보조생식술 관련 영국 HFEA 동의서식의 내용과 의의 : 자기결정권 보장 및 생식물질 관리 관련 내용을 중심으로

김은애 이화여자대학교 생명의료법연구소 2012 생명윤리정책연구 Vol.6 No.2

The informed consent of the person related to using the assisted reproductive technology is very important to protect their right to self determination and to manage their gamete and embryo. So, the Korean Ministry of Health & Welfare has offered the informed consent form as the official form through the enforcement rule of Bioethics and Safety Act and its guidebook. Also, the UK HFEA(Human Fertilisation and Embryology Authority) has offered all informed consent form related to using the assisted reproductive technology officially. The UK consent form is very useful to both the institution and the right holder because the form is appropriately classified considering the different kinds of the way to treat the infertility such as the artificial insemination or in vitro fertilization, the additional use of donor’s gamete/embryo, the involvement of surrogate mother as well as the position of different parties such as the woman directly involved, her spouse, the gamete/embryo donor. And the contents of UK consent form is abundant to confirm the consent holder’'s decision, so the institution is able to manage the consent holder’'s gamete/embryo accurately. The completely revised Bioethics and Safety Act will enforce from the next year. So, the Korean Ministry of Health & Welfare is preparing the draft of amended enforcement rule of Bioethics and Safety Act including the official form related to using the assisted reproductive technology. I hope that the Korean Ministry of Health & Welfare takes the opportunity to improve the Korean consent form considering the advantage or strength of the UK consent form for stronger protection of he right to self determination and more exhaustive management of the human gamete and embryo.

소비자의 개인정보 제공 동의 인식에 대한 탐색적 연구

구혜경(Koo, Hye-Gyoung),나종연(Rha, Jong-Youn) 한국소비문화학회 2014 소비문화연구 Vol.17 No.2

This study focus on the self-determination of personal information usage. In the modern society, many consumers give consent to the use of personal information by some firms or government branches. Although the right to consent is not only the basic human right but also the property right, many consumers don't pay enough attention to the consent process and the terms of privacy policy. Therefore this study had to focus the behavior and perception of consumers' related with personal information through depth interview methodology. As a results, many consumers don't read the terms of privacy policy, and the behaviors could be differentiated with situation giving consent such as online-offline context and they think there are no right to choice giving consent or not. Futhermore, consumers recognized there are three parts of problems, those are consumer cognition problem, structural problem at giving consent context, and the form related problem. At first, consumer's cognitive problem is related with consumer's perception when consumers give consent, for example, they don't want to read the terms of privacy policy or they can't understand the contents of privacy policy because of the jargon of the terms. Secondly, there are structural problem at consumers' giving consent context. Most users of personal information don't effort to develop the level of consumer's understanding, actually at the consent situation, consumers can't have real right to choose consent or not. Thirdly, there are formation problem of the privacy policy documents. There are so many contents, the character is very small, finally the legibility is very bad so that the documents made consumers not to read the terms. And another issue is the perception of the main concept of privacy policy jargon such as "the third party provision" or "sensitive information of individuals". We can find the gap between consumer's perception and the real meaning of the terms of privacy policy. Last issue is the thought of the responsibility about personal information protection. Consumers judge the responsibility subject to business part, government part, and consumer-self part. Business part is the very subject to get real benefit through using individual information, so consumers want business part to play role to develop personal information protection area. Futhermore consumers need to more powerful regulation to arrange the market's role and to correct the wrong behavior of business part. And lastly, consumers know self-problem of gap between the recognition of personal information value and the level of giving consent behavior. This study could check various opinion about personal information protection issues, and to suggest better way to reflect personal information policy, we held the experts conference that is composed of personal information scholars, administrators, businessman of global firm. They discussed various issues those are the results of consumer's depth interviews and they suggest the ideas to develop personal information protection policy in Korea. Firstly many consumers think that they couldn't haver real right to consent, the experts analyzed the reason that there are too many consent contents including indispensible information such as name, address to deliver commodity or services of information users. Therefore, the essential information to give users have to be noticed consumers to understand intuitionally, the optional information for more services have been disclosed consumers to choose giving personal information or not. For this, it is needed to standardize the privacy policy and consent documents for informed consent by consumers. Secondly, Privacy Protection Act guarantee the right to redress. If consumers give consent to user personal information at online, it will have to be possible to redress or change the level of personal information usage of users at online easily. But practically consumers have to go to the office of persona 소비자의 개인정보는 그 동안 프라이버시, 인권의 측면에서 논의되었으나, 현대사회에서는 재산권으로서의 기능을 포함하고 있어 개인정보보호에 관한 관점이 변화될 필요가 있다. 다수의 소비자가 개인정보가 중요함을 인식하나, 개인정보제공 동의에 있어서는 매우 형식적인 과정으로 인식하여 동의서 내용을 제대로 확인하지 않는 경향이 큰 것으로 보인다. 이미 현대사회에서는 개인정보를 제공하지 않는 방법으로는 보호할 수는 없는 상황이며, 개인정보를 제공하고 다양한 서비스를 이용하는 것이 일반적인 상황이다. 따라서 개인정보 제공 동의시, 얼마나 내용을 제대로 이해하고 동의하였는지의 여부가 개인정보의 자기결정권에 있어 중요한 기준이 될 것이다. 이에 본 연구에서는 현행법률상에서 사업자가 개인정보를 수집하고 이용하기 위해 소비자에게 고지해야 하는 주요 내용을 확인하고, 이에 관한 소비자 인식을 확인하고자 하였다. 더불어 소비자의 개인정보제공 동의행동에 대한 확인 및 개인정보제공 동의상황의 문제점을 다각도로 확인하고자 하였다. 왜냐하면 정보정책의 수립에 있어서는 다양한 현상을 이해하고, 이를 보완할 수 있는 정책의 수립이 이루어져야 하기 때문이다. 개인정보제공 동의 문제는 소비자의 인지적 문제와 동의상황의 구조적 문제(Solove 2013)로 구분되며, 본 연구의 결과는 이 틀에 근거하여 해석하였다. 개인정보 제공 동의에 대한 인식확인을 위해 20~50대의 성인남녀를 대상으로 탐색하였으며, 결과를 정책반영하는데 있어 실효성을 높이기 위해 전문가 회의를 병행하였다. 연구결과, 개인정보제공동의과정에서의 문제점은 내용의 어려움, 과다한 내용, 소비자의 휴리스틱적 의사결정 등 소비자의 인지적 문제와 실제로 동의거부권이 없는 것으로 여겨지는 동의사황, 개인 소비자가 다수의 사업자와 거래를 형성하다 보니 상대적으로 협상력이 적어지는 등의 구조적 문제로 구분할 수 있었으며, 인지적 문제와 구조적 문제는 상호독립적인 것이 아니라 상호 의존적으로 악순환인 상황으로 보인다. 더욱이 우리나라는 산업권별로 개인정보보호를 관장하는 법률과 관리감독 기구가 달라 구조적인 문제의 해결이 시급하다. 이에 본 연구에서는 우선 개인정보제공에 있어 중요한 내용들에 대한 소비자의 인식차이가 매우 큰 현 상황에서 소비자가 제대로 내용을 인식하고 동의할 수 있도록 동의서식의 표준화 및 동의서 내용의 개선 필요성을 강조하였다. 이러한 과정은 정보내용을 이해하고 동의할 수 있도록(informed consent) 하는 것에 초점을 맞추는 것으로, 정보의 자기결정권 혹은 동의권이라는 기본 권리 실현의 가장 기본 전제를 충족시키는 과정으로서 의미가 크다고 볼 수 있다.

보조생식술에 있어 Informed Consent에 관한 연구 : 우리나라와 영국의 동의 체계 및 동의 서식에 대한 비교를 중심으로

김은애 이화여자대학교 생명의료법연구소 2012 생명윤리정책연구 Vol.6 No.1

In receiving the medical treatment service like as the assisted reproductive technology for the pregnancy and the gamete donation, Informed Consent is the most important thing to protect the right to self determination as well as to manage the human gamete and embryo. To the appropriate informed consent, the Informed Consent Form and System should be prepared appropriately. In UK, Human Fertilisation and Embryology Authority has offered all Informed Consent Form related to using the assisted reproductive technology officially. The UK HFEA forms are classified so much according to the right holder of the consent. And the contents of these forms are concreted so much according to the details to be obtained the consent as well as offered with the explanation of the details to be obtained. In Korea, some Informed Consent Forms related to using the assisted reproductive technology has offered by the law and some Informed Consent Forms has offered by the Ministry of Health and Welfare. But some necessary Informed Consent Forms has not offered by both of them. Also, these offered Informed Consent Forms is not appropriate to protect the right to self determination as well as to manage the human gamete and embryo because they are not enough to confirm so many details to be determined by the right holder of the consent. This article analyzes the UK HFEA Informed Consent Forms and System related to the assisted reproductive technology and compares them and KOREA Informed Consent Forms and System to seek the way to improve them.

소비자의 개인정보 제3자 정보 제공 인식에 관한 탐색적 연구

구혜경,나종연 한국디지털정책학회 2014 디지털융복합연구 Vol.12 No.8

유전자 검사 및 연구에서의 동의 획득의 문제

배그린(Bae Green),최경석(Kyungsuk Choi) 이화여자대학교 생명의료법연구소 2009 생명윤리정책연구 Vol.3 No.2

Various genetic tests are available. Genetic research is expected to contribute to the development of medicine. Genetic test and research, however, have raised some important ethical issues including genetic privacy, confidentiality, and discrimination. Due to the sensitive characters of genetic information, protecting privacy and keeping confidentiality are the basic requirements. Obtaining informed consent is also mandatory to respect a donor’s or a patient’s autonomy and protect their personal information. Bioethics and Safety Act in Korea regulates genetic test and research. The same rule to regulate genetic test applies to genetic research. Especially the Act enacted a single legal form for both genetic test and research. But genetic research fundamentally differs from genetic test in that the former is research. Thus, the legal form reveals some problems when it is used for genetic research. First, the right to know the outcomes of genetic test might be often waived in genetic research while it should be respected in genetic test. Second, the period for keeping genetic samples should be consented after researchers basically set it up. It is not a good idea that “5 years” is provided as an option in the current legal form. Third, the right to withdrawal of consent should be respected at any time in the course of research regardless of its reasons. Samples should be destroyed without generating further data although data already made until the withdrawal may be used with the permanent deletion of personal identifiers. Therefore, a new consent form for genetic research should be made.

유전자 검사 및 연구에서의 동의 획득의 문제

배그린,최경석 이화여자대학교 생명의료법연구소 2009 생명윤리정책연구 Vol.3 No.1

Various genetic tests are available. Genetic research is expected to contribute to the development of medicine. Genetic test and research, however, have raised some important ethical issues including genetic privacy, confidentiality, and discrimination. Due to the sensitive characters of genetic information, protecting privacy and keeping confidentiality are the basic requirements. Obtaining informed consent is also mandatory to respect a donor’s or a patient’s autonomy and protect their personal information. Bioethics and Safety Act in Korea regulates genetic test and research. The same rule to regulate genetic test applies to genetic research. Especially the Act enacted a single legal form for both genetic test and research. But genetic research fundamentally differs from genetic test in that the former is research. Thus, the legal form reveals some problems when it is used for genetic research. First, the right to know the outcomes of genetic test might be often waived in genetic research while it should be respected in genetic test. Second, the period for keeping genetic samples should be consented after researchers basically set it up. It is not a good idea that “5 years” is provided as an option in the current legal form. Third, the right to withdrawal of consent should be respected at any time in the course of research regardless of its reasons. Samples should be destroyed without generating further data although data already made until the withdrawal may be used with the permanent deletion of personal identifiers. Therefore, a new consent form for genetic research should be made.

전자의무기록 기반의 심폐소생술금지 동의서의 전자서식 개발

박지경 보건의료산업학회 2016 보건의료산업학회지 Vol.10 No.3

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.