Korean Regulations of Clinical Trials and Research with Human Subjects

Park, Soo Hun 이화여자대학교 생명의료법연구소 2012 BIOMEDICAL LAW & ETHICS Vol.6 No.1

Clinical trials and research with human subjects are conducted throughout the world including both the developed and the developing countries. Clinical trials and research with human subjects have the common concerns on how to protect the rights, safety, and welfare of the human subjects properly and adequately. In this article, I examined government regulations of Korea that formulate the basic frame and minimal requirement for the researchers to comply with when they conduct clinical trials and research with human subjects. Especially, I explored Constitutional Law, the Bioethics and Safety Act, the Pharmaceutical Affairs Act, the Medical Device Act, and Korea Good Clinical Practice. As a result, I found some defaults in our laws and regulations in protecting human subjects. In case of Constitutional law, there is no principle of beneficence necessary for researchers to protect human subjects by analyzing the risk and benefit of making them participate in clinical trials and research unlike the global standards. In case of BEASA, it has limited jurisdiction in research with human subjects in the specific life science areas such as human embryonic research, genetic testing, and gene therapy. In addition, BEASA is not applied to human behavioral research and does not have a definition on research. As to PAA, it has a “swiss cheese” syndrome in three ways: no provision on vulnerable populations, no provisions on Informed Consent and IRBs, and no provision on the research participants’ protected health information. Finally, KGCP also needs to insert some provisions such as much more specified kinds of vulnerable populations, types of conflict of interest, and the use of placebo, to protect human subjects in accordance with the global standards.

생명윤리와 연구대상자 보호

손영화 한국법정책학회 2023 법과 정책연구 Vol.23 No.1

Since the beginning of this century, ethical guidelines for human research have been established, and ethical examinations have to be conducted when conducting human-targeted research and human-derived research. The Bioethics and Safety Act includes not only medical research, but also social science research and humanities research conducted through interaction with people who have nothing to do with natural science experiments. Depending on the field of study, the Bioethics Committee of the Organization is required to review papers and applications for research funds in academic journals. The history of human research ethics can be divided into three cases: the Nuremberg Code, the Helsinki Declaration made by the World Medical Association based on the Nuremberg Code, and the Belmont Report, which embodies the Helsinki Declaration. Although this bioethics originated from reflection on human experiments by the German Nazis, research bioethics have naturally been developed to respect human rights from reflection on inhumane and anti-ethical human experiments. Today, the Institutional Bioethics Committee is conducting tasks such as deliberating research plans, investigating ongoing research at the institution, supervising, educating, establishing measures to protect vulnerable research subjects, and preparing ethical guidelines for researchers. The deliberation focuses on the ethical and scientific validity of the research plan, whether consent has been obtained through due process, safety of research subjects, personal information protection measures for research subjects, and matters related to the bioethics and safety of institutions. Researchers who want to conduct human research must start research after obtaining approval from the Bioethics Committee, so they must apply for deliberation in accordance with the designated form of the Bioethics Committee. If the research is to be continued or there are any changes or violations or omissions during the course of the research, the relevant matters shall be deliberated, and when the research is completed, the research results report shall be submitted for deliberation. It is important to remember that the main focus of institutional bioethics is the protection of those under study. Therefore, researchers should eliminate the possibility of conflicts of interest in research. Furthermore, the safety of the individuals subject to the study should be fully taken into account and the risk should be minimized. Individuals and groups in vulnerable environments must be especially protected. Care should be taken to allow participants to participate voluntarily and not inflate economic benefits or reduce risks. In other words, when conducting human research and human-derived research, the participants must obtain voluntary consent to participate in the research. In addition, since protection of the subjects is important in human research, attention should be paid to protecting the personal information and guaranteeing confidentiality of the subjects. When planning, performing, or reporting research results, researchers should ensure that the basic ethical principles of Belmont Report 3 are met, such as respect for humans, good deeds, and justice, and comply with the basic principles and related arguments set out in Article 3 of the Bioethics and Safety Act. When we comply with the ethical principles and laws that human researchers must abide by, it should be remembered that scientific credibility of the results as well as the human rights, safety, and welfare of the study subjects is guaranteed. 금세기 들어 사람을 대상으로 하는 연구에 관한 윤리지침이 제정되어 인간대상연구 및 인체유래물연구를 하는 경우 윤리심사를 하지 않으면 안되게 되었다. 종래 대표적인 인간대상연구를 하던 의학 연구뿐 아니라 자연과학적인 실험과는 전혀 상관이 없는 사람과의 상호작용을 통해서 수행되는 사회과학 연구나 인문학 연구도 「생명윤리 및 안전에 관한 법률(이하, 생명윤리법)」의 규율 대상에 포함되게 된 것이다. 학문분야에 따라서는 학회지에 논문 투고나 연구비를 신청할 때도 기관생명윤리위원회의 심사가 요구되고 있다. 인간을 대상으로 한 연구윤리의 역사는 제2차 세계대전 중 인체실험을 계기로 한 '뉘른베르크 강령', 뉘른베르크 강령을 바탕으로 세계 의사회가 작성한 '헬싱키 선언', 그리고 헬싱키 선언을 보다 구체화한 '베르몬트 리포트'라는 3가지 사건으로 나눌 수 있다. 독일 나치의 인체실험의 반성에서부터 출발한 생명윤리이지만 비인간적, 반윤리적 인체실험에 대한 반성에서 자연스럽게 인권존중을 위한 방향으로 연구생명윤리가 형성되고 발전되었다고 할 것이다. 오늘날 기관생명윤리위원회는 연구계획서의 심의, 해당 기관에서 진행중인 연구에 대한 조사, 감독, 교육, 취약한 연구대상자 보호대책 수립, 연구자를 위한 윤리지침 마련 등의 업무를 수행하고 있다. 심의는 연구계획서의 윤리적·과학적 타당성, 적법한 절차에 의한 동의 획득을 받았는지의 여부, 연구대상자 등의 안전, 연구대상자 등의 개인정보 보호대책, 기관의 생명윤리 및 안전에 관한 사항 등에 초점을 두어 심의하고 있다. 인간대상연구를 하고자 하는 연구자는 반드시 기관생명윤리위원회의 승인을 받은 후 연구를 시작하여야 하므로 소속 기관생명윤리위원회의 지정된 양식에 따라 심의를 신청하여 일정한 심의과정을 의무적으로 거쳐야 한다. 만약, 연구 수행 중에 연구를 지속하고자 하거나 변경 사항 또는 위반, 이탈이 있다면 해당 사항에 대하여 심의를 받아야 하며, 연구 종료 시에는 연구결과보고서를 제출하여 심의를 받아야 한다. 기관생명윤리는 무엇보다도 연구대상자의 보호에 그 주안점이 있음을 기억할 필요가 있다. 그러므로 연구자는 연구에 있어서 이해충돌 가능성을 없애야 한다. 또한 연구에 있어서 연구대상자의 안전을 충분히 고려하고 위험은 최소화하여야 한다. 취약한 환경에 있는 개인이나 집단은 특별히 보호되어야 한다. 연구대상자가 자발적으로 참여할 수 있도록 하며, 경제적인 이익을 부풀리거나 위험을 축소하지 않도록 주의해야 한다. 다시 말해, 인간대상연구와 인체유래물연구를 수행할 때에는 반드시 대상자 본인으로부터 연구참여에 대한 자발적 동의를 받아야 한다. 또한, 인간대상연구에서는 연구대상자에 대한 보호가 중요하므로 연구대상자의 개인정보보호와 비밀보장이 되도록 주의를 기울여야 한다. 연구자는 연구의 계획, 수행, 결과보고를 하는 경우 벨몬트 보고 3 기본윤리원칙인 인간존중, 선행, 정의에 맞도록 하고, 생명윤리법 제3조에 제시된 기본원칙과 관련 주장을 잘 준수하여야 한다. 인간대상연구의 연구자가 지켜야 할 윤리원칙과 법률을 잘 지킬 때 연구대상자의 인권, 안전, 복지가 보장됨은 물론 연구결과에 대한 과학적 신뢰성이 확보될 수 있음을 잊지 말아야 할 것이다.

불법 행동이나 잠재적 불법 행동에 대한 연구에서 기밀 유지에 대한 법적,윤리적 고려

최은경 ( Eun Kyung Choi ),김도균 ( Do Kyun Kim ),김옥주 ( Ock Joo Kim ) 한국의료윤리학회 2008 한국의료윤리학회지 Vol.11 No.2

Confidentiality has been regarded as one of the most important ethical principles for research on human subjects. Protecting research subjects` confidentiality derives from the principle of respect for persons. As it is essential to maintain trust between researchers and subjects, research on human subjects cannot be conducted without protecting confidentiality, although it is not always easy to do so. Research that involves recording and observing illegal activities, including illegal drug studies, demands an especially high degree of confidentiality. Breach of research confidentiality can result in criminal or civil liability for the subjects in such research. When the researchers are subpoenaed, they are forced to provide information on their subjects. Most countries have no legal framework to protect both subjects and researchers from breaches of confidentiality. This paper discusses the ethical and legal considerations regarding the confidentiality of research on illegal activities. After examining domestic and international cases in which confidentiality and court orders were in conflict, the authors examine relevant policies and legal frameworks, including the Certificate of Confidentiality issued by the U.S. National Institute of Health (NIH). The authors argue that legal assurance to protect confidentiality should be provided to research subjects and researchers, especially considering the recent increase in research on illegal activities in Korea.

對漢語主觀減量標記的共時、歷時研究——以 “不怎麽”、“不那麽” 爲中心

梁英梅 경성대학교 한국한자연구소 2020 한자연구 Vol.0 No.27

As part of research on the Chinese subjective decrement markers, this study is aimed at analyzing the combinatorial aspect and semantic characteristic of them through a synchronic and diachronic research especially into ‘不怎么’ and ‘不那么’, both of which are of profound significance for expressions denoting the subjective decrement. By means of doing so, the work seeks to understand the background, and further to clarify the grammaticalization process whereby they are used as markers showing the subjective decrement. “Quantity is an important category with which humans perceive, understand and make expressions of the world”, and “the quantitative category of the linguistic world is divided into objective quantity and subjective one”. The subjective quantity is defined as that which comes to have subjectivity due to the speaker's subjective evaluation of the objective quantity, and is usually divided into large and small one. Research related to the subjective quantity has attracted the attention of many scholars and there have been remarkable achievements made with regard to it even in Chinese language studies. However, there has been a limitation, on the other hand, that most of the studies have focused only on the syntax, semantics and pragmatics of expressions denoting the large subjective quantity and small one. What needs to be paid attention to, in this respect, is that the Chinese language also has expressions for the subjective decrement such as ‘不怎么’ and ‘不那么’ in addition to those for the large and small subjective quantity. For all that, few researchers have observed and analyzed them from the perspective of the subjective quantity. For such a reason, this study considers ‘不怎么’ and ‘不那么’ to be the subjective decrement markers most of all, analyzing the combinatorial aspect and semantic characteristic of and the difference between them through a synchronic research. Then, another analysis of their degrees of lexicalization is conducted through a diachronic research into their semantic expansions and frequency increases based on the examination of their periodic examples. The work, in the last analysis, deduces their grammaticalization processes along with the background analysis of how meanings of the subjective decrement have come to be generated in them despite the fact that they have not in other interrogatives or demonstratives.

최근 일본의 의학계 연구규율의 특색

송영민 대한의료법학회 2019 의료법학 Vol.20 No.2

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects. 본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구․치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

군사학 학문연구 동향 탐색: 한국군사학논총 논문 분석을 중심으로

설현주 미래군사학회 2019 한국군사학논총 Vol.8 No.2

The purpose of this study is to investigate the trends of what kind of research is actually being conducted on the military studies. To do this, the research analyzed the articles published in the Review of Korean Military Studies. As a method for analysis, a topic modeling technique, which is one kind of text mining, was used. As a result, it was found that the research was mainly conducted on nine subjects. In view of the nature and content of the subject, despite the fact that the military studies is a fusion of literature, the paper published in the Review of Korean Military Studies has found that the thesis of the humanities and sociological approach is mainstream. In order to investigate the research trends of military studies and to examine the relationship among the research topics, an association rule mining was conducted. As a result, it was found that the research topics derived from the topic modeling analysis were dealt with in some ways with some relevance. The most peculiar thing is the subject related to politics and diplomacy, which, along with almost all the subjects, are relevant and appear in the study, which is a military studies that talks about war, but political and diplomatic solutions or approaches are important in solving military problems. This study is an exploratory study to identify trends in the field of military studies, and it is expected to be helpful in looking at the achievements of the Korean association of future military affairs of the past decade and in the future development of military science.The purpose of this study is to investigate the trends of what kind of research is actually being conducted on the military studies. To do this, the research analyzed the articles published in the Review of Korean Military Studies. As a method for analysis, a topic modeling technique, which is one kind of text mining, was used. As a result, it was found that the research was mainly conducted on nine subjects. In view of the nature and content of the subject, despite the fact that the military studies is a fusion of literature, the paper published in the Review of Korean Military Studies has found that the thesis of the humanities and sociological approach is mainstream. In order to investigate the research trends of military studies and to examine the relationship among the research topics, an association rule mining was conducted. As a result, it was found that the research topics derived from the topic modeling analysis were dealt with in some ways with some relevance. The most peculiar thing is the subject related to politics and diplomacy, which, along with almost all the subjects, are relevant and appear in the study, which is a military studies that talks about war, but political and diplomatic solutions or approaches are important in solving military problems. This study is an exploratory study to identify trends in the field of military studies, and it is expected to be helpful in looking at the achievements of the Korean association of future military affairs of the past decade and in the future development of military science.

국내 뇌성마비 아동 연구 동향 분석 : 특수교육 관련 학술지를 중심으로(2001∼2010년)

김시원,김정연,황지현 한국지체.중복.건강장애교육학회 2012 지체.중복.건강장애연구 Vol.55 No.2

The purpose of this study was to suggest a future direction by finding out the recent research trends regarding children with cerebral palsy of 152 studies registered in scholarly articles related special education in the last decade in Korea. The study analyzed research subject, research method to find out the general research trends and research design, research subject regarding experimental research. Results of the study are as follows. First, the major research subjects were about physical-exercise, followed by about psychology-learning and language communication. Second, most of the research method applied was experimental research. Third, group research and single subject research were implemented similar rate in research design of experimental research. AB design and multiple baseline design across subjects were the majority of the single subject research. Forth, therapy activity was used the most for independent variables while physical activity was the most used for dependent variables. 본 연구는 국내의 2001년부터 2010년까지의 뇌성마비 아동을 대상으로 한 연구를 중심으로 연구 동향을 분석하였다. 분석대상 논문은 국내의 특수교육 관련 학술지에 게재된 152편이며, 분석변인은 일반적인 연구동향을 알기 위해 연구주제, 연구방법과 실험연구를 대상으로 한 연구방법과 연구주제를 분석하였다. 분석결과는 다음과 같다, 첫째, 연구주제는 신체-운동에 관한 연구가 가장 많았으며, 인지-학습과 언어-의사소통이 주를 이루었다. 둘째, 연구방법은 실험연구 비율이 가장 높은 것으로 나타났다. 셋째, 실험연구의 연구방법은 집단연구와 단일대상연구가 비슷한 비율로 이루어지고 있었으며 단일대상연구에서는 AB설계와 중다기초선설계에 의한 연구가 주를 이루었다. 넷째, 연구주제의 독립변인 영역 중 치료활동에 관한 중재가 가장 많았으며, 운동프로그램과 인지학습전략, 보완·대체의사소통이 주를 이루었다. 종속변인 영역으로는 신체능력에 관한 연구가 가장 많이 이루어지는 것으로 나타났다. 이러한 결과들에 근거하여 연구방향을 논의하였으며, 향후 뇌성마비 아동 연구에 대한 제언을 제시하였다.

사회행동과학연구(SBR)의 연구자-연구대상자 관계에서 도덕 판단 원리로서 ‘공감’의 의의 : 질적 연구를 중심으로

김진경,김택중 한국생명윤리학회 2016 생명윤리 Vol.17 No.2

As part of social behavioral research(SBR), a qualitative research is to determine qualitative characteristics inherent in human and society. With interest in human and social contexts, the qualitative study aims to provide solutions to problems with those contexts so it may be likely to be affected by personal values that its conductor, or researcher has. The qualitative research may be less likely to be proceeded in accordance with certain objective standards because it tends to put more importance in interactions between the researcher and the subject and contexts of its process. In the qualitative research, therefore, not only the scientific and ethical performance of that research, but also the protection of the subject's safety and rights are greatly dependent on how much the researcher ethically prepare themselves in terms of consciousness and value. And how much the researcher and the subject trust each other is quite important to the better performance of the qualitative research. The purpose of this study was to examine the characteristics of qualitative research as part of SBR, determining limitations that obtaining consent by sufficient explanation may have as a way to protect the safety and rights of the subject. The study also tried to examine the very principle of moral judgement in the researcher-subject relationship, that is, ‘sympathy’ that includes “following the other's feeling” and “sharing a same feeling with the other”, and discussed moral implications that sympathy has in that relationship. 사회행동과학연구(Social Behavioral Research, SBR)의 질적 연구는 인간과 사회의 저변에 내재된 질적 특성을 파악하고자 하는 것으로서 인간과 사회적 맥락에 관심을 기울이며 이에 대한 문제 해결을 지향하기 때문에 연구 과정에서 연구자의 주관적 가치를 배제하기 어렵다. 또한 연구자와 연구대상자 간의 상호 작용, 연구 과정의 맥락 등을 중요시하는 질적 연구 방법의 특성상 연구 과정이 객관적인 기준을 따르기 어렵다. 이러한 점에서 질적 연구의 경우 연구자가 어떠한 윤리적 의식 및 가치를 가지는가는 연구의 과학적․윤리적 수행과 연구대상자의 안전과 권리 보호를 위한 핵심 요소가 된다. 그리고 연구 과정에서 연구자와 연구대상자가 형성하는 신뢰 관계는 연구를 수행하는 데 매우 중요한 역할을 한다. 이에 본 논문에서는 SBR의 질적 연구의 특성을 알아봄으로써 연구대상자의 안전과 권리를 보호하는 방안으로서 충분한 설명에 의한 동의가 가지는 한계점을 고찰할 것이다. 그리고 연구자-연구대상자 관계의 도덕 판단 원리로서 “따라 느끼는 것”과 “함께 느끼는 것”으로서‘공감’에 대해 알아봄으로써 질적 연구 과정의 연구자-연구대상자 관계에서 공감이 가지는 도덕적 의의에 대해 논의해 보고자 한다.

「생명윤리 및 안전에 관한 법률」 전부개정안의 내용과 의의 : 임상연구와의 관계를 중심으로

김은애 대한의료법학회 2011 의료법학 Vol.12 No.1

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject’s information confidentiality and the human subject’s privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

뇌신경과학 연구에서 연구대상자 보호: 인격주의 생명윤리적 고찰

엄주희 가톨릭대학교(성의교정) 가톨릭생명윤리연구소 2019 인격주의 생명윤리 Vol.9 No.2

The development of neuroscience can help the disabled physically and mentally, assist patients in therapy and make people manipulate characters in the game through games, or move machines at remote locations. It also can make anticipates the emergence of cyborgs that overcame a significant portion of the body's defects and deficiencies. The development of technology requires Human subject to participate in the research, and the contributions of researchers and Human subject as well as the accumulation of research findings are likely to play a major role. As the impact of neuroscience technology on society is important, all societal side effects and risks due to research carried out to implement the technology should be considered. Therefore, in this study, how to protect the research subjects in the neuroscience research and the guideline to guide the researcher from the viewpoint of personalistic bioethics is reviewed. In addition to the existing guidelines for protection of research subjects, there is a need to develop a special ethical system that should be included in neuroscientific science research, including the need for protection of research subjects and the safety factors for various types of neuroscience technologies, such as the perspective of benefits and burdens and invasive or non-invasive technology. Guidelines for the protection of research subjects were provided in consideration of the special ethical and normative factors that should be included in the neuroscientific science research. 뇌와 컴퓨터를 연결하는 뇌-기계 인터페이스(Brain-machine interface, Brain-computer interface : BMI 또는 BCI) 기술, 증강 약물, 신경 조절 등의 뇌신경과학기술은 신체의 장애를 극복하고 정신 질환을 치료하고 회복하는데 도움을 주는 기술로 각광을 받고 있다. 장애인에게 신체와 정신을 보조하거나 환자에게 치료 효과를 줄 뿐 아니라, 일반인에게는 게임 속 캐릭터를 조작하거나, 원격지에 있는 기계를 조정할 수 있게 하고, 신체의 부분적 장애나 부족한 부분을 극복한 사이보그의 등장까지도 예견되고 있다. 뇌신경과학기술이 발전하기 위해서는 연구에 참여하는 사람들을 필요로 하고, 이 연구대상자들의 기여와 연구 결과들의 축적이 기술 발전에 큰 역할을 할 것으로 보인다. 뇌신경과학기술이 사회에 미치는 영향이 크고 불확실성이 존재하는 만큼, 그 기술을 구현하기 위해 수행되는 연구로 인한 전사회적인 부작용과 위험도 감안하여야 한다. 따라서 본 연구에서는 뇌신경과학 연구에 있어서 연구대상자들을 어떠한 방법으로 보호를 할 수 있을지를 주목하고, 연구자를 지도할 수 있는 가이드라인을 인격주의적 생명윤리의 관점에서 검토하였다. 이익과 부담의 관점을 고려하고, 침습적 또는 비침습적 기술 등 신경과학기술의 여러 유형별로 연구대상자의 보호 필요성과 안전 요소를 도출하고, 기존의 연구대상자보호 가이드라인에 추가하여 뇌신경과학 연구에 들어가야 할 특수한 윤리적⋅ 규범적 요소를 감안하여 연구대상자 보호를 위한 가이드라인을 제시하였다.