Policy and Attitudes towards Collection of Personal DNA in genetic databases in Japan

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Eiko Suda*/Darryl Macer**

Policy and Attitudes towards Collection of Personal DNA in
genetic databases in Japan
Abstract
This paper presents the results of a public opinion
research conducted in Japan on the willingness of
persons to contribute their DNA to a genetic database, and the reasons behind their choices. The
results are discussed in light of the Act Concerning
Protection of Personal Information issued in 2003,
and with reference to genetic database projects thathave been conducted in Japan. There appears to be
increasing concerns about privacy in Japan, despitea high level of support for science and technology.
While 44% said they would agree to blood donation
for a DNA bank, 28% were negative to donate, andanother 28% answered they ”don’t know”. The reasons behind these choices and the concepts of storage of genetic databases are partially reflected in
the guidelines applied to collection of genetic databases, but greater and more independent community engagement will be important to increase public involvement in large scale genetics projects inJapan.

Genetic Databases
The Human Genome Project, the completion ofwhich was declared in April 2003, was the international collaborative project to sequence the wholehuman genome of three billion base pairs. It wasstarted in 1990 and took more than ten years toaccomplish. Now in the “post-genome age”, genetic
projects are being conducted in a number of countries to explore human genetic variation. Theselarge scale genetic research projects generally collect and analyze human genetic information
together with health information, lifestyle information, and family information. In the case ofJapan or the UK biobank this is from several hundred thousand people. This type of research also
will continue for long time, not only retrospectively but also prospectively, because it is important togather such kind of medical science research to substantiate the output from it by following donors fora sufficiently long time. To establish the tools toenable multidimensional investigation across thehuge pool of genome information the research on
SNPs (single nucleotide polymorphisms) and haplotype markers has been actively conducted. In someof those research projects, analyzed data, collected
JIBL Vol 04 I 2007. 10.1515 / JIBL.2007.009

samples including DNA, cell lines, blood and tissues are stored and maintained in databases, DNAbanks, tissue banks or cell banks to develop useful
research sources for future medical research.
Concurrently with the progress of humangenome research various issues regarding ethical,
legal and social implications (ELSI) have been pointed out. Various international bodies including
UNESCO (United Nations Educational, Scientificand Cultural Organization), OECD (Organization
for Economic Co-operation and Development) andHUGO (Human Genome Organization), have convened discussions on such issues from international or regional aspects, and many declarations, recommendations, and reports have been published.
Although the ELSI research program itself has been
controversial, it is a fact that it was very significant
to contribute to accumulate numerous products ofinvestigation and analysis, to provide informationand educate the public including ordinary people
and experts in multidisciplinary analysis, to develop human resources in ELSI fields (Clayton, 2003;
Cambon-Thomsen, 2004). The wide type of information being gathered raises numerous privacy
implications (Maekawa and Macer, 1999), and thispaper examines some of these issues in a Japanesecontext. This paper also presents results of researchon people’s attitudes to donating genetic samples inJapan, including analysis of comments given, froma survey of the general public in 2003 (N=377). The
paper reviews some of the laws and genetics
research projects, and relates the concerns people
expressed to the considerations made in community engagement for human genetics research.

*

Eiko Suda, Doctoral Program, Graduate School of Lifeand Environmental Sciences, University of Tsukuba, 11-1 Tennoudai, Tsukuba Science City, Ibaraki, 305-8572,
Japan,Email: fwhv4551@mb.infoweb.ne.jp** Darryl Macer, Regional Advisor on Social and Human
Sciences in Asia and the Pacific, Regional Unit forSocial and Human Sciences in Asia and the Pacific(RUSHSAP), UNESCO Bangkok, 920 Sukhumwit Road,
Prakanong, Bangkok Thailand 10110; AffiliatedProfessor, Institute of Advanced Studies, United
Nations University, Yokohama, Japan, Email:d.macer@unescobkk.org

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Public understanding regarding genetic research and ELSI issues

Eiko Suda/Darryl Macer

To analyze the reasons behind their attitudes
towards blood donation for DNA bank, we classified
their comments into 20 categories. Illustrative
comments of the categories are given below. Those
20 categories could be grouped into 5 groups, for”the progress in science and medicine”, ”to help
other people or public society”, ”if there are personal benefits”, ”conditionally” for example anonymous, only for public bank, necessary of personal
notification, and ”negative reasons”. Figure 2
shows the number of comments in each group.

A random anonymous mail response survey was
conducted over Japan in 2003 (Inaba and Macer,2003). The results of the questions on donation ofblood for genetic research and its storage in genetic
databases are presented here. While Japanese people have shown to have certain extent of knowledge
and understand about the genetic research andrelated ELSI issues in previous research, this survey
obtained comments from 377 persons that reveal
More than half of comments from the ”Yes” groupmore of the reasoning that they have. There is a mix
people were supportive for science and medicine.
of different sectors of the Japanese public, educaAlso some particular comments for the ”Yes” grouption, different occupations (not shown), and rural
were categorized into help others, especially among
and urban populations in each sample. We estimate
people who accepted to donate their sample for persample error at +/- 5%. This type of analysis is usemanent or not specified DNA banks. Example comful for policy makers to know what are the real conments are listed below (Y=yes, non-specified;cerns of people, and help them to make policies
t=temporary storage, p=permanent; N=no;based on the facts. This method focuses on descripDK=don’t know).
tive bioethics, that is, how do people think aboutbiotechnology (Macer, 1994).
Scientific research
There were few pessimists about science in genY(t) It’s very significant for the research.
eral. Most people thought science does ”more good”
Y(t) Although I don’t know about such research oror the “same” as harm, and people who thought sciDNA bank very well, if it will contribute forence does more harm has been a low number in past
the research, I want to donate my blood.
decade. The general images of science and technology Japanese people had were positive. However,Medicine
when people were asked specific questions, theirY(t) It is significant for medical service andconcerns were revealed, and respondents differentihealthcare.
ated several applications of biotechnology (Inaba
and Macer, 2004).
The first related question was
regarding their willingness todonate for a genetic database,“Would you be willing to give bloodfrom which DNA would be extracted to be put anonymously into a
DNA bank so that researchers could
study human genetic variation.
This research would not personallyhelp you because the sample isanonymous but would be useful for
medical research in general.” Theanswer could be selected fromthese options: “Yes” in general,“Yes” only for a temporary bank,“Yes” for permanent bank, “No”, or“Don’t know”. 44% said “Yes” toblood donation for a DNA bank. 28%
were negative to donate and another 28% answered they “don’t know”.
One third of the “Yes” group
allowed donating their blood only Figure 1: Japanese public attitudes toward blood donation for genetic
research (N=377)
for temporary storage (Figure 1).

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Policy and Attitudes towards Collection of Personal DNA in genetic databases in Japan

10
Y(t)

Y

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Anonymous important
I don’t think there are any
problems to donate samples
for
the
bank.
However, all samples
must be anonymized.
If the sample is madeanonymous in front ofmyself when I donate it, itis acceptable for me thatmy blood is utilized forthe research.

11
If efficient it is usefulY(p) If it will be used efficiently, donation is acceptable
for me.
Y
If it is useful in futureages, it is acceptable forme to donate.

Figure 2: Reasons given regarding temporary, permanent or non-specified time period for storage of genetic data (N=377)

Helping others
Y(p) If it will be helpful for someone else.

13
Y

If strict conditions
Y(p) If the research group is sufficiently trustworthy, I can agreewith donation because it is meaningful.
N
It is a trust problem. I can’t trust.

DK

Not to companies
Y(p) 7,2 If it will be used effectively, I will donate
because I can understand it is necessary thatthe bank has sufficient number of samples.
But I will donate on the premise of that the
sample will go to the public institutes. I neverdonate my blood to any private companies.
(+Scientific research)
Conditional
Y(t) If there is no possibility to do any harm to me,
it is acceptable for me.
N
I can’t understand the necessity of it.
9Y(t)Insecure feeling if permanent
I can donate my blood if it is just transientbank. I feel insecure about donating to a permanent one.

JIBL Vol 04 I 200712
No problem
Y(p) I don’t care about donation of my blood.

Personal benefit
I’m curious to know what kind of genes aremaking myself.
I’m in my 50s. I can’t take any advantage fromdonation of my blood.

14
Personal experience
Y(p) I’m very keen to make contribution for the
medical research. Actually now I’m donating
my blood for the research. (The opinion from apatient with a genetic disease). (+Medicine).
N
I am often asked to donate my blood because
my blood type is Rh negative, that makes me
more nervous to do so. If it is for my children
or my neighborhood, maybe I can give my
blood for them. (+Painful/burden)
15
Painful/burdenY(p) I am willing to donate my blood if it is not so
painful and I can be paid some money (if possible).
Y
I think it is meaningful to contribute for thecommunity if it is not so burdensome for individuals. (+Helping others)N
I’m fatigued by hard work too much, so I don’t
want to donate my blood. I don’t like evenusual blood donation, either.

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16
N

DK

Need personal notification
This is an emotional issue for me. I don’t likemy genetic information to be utilized without
any notification to me in somewhere I don’t
know.
If I will not be informed what kind of medicalcare the research will be useful for, or if the
progress of the research will not be shown tome, I can’t donate my blood.

17
NN

Bad feeling
I don’t think I want to donate my blood.
Now I can’t help feeling scared (I can’t makesure what kind of fear this is, though.), I probably will not donate my blood.

18
N

Fear of abuse
Although I want to contribute for the research
progress, I can’t trust researchers totally. Even
if it will be made anonymous, I can’t help feeling scared thinking if it is abused, so I can’t
donate. (+Anonymous important)I feel scared what kind of research my blood
will be used for. It is very horrific for me toimagine something like that a cloned humanbeing of me might be born somewhere and be
utilized as research material.
I worry about that it might be abused.

N

N
19
N

Other negative reasons
I don’t want anything that came from me toremain.

20
N

Don’t wantI think the research is not necessary significant.

Eiko Suda/Darryl Macer

the results would be utilized for them, they would
like to know their own genetic information, theywould like to know the results, they would like to
be informed what kind of research their samples
were used, also interests to have certain compensation or direct benefit for donation, and they would
like to receive the benefits from new science or
technology. Among comments categorized into”negative reasons” people expressed just fear ofabuse, a bad feeling to be utilized their own DNA
for unknown research without any notification tothem, distrust to researchers or private companies,
or just donation was a burden.
The second question was about the consideration of anonymity versus the benefit to know individually useful genetic information. The questionwas ”Would you prefer to learn any genetic information that might help you lower your risk ofdeath, although the sample could not then beanonymous? Assuming researchers still protectedyour privacy.” The result of this question was analyzed combined with the first question result(Figure 3). People who answered ”Yes” toward
donation for a DNA bank tended to show a positive
attitude more frequently to know their genetic
information if that is useful for their welfare, even
if the sample later came to be not anonymous.
While people who answered ”No” to donation
showed a more negative tendency to know thegenetic information than the ”Yes” group people
regarding the DNA banking. From the comments
they made for the previous question, it was speculated that they feel bad for their DNA to be utilized
for research because of fear of harm or distrust
towards science or researchers.

Evolution of the regulatory situation in Japan
Some comments were cross-categorised (as indicated above). The comments that were categorized into
”conditionally” could be found in all groups, but
especially in the negative group, this category was
the second most common. Concretely the sufficient
security to protect privacy, sample anonymization,
the examination of the appropriate purpose of theresearch, and the public nature were raised as
essential points to be considered.
Many of the comments mentioned that since
they couldn’t understand about the research itself
or the significance of the research, they couldn’t
decide easily to say, ”Yes”. There were several comments, which mentioned about personal benefit.
The comments referring the blood samples or
genetic information as ”my own”, ”property” or”part of myself”, were recognized. Some concrete
wishes of ordinary people were found for example,

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In Japan the budget for ELSI research program wasallocated in the initial stage of Human Genome
Project, but after that less than 1% of the budget
has been spent on ELSI purposes (Macer, 1992).
Following the global trend, eventually guidelines
for genome research that are relatively strict byinternational standards have been developed in2001 in Japan, ”Ethical Guidelines for Analytical
Research on the Human Genome/Genes” (Ministryof Education, Culture, Sports, Science andTechnology, 2001). However, compared with
European countries or the United States or Canada,
it is difficult to say the accumulation of basic
research products and analyzed data to clarify theJapanese situation has been sufficiently developedin Japan. There are not so many products of ELSI
research, including research papers, official papers
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Policy and Attitudes towards Collection of Personal DNA in genetic databases in Japan

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and storage to respect humandignity, and to protect freedom
and human rights.
Also from other internationalorganizations several declarations, statements and guidelines regarding human genome,
genetic research and its applications have been published. For
example HUGO published the”Statement on the Principled
Conduct of Genetic Research” in
1996, WHO made a draft”Proposal
International
Guidelines on Ethical Issues in
Medical Genetics and Genetic
Services” in 1998, and CIOMS
published ”International Ethical
Guidelines
for
Biomedical
Research Involving Human
Figure 3: Japanese public attitudes toward anonymity in genetic research Subjects” in 2002. Although
for temporary, permanent or non-specified time periods of storage of none of them has any legal bindtheir genetic data (N=377)
ing force, they have affected thedevelopment process of international or regional regulations in the world as global
and reports, or analyzed survey data that should bestandards.
the most basic intellectual foundation for bioethics
In Japan to accompany the Millennium Projectin the policymaking process, the development offor genetic research (2000-2004) fundamental ethihuman resources, or public education, for example.
cal guidelines were established regarding the
The impetus for the 2001 guidelines came fromhuman genome, genetic research and its clinical
UNESCO declarations. Following the global recogniuses following the global standards. In 2001,
tion of the significance to apply genome research
Ministry of Education, Culture, Sports, Science andfindings for the treatment or diagnosis of diseases
Technology (MEXT), Ministry of Health, Labour andand the necessity to consider about the human digWelfare (MHLW), and Ministry of Economy, Tradenity and human rights, the ”Universal Declaration
and Industry (METI) notified under the joint signaon the Human Genome and Human Rights” wastures of three ministries ”Ethical Guidelines for
adopted in 1997. It prescribes the general principles
Analytical
Research
on
the
Human
on the management of human genome in genetic
Genome/Genes”. It prescribes the concrete proceresearch and its applications. Corresponding to thedure for genetic research including the informed
progress of the Human Genome Project, in light ofconsent process, institutional review board (IRB)
projects on applied genome research and of theinvestigation on the research protocols, anonymizaquality and quantity of information collected fromtion, sample management, and privacy protection
the research subjects, UNESCO International
purposing to protect human dignity and human
Bioethics Committee (IBC) also developed a draft
rights.
document, that the UNESCO Genral Conference
Following that related guidelines on recent
adopted as the ”International Declaration on
expanded genetic research to explore genetic inforHuman Genetic Data” in 2003.
mation analyzing together with other information
This declaration describes how human genetic
including health, environmental, or family infordata should be considered with certain attention
mation have been developed in the same period. In
because of its possibility to identify people’s genet2002, MEXT and MHLW delivered communally
ic predisposition of certain diseases or affect not”Ethical Guidelines for Epidemiological Studies”.
only that person but also blood relations or the comMEXT and MHLW also published ”Guidelines formunity to which they belong. Also it suggests conClinical Studies of Gene Therapy” in 2002. Alsocrete procedures to manage genetic samples and
MHLW published ”Ethical Guidelines for Clinicaldata regarding collection, treatment, utilization
Studies” in 2003.
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Importantly in Japan the legal framework to protect human privacy has been established and thelegislation to protect personal information was
enforced from April 2005 as the Act Concerning
Protection of Personal Information. Although academic research activities are exempted from thislaw’s application, to make such activities consistent with the new legal framework, the above-mentioned guidelines were reexamined in 2004 and also
revised to adjust to the current situation. Medical
research use of personal genetic and other information has been discussed in this process.
The Act Concerning Protection of Personal
Information was issued on 30 May, 2003, with total
enforcement on 1 April, 2005. The Act is composedof a set of three laws: (1) the 2003 Law No. 57 applies
to all enterprises collecting, storing, or handling
data of more than 5,000 persons, except national
and local administrative bodies and independentadministrative corporations (IAC) including national universities, national hospitals, and attached-tonational-university hospitals; (2) the 2003 Law No.
58 applies to administrative bodies; and (3) the 2003
Law No. 59 applies to the IAC ([Act concerning
Protection of Personal Information (Japan Law No.
57, issued on 30 May 2003)].
Enterprises collecting/storing/handling data offewer than 5,000 persons or individuals using personal data not for business purposes are exempt
from the Act. The main purpose of the Act is to state
the basic concepts and basic policies regarding theproper handling and protection of personal information, the protection of the rights and interests ofindividuals, the governmental duties in relation
therewith, and at the same time the appropriate
utilization of personal information. Its essential
framework is based on the recommendation andthe eight principles governing the Protection ofPrivacy and Transborder Flows of Personal Data in
1980 by the Council of the Organisation for
Economic Co-operation and Development (OECD),
which aimed to harmonize privacy protection andprevention of economic interruptions in international flows of data. Therefore, the enterprises concerned are basically obliged: (1) to specify the purposes of personal data utilization, (2) not to use thatdata beyond these specified purposes withoutobtaining the consent of the data subject, (3) not totransfer that data without her consent, (4) not tocollect personal data in a wrong or fraudulent way,(5) to keep that data accurate and up-to-date, (6) totake necessary measures for safeguarding thatdata, (7) to monitor their data handling personnel
and consignees, (8) to secure confidentiality of thatdata, (9) to open the purposes of that data utiliza-

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Eiko Suda/Darryl Macertion to the data subject or to the public, (10) to makethe names of the enterprises and the purposes ofthat data utilization readily available, (11) to disclose or correct the data relating to the data subject
at her request, (12) to suspend the utilization of thatdata at her request because of the misconduct
regarding (2) or (3), and (13) to deal with complaints
regarding personal data which they have.

Human genetic variation research projects in
Japan
In Japan large-scale genetic epidemiology projects
were enthusiastically started from the end of 1990s.
Especially national projects, they were aiming not
only research achievements, but also building
infrastructures including technological development, facility enhancement, and researchresources establishment to empower Japanese life
science field in the genomic era. Also it was expected to build up collaborative structures for humangenome research or epidemiological research inJapan to coordinate industry, government and academia including universities, hospitals, institutes,
and related industries.
One of the main early national initiative projects
was the Millennium Project (2000-2004), life science and technology was one of the three main
focus fields of this project. As part of the project,human genome research programs including functional analysis of human genome, SNP (single
nucleotide polymorphisms) analysis, genetic studies focusing on the main five lifestyle-related diseases or drug response, and building databases ofthe products were funded. This project also included consideration for ELSI issues including building
the framework to ensure security for individual
information and privacy, and public understanding
on such research and its applications. Concretely itestablished rules and guidelines simultaneously inthe project.
Focusing on pharmacogenetics, pharmacogenomics and personalized medicine based on
genome research products, 43 Japanese pharmaceutical industries conducted the Pharma-SNP
Consortium (PSC) project (2000-2003). They collected blood samples from 1000 healthy Japanese,established cell lines, and analyzed DNA extracted
from them. Health, environmental and family
information was collected from donors also. They
studied on genes related to drug metabolism ortransportation to explore genetic variations that
affect on drug response of Japanese. The analyzed
data and cell lines have been made public after
making them anonymized. They also aimed to
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Policy and Attitudes towards Collection of Personal DNA in genetic databases in Japanestablish the model including informed consent
process, management of data and samples, andanonymizing methodology to conduct such kind ofresearch involving human subjects following both
Japanese and global regulatory standards. Throughthe Millennium Project and PSC project, standard
model for informed consent process, anonymization, privacy protection, and samples management
have been developed and educated to regarding people.
Now in post Millennium Project age, based on
the scientific achievements and progressed infrastructures, various genetic research programs arebeing more enthusiastically and extensively conducted both in academic and industrial areas. The
globalization and international competition of theresearch in this field is being advanced also. The
BioBank Japan Project was initiated as MEXT funded five years project (almost 200 million dollars)from June 2003. In the project DNA and serum samples from 300,000 patients of 46 different multifactor diseases, various factors including genetic andenvironmental backgrounds are involved in theestablishment of them, are aimed to be collected
and stored in the biobank to develop the significant
research infrastructure (http://www.src.riken.
go.jp/eng/src/project/person.html). Various kindsof information including health, environment, andfamily details are being collected also. Using thesesamples and information, the mechanism of thedisease establishment and drug response will beanalyzed. Since November 2004, when the project
had collected samples from almost 80,000 patients,
they started to distribute collected samples forother research use under the investigations
approved by associated IRBs from the beginning ofJanuary 2005.
The Haplotype Mapping (HapMap) Project is aninternational collaborative project to determine thecommon patterns of DNA sequence variation acrossthe human genome by genotyping four populationsin the world including Japanese, Han Chinese,
Northern and Western European ancestry (CEPH)
and Yoruban ancestry. This project is positioned as
post Human Genome Project, and the products of it
have been enthusiastically expected to empower the
progress in life science research in ”post-genomeage”. The database including developed map andthe cell bank of collected samples is freely available
in the public domain to be utilized for future genetic research by researchers in the world. The project
was initiated by the International HapMap
Consortium consisted of organizations and institutions of five countries, USA, Japan, United
Kingdom, Canada and China from October 2002.
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ARTICLESJapanese government MEXT is supporting almost 25% of total budget for the project, and University ofTokyo, Institute of Medical Science and RIKEN SNP
Research Center are genotyping almost 25% of total
genome also.
The International HapMap Consortium consists
following working groups for; genotyping centers,
community engagement/public consultation andsample-collection groups, analysis groups, Ethical,
Legal and Social Issues, SNP discovery, scientificmanagement, and initial planning groups. Prior to
the activity of Japanese community engagement/
public consultation and sample-collection group inwhich the authors worked as two of four members,
this opinion survey was conducted (International
HapMap Consortium, 2004).

Discussion
In the public survey results towards their donation
for a genetic database, the Japanese population was
split into three major groups, ”Yes”, ”No” and”Don’t know” without significant difference.
Respondents (one-fifth of those requested toanswer the anonymous mail response survey) had
some knowledge of ”genetic research”, ”informed
consent” and ”privacy protection”, and it seemedthat the resources of their knowledge were mainly
due to their own direct and indirect experiences,
newspapers and TV programs. Irrespective of their
willingness for donation, both positive expectations
and concerns toward science and medicine, andboth trust and distrust to research and researchers
were found among the comments people made. As
illustrated by the comments, some people showedwillingness to contribute to science or help others,
and also fears about causing discrimination orabuse simultaneously. But whether showing willingness or fear, there were few deep considerations
regarding the meaning of participation to genetic
study, progress of medicine, effects on community
and relationship between citizen and society.
In follow-up public meetings, some common
issues discussed currently globally from the ELSI
perspective regarding the biobank projects werealso found among their comments, including
issues of genetic information and biological materials as the property of the donating individuals orcommunity (Japan), patent issues, benefit sharing
issues and informed consent for conditional use in
future research.
Considering that the stored samples in the banks
will used for other research applications than thosethe initial samples have been donated for, todescribe the research utilizations in specific man-95

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ner is getting impractical, although it is required
regarding the informed consent procedures in current norms or guidelines. In this case, it is also difficult to understand about possible risks caused by
future research use for donor candidates in theinformed consent process. Under such changing
circumstances, certain reviews on traditional
informed consent procedure might be necessary(Kegley, 2004). In the HapMap project, the willingness to be notified regarding the research use of
donated samples was observed among not a few lay
people in Japan. People showed their interests toknow the detail of researched donated samples will
be used for, the progress of them, and even the scientific or profitable results.
To build the reliable framework for the public in
the genetic research project, community engagement is important, and in this process it is necessary to involve a range of ordinary citizens including both donors and non-donors. It is difficult to
consult really ordinary people in community
engagement, not only the activists having very negative or positive voices and used to make remarks.
Citizens’ groups may also be useful, but there are
few in Japan. Still a survey itself is not sufficient toengage public opinion to gain valuable input forpolicy development.
Building well balanced knowledge and deep considerations among the public is expected to develop
the awareness of the issues regarding genetic
research among ordinary people, and persons having such awareness will be able to join to the discussion across people with multidisciplinary backgrounds. The citizens who are not activists may not
be used to make remarks but have capabilities todialogue from a citizen’s standpoint across multidisciplinary people based on well-balanced knowledge, not only on technical matters but also ethics,
regulations, and social issues, may be expected to
be involved in the community engagement.

Acknowledgments
We would like to thank the respondents to the survey, the assistance of Mr. Masakazu Inaba and others in conducting the survey. We appreciate thecomments of Professor Ichiro Matsuda, and others
in discussions of the ethics of genetic research inJapan.

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Eiko Suda/Darryl Macer[Act concerning Protection of Personal Information
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