식품의약품안전처(이하 ‘식약처’라 한다)는 2014년에 “임상시험 및 대상자보호프로그램(Human Research Protection Program, 이하 ‘HRPP’라 한다) 가이드라인”을 배포한 이후, 2017년부터는 식약 처가 정한 기준에 따라 HRPP를 운영하는 기관에게 연구자임상시험, 교육, 자체점검과 관련하여 인 센티브를 주고 있다. 그러나...
韩国食品医药品安全处(以下简称“食药处”)于2014年"临床试验及保护对象(human research protection program,以下称为“hrpp”)发布的指导方针",此后,从2017年开始,按照食药部门规定的标准hrpp研究者给运营的机关,教育,자체점검和有关临床试验的厘米布的服务。但是。。。
{"title":"임상시험 및 대상자보호프로그램(HRPP)의 효과적 운영 방안","authors":"김인순, 최수완, 정성직, 최윤정, InsoonKim, SuWanChoi, SungJikJung, YoonJungChoi","doi":"10.38046/APJHLE.2020.13.2.003","DOIUrl":"https://doi.org/10.38046/APJHLE.2020.13.2.003","url":null,"abstract":"식품의약품안전처(이하 ‘식약처’라 한다)는 2014년에 “임상시험 및 대상자보호프로그램(Human Research Protection Program, 이하 ‘HRPP’라 한다) 가이드라인”을 배포한 이후, 2017년부터는 식약 처가 정한 기준에 따라 HRPP를 운영하는 기관에게 연구자임상시험, 교육, 자체점검과 관련하여 인 센티브를 주고 있다. 그러나...","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"13 1","pages":"59-87"},"PeriodicalIF":0.0,"publicationDate":"2020-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41469230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-30DOI: 10.38046/APJHLE.2020.13.2.004
Eun-Ae Kim
{"title":"A study on the paternity problems and informed consent in non-spousal assisted reproductive technology: Focusing on the Supreme Court’s Decision en banc Decision 2016Meu2510 decided October 23, 2019 about parent-child relationship between birth using third party sperm and father","authors":"Eun-Ae Kim","doi":"10.38046/APJHLE.2020.13.2.004","DOIUrl":"https://doi.org/10.38046/APJHLE.2020.13.2.004","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"16 1","pages":"89-117"},"PeriodicalIF":0.0,"publicationDate":"2020-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70080609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.38046/APJHLE.2020.13.2.001
Seo-hyung Lee
{"title":"Review of the Legislation and Directions for Revision of the Personal Information Protection Act from the Perspective of Privacy Protection: Focusing on Public-Private Dichotomy","authors":"Seo-hyung Lee","doi":"10.38046/APJHLE.2020.13.2.001","DOIUrl":"https://doi.org/10.38046/APJHLE.2020.13.2.001","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"13 1","pages":"1-38"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70080790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.38046/APJHLE.2020.13.2.002
Jaiyong Kim
{"title":"Primary and secondary use of personal health information: social context and governance issues","authors":"Jaiyong Kim","doi":"10.38046/APJHLE.2020.13.2.002","DOIUrl":"https://doi.org/10.38046/APJHLE.2020.13.2.002","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"13 1","pages":"39-57"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70080904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.38046/APJHLE.2020.14.1.004
Christopher B. Shook, Ji-Hyun Lee, Mikyung Kim
{"title":"Promoting Science and the Integrity of Biomedical Research at Universities: SNUCM as an Example","authors":"Christopher B. Shook, Ji-Hyun Lee, Mikyung Kim","doi":"10.38046/APJHLE.2020.14.1.004","DOIUrl":"https://doi.org/10.38046/APJHLE.2020.14.1.004","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"14 1","pages":"95-128"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70080701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-11-30DOI: 10.38046/APJHLE.2019.13.1.004
Kyoungyeon Do, Kim Eun-Ae, Sujung Yoo
{"title":"The children as research participants, what kind of being should we look at them and how should we protect them?: Focusing on the analysis about the main contents related to the research involving children in","authors":"Kyoungyeon Do, Kim Eun-Ae, Sujung Yoo","doi":"10.38046/APJHLE.2019.13.1.004","DOIUrl":"https://doi.org/10.38046/APJHLE.2019.13.1.004","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"13 1","pages":"71-100"},"PeriodicalIF":0.0,"publicationDate":"2019-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47646072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-08-01DOI: 10.38046/APJHLE.2018.11.3.001
Eunjeong Ma
Inspired by a notion that machines can emulate human touch, the paper first examines the adoption of surgical robots in operating rooms at the global and local levels. The adoption of the technology has occurred almost concurrently in many countries without much time lag, and this near-simultaneous acceptance of the technology invites us to rethink technological supremacy in relation to patient care in the field of surgery. With focus on the da Vinci surgical system, this paper presents social and ethical implications of how (not) to regulate robotic surgery with potential and invisible risks with respect to patient care. Based on documentary analysis of news media in combination with literature review of medical journals, Korean news media, and Korean technology assessment reports on surgical robots, the paper explores how prevalently the idea of social progress is embedded in the promotion of advanced technology at the societal and governmental levels. I contend that the ideology of social enhancement has served to shape regulatory practices (or their absence) at the expense of patient care in emergent technologies such as robotic surgery in South Korea. Thus, social scientists and bioethicists should be involved in articulating ethical dimensions of the technology even from the stage of development in order to remedy the gap between technical advancement in surgery and patient care.
{"title":"Robotic Surgery: Transforming Patient Care in the 21st Century?","authors":"Eunjeong Ma","doi":"10.38046/APJHLE.2018.11.3.001","DOIUrl":"https://doi.org/10.38046/APJHLE.2018.11.3.001","url":null,"abstract":"Inspired by a notion that machines can emulate human touch, the paper first examines the adoption of surgical robots in operating rooms at the global and local levels. The adoption of the technology has occurred almost concurrently in many countries without much time lag, and this near-simultaneous acceptance of the technology invites us to rethink technological supremacy in relation to patient care in the field of surgery. With focus on the da Vinci surgical system, this paper presents social and ethical implications of how (not) to regulate robotic surgery with potential and invisible risks with respect to patient care. Based on documentary analysis of news media in combination with literature review of medical journals, Korean news media, and Korean technology assessment reports on surgical robots, the paper explores how prevalently the idea of social progress is embedded in the promotion of advanced technology at the societal and governmental levels. I contend that the ideology of social enhancement has served to shape regulatory practices (or their absence) at the expense of patient care in emergent technologies such as robotic surgery in South Korea. Thus, social scientists and bioethicists should be involved in articulating ethical dimensions of the technology even from the stage of development in order to remedy the gap between technical advancement in surgery and patient care.","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"11 1","pages":"1-25"},"PeriodicalIF":0.0,"publicationDate":"2018-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44534546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In the name of state interests, advance directive statutes almost universally include language requiring that a patient be in a particular physical state as a condition precedent to operation of a directive. This article urges state legislatures to recognize and rectify the conflict they have created by imposing such triggering conditions. First, it examines states’ efforts to facilitate autonomous end-of-life decision making through advance directive statutes. Then it proposes amending those statutes to align the law with medical ethics by eliminating specified physical triggering conditions burdening the exercise of patients’ rights to refuse life-sustaining treatment. Such amendment will improve end-of-life care and serve as an expression of a more caring medical and legal culture.
{"title":"Give Me Liberty to Choose (a better) Death: Respecting Autonomy More Fully in Advance Directive Statutes","authors":"K. Cerminara, Joseph R. Kadis","doi":"10.2139/SSRN.3118710","DOIUrl":"https://doi.org/10.2139/SSRN.3118710","url":null,"abstract":"In the name of state interests, advance directive statutes almost universally include language requiring that a patient be in a particular physical state as a condition precedent to operation of a directive. This article urges state legislatures to recognize and rectify the conflict they have created by imposing such triggering conditions. First, it examines states’ efforts to facilitate autonomous end-of-life decision making through advance directive statutes. Then it proposes amending those statutes to align the law with medical ethics by eliminating specified physical triggering conditions burdening the exercise of patients’ rights to refuse life-sustaining treatment. Such amendment will improve end-of-life care and serve as an expression of a more caring medical and legal culture.","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"10 1","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2018-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46587393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Societal Impacts of Climate Anomalies During the Past 50,000 Years and their Implications for Solastalgia and Adaptation to Future Climate Change","authors":"E. P. Richards","doi":"10.2139/ssrn.3510319","DOIUrl":"https://doi.org/10.2139/ssrn.3510319","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"18 1","pages":"131"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68600005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-01-01DOI: 10.38046/APJHLE.2016.9.3.007
Eun-Ae Kim
{"title":"A study on the research related conflict of interest as seen through the Dan Markingson case in U.S.A.","authors":"Eun-Ae Kim","doi":"10.38046/APJHLE.2016.9.3.007","DOIUrl":"https://doi.org/10.38046/APJHLE.2016.9.3.007","url":null,"abstract":"","PeriodicalId":80027,"journal":{"name":"Journal of health law","volume":"32 1","pages":"185-221"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70080736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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