• 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 Korean Journal of Health Service Management
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• v.10 no.3
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• pp.99-111
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• 2016

Objectives : This study developed an iPad-based animation for an electronic informed consent to directly help patients prepare an informed consent. The goal was to raise patients' understanding about the contents contained in a DNR informed consent in the current medical situation in which DNR informed consents are mostly written by a guardian. Methods : The development of a DNR electronic informed consent was done in 3 stages: analysis, design and development. The analysis stage was done with a survey on the real status of preparing a DNR informed consent in a medical institution. The design stage was done with the contents in the DNR electronic informed consent through a primary and secondary Delphi survey. The development stage created a DNR electronic informed consent and evaluated it through a tertiary Delphi survey. Results : After evaluating the appropriateness of the composition of the contents, the understanding of the contents, the convenience of use, the reflection of an expert opinion, and the suitability of the application, all had scores higher than 4 points. Conclusions : The results of this study show that our proposed DNR electronic informed consent can help patients better understanding the contents of a DNR informed consent.

• Journal of Korean Clinical Nursing Research
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• v.14 no.2
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• pp.59-70
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• 2008

Purpose: Purposes of this study were to promote understanding on mutually informed consent by comparing and analyzing the perception and experience of informed consent among physicians, nurses, and patients. Method: Participants in the study were 145 physicians, 300 nurses, and 178 patients from eight hospitals in Busan. To examine their understanding and experience with informed consent, all participants responded to a questionnaire. The collected data were analyzed using SPSS/PC 12.0 program. Results: On the necessity of informed consent, the affirmative percentages were 95.9% for physicians, 99.0% for nurses and 84.8% for patients. As to the most important reason for informed consent 47.6% of the physicians and 64.3% of the nurses answered 'because it is an occupational and ethical duty', while 46.6% of the patients answered 'because it is protection for physicians'. Regarding the legal decision maker for informed consent, 33.1% of the physicians, 27% of the nurses, and 42.1% of the patients answered that the legal decision-making right belonged to the 'patient'. The agreement rate on the necessity of providing a comprehensive explanation about informed consent was 89.0% for physicians, 98.3% for nurses, and 96.1% for patients. Conclusion: Most physicians, nurses, and even patients have inaccurate perceptions and inappropriate experience with informed consent.

• Journal of Korean Academy of Nursing Administration
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• v.12 no.2
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• pp.255-264
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• 2006

Purpose: This study was carried out to understand the in-patients' experiences related on informed consent for examination, treatment or surgery. Method: The study was conducted with 578 patients who were admitted to the departments of internal medicine and surgery for examination, treatment or surgery requiring informed consent from November 1 to 30, 2004 at three general hospitals in Daegu, Busan and Gyeongsangbuk-do. The data was analyzed by using SPSS 11.5 for Windows. Results: Although the one who explains during the process of informed consent should be doctors, 6.6% was informed by nurses or others. In addition, the majority has been told for complications and risk while relatively fewer patients were informed for necessity, method and costs of the procedure, and no one ever heard of other alternatives or the right to terminate the procedure at any time. While 40% of patients were not the final decision-makers of examination, treatment or surgery, 11.9% of patients answered their opinions were not considered during the final decision-making process. Conclusion: The study suggest that the ethically appropriate informed consent has not been achieved in the clinical practice, and therefore it is necessary to develop the specific behavioral guidelines and nursing ethics education program for nurses in order to settle down the desirable informed consent at the dimension of nursing management.

• Korean Journal of Adult Nursing
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• v.19 no.4
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• pp.556-566
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• 2007

Purpose: This study attempted to analyze problems of informed consent in the clinical setting and appraise ethical aspects inherent in such issues in order to boost awareness of informed consent and its implementation among healthcare professionals. Methods: Study methods included identifying ethical meanings of informed consent in the clinical setting based on the principal ethics, and exploring the process of informed consent utilizing communicative ethics and feminine care ethics Results: The ethical basis of informed consent encompasses not only respect for autonomy but also prohibiting malice, practicing beneficience, and establishing justice. These principles, however, are limited in illustrating the ethical aspects of communicative ethics and care ethics that are entailed in informed consent within clinical settings. The ethical meaning of informed consent involves a communicative and caring process between healthcare professionals, patients, and family built on mutual respect. Conclusion: Healthcare professionals must fully understand the ethical meanings of informed consent and in turn respect and protect the clients' right to know and making decisions. Nurses especially, must take on the role of mediator and advocate throughout the process of obtaining informed consent, and practice ethical caring by facilitating communication grounded in mutual understanding among the physician, patient, and family members.

• Journal of Preventive Medicine and Public Health
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• v.41 no.5
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• pp.339-344
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• 2008

Objectives : The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. Methods : The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. Results : It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Conclusions : Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

• Journal of Sasang Constitutional Medicine
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• v.23 no.3
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• pp.318-329
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• 2011

1. Objectives: We surveyed the attitude and awareness of Sasang Constitution investigators on informed consent in clinical study. This study was performed in order to improve the quality of ethical aspects in clinical study by surveying the process of obtaining informed consent. 2. Methods: We sent the questionnaire by email to Sasang Constitution investigators who had the experience in clinical study. The question was about the necessity of informed consent and the process of obtaining it. 3. Results: Twenty-two out of 24 questionnaires were collected. All of investigators recognized that informed consent is needed for clinical study. Sixty-four percent of the respondents 'fully' or 'mostly' explained the informed consent but they added only 41% of participants 'fully' or 'mostly' understood. Fifty-four point five percent of respondents provided participants enough time and opportunity to inquire the study in details to decide whether or not to participate in the study, the rest of respondents obtained informed consent without providing enough time for decision. 4. Conclusions: Sasang Constitution investigators had high awareness of necessity for informed consent in clinical study. But participants' understanding was low despite of the degree of investigators' explanation. A various strategies should be designed for improving consent forms and process. Most of all, investigators should make sure that informed consent intends to protect participants and promote ethical research conduct.

• Journal of Korean society of Dental Hygiene
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• v.15 no.5
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• pp.881-887
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• 2015

Objectives: The purpose of the study was to investigate the awareness toward the informed consent in the dental hygienists and the patients before treatment. Methods: A self-reported questionnaire was completed by 200 dental hygienists and 200 dental patients in Changwon after explaining the purpose of the study from June 15 to September 15, 2014. The questionnaire was developed as two types for the dental hygienists and the patients. The questionnaire consisted of general characteristics of the subjects, awareness toward the informed consent before treatment, and experience before the treatment. Results: In the necessity of informed consent, 49.5% of dental hygienists and 72.0% of the patients answered that informed consent is very necessary. In the written informed consent, 33.3% of dental hygienists and 54.9% of the patients answered that the dispute can always happen during treatment. Conclusions: The informed consent is recognized as a defensive means for medical malpractice. For the sake of the dental hygienists and the patients, mutual respect and compromise is the very important factor.

• Archives of Plastic Surgery
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• v.43 no.5
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• pp.402-410
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• 2016

Background In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. Methods We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Results Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Conclusions Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers.

• 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.