Clin Eval 40（1）2012

Revision of Bioethics and Safety Act
in South Korea
─ Comprehensive system of human researchsubjects protection and quality assuranceof research, comparing with Japan ─＊
Chieko Kurihara
Molecular Imaging Center, National Institute of Radiological Sciences

Abstract
In South Korea, the Bioethics and Safety Act initially enforced in 2005 was revised and is to be
enforced from February 2013. This Act was legislated to regulate biotechnologies utilizing human embryo,cells and genes but now its scope is expanded to general research involving human subjects. Clinical trialsof drugs and medical devices are separately regulated by GCP (Good Clinical Practice) Ordinance under
the Pharmaceutical Affairs Law. Covered by these research governance frameworks, research review
committees are to be accredited, inspected, educated and evaluated by the regulatory authority.
Additionally, research review experts are dispatched to the United States (US) for training and then they
introduce US-style Human Research Protection Program into their own institutes. Based on such
improvement and assurance of human subject protection, government and research institutes take somemeasures to streamline some administrative procedures.
In this article the author describes the background and actual situation of the revision of the South
Koreaʼs Bioethics and Safety Act, comparing them with the situation in Japan, where research governanceframeworks are composed of many separate guidelines without sufficient legal bases for them.
Key words
bioethics, protection of human research subjects, clinical trial, Good Clinical Practice (GCP), ethics
committee＊ Original version of this article is in Japanese and is included in the Japanese journal()．2012；40（1）：79-90．and the English version is published on the journal web site http://homepage3.nifty.com/
cont/40̲1/p79-90eng.pdf.
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臨床評価

40 巻 1 号

2012

funded by the government, to the United States

1．Introduction(US) for training. They come back to implement a
US-style Human Research Protection Program,

In South Korea the Bioethics and Safety Act

and also a US-style-applied primary reviewer

was established in January 2004 and enforced inmethod for the ethics review. By means of such

January 2005, and its entire revision was announced

methodology, they sometimes review dozens of new

in 2012, and is to be enforced from February

protocols at one time in a review meeting. Addition-

1）2013 . The Act was initially legislated covering

ally, the regulatory authority is going to implement

advanced life science and biotechnology, utilizing

such a system that streamlines their inspection at

human embryos, cells, and genes. Clinical trials of

the institutes that have their own quality assurance

drugs and medical devices have been covered bysystem.

GCP (Good Clinical Practice) regulations underThis article describes the background and actual

the Pharmaceutical Affairs Law, compliant withsituation of the revision of the Bioethics and Safety

ICH-GCP. This time, revision of the Bioethics and

Act in South Korea, comparing it with the situation

Safety Act expands its scope widely coveringin Japan. The focus is especially on the comprehen-

research involving human subjects, except clinicalsive design of the Act and system of human research

trials under GCP. Its scope covers not only “medi-

subject protection, but not on detailed issues ofcal” research involving human subjects, which isadvanced technologies such as human embryo,covered by the Japanese “Ethical Guidelines forgenetic related research, transplantation, regener-

Clinical Research” or the World Medical Associa-

ative medicine, and cell therapy.

tion (WMA)ʼs “Declaration of Helsinki”, including

2．Background of the revision of
Korean Bioethics and Safety
Act (Table 1) 6 〜 52）

research to use individual-identifiable human material as well. The Act also covers human materialbanking and any research not limited to medical
areas if the research has interventions to or inter-

2.1 Initial legislation of the Bioethics andactions with humans. The categories of research

Safety Act and its revision

covered by the Act and minimal-risk research forwhich an ethics review can be expedited are to be

The initial legislation of the Bioethics and Safety

defined in the draft proposals of the Enforcement

Act was realized in January 2005, after the first

Decree 2）and Enforcement Rule 3）which have called

proposal of outlines in 2001. Both the citizens

for public comments.

groups and bioethicists concerning rapid develop-

In South Korea, a comprehensive research gov-

ment of life science and the industries and govern-

ernance framework under the Bioethics and Safety

ment bodies seeking rapid development of science

Act and GCP Ordinance under the Pharmaceuticaland technology proposed with congress members

Affairs Law is to be established and ethics commit-

each draft bill, and after all the surveys and sev-

tees are going to be accredited, inspected, edu-

eral committeesʼ discussions, the Act was estab-cated, and evaluated by the regulatory authority,

lished 4, 5）. Touched off by the birth of cloned sheep

more intensively than previously. In such a regula-

Dolly in 1996 17）, international society required

tory environment, the leading research hospitals

legal control to prohibit human cloning 19, 30）.

have been dispatching experts in research ethics,

Responding to such a trend, the scope of the initial−2−

Clin Eval 40（1）2012

Table 1

Historical background of human research governance framework development
in South Korea comparing world and Japanese trend
World trendSouth Korea

Japan

1946 Nuremberg Code 6）
1962 US Kefauver-Harris Amendment Act to regulate drug clinical trial
1964 WMA Declaration of Helsinki 7）
1966 UN International Covenant on Civil andPolitical Rights 8）1974 US National Research Act
1982 CIOMS Guidelines for Biomedical Research
1988 French Act for Biomedical Research 9, 10）1987 First IRB at Catholic Medical School

1990 EC-GCP 11）1991 US Regulations for Protection of Human
Subjects became Common Rule through the
Departments 12）1991 CIOMS Guidelines for EpidemiologicalResearch 13）
1993 CIOMS Guidelines for Biomedical Research(Ver. 2) 14）
1994 French Act on Bioethics 9）1995 WHO-GCP 15）1995 GCP guidelines
1996 ICH-GCP 16）
17）1996 Publication of cloned sheep Dolly
1997 Council of Europe Convention on Human
Rights and Biomedicine 18）
1997 G8 Agreement on prohibiting human cloning 19）
1997 UNESCO Declaration on Human Genome 20）
1998 Netherlands Act on Medical Research
1998 Accreditation system of drug clinical trial
involving Human Subjects 21）
institutes started (since 2006 for device
1998 ICH-E5 (Ethnic Factors) 22）
clinical trial) 23）

2001 EU Clinical Trial Directive 25）

2002 CIOMS Guidelines for biomedical research(Ver. 3) 26）
2003 Sweden Human Research Ethics Review
Act 27）
2003 UNESCO Declaration on Human Genetic
Information 28）
2004 EU Human Cells and Tissue Directive 29）2005 UN Convention Against Reproductive Human
Cloning 30）
2005 UNESCO Declaration on Bioethics andHuman Rights 31）

2008 WMA Declaration of Helsinki (Ver. 7, atGeneral Assembly at Seoul)2000 Korean GCP revised for being harmonizedwith ICH-GCP 32）
2001 Outlines of initial Bioethics and Safety Act
was proposed; Bridging concept (ICH-E5)
was introduced
2002 Separate of IND from NDA; Establishmentof Korean Association of IRB (KAIRB) 33）
2003 Publication of the KAIRBʼs survey on IRBs
in Korea 34）
2004 Start of Regional Clinical Trial Center 35）(Until 2012, 20 Centers including 15 Core
Center have been designated) 36） by the
Ministry of Health2005 Establishment of Bioethics and Safety Act;
Scandal of fabricated report of human-cloned
embryo derived stem cell lines
2006 Accreditation by KFDA of medical device
clinical trial institutes started 37）; Leading
hospitals are starting to get accreditation of
WHO and/or US-AAHRPP 36）
2007 KFDA started New Inspection Program 38） on
clinical trial institutes and project of
KoNECT 35）; Ministry of Health started
training program to dispatch ethics review
experts to US IRB, OHRP, AHRPP, NIH(to stay 2, 3 〜 6 months)
2007-8 GCP was revised to enable joint IRBs 39）
2010 KAIRB began to evaluate IRB initiated by
Ministry of Health2011 OECD Report on non-commercial clinical
trials 50）
2012 Announcement of total revision of Bioethics
and Safety Act 1） (to be enforced from 2013)−3−

1982 First ethics committee at the Tokushima
University for in vitro fertilization
1989 GCP guidelines (Notification)

1997 GCP Ordinance, compatible with ICHGCP 24）

2000 Act on Human Cloning 40）
2001 Guidelines for Specified Embryo 41）;
Embryonic Stem Cell Derivations andUtilization 42）; Genetic Analysis Research 43）
2002 Guidelines for Gene Therapy Research 44）;
Epidemiological Research 45）
2003 Revision of GCP Ordinance to enable
doctor-initiated clinical trial; Guidelines forClinical Research 46）

2006 Guidelines for Human Stem Cell ClinicalResearch 47）
2007 10 Clinical trial core hospitals; 30 (later
decreased to 20) clinical trial bases
institutes; and 7 Translational ResearchCenters are selected and funded by thegovernment. (There are also several otherinfrastructure development projects.)
2008 GCP was revised to enable joint IRB; IRB
registration started
2009 Guidelines for ES cell were separated for“Derivation and Distribution” 48） and for“Utilization” 49）2010 Guidelines for Creation of Reproductive
Cells from iPS Cells 51）
2010 Guidelines for reproductive medicine creatingembryo 52）
2011 5 Early phase clinical trial centers were
designated2012 5 Clinical research core centers, 2 Japanoriented global clinical research centers were
designated臨床評価40 巻 1 号

2012

Act focused mainly on prohibition of human cloning

sus development.

and expanded its scope covering assisted reproduc-

2.2 GCP and clinical trial infrastructuretion technology and regenerative medicine. Also

development

responding to the completion of the human genome
project at the beginning of this millennium and

Besides the Bioethics and Safety Act, in the areainternational declarations to prohibit discrimina-of drug clinical trials, responding to the trend thattion based on genetic information 20, 28）, the Act cov-

EC (European Community)-GCP 11） in 1990 andered genetic tests, gene therapy, and gene banking,WHO (World Health Organization)-GCP 15）in 1995

as well. The Act established the system of regis-

had been issued, Korean Food and Drug Adminis-

tration of institutes to conduct these kinds of med-

tration (KFDA) under the Ministry of Health issued

ical technologies on human; and also established the

GCP guidelines in 1995, which later was revised in

National and Institutional Bioethics Committees;2000 32） to be compliant with 1996 ICH-GCP 16）,and defined the requirements of informed consent

and then became an Ordinance in 2011. In Southand other ethics and safety assurance measures, allKorea, domestic clinical trials had not been requiredin this single Act. In May 2005, establishment offor marketing approval of drugs already approved

human cloned embryo (SCNT (somatic cell nuclear

in foreign countries but ICH-E5 guidelines fortransfer) embryo)-derived stem cells was reported

bridging studies 22） were implemented in 2001, andby Hwang Woo-Suk, who used to be a professor atsince 2002 IND (Investigational New Drug applica-

the Seoul National University, which was investi-tion) and NDA (New Drug Application) came to begated and concluded in January 2006 by the Univer-

separate. Since then, a comprehensive legal frame-sity to be fabricated results. This scandal also

work of drug clinical trial, not limited to the ones

facilitated further strengthening of research gov-

aiming at NDA, has been established composed ofernance in South Korea.

the Pharmaceutical Affairs Law; the laws enforc-

The revision of the Act was discussed by theing it; and guidelines for GCP, IND, and forcommittee under the Ministry of Health, Welfare

accreditation of clinical trial institutes.

and Family (hereafter called “Ministry of Health”).

In 2002, the Korean Association of Institutional

There have been deservedly objections from the

Review Boards (KAIRB) was established in coop-view of academic freedom to such wide ranging

eration with researchers, industries, and regula-comprehensive regulations. However, the above

tory authorities 33）, which later in 2007 became

mentioned scandal promoted opinions that it isfunded by the Ministry of Health. KAIRB con-irrational to protect the embryo but not to protect

ducted a questionnaire survey on IRBs throughout

human subjects generally. People also have recog-

the country and its results were reported in 2003 34）.

nized that international norms such as the Declara-

Among the 74 IRBs, 63 responded to the survey

tion of Helsinki

7）(response rate: 85.1%), among which 72% review

and European Convention on
18）

require legal pro-

only 1 protocol per month, covering only clinicaltection of human dignity and human rights, which

trials under GCP, which was regarded not to reachleads to a consensus for revision of the Act.

the internationally required level. The report con-Additionally, the following activities toward assur-

cluded that it was necessary to facilitate IRBsʼ

ance of ethical and sound scientific clinical trials

association, development of an educational pro-

under GCP regulations have contributed to consen-

gram, and introduction of an audit system.

Human rights and Biomedicine−4−Clin Eval 40（1）2012

2.3 Capacity development of conduct andfunded by the Ministry of Health, with its mission

review of research

to develop an infrastructure of clinical trials
nationwide 35）.

Since then, in both research governance frameworks based on the Bioethics and Safety Act andSince around 2006, leading research hospitals

based on GCP under the Pharmaceutical Affairs

started to receive recognition/accreditation by

Law, a system of accreditation and inspection of

WHO FERCAP (Forum for Ethical Review Com-

research institutes and research review committees

mittees in the Asian and Western Pacific Region)and education programs have been developed.

and US AAHRPP (Association for the Accreditation

In 2004 the Ministry of Health set up regionalof Human Research Protection Programs) (Table, which2) 36）. AAHRPPʼs accreditation requires not only aexpanded in 2012 to designate 20 centers including

standard research review system but also a com-

clinical trial centers designating 2 centers

35）

36）

. In 2006, KFDAʼs accreditationprehensive high standard and efficient humanon clinical trial institutes which started in 1998

research protection program. In 2007, The Ministry

15 core centers

expanded its scope to medical devices

37）. In 2007of Health started a program to fund experts of eth-

KFDA started a new inspection program of clinical

ics review to study in the US and stay 2 or 3 to 6

trials 38）. In Japan, inspection is conducted only

months at Western IRB (private IRB); OHRP

after NDA, but in South Korea inspection is con-

(Office of Human Research Protection) of theducted both during and after conduct of a clinical

Ministry of Health and Welfare; AAHRPP; andtrial. Also in 2007 KoNECT (Korea National Enter-

National Institute of Health (NIH). Additionally inprise for Clinical Trials) was established being

2012, KFDA issued a guideline that they may

Table 2

Trend of acquiring authorization of US-AAHRPP and WHO-FERCAP/SIDCER in South Korea ＊ 1
WHO-FERCAP/SIDCER＊2 recognized

AAHRPP accredited
2006 Samsung Medical Center (Seoul)

2006, 2009 Seoul National University Hospital (SNUH) IRB (Seoul)
2006, 2009 Asan Medical Center IRB (Seoul)2007 Kangnam St. Maryʼs Hospital IRB (Seoul)
2007, 2010 Chonnam National University Hospital IRB (Gwangju)
Inje University Busan Pail Hospital IRB (Busan)
2008 Kyung Hee University Hospital IRB (Seoul)
2008, 2011 Halym University Sacred Heart Hospital IRB(Gyeonggi-do); Daegu Catholic University Medical Center
IRB (Daegu); Ajou University Hospital IRB (Gyeonggi-do)
2009 Inha University Hospital IRB (Incheon); Kangbuk Samsung
Hospital IRB (Seoul); Chungnam National University Hospital
IRB (Daejeon); International Vaccine Institute IRB (Seoul)2010 Severance Hospital (Seoul); Yonsei University College ofMedicine (Seoul); The Catholic University of Korea Catholic
Medical Center (Seoul)(Under application)2012 SNUH; Bundang SNUH; Borame SNUH (Seoul)2010 Keimyung University Dongsan Hospital IRB (Daegu); Kyungpook
National University Hospital IRB (Daegu); Yeungnam University
Medical Center IRB (Daegu); Kangdong Sacred Heart Hospital
IRB (Seoul); National Cancer Center Hospital IRB (Seoul);
CHA Bundang Medical Center IRB, CHA University(Gyeonggi-do); Busan Dong-A University Hospital IRB (Busan);Anam Hospital IRB, Korea University Medical Center (Seoul)
2011 Soon Chun Hyang University Bucheon Hospital IRB(Gyeonggi-do); Korea University Guro Hospital IRB (Seoul);
Gachon University Gil Hospital IRB (Incheon)＊ 1：Revised from the material provided by Prof. Goo Shin 36), according to the web-sites of AAHRPP and FERCAP.
＊ 2：SIDCER：Strategic Initiative for Developing Capacity in Ethical Review

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abbreviate inspection of a clinical trial site if the

2.5 Human Research Protection Program

institute has its own quality assurance system. Welland “primary reviewer” systemdesigned and managed Human Research Protection(In the case of the Seoul National

Programs may be relevant to the conditions of this

University Hospital)

standard.

Some leading hospitals in South Korea use

Through these processes, leading research hos-research review systems to review dozens of newpitals have voluntarily developed their own systemprotocols at one time during a committee meeting,to cover not only clinical trials under GCP and

which is similar to the “primary reviewer” systemembryonic, genetic research under the Bioethics

in the US. Such a system can be developed based

and Safety Act but also research involving humanon an enhanced institutional framework of researchsubjects to be reviewed by their IRBs or ethics

subject protection. In the case of Seoul National

committees.

University Hospital (SNUH), Center for Human
Research Protection (CHRP) manages the Human

2.4 Common review system

Research Protection Program (HRPP), and it is

Not only expanding the regulatory framework,

applying for AAHRPP accreditation. The CHRP

but also streamlining procedures based on capacity

has not only an IRB office but also separate teams

development has been facilitated.

each engaged in quality assurance; education; regu-

GCP regulations were revised in 2007 to 2008

latory affairs (policy and SOP (standard operating

to enable “joint IRBs” 39）and in 2010 the pilot proj-

procedure) development); and being research sub-ect of the Ministry of Health to establish a public

ject advocates. The author had an opportunity tocommon IRB. At this moment, this public common

observe an IRB meeting on August 2, 2012.

IRB can review only phase 4 clinical trials of

In SNUH, each of the 4 IRBs has a meeting once

already approved drugs. Also in the revised

a month so a total of 4 IRB meetings are held every

Bioethics and Safety Act, the “Common Institutional

month, and more than 10 to around 30 new proto-

Bioethics Committee” was defined and detailed

cols are reviewed in each meeting. In 2011 a total

procedures are described in the draft proposal ofof 1,501 new protocols (275 industrial sponsored

Enforcement Decree and Enforcement Rules of theresearch projects and 1,226 academic ones) wereAct.

reviewed in full committee and 12,187 expedited

The number of multi-national clinical trials in

reviews were conducted. When a new protocol isSouth Korea is around the largest among the Asiansubmitted to the IRB, it is assigned to MRCC, a

36）. For such multi-national trials, theprimary reviewer, a layperson and expert secretary

number of domestic subjects required for estab-at the same time. MRCC (Medical Researchlishment of evidence is not so large compared toCollaboration Center) is composed of about 30 bio-the case of single-national domestic trials. Further-statisticians and nurses who review scientificmore, Korean leading hospitals have 1,500 to 3,000

aspects such as design and statistical power of thebeds. Therefore, the necessity of a common IRB isprotocol; each protocol is assigned for review to a

not so urgent compared to Japan. However, expan-

team composed of 1 biostatistician and 1 nurse insion of a joint review system in South Korea is

MRCC. The primary reviewer is usually one clini-

expected in the near future, reflecting the revision

cal M.D. scientist for one protocol, whose expertiseof the Act.

is suitable to review the protocol, and the layper-

countries−6−

Clin Eval 40（1）2012

son member ‒ lawyers, clergymen, or social work-

for approval; conditional approval; or disapproval.

ers ‒ review the informed consent form. The expert

For many of the protocols 10 to 30% of the mem-secretary is an experienced IRB member, who col-bers show their opinions opposite to the majority

lects and synthesizes the review results and leads

and some of the protocols are disapproved.

the presentation of the review of the protocol at

3．Outlines of revision of the Act

the board meeting.
At the full meeting, summaries and primary
reviewersʼ opinions of all the protocols are distrib-

Table 3 shows the main points of the revision of

uted in printed material, and each protocol is dis-the Act compared with the related points ofcussed in 5 to 10 minutes efficiently focusing on

Japanese research regulations. Fig. 1 shows the

ethically and scientifically critical points. Then allorganization of research governance bodies after

the members vote each protocol raising a hand.

the revision of the Act.

In many of Japanese IRBs, SOPs define that theSouth Koreaʼs Bioethics and Safety Act has

protocol should be approved by a majority vote ofclear objectives to protect human dignity, to pre-more than 1/2 or 2/3 members, and in reality

vent harm to human, to assure bioethics and safety

approval seems to be unanimous but many of theand to improve peopleʼs health and quality of life.

members do not show their real opinions. Such

It expanded its scope from advanced technology andscenes cannot be seen in SNUH-IRB and all mem-

research utilizing human embryo and gene, tobers indicate their opinions by raising their hands

research involving human subjects with interven-

Table 3

Points of the revision of South Koreaʼs Bioethics and Safety Act
and related Japanese research regulations

Korean Bioethics and Safety Act
After the 2012 revision 1）
Before the 2012 revision (Source: the versionof 2008 revision 53）)
【Objective】- Protect human dignity, prevent harm to human.
- Assure bioethics and safety, improve peopleʼs health and quality of life.

【Definitions (related to scope of the Act)】- “life science and biotechnology” refers toscience and technology using human embryo,cells, and genes.

- “research involving human subjects” refers
research with intervention in or interaction
with human; to use individual-identifiable data.

- “embryo”, “spare embryo”, “SCNT”, “SCNT embryo”- “spare oocyte”, “monogenetic reproduction” areadded.
- “stem cell lines”- Changed to “embryonic stem cell lines”.
- “genetic information”, “genetic test”, “gene therapy”- “human derived material”, “individualidentifiable information”, “individual information” are added.

- “gene bank”- Expanded to “human derived material bank”.

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Related Japanese research regulations- The wording such as human dignity, humanrights, development of medicine and improvement of quality life are included in each of theseparate regulations, not perfectly and thelegal bases are not sufficient.
- Guidelines for “Clinical Research” 46） and“Epidemiological Research” 45） limit the scopeof these terms to research in medical area. In
addition, there are specific guidelines forembryonic 48, 49, 52）, genetic 43, 44）, stem
cell 47〜49, 51） research, but there is no governmental guideline for social behavioral research.
- The terms related to embryonic research aredefined in the Act on Cloning 40）; Guidelines forSpecified Embryo 41）; Embryonic Stem
Cell 48, 49） Research. There is no specificconsideration for monogenetic reproduction.
- There are guidelines for Genetic Analysis(limited to germline mutation or polymorphism
related) 43） and for Gene Therapy 44） but for
Genetic Test, there are only industry/
academia-initiated guidelines but no governmental guidelines.
- Human-derived material and individual-identifiable information are defined in each of theseparate guidelines. Because the Act ofProtecting Individual Information excludes
academic research, each guideline includes textof this Act in it.
- There are no specific guidelines for humanderived material bank.

臨床評価40 巻 1 号

2012

Korean Bioethics and Safety Act
Before the 2012 revision (Source: the versionof 2008 revision 53）)
【Responsible Authority】- The Authority responsible for registration,authorization, licensing is the Ministry of
Health, Welfare, and Family (The Ministry of
Health).

Related Japanese research regulations
After the 2012 revision 1）- In the revised Act, the Authority responsible
for registration, authorization, licensing is the
Director of Division of Health and Welfare
under the Ministry of Health.
【Bioethics Policy Research Center】- Designated by the Authority, its mission ispolicy study and education on bioethics.

【National Bioethics Discussion Committee】- Designated by the President, discuss about national bioethics policy and the following issues:- Issues concerning spare embryo, SCNT,- Issues concerning spare embryo, embryonic
genetic test, gene therapy.
stem cell line, genetic test.
- Work of Common Institutional Bioethics
committee; Exemptions of review of humanresearch, human material research; Retention
and disclosure of information.
- Other important issues.

【Institutional Bioethics Committee】- Should be established at the institutes whereembryonic or genetic technologies defined bythis Act are conducted as research or medical
practice.
- Should be registered to the Authority.
- Each institute has responsibility to provide
education to the committee.
- Review research and practice utilizing humanembryonic, genetic technologies defined by thisAct.

- Should be established at the institutes where
research involving human subjects; embryonicor genetic technologies; or human materialbanking, that defined by this Act, areconducted as research or medical practice.
- Should be registered to the Authority.
- The Authority has responsibility of education,
evaluation, inspection of the committee.
- Additionally to the left, review any research
involving human subjects and human materialbanking defined by this Act (not including
GCP-regulated clinical trials).
【Common Institutional Bioethics Committee】- Each institute can submit a review to the
Common Committee based on agreement.
- Researchers who do not belong to research
institute/hospital can submit to a Common
Committee.
- Single committee can be selected as a Common
Committee in case of multi-central research.

【Human subjects protection】- Human subject protection rules are defined
only for subjects of the technologies under thisAct (i.e., embryonic, genetic technologies).

- Following rules of human subject protection
come to be applied for all the research andpractice defined by the Act: Protocol review;
Informed consent; Proxy consent; Safetymeasures; Compensation for loss; Individual
information protection; Retention anddisclosure of information.
【Human embryonic and assisted reproductive technologies】- Prohibition of human reproductive cloning and reproduction of human-animal hybrid individual.
- Restriction of artificial fertilization for gender selection; or using reproductive cells of non-living
human; or of under-aged except the cases of after marriage.

- Designation of embryo producing institute by the Authority; Registration of spare embryo
research institute to the Authority; Authorization of spare embryo research by the Authority;
Registration of embryonic stem cell line to the Authority. Same rules are applied to SCNT
embryo.
- Comprehensive regulations of assisted reproductive medicine and medical research utilizing
reproductive cells.
【Gene bank】【Human material bank and research】- Should be licensed by the Authority and- Human material bank should be licensed by the
conduct of research and management of human
Authority and conduct of research and handlinggene material is regulated.
of human material is regulated.
【Genetic test, genetic research, gene therapy】- Prohibition of discrimination based on genetic information and forcing others to take genetic test.
- Restriction of genetic test on reproductive cells or fetus.
- Restriction of gene therapy allowing only in defined serious cases.
- Report/registration of genetic test and gene therapy institute.
【Penalty】- Criminal and administrative penalties are defined for each specified violation.

−8−- 1 to 3 among the Ministries of Education,
Health, or Economics issue the guidelines andthe Ministry which issued guidelines is the
responsible authority of the topics covered in
the guidelines.
- There is no governmental establishment ofinstitute specialized in bioethics policy
research or education.
- Bioethics Specialized Survey Committee isdesignated by, as one of sub-committees, theGeneral Science and Technology Committee(designated by the Prime Minister). This
Committee has been discussing intensively
about human cloning, specified embryo, andembryonic stem cell research, but for othercategories of research or ethical issues,
discussion is limited and fragmentary. For
other guidelines, separate ad hoc committees
are created and they discuss about revision ofeach of the guidelines.
- There are systems of registration of researchreview committees under regulations of
GCP 24）, Clinical Research 46）, Genetic
Analysis 43） Research.
- Responsibility of education is committed toeach institute. Evaluation and inspection by the
Authorities have not actually been conducted
for review committees.
- Issues to be reviewed are defined in eachguidelines.

- Guidelines for Genetic Analysis 43） and for
Epidemiological research 45） define that in casean institute does not have a review committee
it can submit a review to an outside committee.
- GCP Ordinance 24） and Guidelines for ClinicalResearch 46） define that even in case an
institute has its own committee it can submit areview to an outside committee.
- Other guidelines do not allow outsidecommittee review.
- These provisions for protecting subjects areincluded in each guideline.
- Only for GCP 24） -covered clinical trials andfor the “Interventional Clinical Research”
using drug or device under Guidelines forClinical Research 46） are obligated to provide
compensation for research-related injury.
- Prohibition of human cloning and human-animal
hybrid being are defined in the Act on
Cloning 40） and Guidelines for Specified
Embryo 41）.
- There is no regulations for fertilization forgender selection, for using reproductive cellsof non-living human or of under-aged.
- For Specified Embryo 41）; ES cell 48, 49）;
reproductive cell creation from iPS cell 51）;
reproductive medicine creating embryo 52）,
there are registration systems of individual
plans submitted to the Authority. There is no
registration system of institute.
- There is no specific guideline for “humanderived material bank”.
- In each guideline there are some provisions
concerning depository and disposal of
human-derived material.
- There is no governmental guideline for genetic
test. There is no legal provision to prohibit
discrimination based on genetic information.
- Gene Therapy guideline 44） defines registrationof each protocol to the Ministry.
- Provisions of penalties are defined only in the
Act on Cloning 40）. Other guidelines do not haveprovisions of penalties but other administrative
documents define that in case of serious
violation public funding should be withdrawn.

Clin Eval 40（1）2012

Fig. 1

Organization of research governance designed by the revisedSouth Koreaʼs Bioethics and Safety Act
President

Establishment
Commission

National Bioethics Discussion Committee
Specialized Subcommittee

Ministry of Health, Welfare, and Family
Director of Division of Health and Welfare

Oversight, Support
Accreditation Inspection,
Education, Evaluation

Designation

Designation

Designation
Permission

Bioethics Policy Research Center

Registration

Registration
Common Institutional
Bioethics Committee

Institutional Bioethics
Committee- Commitment of review
based on agreement- Single committee review
for multi-central research

Establishment- Institute to create embryo (Designation)- Institute to research spare embryo, cloned embryo(Registration of institute, Authorization of research
protocol)- Establishment, importation (Registration), Provision(Report) of ES cell line
- Human material bank (Permission)- Institute of gene therapy, genetic test (Report)

Review

Review

Protocol, Conduct- Research on human and/or human material
Protocol, Conduct- Review protocol submitted by researcher
of institute without committeetion in or interaction with human and human-derived

and iPS cell 51） research; other separate adminis-

material banking activities. In an explanatory docu-

trative guidelines for reproductive medicine involv-

ment, categories of research and activities are

ing creation of embryo 52）; human genome analysis 43）;

described to be not only general human research

gene therapy 44）; epidemiological research 45）; clini-but also human material banking, epidemiologicalcal research 46）; and human stem cell clinicalresearch, questionnaire surveys, social and behav-

research 47）.

ioral research, sports physiological research andAdditionally, what are established in South

educational research.

Korea but not in Japan are: legal rules on genetic

The activities which are controlled in Southtesting; human material banking; human research

Korea by 2 legal frameworks: GCP Ordinanceoutside medical areas; legal authorized organiza-

under

the

tions engaged in bioethics research survey andBioethics and Safety Act are controlled in Japan

policy development; regulatory authorityʼs systemby 3 legal rules and 9 regulations without acts orof registration, accreditation, investigation, evalu-

law to define them: GCP Ordinance under Pharma-ation and education for research institutes andceutical Affairs Law (limited to clinical trials aim-

research review committees; legally explicit rules

Pharmaceuticaling at NDA)

24）

Affairs; Act on Cloning

Law

40）

and

on common/joint review for multi-central research;and Guidelines

for Specified Embryo 41）under this Act; 3 separate
administrative guidelines related to ES celland legally explicit penalty clauses.

48, 49）

−9−

臨床評価

40 巻 1 号

2012
appreciates Prof. Dong Soo Lee, M.D., Chairman, Prof.

4．Conclusion

Keon W. Kang, M.D., Prof. So Won Oh, M.D., and all theother members of the Department of Nuclear Medicine,

The design of the revised Korean Bioethics and

SNUCM and Prof. Jun Soo Kwon, M.D., Chairman,

Safety Act is a kind of combination of the French

Department of Psychiatry, SNUCM, from all whom to

Act on Biomedical Research 9, 10）and French Act onlearn how people in SNUCM conduct high quality ethical,

Bioethics

9, 54）, and the actual Korean system ofsound scientific research.

research governance and research review is similar
to US system. Leading hospitals in South Korea

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臨床評価40 巻 1 号

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Workshop on Medical Devices: Use of clinical evidence

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指針．平成 13 年 9 月 25 日．平成 21 年，「樹立及び分配」の指針と「使用」の指針に分かれた．文献 48），

English version available］

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and, Science and Technology．The Guidelines for指針．平成 21 年 8 月 21 日，平成 22 年 5 月 20 日改正．

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www.lifescience.mext.go.jp/files/pdf/n796̲00.pdf］

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する指針．平成14（2002）年3月27日，平成20（2008）

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lifescience.mext.go.jp/files/pdf/6̲7.pdf［Guidelines

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international cooperation in non-commercial clinical45）文部科学省，厚生労働省．疫学研究に関する倫理指

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Available from：http://www.lifescience.mext.go.jp/の生殖細胞の作成を行う研究に関する指針．平成 22

files/pdf/37̲139.pdf［Ministry of Education, Cul-

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sion available］

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臨床評価40 巻 1 号

2012

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English translation version 3.0．Bioethics Policy

extent utilization of human body is acceptable?］．

Research Center，Institute for Biomedical Law &Tokyo：Kodansha Gendai Shinsho；2001．Japanese．

Ethics，Ewha Womans University．Seoul；2009．

＊＊− 14 −＊