• Title/Summary/Keyword: informed consent

Search Result 435, Processing Time 0.027 seconds

Normative Issues in Next Generation Sequencing Gene Testing

  • Na-Kyoung Kim
    • Development and Reproduction
    • /
    • v.27 no.1
    • /
    • pp.47-56
    • /
    • 2023
  • Despite the commercialization of Next generation sequencing (NGS) gene testing, only a few studies have addressed the various ethical and legal problems associated with NGS testing in Korea Here, we reviewed the normative issues that emerged at each stage of the wet analysis and bioinformatics analysis of NGS gene testing. In particular, it was in mind to apply various international guidelines and the principles of bioethics to actual clinical practice. Considering the characteristics of NGS testing, wet analysis of additional testing can be justified if presumptive consent is recognized. Furthermore, the medical relationship between diseases needs to be established and it should be clear that the patient would have given consent if the patient had been aware of the correlation between genes. At the stage of bioinformatics analysis, the question of unsolicited findings arises. In case of unsolicited and relevant findings, according to American College of Medical Genetics and Genomics (ACMG), a recognized relationship between genes and diseases needs to be established. In case of unsolicited and not-relevant findings, it is almost impossible to determine whether knowing or not knowing the findings is more beneficial to the patient. However, it seems to be certain that the psychological harm an individual may suffer from such information is likely to be greater if the disease is severe and if there is no cure. The list of genes for which the ACMG guidelines impose reporting obligations is a good reference for judgment.

Nursing Professor's inspection and Status of Patient's Records and Informed Consent for Clinical Practice of Nursing Student in Korea and Japan (한·일 간호대학생의 임상실습 시 환자의 설명동의 및 기록관리와 지도실태)

  • Cho, Yooh-Yang;Kim, In-Hong;Yamamoto, Fujie;Yamasaki, Fujiko
    • Journal of agricultural medicine and community health
    • /
    • v.31 no.1
    • /
    • pp.35-46
    • /
    • 2006
  • Objectives: In recently. the management and protection on individual information in patient's medical & nursing records have been very important, and that need a guideline. The purpose of this study was to investigate the status of using the patient's nursing records of nursing students in clinical practice, to find and discuss the patient's informed consent, and status of education and management concerned to patient's nursing records. Methods: This study used a mailing survey. data collected from September 24th to October 31th in 2002. The subject were 333 professors who are major in adult nursing, pediatric nursing, psychological nursing of 111 university of nursing department and nursing college. And then we received the survey mail from 103 professors that respondent rate was 30.9%. Results: The characteristics of study subjects showed 49.0% of university. 51.0% of college of nursing. 50.0% of the subjects practiced point the patient by oral approval in clinical practice. But when the decision of the patient was very difficult, 21.6% of the subjects take to informed consent from his or her families. During the clinical practice, 49.0% of the subjects were explain to patient about clinical practice and contents of the nursing student, only 7.8% of the subjects were explain to patient with nursing records. 52.0% of the subjects were took out records from the hospital, only 17.6% of the subjects had standard of the patient's informed consent and standard of handling practice records. 17.6%-92.2% of the subjects that educate and manage concern to patient's nursing records.

  • PDF

Patient's 'Right Not to Know' and Physician's 'Duty to Consideration' (환자의 모를 권리와 의사의 배려의무)

  • Suk, HeeTae
    • The Korean Society of Law and Medicine
    • /
    • v.17 no.2
    • /
    • pp.145-173
    • /
    • 2016
  • A patient's Right to Self-Determination or his/her Right of Autonomy in the Republic of Korea has traditionally been understood as being composed of two elements. The first, is the patient's Right to Know as it pertains to the physician's Duty to Report [the Medical Situation] to the patient; the second, is the patient's Right to Consent and Right of Refusal as it pertains to the physician's Duty to Inform [for Patient's Consent]. The legal and ethical positions pertaining to the patient's autonomous decision, particularly those in the interest of the patient's not wanting to know about his/her own body or medical condition, were therefore acknowledged as passively expressed entities borne from the patient's forfeiture of the Right to Know and Right to Consent, and exempting the physician from the Duty to Inform. The potential risk of adverse effects rising as a result of applying the Informed Consent Dogma to situations described above were only passively recognized, seen merely as a preclusion of the Informed Consent Dogma or a denial of liability on part of the physician. In short, the legal measures that guarantee a patient's 'Wish for Ignorance' are not currently being understood and acknowledged under the active positions of the patient's 'Right Not to Know' and the physician's 'Duty to Consideration' (such as the duty not to inform). Practical and theoretical issues arise absent the recognition of these active positions of the involved parties. The question of normative evaluation of cases where a sizable amount of harm has come up on the patient as a result of the physician explaining to or informing the patient of his/her medical condition despite the patient previously waiving the Right to Consent or exempting the physician from the Duty to Inform, is one that is yet to be addressed; that of ascertaining direct evidence/legal basis that can cement legality to situations where the physician foregoes the informing process under consideration that doing so may cause harm to the patient, is another. Therefore it is the position of this paper that the Right [Not to Know] and the Duty [to Consideration] play critical roles both in meeting the legal normative requirements pertaining to the enrichment of the patient's Right to Self-Determination and the prevention of adverse effects as it pertains to the provision of [unwanted] medical information.

  • PDF

The Validation of a Measurement for Assessing the Capacity of Korean Older Adults to Consent to Research (한국노인의 연구참여를 위한 동의능력평가척도의 타당성 연구)

  • Lee, Min-Hong
    • Korean Journal of Social Welfare
    • /
    • v.61 no.3
    • /
    • pp.55-76
    • /
    • 2009
  • This study tested the psychometric properties of the Korean version of the Capacity-to-Consent Screen: K-CCS) scale. A total of 404 South Korean older adults were e Cruited using the purposive sampling method. The participants were asked to res-Cod to a structured questiConaire which included older adults' characteristics, ADLs, IADLs, cognitive impairments and creen: K-CCS) scale. A total of. Item analysis, explonalory factor analysis(EFA), and ) sfirmalory factor analysis(CFA) were cCoducted to verifK-Che psychometric properties of the Korean Version of CCS. The sample was divided into two groups: one group for EFA(n=202) alysis(Eois(r group for CFA(n=202). The totults revealeysisae. he final version of the 8-item K-CCS with two dimensions had a excellent internof. Itemstencyonofpha value=.f) alysa CFA) sfirmed the acceptaas diviof the modef.fdi(RMSEA=.057, NNFI=.f4, IFI=.f6, CFI=.f6) to twaddition, claims for the convergent and criterion-related validdiviwere demItetnaled. Ity-tnclusion, the K-CCS can be rmed for professi sams to asersioolder participants' capacity to consent to clinical or survey research.

  • PDF

Physician's Duty to Inform Treatment Risk: Function, Requirements and Sanctions (의사의 위험설명의무 - 법적 기능, 요건 및 위반에 대한 제재 -)

  • Lee, Dongjin
    • The Korean Society of Law and Medicine
    • /
    • v.21 no.1
    • /
    • pp.3-32
    • /
    • 2020
  • Under the Korean case law, physicians are obliged to disclose or inform the risk associated with a specific treatment to their patients before they perform the treatment. If they fail to do this, they are liable to compensate pain and sufferings. If the patient can establish that he or she would not have consented at all to the treatment had he or she been informed, the physicians are liable to compensate all the loss incurred by the treatment. In this article, the author examines the legitimacy of this case law from the perspective of legal doctrine as well as its practical affect on the medical practice and the furtherance of self-determination of the patient. The fundamental findings are as follows: The case law that has physicians who failed to inform treatment risk compensate pain and sufferings for the infringement of the right of self-determination seems to be a disguised and reduced compensation of all the loss based on the possible malpractice, which cannot be justified in view of the general principles of tort liability. It is necessary to adhere to the requirements of causation and imputation between the failure to inform treatment risk and the specific patient's consent to the treatment. If this causation and imputation is established, all the loss should be compensated. Otherwise, there shall be no liability. The so-called hypothetical consent defence shall be regarded as a part of causation between the failure to inform and the consent. The suggested approach can preserve the essence of physician-patient relationship and fit for the very logic of informed consent better.

The Comparison of Plantar Foot Pressure Distribution in Adult and Elderly according Obstacle Heights (장애물 높이에 따른 성인과 노인의 족저압 분포 비교)

  • Chang, Jong-Sung;Lee, Myoung-Hee
    • The Journal of Korean Physical Therapy
    • /
    • v.26 no.4
    • /
    • pp.257-261
    • /
    • 2014
  • Purpose: The purpose of this study was to compare plantar foot pressure distribution in adults and elderly according to obstacle height. Methods: Nine healthy adults and nine older adults were recruited and the subjects provided written informed consent consent prior to participation. Both groups walked and crossed obstacles with heights of 0%, 10%, 20%, and 30% of their height. Foot pressure was measured by peak pressure using the Pedar System (Novel Gmbh, Germany) during obstacle walking with barefeet in shoes. Three trails were calculated on eight areas and then averaged for data analysis. Results: A significant difference in great toe, little toes, and lateral metatarsal area was observed between adults and elderly groups, but other areas did not show significant differences. Foot pressure was increased in groups according to obstacle height. Conclusion: These findings showed that change in foot pressure distribution is more lateral in elderly in order to maintain postural control during obstacle crossing.

Obtaining Informed Consent Using Patient Specific 3D Printing Cerebral Aneurysm Model

  • Kim, Pil Soo;Choi, Chang Hwa;Han, In Ho;Lee, Jung Hwan;Choi, Hyuk Jin;Lee, Jae Il
    • Journal of Korean Neurosurgical Society
    • /
    • v.62 no.4
    • /
    • pp.398-404
    • /
    • 2019
  • Objective : Recently, three-dimensional (3D) printed models of the intracranial vascular have served as useful tools in simulation and training for cerebral aneurysm clipping surgery. Precise and realistic 3D printed aneurysm models may improve patients' understanding of the 3D cerebral aneurysm structure. Therefore, we created patient-specific 3D printed aneurysm models as an educational and clinical tool for patients undergoing aneurysm clipping surgery. Herein, we describe how these 3D models can be created and the effects of applying them for patient education purpose. Methods : Twenty patients with unruptured intracranial aneurysm were randomly divided into two groups. We explained and received informed consent from patients in whom 3D printed models-(group I) or computed tomography angiography-(group II) was used to explain aneurysm clipping surgery. The 3D printed intracranial aneurysm models were created based on time-of-flight magnetic resonance angiography using a 3D printer with acrylonitrile-butadiene-styrene resin as the model material. After describing the model to the patients, they completed a questionnaire about their understanding and satisfaction with aneurysm clipping surgery. Results : The 3D printed models were successfully made, and they precisely replicated the actual intracranial aneurysm structure of the corresponding patients. The use of the 3D model was associated with a higher understanding and satisfaction of preoperative patient education and consultation. On a 5-point Likert scale, the average level of understanding was scored as 4.7 (range, 3.0-5.0) in group I. In group II, the average response was 2.5 (range, 2.0-3.0). Conclusion : The 3D printed models were accurate and useful for understanding the intracranial aneurysm structure. In this study, 3D printed intracranial aneurysm models were proven to be helpful in preoperative patient consultation.

Ethical considerations in publication of medical papers (의학논문 출판윤리)

  • Bae, Chong-Woo
    • Clinical and Experimental Pediatrics
    • /
    • v.51 no.5
    • /
    • pp.447-451
    • /
    • 2008
  • It is fair to say that there are many ethical issues concerning the publication of medical papers. To define the best practice in the ethics of scientific publishing and a proper understanding of appropriate reporting in medical papers, this review should be useful for authors dealing with ethical issues which involve the protection of human and animal rights, the protection of confidentiality and informed consent, fabrication, falsification, plagiarism, author and authorship, copy right transfer, duplicate publication, conflict of interest, and dealing with misconduct cases.

A Survey on Safety of Fundamentals of Nursing Practicum in Korea (기본간호학실습 안전실태 조사)

  • Chaung, Seung-Kyo;Shin, Yun Hee;Park, Soohyun;Choi, Dongwon;Jeong, Hye Sun;Kim, Hyun-Ju;Kim, Ji-Su;Sohng, Kyeong-Yae;Park, Hyoung Sook;Kang, Youngmi
    • Journal of Korean Academy of Fundamentals of Nursing
    • /
    • v.26 no.2
    • /
    • pp.96-106
    • /
    • 2019
  • Purpose: The purpose of this study is to investigate the safety of nursing students during fundamentals of nursing practicum in Korea. Methods: This study used a descriptive design. A total of 106 nursing instructors teaching fundamentals of nursing longer than one year participated in this study. Data were collected using self-report questionnaires from July 24 to August 28, 2018. The questionnaires consisted of general characteristics, characteristics of fundamentals of nursing course, physical and emotional safety issues during fundamentals of nursing practicum, and obtaining an informed consent prior to practicum. Results: The average number of physical safety accidents during practicum of fundamentals of nursing in the past 5 years was $1.12{\pm}2.44$. The most common safety accident was punctured wound. The mean score of the participants' stress on physical safety accidents was $3.53{\pm}1.12$ out of 5. The average number of emotional safety accidents of fundamentals of nursing practicum in the past 5 years was $1.05{\pm}2.72$. The mean score of stress on emotional safety accident was $3.00{\pm}1.09$ out of 5. We found that 47.2% of the participants obtained an oral consent or a written consent for safety of fundamentals of nursing practicum. Conclusions: The results of this study indicate that it is necessary to establish safety strategies for fundamentals of nursing practicum for nursing students.

Analysis of Ethical Requirements for the Publication Guidelines of Oriental Medicine Journals in Korea (국내 한의학 관련 학술지 투고규정의 윤리기준 분석)

  • Kim, Yun-Young;Kwon, Ji-Hye;Lee, Si-Woo;Jang, Eun-Su;Yoo, Jong-Hyang
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.26 no.3
    • /
    • pp.392-398
    • /
    • 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.