• 제목/요약/키워드: Broad Consent

검색결과 5건 처리시간 0.02초

인체유래물연구에 대한 동의 소고(小考) - 개정 생명윤리법 제42조의2를 계기로 - (Consent for using human biological material in research: based on the revised Bioethics and Safety Act)

  • 이동진;이선구
    • 의료법학
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    • 제20권2호
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    • pp.111-140
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    • 2019
  • 생명윤리 및 안전에 관한 법률은 인체유래물연구와 인체유래물은행에 관하여 일련의 규율을 가하고 있다. 같은 법은 인체유래물연구에 대하여는 연구목적을 정하여 설명 후 동의를 받게 하는 반면, 인체유래물은행의 경우 연구목적을 정하지 아니한 채 기증받게 한다. 나아가 보건복지부령으로 정하는 인체유래물 연구 동의서식을 보면 연구목적을 정하는 경우에도 '포괄적으로 연구에 대하여' 동의하는 개방동의·백지동의가 허용된다. 덧붙여 2019. 4. 23. 개정된 제42조의2는 진단·치료과정에서 채취된 인체유래물의 잔여검체에 대하여 본인이 거부의사를 명시하지 아니하는 한 목적도 정하지 아니한 채 인체유래물은행에 제공하는 것을 허용한다. 이러한 입법은 과도하다고 보인다. 국제적으로 인체유래물기증자의 자율성과 인체유래물은행 및 인체유래물연구의 특성을 고려할 때 포괄동의를 수용할 필요가 있음은 부정하기 어렵다. 그러나 인체유래물연구에는 생명윤리 및 안전에 관한 법률 이외에 종종 개인정보 보호법도 적용되고 국내·외적으로 이 영역에서는 개방동의·백지동의는 물론, 포괄동의의 허용성도 논란의 대상이었음을 염두에 둘 필요가 있다. 또 근래의 발전된 정보통신기술에 비추어볼 때 완전한 동적동의는 아니라 하더라도 특히 위험한 경우에는 동적동의를 통한 특정동의요건의 충족이 필요하고 가능한 사안도 있다. 이는 인체유래물의 제2차적 사용 내지 인체유래물은행의 운영에 관한 거버넌스 설계와 그에 대한 설명 후 동의 및 인체유래물기증자에 대한 투명성, 인체유래물기증자의 참여권 보장을 포함한다.

미국 Common Rule의 주요 개정 내용과 시사점 (Implementation of the Revised Common Rule in the United States and its implications for Human Research in Korea)

  • 최병인
    • 대한기관윤리심의기구협의회지
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    • 제2권1호
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    • pp.1-5
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    • 2020
  • The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.

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임의적(任意的) 갱생보호제도(更生保護制度)의 개선방안(改善方案) (A STUDY on After-Care System for After-Care Probationer)

  • 정주영
    • 시큐리티연구
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    • 제2호
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    • pp.227-258
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    • 1999
  • In a broad sense, ‘After-care SYSTEM’ for discharged prisoners mean legal actions of prisoners who have been released from lawful detention In its narrow sense, mean preventive protection and observation activities under regular guidance and supervision against those released from penal facilities after a certain period of detention Therefore, they should not be viewed as objects of mere concern or social work programs but preventive protection should he provided to them as part of national criminal policy After-care system is in the following two ways, The one is based on individual prisoner's request and consent, which is called 'Voluntary After-care system', The other is the one which is not based in personal request or consent but is based on obligation, which is named 'Compulsory After-care system In Korea, however no Compulsory After-care system is in practice Voluntary After-care system is to be carried out 6 method in the following by existing Probation, Parole Law. (1) offer of board and lodging (2) allowance of Traveling expense (3) allowance of occupation instrument or lending rehabilitation fund (4) training of occupation and vocational guidance (5) self-reliance support for After-care probationer (6) guidance of good deed And then to establish the society without offenders is the ideal of human beings, but criminal acts don't fade away, so in the field of the science of criminology, the importance of correctional system has become greater. The correctional idea has moved from severe punishment to educational rehabilitation for the goal of protecting both offender and security from the threat of crime in to day Some it is required that Compulsory After-care system is most important system in effective measures, and that existing Probation, Parole Law in Korea is renewed into Compulsory After-care system in the future.

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The Determinants and Barriers of Outsourcing Third-Party Online Delivery: Perspectives of F&B Entrepreneurs in Malaysia

  • SIN, Kit-Yeng;LO, May-Chiun;MOHAMAD, Abang Azlan
    • The Journal of Asian Finance, Economics and Business
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    • 제8권5호
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    • pp.979-986
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    • 2021
  • Online food delivery and food delivery apps have continued to grow exponentially in Malaysia. Fundamental aspects in entrepreneurship of the food and beverage industry, such as knowledge and attitudes towards online food delivery services being outsourced, have yet to be extensively recognized. The present study intends to explore this area of subject matter within the Malaysian context by using behavioral reasoning theory. The actual interview for this study took place in May 2020, and 14 interviews had been carried out. All interviews were audio-recorded with the consent from the respondents for reference purposes and subsequently transcribed verbatim. The transcripts were then checked against audio records. Content analysis was used to analyze the transcripts by focusing on n frequency counts and coding of themes. A qualitative method has been adopted by employing an interview to elicit the perspectives of entrepreneurs from Sarawak on the determinants and barriers in outsourcing online food delivery services. Results indicate that high potential in revenue, broad exposure to reach customers, convenience, and provision of job opportunities are the four factors that determine to outsource. In contrast, food quality maintenance, trustworthiness, high cost incurred, and consumer technology resistance are four factors that serve as barriers towards outsourcing third-party online delivery.

보건의료정보의 법적 보호와 열람.교부 (A Study on Legal Protection, Inspection and Delivery of the Copies of Health & Medical Data)

  • 정용엽
    • 의료법학
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    • 제13권1호
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    • pp.359-395
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    • 2012
  • In a broad term, health and medical data means all patient information that has been generated or circulated in government health and medical policies, such as medical research and public health, and all sorts of health and medical fields as well as patients' personal data, referred as medical data (filled out as medical record forms) by medical institutions. The kinds of health and medical data in medical records are prescribed by Articles on required medical data and the terms of recordkeeping in the Enforcement Decree of the Medical Service Act. As EMR, OCS, LIS, telemedicine and u-health emerges, sharing and protecting digital health and medical data is at issue in these days. At medical institutions, health and medical data, such as medical records, is classified as "sensitive information" and thus is protected strictly. However, due to the circulative property of information, health and medical data can be public as well as being private. The legal grounds of health and medical data as such are based on the right to informational self-determination, which is one of the fundamental rights derived from the Constitution. In there, patients' rights to refuse the collection of information, to control recordkeeping (to demand access, correction or deletion) and to control using and sharing of information are rooted. In any processing of health and medical data, such as generating, recording, storing, using or disposing, privacy can be violated in many ways, including the leakage, forgery, falsification or abuse of information. That is why laws, such as the Medical Service Act and the Personal Data Protection Law, and the Guideline for Protection of Personal Data at Medical Institutions (by the Ministry of Health and Welfare) provide for technical, physical, administrative and legal safeguards on those who handle personal data (health and medical information-processing personnel and medical institutions). The Personal Data Protection Law provides for the collection, use and sharing of personal data, and the regulation thereon, the disposal of information, the means of receiving consent, and the regulation of processing of personal data. On the contrary, health and medical data can be inspected or delivered of the copies, based on the principle of restriction on fundamental rights prescribed by the Constitution. For instance, Article 21(Access to Record) of the Medical Service Act, and the Personal Data Protection Law prescribe self-disclosure, the release of information by family members or by laws, the exchange of medical data due to patient transfer, the secondary use of medical data, such as medical research, and the release of information and the release of information required by the Personal Data Protection Law.

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