Clin Eval 41（2）2013

ReportExpert Conference on the Revisionof the Declaration of Helsinki in Tokyo
─ 2013 revision and perspective

toward the 50th anniversary in 2014 ＊1 ─
Chieko Kurihara 1）＊ 2

Takeo Saio 2）＊ 3

1）Editorial Staff, Clinical Evaluation
2）Collaborator to Editorial Committee, Clinical Evaluation

Abstract
In this article, we report on the discussions at the World Medical Associationʼs (WMA) “Expert
Conference on the Revision of the Declaration of Helsinki” hosted by the Japan Medical Association (JMA),
and held at the Imperial Hotel Tokyo, Tokyo, Japan on February 28 and March 1, 2013. Through thediscussions, the proposed draft of the revision of the Declaration came to be clarified. We introduce heresome discussion points relating to the proposed draft which was released for public consultation in April
2013, and which will be further discussed and hoped to be finally adopted in October 2013.
The aim of the Conference was to gather opinions and inputs from experts and the expert community,
particularly those in Asian countries. We hope that 2013 full-fledged revision of the Declaration is achieved
before the commemoration of its 50 th anniversary in 2014. The main points discussed during theConference and during the revision process were the issues of editorial re-construction; compensation forresearch-related harms; biobank; placebo-controlled trials; resource-poor settings and post-study access;and ethics committees. By collating these discussions, we hope to provide a succinct document formembers of the research community in Japan and the world in order to have a better understanding of the2013 revision of the Declaration and related background discussions.
Key words
Declaration of Helsinki, World Medical Association (WMA), Japan Medical Association (JMA), protection ofhuman subjects, ethical principle of medical research

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Original version of this article is in Japanese and is included in the Japanese journal()．2013；41（2）：337-49．Citation of this English version：Kurihara C, Saio T．Expert Conference on the Revision of the
Declaration of Helsinki in Tokyo ─ 2013 revision and perspective toward the 50th anniversary in 2014 ─．
()．2013；41（2）e．
（http://homepage3.nifty.com/cont/41̲2/p337-49eng.pdf）
Molecular Imaging Center, National Institute of Radiological Sciences
Fuji Toranomon Health Promotion Center, an associate member of the World Medical Association, member of theJapan Medical Association
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Conferences in Brazil in 2010 and in 2011 in Sao

1．Introduction:
Overview of the 2013 revisionof the Declaration of Helsinki

Paulo were held in order to have intensive discussions on “hot issues” concerning placebo-controlled
clinical trials. Additionally, Expert Conferences
have been held in Rotterdam, Netherlands and in“The Declaration of Helsinki: Ethical principles

Cape Town, South Africa both in 2012, also focus-

for medical research involving human subjects” bying on clinical trials in resource-poor settings andthe World Medical Association (WMA) was firstpost-study access issues. This time, the aim of the

adopted in 1964, and 2014 will mark its 50th anniver-Tokyo Conference was to gather opinions of expertssary. Since its inception, the Declaration has under-

particularly from Asian countries, following thegone 6 full revisions and 2 partial revisions by adding

discussions in Brazil and South Africa. We hope a

Notes of Clarification. The WMA convened an “Expert

complete revision of the Declaration would be pre-Conference on the Revision of the Declaration ofpared for the 50th anniversary commemoration. The

Helsinki” on February 28 and March 1, 2013 at theagenda for this Tokyo Conference is shown in Box 1

Imperial Hotel Tokyo, Tokyo, Japan, hosted by the(page 6, 7).

Japan Medical Association (JMA). Following thisAfter the Tokyo Conference, the proposed revi-

Conference, the WMA have been preparing full-sion of the Declaration was released for public

fledged revision, which we hope to be adopted at

consultation on April 16, 2013 (with the deadline

the General Assembly in October 2013.

for submission of opinions set for June 15, 2013).

Since the last revision in 2008, the WMA have

More than 120 opinions were submitted. Considering

held several Expert Conferences. Most notably thethese opinions, further revised draft was discussed

Reception at the time of opening of the “Expert Conference on the Revision of the Declaration of Helsinki”(Imperial Hotel Tokyo, February 28, 2013)−2−

Clin Eval 41（2）2013

at the WMA conference in Washington D.C. on August

2．Discussions at the WMA Expert
Conference in Tokyo26, 2013, and we hope that the final version of therevision is adopted at the General Assembly of the
WMA to be held in Brazil on October 16-19,

2.1 Welcome address

2013.
The following main topics were discussed during

Dr. Yoshitake Yokokura, President of the Japanthe process described above and were included in

Medical Association (JMA) and Prof. Fumimaro

the proposed revision:

Takaku, President of the Japanese Association of●Issues discussed during the Tokyo Confer-

Medical Sciences opened the Conference by delivering

ence and included in the proposed revision:

congratulatory addresses and welcoming remarks

�Editorial re-construction including adding

on behalf of their respective organizations. Their

subheadings to make the document more

speeches were followed by an address from Dr.

reader-friendly;

Cecil B. Wilson, President of the World Medical
Association. The author (Kurihara) had the oppor-

�Strengthen the concept of compensation fortunity to interview Dr. Wilson during the morning

research-related harms;
�Add the concept of biobank/biobanking;coffee break on the first day of the Conference.

�Provide logical clarification on ethical accept-

Below is an excerpt from Dr. Wilsonʼs speech andcomments during the interview:

ability of placebo-controlled clinical trial(not discussed in the Tokyo Conference but

Comments by Cecil B. Wilson, President

included in the proposed revision);of the World Medical Association

�Greater consideration for research in resource-

The World Medical Association is a global

poor settings and post-study access;federation of 102 national medical associations

�Strengthen protection of vulnerable popula-

representing millions of physicians worldwide.

tions;The Association endeavors to achieve the high-�Transparency and strengthening the func-

est possible standards of medical care, ethics,

tions of research ethics committee.

education, and health-related rights for all peo-

●Other important points to consider in theples. Those physicians who came together toproposed revision:

form the WMA in 1947 understood that an orga-

�Add ideas that will ensure risk minimization

nization was needed to become the authoritativeand strengthen monitoring by the researcher.

voice on global standards of medical ethics and�Strengthen ethical obligation to design andprofessional conduct. From the beginning, theto conduct research subsequently after the

WMA has codified these standards in its interna-

therapeutic use of unproven intervention ontional code of medical ethics and the Declarationa patient.

of Geneva (also known as the modern Hippocratic

The following are excerpts of the lectures andOath). Other declarations from the WMA which

discussions during the Tokyo Conference on thewere developed over the years have addressed

above-mentioned points. The title and affiliation ofissues such as patient safety, medical ethics,

each lecturer are shown in Box 1.

advanced technology, end-of-life care, access tocare, protection of medical personnel in times ofarmed conflict, and more recently the use of social
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Cecil B. Wilson, MD, an internist
from Winter Park, Florida, USA,was inaugurated as President of theWorld Medical Association (WMA)in October 2012 at its General Assembly meeting in Bangkok, Thailand.
Dr. Wilson is Chair of the American
Medical Association (AMA) delegation to the WMA. He has served as amember of the WMA committees on
Medical Ethics, Finance and Planning and Socio-Medical Affairs. In
addition, he has served for the past
three years as a private sector advisor to the United States Delegation
to the World Health Assembly at theWorld Health Organization in Geneva.
He served as the 165th president of
the AMA from June 2010 to June
2011. He was a member of the AMA
Board of Trustees (BOT) and served
as chair of the AMA-BOT from2006 to 2007.

Cecil B. Wilson, MD, President, World Medical Association

Quoted from the following source：http://www.wma.net/en/60about/40leaders/CV̲Cecil̲B̲Wilson̲WMA̲President̲2012-13.pdf

media. But perhaps thereʼs no clearer example of

Finland, and it was presented to the President ofaddressing ethics in medicine than the Declaration

Finland. Next year, 2014, the WMA will com-of Helsinki.

memorate the 50th anniversary of the Declaration.

The Declaration of Helsinki is the loadstone

The WMA hopes to have the new revised docu-

that guides physicians, governments and industry

ment to present at the 2014 General Assembly.

in the arena and dais of doing medical research

2.2 Opening remarks, keynote speeches,on human subjects. The purpose of the Conference

biobankin Tokyo is to look at potential revisions of the
Declaration; not to change core principles but to

Dr. Ramin Parsa-Parsi, Chair of WMA Declara-

determine where more guidance is needed totion of Helsinki Workgroup (DoH-WG) delivered

respond to the complexities of a changing world.

the opening remarks, giving a brief background and

There are a number of issues that will be dis-the report of the activities of the WG. Dr. Parsa-

cussed at the Tokyo Conference, such as informed

Parsi then introduced Prof. Urban Wiesing, Uni-

consent, ethics committees and placebo use whereversity of Tuebingen, Germany, a member of thethere is actually a proven effective treatment.

DoH-WG, who gave the first keynote speech. Prof.

These are already in the Declaration, but whether

Wiesing explained that as an ethical principle, theor not they need to be revised should be consid-

Declaration of Helsinki should be, as much as pos-

ered. Other things, such as biobanking, are actu-

sible, short enough to be read through in a shortally not in the Declaration yet and should also betime. As such, the current revision includes edito-considered as we are seeing rapid progress inrial re-construction of the provisions (including

this area.

adding sub-headings) to make the Declaration a

The Declaration was first adopted in Helsinki,

more reader-friendly document. He emphasized−4−

Clin Eval 41（2）2013

that the Declaration is different from the ICH-

concerning individual-identifiable human material or

GCP which is a technical document.

data. The proposed revision says that where con-

The second keynote speech was delivered by Prof.

sent would be impossible or impracticable, research

Heather Widdows, a philosopher and ethicist frommay be done only after consideration and approval of

the University of Birmingham (UK). Her speech,a research ethics committee. This is quite similar

which served as a prelude to the discussion on

to the conditions described in the Japanese Ethicalbiobanks, included a lecture about the regulation

Guidelines of Clinical Research (These guidelines

and actual management of biobanks in the United

are under discussion for revision in 2013).

Kingdom. She offered some ideas and consider-

2.3 Compensation for research-related

ations concerning issues of genetic research andharms

biobanking, which may be included in the revisionof the Declaration.

The first session topic during the second day of

The first session of the Conference was devoted

the Conference was on “Insurance/Compensation/on the topic of Biobanks, with Prof. Ryuichi Ida

Protection”. Prof. Tatsuo Kuroyanagi, Attorney-from Doshisha University giving the first talk.

at-law, Legal Advisor of the JMA, raised the issue

Prof. Ida proposed necessary ethical considerationsof the discrepancy between the rules on research-in depth about the organization and management ofrelated injuries for clinical trials under thebiobanks. This was followed by the presentation of

Pharmaceutical Affairs Law and the rules forProf. Alastair Campbell, Centre for Biomedical

research under the Ethical Guidelines of Clinical

Ethics, National University of Singapore, who dis-Research in Japan. He also introduced some exam-

cussed ethical considerations in biobanking. He dis-ples of actual amounts of compensation as containedcussed the management of biobanks in Singapore.

in the insurance agreements by some companies. He

There have been substantial discussions on the

pointed out the insufficiency of the current situa-

issues of broad consent, withdrawal of consent,tion of providing compensation in Japan, from theconfidentiality and governance framework. In theview of human subject protection. On this point,

proposed revision released for public consultation,

Kurihara commented that after the publication of

the idea of biobanks was included in the paragraphthe article featuring the discussion between

Welcome address

Keynote speech

Session 1: Biobanks

Prof. Fumimaro Takaku

Prof. Urban Wiesing

Prof. Heather Widdows

Prof. Ryuichi Ida

Prof. Alastair Campbell(President of theJapanese Associationof Medical Sciences)(University of Tuebingen)(University of Birminghan)(Doshisha University)(National Universityof Singapore)

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Box 1

Expert Conference on the Revisionof the Declaration of Helsinki
28 February - 1 March 2013, Tokyo
Imperial Hotel Tokyo, Tokyo, Japan

AgendaDay 1 ‒ Thursday, 28 February 2013 ‒ Sakura Room
2：00 Welcome address
Yoshitake Yokokura, President of the Japan Medical Association (JMA)
Fumimaro Takaku, President of the Japanese Association of Medical Sciences
Cecil B. Wilson, President of the World Medical Association (WMA)
2：15 Welcome remarks
Tetsuya Yajima, Health Service Bureau, on behalf of Norihisa Tamura, Minister,
Ministry of Health, Labor and Welfare, Japan
2：20 Opening remarks
Ramin Parsa-Parsi, Chair of the WMA DoH Workgroup, Germany
2：30 − 3：45
2：30
3：00
3：30
3：45
4：15 − 5：30

4：15
4：35
4：55
5：30

Keynote speeches
Chair: Ramin Parsa-Parsi, Chair of WMA DoH Workgroup
Keynote speech 1
Urban Wiesing, University of Tuebingen, WMA DoH Workgroup, Germany
Keynote speech 2
Heather Widdows, University of Birmingham, UK
Discussion
Coffee break
Session 1: Biobanks
Chair: Masami Ishii, JMA, Vice-Chairman of Council of the WMA & WMA DoH Workgroup
Chair: Miguel R. Jorge, Brazilian Medical Association & WMA DoH Workgroup
Ryuichi Ida, Doshisha University, Japan
Alastair Campbell, Centre for Biomedical Ethics, National University of Singapore,
Singapore
Discussion
End of Day 1

Day 2 ‒ Friday, 1 March 2013 ‒ Hikari Room
9：00 − 10：15 Session 2: Insurance/compensation/protection
Chair: Wonchat Subhachaturas, Past President of the WMA, Thailand
Chair: Torunn Janbu, Chairperson of WMA Medical Ethics Committee & WMA DoH
Workgroup member, Norway
9：00 Tatsuo Kuroyanagi, Legal Advisor of the JMA, Japan, and of the WMA Medical Ethics
Committee
9：15 Daniel Fu-Chang Tsai, Department of Social Medicine, National Taiwan University
College of Medicine, Taiwan
9：30 Elmar Doppelfeld, Council of Europe, Co-Editor of World Medical Journal, Germany
9：45 Discussion
10：15 Coffee break−6−

Clin Eval 41（2）2013

10：35 − 11：50

10：35
10：50
11：05
11：20
11：50
1：20 − 2：20

1：20
1：35
1：50
2：20 − 3：10

2：20
2：40
3：10
3：30 − 4：15
3：30
3：35
3：40
3：45
3：50
4：15 − 5：15
4：15

4：45

5：15

Session 3: Resource poor settings / Post-study arrangements
Chair: Dong Chun Shin, Chairman of Council of the CMAAO, South Korea
Chair: Poul Jaszczak, Danish Medical Association & WMA DoH Workgroup
Somkiat Wattanasirichaigoon, Scientific Session of the Medical Association of Thailand& Faculty of Medicine, Srinakarinthwirot University, Thailand
Prijo Sidipratomo, Indonesian Medical Association Medical Ethics Committee, Indonesia
Jose Asa Sabili, Philippine Medical Association, Philippines
Discussion
Lunch
Session 4: Vulnerable groups
Chair: Ming-Been Lee, President of the CMAAO, Taiwan
Chair: Mukesh Haikerwal, Chairman of Council of the WMA, Australia
Bomoon Choi, College of Medicine, Catholic University of Korea, & Korean Society for
Medical Ethics, Republic of Korea
Ajay Kumar, Indian Medical Association, India
Discussion
Session 5: Ethics Committees
Chair: Margaret Mungherera, Uganda Medical Association & President-Elect, World
Medical Association
Chair: Peter Carmel, American Medical Association & WMA DoH Workgroup
Kaori Muto, Department of Public Policy, Institute of Medical Science, University ofTokyo, Japan
Discussion
Coffee break
Session 6: General Comments
James McCormick, U.S. Embassy Tokyo, on behalf of the U.S. Department of Health andHuman Services (HHS)
Yasuyuki Sahara, Research and Development Division, Ministry Health, Labor andWelfare (MHLW), Japan
Isao Teshirogi, Japan Pharmaceutical Manufacturers Association (JPMA)
Salvatore Alesci, Scientific Affairs, Pharmaceutical Research and Manufacturers ofAmerica (PhRMA)
Discussion
Consensus building / summing up
Round table discussion
Facilitator: Jeff Blackmer, Canadian Medical Association & WMA DoH Workgroup
Facilitator: Peter Carmel, American Medical Association & WMA DoH Workgroup
Closing & next steps
Otmar Kloiber, Secretary General of the WMA, Germany
Tai Joon Moon, President Emeritus of the KMA, former President of the WMA, South Korea
Takashi Hanyuda, Vice-president of the JMA
End of Day 2

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laws and regulations concerning research-related

Kuroyanagi and another Japanese attorney-at-law,
1）

in the journal

injuries, and introduced the situation in Taiwan, the attitude of Japanese pharmaceutical com-

where it recently, became mandatory, under the law

panies has been changing towards the trend ofon medical care, to explain about compensation forproviding a wider range of compensation to injured

research-related injuries in the process of obtaining

research subjects. Additionally, the results of ainformed consent. Because of this, the number ofsurvey by a task force lead by Prof. Hiroshi

insurance contracts providing compensation for

Tadahiro Mitsuishi

2）

revealed a high rate of Japanese com-

research related injuries has been increasing. The

panies granting compensation for injured patients,

next speaker, Prof. Elmar Doppelfeld, from thealthough this survey has some limitations. ThisCouncil of Europe, introduced the issue of compen-

improvement in the situation and trend in compen-

sation in the Additional Protocol to the Convention

sation for research-related injuries in Japan is one

on Human Rights and Biomedicine concerning bio-of the achievements of Prof. Kuroyanagi.

medical research 3）issued by the Council of Europe.

WatanabeProf. Daniel Fu-Chang Tsai from the National

He commented that there is already a provision

Taiwan University reviewed international norms,

that covers the issue of compensation for research

Session 2: Insurance/compensation/protection

From the left, Prof. Daniel Fu-Chang Tsai (National Taiwan University), Prof. Tatsuo Kuroyanagi(Legal Adviser of Japan Medical Association), Prof. Elmar Doppelfeld (Council of Europe)−8−Clin Eval 41（2）2013

related harm in this European document and

The major contention in these debates is that rich

instruments of the Council are the only internationalcountries conduct clinical research in a resource-

protective legal instruments covering all medicalpoor region, but the therapy or drugs proven to beresearch on human beings, and that the actual real-effective during the research becomes available

ization of such a provision will depend on the

only in rich countries and not in the poor regions.

establishment of relevant laws and regulations by

So the countries sponsoring such research aregovernments in each country.

accused of exploiting the vulnerability of researchsubjects in those poor countries. The WMA

2.4 Resource poor settings, post-study

responded to this debate, and through these inten-

arrangements, and vulnerable

sive debates, adopted a 2000 revision subsequently

populations

adding a Note of Clarifications in 2004 to the 2000

Since the 1990s, issues and ethical challenges

version of the Declaration. Additionally, in therelating to clinical research in resource-poor set-2008 revision, the WMA made an even moretings and post-study access to the therapy provenemphatic position and now has reached the 2013

to be beneficial have been the subject of debates.

proposed revision.

Session 3: Resource poor settings/Post-study arrangements

From the left, Dr. Prijo Sidipratomo (Indonesian Medical Association), Dr. Somkiat Wttanasirichaigoon(Medical Association of Thailand), Dr. Jose Asa Sabili (Medical Association, Philippines)
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Prof. Somkiat Wattanasirichaigoon, Medical

where naive patients, who cannot access medicines

Association of Thailand, Dr. Prijo Sidipratomo,

or treatments due to economic reasons, have par-Indonesian Medical Association, and the Dr. Jose

ticipated in clinical trials sponsored by multina-

Asa Sabili, Philippine Medical Association eachtional companies; yet the majority of these patients

reported on the situation in their respective coun-cannot access even basic medical treatment. He

tries and the efforts being made to develop medical

stressed that “honesty” of sponsors and research-

research governance framework in conducting

ers is significantly important in order to avoid

research in resource-poor settings to ensure theexploitation.

protection of patients participating in such research.

Prof. Bomoon Choi, Catholic University of Korea

Dr. Sabili particularly raised a new issue about theand Korean Society for Medical Ethics, talked

disposal of research drugs and materials and theabout categorizing vulnerable groups in the Decla-

impact of such disposal on the environment. In theration and expressed an opinion that it is not appro-session on “vulnerable groups”, Dr. Ajay Kumar ofpriate to put too much detailed description of thisthe Indian Medical Association raised the issue ofcategorization in the Declaration.

exploitation of research subjects in his country

In response to these discussions, the proposed

Session 4: Vulnerable groups

From the left, Prof. Bomoon Choi (Catholic University of Korea), Dr. Ajay Kumar(Indian Medical Association)− 10 −

Clin Eval 41（2）2013

2.5 Ethics Committees

revision now includes the following statement: “In the session on Ethics Committees, Prof. Kaori
Muto, Institute of Medical Science, University ofTokyo, reported on her analysis of ethics committees from viewpoint of a sociologist, by reviewing
the academic literature. Her analysis revealed thata recent trend in academic discussions is to focus
not only on traditional functions of an ethics committee, but more on issues relating to quality assurance, efficient management of an ethics committee,”
During the Q&A forum, Kurihara asked the lec-

and the joint review of multicenter clinical studies.

turers for their opinion regarding the changing

Participants discussed focusing on the necessity oftrend among the bioethicists in the U.S., especially

dual review especially in the case of collaborativein the U.S. National Institutes of Health, who

studies between rich and resource-poor countries

believe that vulnerable populations should not be

and on another point concerning the review of non-excluded from the opportunity to participate in

medical (social, psychological, etc.) research.

research without justifiable reason to exclude

In the proposed revision of the Declaration, new4）them . The idea is that if research involving vul-

wordings were added to emphasize the necessity ofnerable population is limited to those studies which

ensuring transparency of the committee and thecannot be carried out in a non-vulnerable popula-qualifications of such a committee (committee “musttion, patients in the vulnerable population will not

be duly qualified”).

be able to get early access to new therapeutic
treatments which could possibly benefit them also

2.6 General comments

but which were studied only using non-vulnerable

In the session on General Comments, Dr. Jamespopulation groups. Some of the lecturers responded

McCormick of the U.S. Embassy Tokyo, read athat such an idea is a little bit “tricky”. In anotherstatement on behalf of the U.S. Department ofsituation, Kurihara asked for the opinions of the

Health and Human Services. Other delegates in5）this group session ‒ Dr. Yasuyuki Sahara, Ministry

provides that the conduct of a research which couldof Health, Labour and Welfare (MHLW) in Japan,

contribute to capacity development of community is

Dr. Isao Teshirogi, Japan Pharmaceutical Manu-

justified even if the sponsors of such research can-facturers Association (JPMA) introduced thenot provide post-study access. Some of the lectur-

Japanese regulatory framework and their activities;

ers said that capacity development is the obligation

and Dr. Salvatore Alesci, Pharmaceutical Researchof the national authority.

and Manufacturers of America (PhRMA) ‒ briefly

lecturers on the idea that the CIOMS guidelines

Our general impression was that the lecturers

stated their comments. Historically, the U.S. gov-

representing developing countries expressed aernment and the American Medical Associationstrong wish to avoid exploitation of research sub-have submitted several comments to the WMA whenjects in their regions rather than in seeking bene-

there are principles in the Declaration which did

fits by means of participating in global companiesʼ

not fit U.S. regulations or the actual situation in

multinational clinical trials.

the conduct of clinical trials. Companies engaged in− 11 −

臨床評価41 巻 2 号

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global clinical trials often avoid quoting the newest

Declaration to provide compensation for research-version of the Declaration in their protocols.

related harms; to protect research subjects in

Therefore, the comments of the U.S. representa-

resource-poor settings and of vulnerable groups; totives have attracted our attention. They haveassure transparency in clinical research, and to

expressed explicit opinions on the issues of com-

improve the function of ethics committees.

pensation, post-study access, etc., and their general

In closing, Dr. Otmar Kloiber, Secretary General

opinion is that the Declaration should describe fun-of the WMA, Prof. Tai Joon Moon, President

damental principles and that actual detailed rules

Emeritus of the KMA (Korean Medical Association)

should be described in national laws and regula-and former President of the WMA, and Dr. Takashi

tions of each country.

Hanyuda, Vice President of the JMA, gave speeches.

2.7 Consensus building, summing up, and

2.8 Other issues discussed

closing

The relationship between the Declaration andIn the session on “Consensus building / summing

national laws and regulations was discussed several

up”, Dr. Jeff Blackmer of the Canadian Medical

times during the Conference. Various opinions have

Association and Dr. Peter Carmel of the American

been expressed about the differences between ethi-

Medical Association (both members of WMA

cal principles and legal regulations, i.e. whether

DoH-WG) summed up the discussion and explained

legally-binding regulations work sufficiently tothe direction of the revision process. The next

promote ethical conduct in research or whether therevision stage will strengthen the principles of thesoft-law framework with ethical principles andguidelines is enough.
There are other important points which were not

Session 5: Ethics Committees

Consensus building/summing up

Prof. Kaori Muto
(University of Tokyo)

The scenery of the conference at the time of “closing & next steps”− 12 −

Clin Eval 41（2）2013

discussed during the Tokyo Conference. One is the“such an intervention should be made the object ofissue of placebo-controlled clinical trials which

research, where possible.” In the proposed revi-

was discussed at the Expert Conferences in Brazil

sion, the words “where possible” have been deleted,in 2010 and 2011. We were privileged to have dis-and the ethical obligation of physicians is strength-

cussed this issue during an interview with Dr.

ened by requiring them to make such an interven-

Otmar Kloiber. An article 6） on this interview also

tion the object of research subsequently after theappears in this current issue of the journal

administration of such unproven treatment to a

. This journal has published in the pastpatient in defined conditions. In Japan, the logicalseveral articles related to the revisions of theboundary between research and practice has not

Declaration

7〜11）

been explicitly defined and understood, so we, and international journals haveshould learn from this strengthened principle.

published a substantial number of academic literature on this point.

2.9 Press Conference

Additionally, the following 2 points included in
the proposed revision are especially important:

The authors participated in the press conference�To add ideas to ensure risk minimization andheld after the closing of the Conference. Dr.

monitoring by the researcher.

Yoshitake Yokokura, President of the JMA, Dr.

�To strengthen ethical obligations to design and

Masami Ishii and Dr. Hiromi Ishikawa, both execu-

conduct research subsequently after the thera-tive directors of JMA, Dr. Otmar Kloiber WMA

peutic use of an unproven intervention on a

Secretary General, Dr. Ramin Parsa-Parsi, Chairpatient.

of the WMA DoH-WG fielded questions from the

The importance of risk minimization necessitates

journalists. The perspectives of WMA and JMA

adding a principle to address it. Over the last

expressed during the press conference have clari-decade, we have seen some rapid development andfied the view that Asian experts are seeking stron-

advancement in medical knowledge leading to theger protection of human research subjects. We

integration of various interdisciplinary knowledge.

expressed our gratitude that this kind of opportu-

The integration of various fields of medical knowl-

nity for open discussion was provided, and WMAedge is important in developing “risk-minimization”

expressed their appreciation for the excellent

strategies. It is also important to consider theorganization and hospitality of the JMA.

importance of “monitoring”, especially in Japan where

3．Conclusion

recently, scientific misconduct has been exposedand discussed more often. We are now seriously
discussing the issue of “monitoring and audit” which

The primary reason for holding this Expert Con-is required under the GCP Ordinance but not underference was to hear the opinions of Asian experts.

the Ethical Guidelines for Clinical Research.

In recent years we have visited Asian hospitals andAnother important issue to consider in the revi-

have been holding discussions with medical profes-

sion is the conduct of research involving unprovensionals. From these experiences and discussions

intervention. In the previous version of the Decla-with Asian experts during the Conference of thisration, such research was allowed for the purpose

time, we were surprised at the rapid progress inof saving the life of a patient, subject to strictly

and superiority of Asian medical systems far better

defined conditions, with the recommendation thatthan Japan. On the other hand, the systems have not− 13 −

臨床評価41 巻 2 号

2013

Press Conference

Dr. Yoshitake Yokokura

Dr. Masami Ishii

Dr. Hiromi Ishikawa

President,
Japan Medical Association

Executive Board Member,
Japan Medical Association

Executive Board Member,
Japan Medical Association

Dr. Otmar Kloiber

Dr. Ramin Parsa-Parsi

Secretary General,
World Medical Association

Chair of DoH-WG, WMA
German Medical Association

Press Conference after the closing of the Conference− 14 −

Clin Eval 41（2）2013

developed enough to be shared by all the citizen-

ing to this revision.

ries in some of those countries. This Expert
Conference provides an important opportunity to

Acknowledgement

consider such Asian situations as well as the ethi-

We greatly appreciate the World Medical

cal principles expressed in the Declaration. It is

Association and the Japan Medical Association tointeresting to note that most of the lecturers in thisprovide this precious opportunity to participate in

Conference have expressed strong opinions seeking

the Conference and also to give great support forfor protection of human research subjects from thedevelopment and publication of this article.

perspectives of the people who have difficulty
REFERENCES

accessing the benefits resulting from the development of medical technologies.

1）Kuroyanagi T，Mitsuishi T．Discussion on Para-

The Conference has attracted a distinguishedgraph 30 of the Declaration of Helsinki and the issueroster of attendees, not only eminent lecturersof compensation in the NDA (new drug application)from various health fields, but also medical experts

trials in Japan．

including representatives of medical associations．2003；31（1）：129-39．Japanese．

from each member state and experts in medical eth-2）Watanabe H，et al．Protection of human subjects

ics, providing a vivid and lively discussion of theand compensation for research-related injuries

topics and issues raised. Japanese participants also

Proposal of explanation sheet based on survey of theexpressed their opinions and questions concerning

actual status in Japan．

ethical conduct in international clinical research

2011；39（1）：5-29．Japanese．

．

3）Council of Europe．Additional protocol to the con-and sometimes from the perspective of developing

vention on human rights and biomedicine concerning

countries. Needless to say, the Conference was abiomedical research．Strasbourg Jan 25, 2005．

precious opportunity for international exchange（European Treaty Series No. 195．）

among medical and ethics professionals.

4）Kurihara C．Ethics in research involving children:

In recent years in Japan, the long targeted goal

introduction ─ Historical review over ethical dilemma

to participate in a global clinical development pro-and regulatory development in the world ─．

gram has been mostly achieved, and academia-initi-．2007；34（1）：103-22．Japanese．

ated international clinical development has been5）Council for International Organizations of Medical

promoted. While it is uncertain which of the prin-

Sciences（CIOMS）．International Ethical Guidelines

ciples described in the proposed revision will befor Biomedical Research Involving Human Subjects．
2002．

adopted in October, it is certain that all the pro-6）Kloiber O．Interviewed and translated by Kurihara

posed ideas discussed during the revision process

C，Saio T．Discussion toward the 50th anniversary

are worthy to keep in our minds and hearts. Thisof the Declaration of Helsinki ─ Interview with Dr.

time, we should sincerely consider the voices of ourOtmar Kloiber, Secretary General, World Medicalcolleagues from Asia which were expressed during

Association ─．

the Conference and in the proposed revision. We（2）：351-72．Japanese．

．2013；41

hope that all members of the Japanese and the7）Levine RJ，Tsutani K，Sakanoue M，Mitsuishi T，world research communities will deeply understand

Kawai S，Sato K，Kakee N．Round table discussion:

the forthcoming 2013 revision of the Declaration of

Ethics in clinical trial in the days of globalization of
drug development．

Helsinki and the background discussions culminat− 15 −．1999；

臨床評価41 巻 2 号

201310）Human D．Interviewed by Kurihara C，Mitsuishi T.

26（3）：341-80．Japanese．
8）Sakanoue M．Recent movement at the World Medi-

Interview with Delon Human, Secretary General of

cal Association on revision of the Helsinki Declara-

the World Medical Association: Discussion on thetion．

2000 revision to the Declaration of Helsinki and．1999；26（3）：395-

onwards．

408．Japanese．

．2002；29（2・3）：307-13．Japanese．

9）Levine RJ，Lurie P，Lagakos SW，Interviewed by
Kurihara C．Interview with Robert J. Levine，Peter

11）Tsuboi E．Interviewed by Kurihara C．The 2000

Lurie and Stephan W Lagakos: Discussion on therevision of the Declaration of Helsinki and its impli-

Declaration of Helsinki and its background．

cations in medical ethics: Interview with the WMA
Immediate Past President, Eitaka Tsuboi．

．2001；28（3）：409-22．Japanese．

．2002；30（1）：99-107．Japanese．

Available form：http://homepage3.nifty.com/cont/28-3/contents̲e.html＊＊− 16 −＊