be decrypted after associating with user agent based on the consent procedure of the collection of personal information. During the consent procedure, user agent understands the privacy policy about personal information collection and offers the key to decrypt the data. This kind of personal information collection agreement procedure will satisfy the transparent and freely given consent requirements of GDPR. Thus, we can speculate from here that the proposed procedure will contribute to the evolution of IoT business area dealing with personal information.

A Study on Decision Making Model for Personal Information Collection and Use Policy Establishment through Internet Homepage of Financial Companies (금융회사 인터넷 홈페이지를 통한 개인정보 수집 및 이용 동의 정책 수립 모델 연구)

  • Kim, Seong-hoon;Lee, Kyeong-ho
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.27 no.3
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    • pp.637-651
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    • 2017
  • In order for a financial company to collect personal information, it explicitly notifies consumers of the contents stipulated by law and gets consent beforehand. As a result, as financial products became more complicated and diverse, and the contents of 'Consent form for providing personal information' became more complicated and more. In particular, in the case of internet or mobile, the letter became smaller as the screen size limit, making it more difficult to understand. This is because almost all companies that collecting personal information are in a similar situation, In the position of consumers who use services are, contradictions arise that habitually agree without understanding the consent contents. In this research, in order to present a consent policy establishment decision-making model to rationally collect and use personal information through the Internet website of financial companies, consider the domestic and foreign legal system Then, derive a problem To present improvement measures. In addition, the evaluation factors selected through the research are verified by presenting decision making models and formulas using AHP (Analytic Hierarchy Process) method.

Study on Factors Affecting Effects of Online Behavioral Advertising (온라인 맞춤형 광고 효과에 미치는 요인들 연구)

  • Um, Namhyun;Kim, Sojung
    • 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.

Debate Competence and Strategy (토론 능력과 토론 전략)

  • Jang, Young-Hee
    • The Journal of the Korea Contents Association
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    • v.9 no.2
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    • pp.446-452
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    • 2009
  • This study on strategy and its function in debate offer the materials of education concrete and practical to be able to improve the expression ability and comprehension ability of the students, and can give lots of help to improve the ability of application that can answer quickly in trouble circumstances. The type of strategy in the course of set up the theory are (1) the form of concept definition, (2) the form of solution offer, (3) inductive form and deductive form, (4) the form of example offer. The type of strategy in the course of contradict are (1) the form of soliloquy, (2) the form of claim comparison, (3) the form of partial recognition. The type of strategy in the course of cross examination are (1) the form of question in return and contradict, (2) the form of partial consent contradict. We believe this study will improve the communication ability and negotiation ability and also make a great contribution to improve the leadership of 21-century type if this study will be used in the field of education.

Step-by-Step Strategy in Debate (토론에서의 단계별 대응전략)

  • Jang, Young-Hee
    • The Journal of the Korea Contents Association
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    • v.7 no.10
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    • pp.36-43
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    • 2007
  • This study on strategy and its function in debate offer the materials of education concrete and practical to be able to improve the expression ability and comprehension ability of the students, and can give lots of help to improve the ability of application that can answer quickly in trouble circumstances. The type of strategy in the course of set up the theory are (1) the form of concept definition, (2) the form of solution offer, (3) inductive form and deductive form, (4) the form of example offer. The type of strategy in the course of contradict are (1) the form of soliloquy, (2) the form of claim comparison, (3) the form of partial recognition. The type of strategy in the course of cross examination are (1) the form of question in return and contradict, (2) the form of partial consent contradict. We believe this study will improve the communication ability and negotiation ability and also make a great contribution to improve the leadership of 21-century type if this study will be used in the field of education.