Research Ethics Program
Model Using the Conceptof Values-sharing1

Ethical issues in science
Many Scientific misconducts in Japan
 Taira/Kawasaki Data Fabrication at the University ofTokyo (2005-2007)
 Data Fabrication at Osaka University (2005-2006)
 RIKEN (The Institute of Physical and ChemicalResearch) Data Falsification （1999-2004） And many others
Abroad Embryonic Stem Cell Scandals in Korea （2002(?)2006）
 Schön at the Bell Laboratories（1998-2002）
 Cold Fusion（1989-91）
 Baltimore/Imanishi-Kari（1986-96）

2

Misconduct Cases happened andrecognized by academic societies
from 1999 to 2004 (SCJ) Duplicate publications
 Plagiarism Violation of privacy
 Fabrication of data Falsification of data Misuse of fund Others

And increasing（67：83 cases～）（23：26 cases）（5：14 cases）（2：2 cases～）（2：2 cases）（2：2 cases）（43 cases）
3

Expanding Grant-in-aid forscientific research (KAKENHI)(Billion2000
Yen)
1900
200

170.3
1800
158
1700
1600
141.9
1500
150
131.4
1400
117.9
1300
112.2
1200
101.8
1100
100
92.4
1000 82.4
900
800
700 1994 1995 1996 1997 1998 1999 2000 2001 2002

188 189.5

176.5 183

2003

2004

2005

2006

(FY)

FY

1994

1995

1996

1997

1998

1999

200020012002

2003

2004

2005

2006

Budget(billion Yen)

82.4

92.4

101.8

112.2

117.9

131.4

141.9

158.0

170.3

176.5

183.0

188.0

189.5

compared withthe previousfiscal year
(%)

12.0

12.1

10.2

10.2

5.1

11.5

8.0

11.3

7.8

3.6

3.7

2.7

0.8

*index

－－－－－

－

1.00

1.11

1.20

1.24

1.29

1.32 34 1.34（*） 1.00 in the index is as same rate as 1990 fiscal year’s (2nd S&T Basic Plans were established in 1991 fiscal year)

“Do Scientists BehaveBadly?”(2005)
 How many researchers in the US andfunded by NIH were involved in 20012004?

5

Top Ten Behaviors (1)1. Falsifying or ‘cooking’ research data (0.3)
2. Ignoring major aspects of human-subject
requirements (0.3)
3. Not properly disclosing involvement infirms whose products are based on one’s
own research (0.3)
4. Relationships with students, researchsubjects or clients that may beinterpreted as questionable (1.4)
6Top Ten Behaviors (2)5. Using another’s ideas withoutobtaining permission or giving due
credit (1.4)
6. Unauthorized use of confidential
information in connection with one’sown research (1.7)
7. Failing to present data that contradict
one’s own previous research (6.0)
7Top Ten Behaviors (3)8. Circumventing certain minor aspectsof human-subject requirements (7.6)
9. Overlooking others’ use of flawed dataor questionable interpretation of data(12.5)
10. Changing the design, methodology
or results of a study in response topressure from a funding source (15.5)
8

And the ratio is３３％！
N=3,409, response rate 43%(1,479)
B. C. Martinson et al., “Scientists Behaving Badly,” Nature, 435 (9June, 2005), 737-738
9Other misconducts
11. Publishing the same data or results in two or
more publications (4.7)
12. Inappropriately assigning authorship credit(10.0)
13. Withholding details of methodology or results inpapers or proposals (10.8)
14. Using inadequate or inappropriate research
design (13.5)
15. Dropping observations or data points fromanalyses based on a gut feeling that they were
inaccurate (15.3)
16. Inadequate record keeping related to research
10projects (27.5)

N. Steneck’s conclusion“What Do We Know? ：Two Decadesof Research on ResearchIntegrity”
Presented at the World Conference on
RESEARCH INTEGRITY
Lisbon, Portugal, 16-19 September 2007
www.esf.org/conferences/researchintegrity
11Science & Engineering Indicators 2006, Figure 3-36

Conclusions?
 Findings:
9 Frequency range: ~ 0.1 –> 1.0%
9 over 10 years: ~.01 –> 0.1%

 Implications, cases/year:
9 US ~ 150 -> 1,500
9 EU ~ 100 -> 1,000
9 Japan ~ 60 -> 600
9 Other OECD ~ 40 -> 400

 Cases reported/year: US ~20/year; EU ~ 10/year Conclusions:
9 Evidence does not support view that misconduct is “rare”9 Most research misconduct is not detected, reported and investigated812Code of Ethics for Science inJapan
 “Charter for Scientific Researchers”(1980) by the Science Council, Japan<Reaction to the 1974 UNESCO
Recommendation>, but very limited
influence in Japan The SCJ has established committees
on scientific misconducts since 2003
13

Continued A number of academic societies haveestablished their codes of ethics since
the late 1990s.
 In early 2000s, scientific misconduct
became a hot issue and a number oforganizations started working on thisissue
14

Continued
 SCJ, Ad-hoc committee on the code ofconduct for Scientists was created in Dec.
2005
 MEXT, the Council of Science andTechnology, Special Committee, Feb. 2006
 the CSTP (Council for Science andTechnology Policy) , an official response toscientific misconduct.
15

The CSTP Response “The decision, recognizing that the robust

self-discipline of the scientific community is
the keystone to cope with issues concerning
misconduct, acknowledges the deliberationin the Science Council of Japan indeveloping an ethical code for scientists,and asks universities and research institutes
to set up rules and procedures to manage
misconduct cases. Moreover, funding
ministries must establish their policies
regarding the handling of research funds
related to cases of misconduct.”16

Creation of a Code of Conduct Descriptive study as well as normative study

are necessary Identify appropriate stakeholders
 Reflect values which are significant in Asia
 Various issues in terms of the relationship ofinternational and national standards
 Consultation process can be very political17

Values in Science?
 Internal Values
 External Values

18Responsible Conduct ofResearch： RCR– honesty– accuracy– efficiency– objectivity
N. H. Steneck, ORI Introduction to the
Responsible Conduct of Research (2005)

19

QRP: Questionable Research
Practices (Steneck)
RCRIntegrity- Honesty-Accuracy-Efficiency-Objectivity

QRP

Misconduct

Misrepresentation
Inaccuracy
Bias
Etc.

Fabrication
Falsification
Plagiarism

20

Study done by UNESCO
on Existing Codes
 67 codes were examined21

Expressed Internal Values
Confidentiality of information
 Maintain/upgrade professional competence Avoid and report conflicts of interest
 Honesty
 Cooperation with co-workers
 Integrity
 Follow policies, regulations, laws
 Work only in area of competence Informed consent
 Objectivity
 Respect property rights
 Prevent and report unethical conduct(Source：UNESCO)
22

Internal Values （ORI）
RCRQRPMisconduct

 Integrity– honesty– Accuracy– efficiency– objectivity
23

Expressed ExternalValues
 Environmental responsibility
 Public safety and welfare Respect for human dignity
 Social responsibility
 Enhance/maintain prestige of the profession
 Human rights
 Enhance public understanding of theprofession/discipline（Source：UNESCO）

24

The SCJ Suggestions (Draftwas approved in April, 2006)
 Each organization (academic societies,associations, universities, research
institutes, etc.) should write its own
code of conduct
 Each organization to design andimplement an ethics program toencourage scientific integrity andreduce misconducts25

From the results of survey
 The committee sent a questionnaire to all

Japanese institutions of higher educationand scientific research, and also to Japanese
academic societies and associations.
 By August 2006, 1,323 responses (aresponse rate of 46.9%)
 The code of conduct (Universities)– Yes– Drafting– Planning

14.3% (78 universities/colleges)
3.6%
41.4%

 48 out of 79 were after 2004

26

Statement: Code of Conduct for
Scientists/SCJ/Oct. 3, 2006
 Introduction
 The Code of Conduct for Scientists
 “Toward Autonomous

Implementation of the Code ofConduct for Scientists”

http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-20-s3.pdf

27

“Science for Society”
 World Science Conference in 1999

(Budapest, Hungary) In the preface of the SCJ code, there

is a very clear statement that “Scienceand scientific research exist both withand for society”.
28

SCJ’s definition of “Scientists”:
Engineers included
Here, the word “scientists” refersto researchers and specialists
engaged in activities that create
new knowledge, or in the use andapplication of scientific knowledge,in all academic fields ranging fromhumanities and social sciences tonatural sciences, regardless ofwhich institution they belong to …

 …

29

The Code of Conduct
 Preface (“Science for society”)
 11 provisions under the following headings:– Responsibilities of Scientists, Conduct ofScientists, Effort to Improve Ability, Explanation
and Disclosure, Research Activities, Establishing
Research Environments, Observance of Lawsand Regulations, Consideration to Research
Subjects, Relations with Others, Elimination ofDiscrimination, and Conflict of Interest.
30

SCIENCE WITH HONOR: THE
SCIENCE COUNCIL OF JAPAN’S
CODE OF CONDUCT“However, the Code goes even a stepfurther. It charges scientists to strive inunderstanding the relationships between
science and society and to evaluate thepotential implications of their work.”
AAAS, Professional Ethics Report, Vol. XX, No.
2 (Spring 2007)31

“Toward Autonomous
Implementation of the Code ofConduct for Scientists” 1
 The document describes specificelements for effective implementationof the Code, which should be includedin the ethics programs for research
adopted by individual institutions. All
scientific organizations are requested
to introduce their own research ethics
programs to meet to their purposes
and needs, and to promote honest andautonomous activities of scientists.
32

“Toward Autonomous
Implementation of the Code ofConduct for Scientists” 2
 The document consists of eight articles

covering such issues as theresponsibility of directors andmanagers of institutions, the need for
ethics education programs, the mutualobservation within a research group,
the precautions in research process,the countermeasures against
misconduct, and the establishment ofa self-monitoring system.

33

Elements of Research Ethics Program
Suggested in the Document 1
1.

2.

3.
4.

A code of ethics/conduct should beformulated and circulated among all
members of the organization
Implementation of an effective
research ethics program/Commitment
and leadership of the top management
Research ethics education
Healthy research environment
34

Elements of Research Ethics Program
Suggested in the Document 2
5. The need to observe the Code ofConduct for Scientists
6. Proper complaint/investigation system
7. Rules/regulation for the conflicts ofinterest
8. Self-monitoring system

35

Research Ethics Programs
at Leading Institutions
 National Institute of Advanced

Industrial Science and Technology
 RIKEN The University of Tokyo Nagoya University
 Toshiba/Hitachi
 Tokyo Electric Power Company

36

Value-based program?
 WHO is already using this approach

Presented by Guitelle Baghdadi-Sabeti at the World
Conference on RESEARCH INTEGRITY
Lisbon, Portugal, 16-19 September 2007
www.esf.org/conferences/researchintegrity

37

Efforts to address corruption need coordinatedapplication of two basic strategies
 "Discipline-based approach" (top-down)Ò Laws, policies and procedures against
corruption and for pharmacy practice withadequate punitive consequence for violation
Ò Attempts to prevent corrupt practices throughfear of punishment

 "Values-based approach" (bottom-up)
Ò Promotes institutional integrity throughpromotion moral values and ethical principles
Ò Attempts to motivate ethical conduct of publicservant

38
Department of Medicines Policy and Standards
September 2007 – Good Governance for Medicines 7

PDCA cycle of REP
Institutional mission

Objectives of S&T
Stakeholders

Clarification ofValues

ThirdFeedBackPartyImplementation ofEP

Outcomes
Evaluation ofassessment data

Outcomes assessment
39

Continuous Improvement
for Values-sharing
PlanDoActCheck40

Elements of Research Ethics Program
Suggested in the Document
1.
2.

3.
4.
5.
6.
7.
8.

A code of ethics/conduct should be formulated andcirculated among all members of the organization
Implementation of an effective research ethics
program/Commitment and leadership of the topmanagement
Research ethics education
Healthy research environment
The need to observe the Code of Conduct forScientists
Proper complaint/investigation system
Rules/regulation for the conflicts of interest41
Self-monitoring system

Examples (Graduate Schools)
1．A code of ethics/conduct should beformulated and circulated among all
members of the organization

 Establishment of a code of conduct using

both top-down and bottom-up approaches
 Required at the entrance exams/interview
 Familiarized students with various
orientations and session (Require to sigh awritten oath) ID card42

2．Commitment and leadership of
the top management Committee headed by president
 Review of Ethical Principles at theBeginning of Important Meetings
 Orientation conducted by the topadministration
 Establishment of Devoted Ofiices
 Train specialists for IRB

43

3. Ethics Education
 Required course on research ethics
 Ethics across the Curriculum Bottom-up formulation of a code of

conduct for each lab（active learning）
 Require a Certain Level ofConsideration of social implications ofresearch in proposing and conducting
a research project44

4. Open Communication
 Bottom-up formulation of a code of

conduct for each lab（active learning）

45

Others
8 Establishing self-monitoring system→
Adoption of Engineering Accreditation
Model46

Be Cautious Negative emphasis on Strongercompliance system

 Positive program to encourage RCR

47

The Central Role of Education（clamed by many including Nature）
 Leading by examples （Editorial:Nature, Vol. 445, No. 7125 (18January 2007), p. 229）

48

Objectives
PHS Policy, 2000

1. 研究の責任ある遂行に関連する諸問題に関する知識、および感受性の育成
2. 科学研究に伴う対立や相反に直面した際、倫理的で合法的な選択ができる能力の向上
3. 研究を遂行する上で受け入れられている科学的方法・手段の範囲について正しい認識力の育成
4. PHSの助成による研究の遂行を管理する規則、ポリシー、法令、ガイドラインに関する情報の提供
5. 研究の責任ある遂行について生涯学び続ける
ことに対する積極的態度の涵養49

ORI’s Core Instructional Areas inRCR (2000)
1.
2.
3.
4.
5.
6.
7.
8.
9.

Data management
Mentor/trainee responsibilities
Publication and authorshipPeer review
Research with human beings
Research involving animals
Research misconduct
Conflict of interest and commitment
Collaborative science
50Instructional Methods
 Research ethics in daily activities
 Courses
 Case method（such as materials created by PoynterCenter）
 e-learning– CITI Program– LANGURE (Land Grant University ResearchEthics)
51

What is CITI?
 Collaborative Institutional Training

Initiative CITI is a volunteer organization whose
goal is to develop and distribute highquality, peer reviewed educational
resources designed to raise awareness tothe Responsible Conduct of Research forall members of the research team.
52

CITI – Startup Organizations

9-2000

University of Miami–Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D.

–Karen Hansen, BA–Jeff Cooper, MD–Susan Kornetsky, MPH–Liz Bankert, MA–Ada Sue Selwitz, MA, Norma Epley, MS–Diane Paul, MS–Bruce Gordon, MD, Ernie Prentice, Ph.D.

–Barbara Young, Ph.D., Janelle Erickson, MPH–Helen McGough, MSFred Hutchinson Cancer Research CenterAlbany Medical Center
Children's Hospital-BostonDartmouth College

University of Kentucky

The National Comprehensive Cancer Network
University of NebraskaGroup Health Cooperative
University of Washington

53

CITI Course Materials

Basic course human subjects protection– 12 modules for biomedical research investigators.
– 11 modules for social & behavioral research investigators– 5 general interest modules.

Human Subjects Refresher courses– 2 Biomedical– 2 Social & Behavioral

Good Clinical Practice (GCP)– 14 modules for investigators

Responsible Conduct of Research– >25 modules



HIPS– 18 modules on privacy and security

Animal Welfare (January 2007)54– Course to meet the basic instruction requirements of the NIH and USDA.

Monthly Usage
24000
9-2006

22000

Registrants

20000

NEW LEARNERS

18000
16000

>89% Completion Rate

14000
12000
10000

Completion Reports

8000
6000

Basic course = 79%
Refresher course = 21%

4000
2000
01-0
53-0
55-0
57-0
59-0
51
1105 -06

6-0
68-0
655

Aug
O -00
c
D t-0
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Fe -00bAp -01r
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Thousands

300

Registrations

CITI Cumulative Registrations
500

450
400
350

200

250
Version 6150

100
Version 550
Version 3 Version 4

Ver 1 & 2056

From “Science Education”
to “the Formation of Scientist”
Office of Research Integrity:Introduction to the Responsible
Conduct of Research (2003)
National Academy of Sciences:

On Being a Scientist: Responsible
Conduct of Research (1995)
57

Roles of Other Stakeholders
 Learned/Academic/ProfessionalSocieties
 Academic Journals
 Funding Agencies
 Others

58

Concluding Remarks
1.
2.
3.

4.
5.

The values-sharing approach can be used inresearch ethics
Business ethics models can be used
The Science Council, Japan has alreadyestablished the code of conduct for scientists andrequested each institution to establish andimplement a research ethics program
Research ethics education has a central role inRER
Engineering ethics education model (such as EAC)
is also useful59