February 24, 2021

Organization of JDDW

“Guidelines on Conflict of Interest in Medical Research”
Introduction
A remarkable progress in medicine and healthcare from the latter half of the 20th
century resulted in the development of many new methods of treatment and prevention.
In Japan, the enactment of the Healthcare and Medical Strategy Promotion Act and the
Act on Japan Agency for Medical Research and Development as a national policy in2014, and subsequent establishment of Japan Agency for Medical Research andDevelopment in April 2015, have expanded strategic approaches in the development ofinnovative drugs, biological drugs, and medical equipment and devices and in the
promotionofregenerative

medicinethroughacademic-industry-government

collaboration. The participation of the academia in regenerative medicine andentrepreneurship in relation to medical equipment and devices is beginning to bear fruits,
further invigorating clinical development.
The Organization of Japan Digestive Disease Week (hereafter called the“Organization”) is engaged in activities involving human subjects (including theirsamples and data) towards maintaining and promoting national health and improving
the prognosis and the quality of life of patients, through identification of causes of
diseases, understanding of pathological conditions, prevention of diseases, andverification and improvement of the effectiveness of diagnostic and therapeutic methods
used in healthcare. Further promotion of academic-industry collaboration is extremely
important from the standpoint of evidence-based medicine and medical economics andin fulfilling our social responsibility.
On the other hand, the more researchers at public entities, such as research institutes
and academic societies, promote academic-industry collaboration through medical
research, the deeper they will become involved in the activities of specific companies.
As a result, a clash or conflict inevitably and unavoidably arises between the
researcher’s social responsibility to work for the public good and personal benefits
obtained via collaboration between industry and academia. Such a situation iscommonly referred to as a “conflict of interest (COI)”, and the academic organizations
must manage and resolve such states of COI in their promotion of cooperative activities
between industry and academia. If those engaged in medical research would fail to1

declare appropriately a serious conflict of interest existing in relation to funding
companies or organizations, it could increase the risk of bias, endanger the human rights
and personal safety of the research subjects, and warp the research methods, data
analysis, and interpretation of the results. In fact, a scandal over the antihypertensive
drug valsartan in 2013 threw into doubt the credibility as well as the quality of clinicalstudies at five universities in Japan. The scandal came about as a result of obscurearrangements in corporate donations and acceptance of data management and statisticalanalysis services, and contracts and other safeguards were not used to appropriately
manage bias risks. Data were willfully manipulated to fabricate a conclusion
advantageous to the pharmaceutical company involved. A number of research papers
published in international journals had to be withdrawn, tarnishing not only the quality
but also the credibility of the medical guidelines in question. Partly to prevent suchscandals, the Ministry of Education, Culture, Sports, Science and Technology (MEXT)
and the Ministry of Health, Labor and Welfare of Japan published the Ethical
Guidelines for Medical and Health Research Involving Human Subjects, on December
22, 2014, by integrating existing ethical guidelines on clinical research andepidemiological research. The new guidelines, in particular, clarified the responsibilityof the head of research institute and principal investigator conducting research oninterventions, and sought to strengthen ethical review, monitoring, auditing, and COI
management. Meanwhile, the Association of Japanese Medical Colleges (AJMC) also
published the Guidelines for Investigator-Initiated Clinical Trials, in February 2015.
The AJMC guidelines focused particularly on research on invasive interventions using
approved drugs, and illustrated concrete steps from planning to appropriate conduct ofclinical trials (including public registration of clinical trials, data management, statisticalanalysis, data interpretation, and preparation of theses). The AJMC guidelines also deal
with COI management by using concrete examples, to assure quality and reliability ofclinical trials that allow involvement of enterprises. Subsequently, the Clinical Trials
Act came into effect as of April 2018. This law defined (1) clinical trials of
unauthorized drugs, drugs for off-label use, etc. and (2) clinical trials ofpharmaceutical companies’ drugs, etc. conducted with funding from the same
pharmaceutical companies as “specified clinical trials,” and obligated, for clinical trials
carried out to validate the efficacy and safety of the drugs, etc., a set of processes for the
conduct of the clinical trials, management of conflict of interest, measures for ensuring2

review and comments from a certified clinical trial review committee, and public
disclosure of information about funding for the clinical trials.
Japan Pharmaceutical Manufacturers Association published the Transparency
Guideline for the Relation between Corporate Activities and Medical Institutions in
2011, and its member companies began to disclose the amount of funding they provide
to medical institutions, research institutes, other types of medical organizations,foundations, and healthcare-related individuals on their websites as from 2013. In the
United States, a government agency discloses details about beneficiaries and amounts offunding from pharmaceutical companies in an “open payment program.” Last year, astir was caused when the media reported on an omission by a well-known American
physician to disclose a significant state of conflict of interest in a paper published in aworld-class international journal. In Japan, too, it is possible to do online searches tofind details about financial relations between companies and physicians. Academic
societies in the field of clinical science are expected to meet a rigorous standard of COI
management of individuals participating in development of medical guidelines and tofulfill its accountability if any discrepancies are found in the contents of their COI
disclosures.
On the other hand, research institutes are also involved in development of approaches
for prevention, diagnosis or treatment of diseases and are strengthening their efforts to
use the results of such research to grant licenses to companies or to establish university
spin-offs, and in that sense, research institutes are required to contribute to society andpublic good. If a publicly funded research institute has ownership of patents or stocks ofa manufacturing company or a distribution company, a conflict of interest may
potentially arise. As a result, if senior directors of that research institute who haveauthority over decision-making or auditing of the institute’s activities decide to givepriority to the interest of the institute, it may distort the integrity and reliability of theresearch, increasing risk to the research subjects and patients. If the research institutebecomes involved in promoting the distribution of such drugs and medical equipment
preferentially over other drugs or medical equipment, it may be perceived withsuspicion that it is trying to make wrongful gains or increase its revenues throughpublication of a thesis.
To ensure objectivity, fairness, and integrity of research institutes, the American
Association of Medical College (AAMC) and American Association of Universities
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(AAU) published guidelines in the United States regarding institutional conflict ofinterest of research institutes (hereafter called “institutional COI”) in 2002, andproposed a model policy for management of institutional COI in clinical research
involving human subjects in 2008. The National Science Foundation (NSF) (2005) andthe National Institutes of Health (NIH) (2013) each requires individual researchers todisclose institutional COI. In 2013, the International Committee for Medical Journal
Editors (ICMJE) published the Recommendations for the Conduct, Reporting, Editing,and Publication of Scholarly Work in Medical Journals, which are now used as astandard in some 6,000 medical journals around the world. ICMJE also requires
disclosure of the author’s personal conflict of interest as well as institutional COI of theauthor’s affiliated research institute in its COI disclosure form required for submission
at the time of publication of a thesis. In Japan, the Association of Japanese Medical
Colleges (AJMC) published the Guidance for Management of Institutional Conflict ofInterest in 2018, in which it emphasized the importance of disclosure and managementof institutional COI in clinical research. Considering these trends, the Japanese
Association of Medical Sciences has published a partially revised version of the
Guidelines on COI Management in Medical Research.
To ensure quality and reliability of medical research and fulfill our accountability tosociety, JDDW, which is a collaborative program of multiple gastroenterologicalsocieties, appropriately manages COI by enforcing participating members to thoroughly
abide by the Organization of JDDW’s COI guidelines, which have been revised tomaintain consistency with the Ethical Guidelines for Medical and Health Research
Involving Human Subjects and in consideration of COI management trends in andoutside Japan.
I. Purpose
Considering that the Organization is required to fulfill its social responsibility andmaintain a high level of ethical standards in all of its medical research involving
academic-industry collaboration, the Organization drew up the Guidelines on Conflictof Interest in Medical Research (hereinafter referred as the “Guidelines”). The
Guidelines’ objectives are to have the member societies and participating societies of theOrganization to appropriately manage their states of conflict of interest when engaging inmedical activities, so as to manage bias risks in the conduct of research and in the4presentation, dissemination, and education of research results, to promote soundacademic-industry collaboration while maintaining impartiality and integrity, and tofulfill its social responsibility by contributing to advancing progress in prevention,
diagnosis, and treatment of gastrointestinal diseases. Accordingly, the Organization
requires all academic societies partaking in JDDW to adopt and properly implement
COI guidelines and bylaws of their own. Moreover, the Guidelines present
basic principles on COI management to the member societies and participating societiesof the Organization and others concerned, and requires them to voluntarily and properly
disclose their states of conflict of interest as per the guidelines of the associatedacademic societies and abide by the Guidelines when making presentations for JDDW.
Needless to say, members should also observe employee rules and regulations and COI
guidelines of the research institutes, etc. they are affiliated with.
Basic concepts in COI management of research institutes and researchers are as
follows:(1) Based on the presumption of ensuring ethical, medical, and scientific integrityof medical research through academic-industry collaboration, research institutes
and researchers accepting external funding (donations or agreement-based
research funds), drugs, medical equipment and devices, and/or services fromcompanies, organizations, and individuals who have interest in the research, will
do so in an appropriate manner by concluding an agreement where necessary (toclarify consideration and/or responsibility over research outcomes). However,while the Clinical Trials Act is applicable to a researcher-led clinical study thatuses external funding obtained from a company or organization that refuses totake responsibility over the research outcomes, research institutes andresearchers must avoid entering into an agreement that will enable such afunding organization to exercise influence on the interpretation of the results of a
researcher-led clinical study or on the publication process, as such an agreement
will compromise the independence and integrity of the study.
(2) To ensure quality and reliability of the research results, research institutes andresearchers will appropriately disclose the contents of the agreement (e.g.
sources of funding, role of the funding organization, and the state of conflict ofinterest of the research institutes and the researchers), and take precautionary
measures so that their state of COI does not develop into a problem. Research5institutes and researchers will accurately state and make public such informationin research protocols, IC forms, and theses.
(3) If a question is raised by society at large about the contents of a thesis, thecorresponding author must fulfill their accountability jointly with relatedcompanies.
(4) For a research institute to ensure the quality as well as reliability and integrityof its medical research, education, and medical practice, it must keeptransparent its relations with interested parties by disclosing the institutional
COI of the research institute as well as of the ties between its senior directors
and specific companies and for-profit organizations.

II. Applicable Persons
These Guidelines apply to any of the below persons with a potential state of COI.
(1) Persons making presentations at JDDW (including non-members)(2)Officers (presidents, directors, auditors, staff and advisors) of the Organization,
chairpersons of the standing and special committees and vice chairpersons andmembers of the special committees of this Organization, and persons in charge ofsociety meetings in JDDW (chairpersons of annual meetings of member societiesand participating societies)(3) Personnel of the secretariat of the Organization(4) Spouses, first degree relatives of and persons sharing revenue or property with (1) ~(3)III. Applicable Activities
These Guidelines apply to all projects and activities of the Organization.
(1) JDDW(2) Joint seminars for medical education(3) Dissemination of information on gastrointestinal diseases to the general public or
related public outreach activities(4) Other projects and activities necessary for attaining the missions of the Organization
In particular, disclosure of the state of COI with related companies in the last three6years must be made using a prescribed form when giving presentation or making
publication for the following activities:
1. Making presentations at educational lectures, etc. organized by the Organization
during JDDW
2. Publishing articles in journals and other publicity papers
3. Work carried out by provisionally set up investigative committees and advisorycommittees
4. Making presentations at sponsored events, etc. hosted or cohosted by companies,
corporate organizations, or for-profit organizations; as for sponsored events, etc. hosted
or co-hosted by a company, the chair or moderator must also disclose his or her state ofconflict of interest.
The “medical research” related to presentations means basic or clinical medical
research, subject to ethical screening, implemented with the objective of improving
methods for preventing, diagnosing or treating illnesses via medical care, understanding
the causes and conditions of illnesses, or improving patient quality of life. Medical
research for humans includes both subject-derived specimens and data that enable
individuals to be identified, determined as per stipulations in the Ethical Guidelines for
Medical and Health Research Involving Human Subjects published jointly by theJapanese Ministry of Education, Culture, Sports, Science and Technology and Ministryof Health, Welfare and Labor (December 22, 2014).
IV. “Businesses, incorporated organizations or commercial enterprises associated withmedical research” are any business, organization and enterprise related to medical
research in any of the following ways.
(1) Having requested or jointly implemented medical research (irrespective of whether
research was financially supported or not)(2) Sharing patent rights or other rights for treatment methods, medicines, equipment orother material evaluated in medical research(3) Having provided medicines, equipment or other material used in medical research
free of charge or at special advantageous prices(4) Having aided, donated to or otherwise supported medical research(5) Having provided unapproved medicines, medical equipment or other material for
medical research7(6) Having funded endowed chair, etc.
V. Matters for COI Disclosure and Disclosure Standards
Covered in this section are individuals required to make COI disclosure as well assuch individuals’ affiliated research institutes or the heads of the affiliated research
institutes or divisions with whom the individuals, now or in the past, were in a relationof a co-investigator or research collaborator.
For the personal COI disclosure, applicable persons must, using a prescribed form,
make a disclosure pertaining to the following activities (1) ~ (9) when they exceed thedisclosure standards. Monetary amounts that must be reported in personal disclosure on
COI shall be determined by the COI guidelines and bylaws of the associated JDDW
member societies and participating societies. If a presentation is for an educational
lecture or other event planned by JDDW, monetary amounts that must be reported shallcomply with the standards set by the Organization. The Organization stipulates the
below standard amounts for matters to disclose.
(1) For officers and advisors of businesses, incorporated organizations or commercial
enterprises associated with medical research (hereinafter referred to as “businesses,
incorporated organizations or commercial enterprises”), remuneration from any one
business, incorporated organization or enterprise that is equal to or greater than one
million JPY a year.
(2) Regarding stock ownership, annual profit (total of dividends and profits from sales)from stock of any one company that is equal to or greater than one million JPY or
constitutes a quantity equal to or greater than 5% of all concerned shares.
(3) Patent royalties from businesses, incorporated organizations or commercial
enterprises that are equal to or greater than one million JPY per year per patent.
(4) Daily allowances (lecture fee, etc.) paid by any one business, incorporatedorganization or commercial enterprise to a researcher to attend (speak, give advice,
etc., at) a meeting as compensation for time and labor that total or exceed five
hundred thousand JPY in a year.
(5) Manuscript fees paid by any one business, incorporated organization or commercial
enterprise for contributed articles for pamphlets, articles on round-table discussions,etc. that total or exceed five hundred thousand JPY in a year.
(6) Research expenses for medical research (joint research, consigned research, clinical8

trials, etc.) covered by any one business, incorporated organization or commercial
enterprise, regarding which the total contracted amount for research that thereporting individual essentially has discretion over, total or exceed one million JPY
in a year.
(7) Scholarship donations provided by any one business, incorporated organization orcommercial enterprise to the reporting individual or to the course, field, or researchlab of the reporting individual, regarding which the total donated amount that thereporting individual essentially has discretion over, total or exceed one million JPY
in a year.
(8) The reporting individuals are participating as organizers, presenters, or lecturers incourses sponsored by a business, incorporated organization or commercial
enterprise, and the total sponsored amount that the reporting individuals essentiallyhave discretion over its use total or exceed one million JPY in a year.
(9) Travel support or gifts directly unrelated to research, study or diagnosis/treatment
provided by any one business, incorporated organization or commercial enterprisethat total or exceed fifty thousand JPY in a year.
The “appointment as a board member or advisor of a company or for-profit
organization” in (1) above applies when a researcher affiliated with a research instituteassumes the office of a board member or advisor of a specific company under contract
to regularly and continuously work for that company and receive remuneration. If
advice, etc. is given at the request of a company in discontinuous, isolated instances, theCOI disclosure should be made in accordance with (4) “per diem, honorariums, etc. paidby a company or for-profit organization for the time and energy spent by a researcher toattend or give a presentation or advice at a meeting” above.
In addition, as for (6) and (7) above, COI disclosure is necessary for all individuals if
research expenses or scholarship grants were provided from a related company ororganization to the department (course or field) or laboratory to which the reporting
individual is affiliated with. It is also clearly indicated that the threshold for suchdisclosure of research grants or scholarship grants from related company or organization
is based on the amount that the reporting individual essentially has discretion over theiruse. The specific methods for disclosure and publication will be as stipulated in theprescribed forms.
As for institutional COI disclosure, if the person required to make COI disclosure is9

or was in a relation of a co-investigator or research collaborator either with the research
institute the person is affiliated with or with the head of the affiliated research instituteor division (e.g. university, hospital, faculty, center, etc.), now or in the past, and if sucha relation may have an influence on the Organization’s activities that the person is
involved with, then that person is required to make the institutional COI disclosureusing the prescribed form for the items shown below. The amount set for each item of
institutional COI disclosure is based on the following standards:(1) As for research grants from a company or organization, the research grants areawarded by one company or organization to the research institute or division or thehead of the research institute or division the individual is affiliated with and thetotal amount of the grants that the research institute or division or its headessentially has discretion over their use is ¥10 million or more in a year.
(2) As for donations from a company or organization, the donations are awarded by
one company or organization to the research institute or division or the head of theresearch institute or division the individual is affiliated with and the total amount of
the donations that the research institute or division or its head essentially has
discretion over their use is ¥2 million or more in a year.
(3) In addition, if the research institute or division or the head of the research instituteor division the individual is affiliated with owns a company’s stocks (5% or moreof the issued shares of the company), has received patent royalties from a company
or organization, or has any investment outstanding in a company or organization,these must be disclosed.

VI. Notice on Medical Research and, in Particular, Invasive Intervention Research(1) Clinical trials for approval of new drugs must be carried out in compliance with theGood Clinical Practice (GCP). A researcher-led large-scale intervention study using
a drug that has already been put on the market is conducted for the purpose ofverifying efficacy and safety of the drug, promoting appropriate use of the drug inthe clinical setting, and providing important information and evidence for standard
treatment, and such research must be conducted based on ethical guidelines. As forthe latter studies on already marketed drugs, it has been pointed out that companies,
in view of promoting sale of their products, have a high level of interest in
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supporting post-marketing clinical studies by way of funding or providing labor andservices, and that this tends to increase bias risk in such studies and the potential forscandals. Presenters at JDDW must abide by the “Declaration of Helsinki,” theEthical Guidelines for Medical and Health Research Involving Human Subjects, theClinical Trials Act, COI guidelines, the AJMC Guidelines for Investigator-InitiatedClinical Trials, and related laws and regulations. Presenters at JDDW are required
to pay special attention to protecting the human rights and lives of research subjects
when conducting any intervention study.
(2) When presenters at JDDW voluntarily conduct a researcher-led invasive
intervention study, oftentimes they will have opportunities to use external funding,drugs, medical equipment and devices, and services of experts with technicalknowledge and skills, provided by companies, organizations, and individuals.
Where such clinical research is based on an agreement and has the institute of themember’s affiliation acting as the contact point, such research should be carried out
as joint research or commissioned research, the responsibility of the fund provider
on the research outcomes should be made clear, and any restrictions on the use ofsuch funds, drugs, medical equipment and devices, and services, considerations,and division of roles should be clearly written down. On the other hand, where
there are no restrictions on the use of scholarship grants or research funds,presenters at JDDW can accept such scholarship grants or research funds for use in
a researcher-led clinical study. If external funding for joint research, commissioned
research, or unlimited grant is to be used for intervention research and if suchfunding is equal to or above the Organization’s prescribed COI threshold,presenters at JDDW must clearly indicate the provider of such a funding source andsuch provider’s role in the clinical research, on the principle of making suchinformation public and ensuring transparency.
(3) Making results of medical research widely available for use by healthcare
professionals, patients, and others benefits the public. Therefore, when conducting
medical research involving human subjects, presenters at JDDW must register the
research on a public database and publish the results of the research, in principle, inthe form of a thesis.
(4) When preparing and publishing a thesis, public relations material, or publication,
presenters at JDDW must clarify authorship, bearing in mind international
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standards on authorship, namely, the ICMJE Recommendations. Non-author
contributors, such as medical writers, statisticians, and other contributors, theiraffiliation, and sources of funding should be mentioned in the “Acknowledgement.”
In addition, if any interested party is providing labor or services based on anagreement to assist in the conduct of clinical research or in the preparation of athesis and their involvement is anticipated to influence the contents of the thesis,
the roles played by each of such interested parties must be clearly stated in thesection “Role of the funding source” to ensure transparency. Existence of any otherforms of interest must also be stated and disclosed. In addition, if suspicion of any
wrongdoing is raised by a third party, both the principal investigator and thecompanies concerned must jointly fulfill their accountability.
(5) When a researcher affiliated with a company is dispatched to work in a research
institute as a researcher, graduate student, part-time lecturer, and the like, and sucha researcher is to give a presentation on the research results or publish the research
results in a thesis, such a researcher must also clearly state the name of thecompany he or she is affiliated with.
(6) If a person who had been working for a company leaves his or her job to work for a
research institute and such a person is to present or publish results of research thatpertains to the company he or she had been working for, such a person must clearlystate the name of such a company alongside the name of the research institute he or
she is currently affiliated with, for a period of five years after leaving the company.
VII. Situations to Avoid Because of Potential Conflicts of Interest
1. Situations All Applicable Persons Must Avoid
The dissemination of medical research results (such as presentation at academic
meetings), which contribute significantly to raising the quality of healthcare in ourcountry, should be based purely on scientific evidence and conclusions, and publicbenefit. In reporting medical research results and interpretations, applicable persons
must not be influenced by the selfish intentions of individuals or businesses that provide
funds for the said medical research (such as unjust inducement of transactions or sale)and must not sign any contracts with said parties in which such influences cannot be
avoided.
Specifically, the following should be avoided:12

(1) Receiving out-of-contract incentive payment for acting as an intermediary for or
introducing human subjects in clinical studies(2) Receiving out-of-contract incentive payment for collecting cases within a
specified period of time(3) Receiving out-of-contract performance-based payment for achieving specified
research results
2. Situations Principal Investigators and Research Representatives Must Avoid Relating
to Medical Research
Principal investigators and research representatives who plan and manage medical
research, particularly clinical testing and trials (including those conducted to obtaingovernment approval for drugs and medical equipment), must be selected from among
researchers who are socially recognized to have no serious state of COI in relation toeach of the items shown below (in other words, having relatively little overlapping
interest with the provider of funding), and maintain such status after selection.
Specifically, the principal investigator and research representative, who have a duty
to appropriately disclose monetary relations with the provider of funding, should takeparticular note of and avoid matters indicated below.
(1) Possession of stock of the person or business providing funding for the medical
research or is a director, etc. of such a business(2) Acquisition of patent royalties or rights for the drug, therapy, inspection method, etc.
that is the subject of the research(3) Receiving of expenses for travel, accommodation, etc., other than for the legitimate
reasons of participating in academic meetings, from the person or company
providing funding for the research(4) Acquisition of money and/or gifts outside legitimate remuneration for the time andefforts expended on the research(5) A situation where a researcher affiliated to a company who is dispatched to work in
a research institute and participate in the research as a researcher, part-time lecturer,
or graduate student, engages in such an inappropriate act as concealing the name of
the researcher’s company in the research plan or when presenting or publishing the
research results(6) A situation where the person or company providing funding for the research can13exercise its influence over the collection, storage, statistical analysis, interpretation,or judgment of the research data
(7) Entering into an agreement that allows the provider of funds or interested company
to exercise influence on decisions to present research results at a scientific meetingor publishing research results in a thesis
However, researchers that meet the criteria (1) ~ (4) above may serve as principal
investigators and research representatives in medical research that has very importantsocial significance provided that the said researchers are indispensable towards planningand managing the said medical research and the fairness, neutrality and transparency of
their decisions and actions can be unquestionably ensured. In any event, accountability
to society must be fulfilled.
If there is a possibility that a contract with a company contains matters described in(5) or (6) above, details on the role and involvement of the person or company
providing funding for the research must be disclosed at the end of the thesis whenpublishing the research results.
VIII. Method of Implementation
1. Obligations of Presenters at JDDW
Presenters at JDDW must, upon presenting medical research results, etc., properly
disclose in writing using the specified form as per the guidelines, etc., on COI of theassociated academic society, any state of COI with regard to the said medical research.
And, for educational lectures and other events planned by this Organization, presentersmust properly disclose any state of COI with regard to the said medical research using
the specified form as per the bylaws on COI of this Organization. If a violation of the
COI guidelines of the associated academic society is indicated in the presentation ofresearch, the Board of Directors of this Organization shall contact the respective society
and demand appropriate action. If a violation of these Guidelines is indicated in thepresentation at educational lectures and other events planned by this Organization, theBoard of Directors of this Organization shall instruct the committee with jurisdiction
over COI (hereinafter shortened as “COI Committee”) to weigh in on the matter andshall take appropriate action based on the Committee’s recommendation.

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2. Obligations of Officers, Etc.
The officers (president, directors, auditors, staff and advisors), chairpersons ofstanding committees and special committees, vice chairpersons and members ofstanding committees of this Organization, the persons in charge of academic
conferences of societies participating in JDDW (annual chairpersons of member
societies and participating societies) and secretariats have important roles andresponsibilities in all projects and activities related to JDDW. Upon assuming such
positions, these persons must submit in writing using the specified form (Form 2),
personal disclosures of any state of COI with regards to the said related projects andactivities (covering the period of three years up to the year prior to the year of
appointment). Moreover, if any new state of COI arises in the year of assuming the said
position or thereafter, they must provide additional disclosure addressed to the President,
using Form 2, within eight weeks of such new occurrence of COI. The Board of
Directors must engage in the appropriate personnel management of board members, etc.
in order to maintain fairness and impartiality of the said related projects and activities.
3. Roles of the COI Committee
In the event that a serious state of COI arises with an officer or presenter in projects
or activities of this Organization, or an officer or presenter inappropriately reported COI
in the personal disclosures, the COI Committee must notify the concerned person to that
effect and instruct that person to follow the necessary procedures. Moreover, if
suspicion is indicated over a personal disclosure on COI within an academic society, the
COI Committee shall mandate the concerned society to appropriately manage the COI.
4. Roles of the Board of Directors
The Board of Directors must report to the COI Committee a serious state of COI or
inappropriate personal COI disclosure made by an officer or other persons in theexecution of the projects and activities of this Organization, and based on theCommittee’s recommendation, order the concerned person to improve the situation ortake corrective actions.
The Board of Directors must, as an organization, appropriately and promptly deal
with any suspicion of wrongdoing related to the state of conflict of interest of its
officers and of any presenters at educational lectures and other events organized by theOrganization, and if, as a result of an inquiry, it is deemed that the suspicion or15allegation is unfounded, the Board of Directors must fulfill the Organization’s
accountability to society and as for the allegation made against the particular individualin question, make efforts to regain and secure trust in that individual by issuing theOrganization’s views and statements to society (e.g. by publishing such views andstatements on its website). On the other hand, if such suspicion or allegation is validated,the Board of Directors, needless to say, should disclose the results of the fact-finding
inquiry and communicate the Organization’s measures against recurrence.
5. Roles of Chairpersons of Member Societies and Participating Societies
Persons in charge of academic conferences of societies participating in JDDW
(annual chairpersons of member societies and participating societies) must verify thatthe presenters (including non-members) reporting medical research findings at theannual meetings have appropriately completed their COI disclosure using a prescribed
form. In particular, when a presentation is to be made on the results of research in which
there is involvement of a company, it is the role of the chairpersons to provide anenvironment for the audience to judge whether or not the presentation of the contents of
the research is being done in an impartial and equitable manner. The chairpersons may
take steps to debar delivery of any presentation that runs counter to the Guidelines orthat does not have COI disclosure. In such case, the chairpersons are required topromptly notify the candidate presenter thereof and explain the reason for said action.
The chairpersons may refer such cases to the COI Committee, and based on the reportof the COI Committee, instruct steps to be taken to remedy the situation.
As for breakfast seminars, luncheon seminars, satellite symposiums hosted or
co-hosted by a company or for-profit organization, the chair or moderator must also
disclose to the audience the names of the companies and organizations he or she has
relations with, using slides in a similar manner as the presenters.
6. Institutional COI management of the Organization
Cases of institutional conflict of interest have been reported where senior directors(e.g. director general, director, etc.) in a relation of mentor-mentee, colleague, friend, or
relative with the researcher in question, have been more liable to directly or indirectly
influence medical research, particularly with regard to the conduct of clinical research
involving human subjects and publication of those results. For example, if an academic
16society or its senior directors have received substantial donations from specificcompanies or own stocks of, or receive royalties from, specific companies, it can be
anticipated under such circumstances in regards to the research results as well as the
publication of the results that it would be more challenging to guarantee integrity,
objectivity, and independence from the point of view of COI assessment and ethics. The
Board of Directors must centrally manage amounts paid by companies, corporate
organizations, and for-profit organizations to the Organization by recording in eachaccounting year the number of instances of payments made and their total amounts foreach company in each category of (1) donations and (2) income from academic
conferences and meetings (e.g. company-related seminars and symposiums), andappropriately disclose such amounts as institutional COI.
7. Other
The chairpersons and members of other committees must verify that the projects andactivities they are respectively involved in, are implemented in compliance with these
Guidelines and, in the event a violation of these Guidelines arises, must promptly
examine ways to improve that situation. In dealing with these matters, they may seek
the counsel of the COI Committee and, based on the Committee’s recommendation, theBoard of Directors may order concerned persons to improve the situation or takecorrective actions.
IX. Response to Request for COI Disclosure
If a request is made from outside the Organization (e.g. the mass media, citizens’
groups, etc.) for disclosure of the state of COI of any applicable person and such arequest can be considered reasonable, the Board of Directors will refer the matter to the
COI Committee, which will look into the matter by conducting a fact-finding
investigation while protecting the personal information of those concerned in the
shortest time possible. After receiving a report from the COI Committee, the Board of
Directors will promptly respond to those parties that have made the request fordisclosure.
X. Action against Violators of These Guidelines and Accountability
1. Action against Violators of These Guidelines
17

The Board of Directors of this Organization has the authority to discuss violations ofthese Guidelines. In event of acts committed by officers or others of this Organization,
the Board of Directors may seek the counsel of the COI Committee. If the Committee’s
recommendation and further discussions by the Board deem that the said act constitutes
a serious failure to comply with these Guidelines, the Board may take necessary actionsin accordance with the degree of the violation including but not limited to penalties.
Moreover, in the event of acts by presenters at JDDW that violate these Guidelines, theBoard of Directors may notify the associated academic societies and require them totake necessary actions with the violator as per their rules and regulations.
As for violation by presenters at educational lectures and other events organized bythis Organization, necessary actions may be taken in accordance with the rules andregulations of associated academic societies. The Board of Directors deliberating on
actions against the violator shall request participation of responsible officers fromassociated academic societies at such a meeting of the Board, as necessary, to allow
persons from associated academic societies to take part in the deliberations.
2. Petition for Appeal
Persons subject to penalties may petition for an appeal by filing with the secretariat ofthis Organization an appeal addressed to the President, within seven days of receiving a
notification of the decision of the Board of Directors.
Promptly upon accepting this petition, the president of this Organization shall form aboard for reviewing the petition (Review Board), entrust that committee with reviewing
the concerned matters, discuss the committee’s report with the Board of Directors andnotify the petitioner of a final decision.
3. Process for reviewing a petition(1) Upon receiving the petition for appeal, the President must promptly establish acommittee for the review of the petition (Review Committee). The Review
Committee will consist of several persons from within the Organization and one ormore members from outside the Organization, all of whom are appointed by the
President. The committee members will elect the chair of the Review Committee
from among themselves.
The members of the COI Committee may not concurrently serve on the Review
Committee. The Review Committee will hold its meeting to deliberate on the18petition within 30 days of receipt of the petition.
(2) The Review Committee may, where necessary, listen to the opinions of thechairperson of the COI Committee related to the petition and of the petitioner.
(3) Except where special circumstances exist, the Review Committee will prepare its
report on the review of the petition and submit it to the Board of Directors within amonth of the first committee meeting held for deliberation.
(4) The Board of Directors will make a final decision on the petition based on therecommendation of the Review Committee.
XI. Accountability to Society
If disclosure of COI information of any applicable person is necessary to fulfill socialand moral accountability, the Board of Directors will, after adopting a resolution,
disclose or make public, to the extent necessary, such information within and outside of
the Organization to fulfill its responsibility and accountability to society. The individual
to whom the COI information pertains will be given opportunity to express opinions to
the Board of Directors or the director entrusted with the decision, except where theurgency of disclosing the information or making the information public precludes thepossibility of listening to the opinions of the individual concerned.
XII. Coordination with Related Societies
This Organization shall coordinate closely with JDDW member societies andparticipating societies, and provide opportunities to share with them information onreviews of these Guidelines and bylaws.
XIII. Amendments to These Guidelines
This Organization may periodically review and amend these Guidelines in line withsocial factors, the establishment of or amendment to laws and regulations governing
cooperation between industry and academia, and the various situations surrounding
medical care and research.
XIV. Date of Enforcement
These Guidelines shall come into force as of April 19, 2013.
These Guidelines shall be revised on July 28, 2015 to take effect as of January 1,
19

2016.
These Guidelines shall be revised on March 2, 2018 to take effect as of the same day.
These Guidelines shall be revised on February 24, 2021 to take effect as of the same
day.

20

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Appendix 1. Definitions
In preparing the definitions of terms related to medical research, reference was madeto the Japanese translation, by Japan Medical Association, of the Declaration of
Helsinki and to the Ministry of Health, Labour and Welfare’s Ethical Guidelines for
Medical and Health Research Involving Human Subjects. Efforts were also made toensure compatibility between these documents and the contents of the Guidelines asmuch as possible.
1. Medical research involving human subjects
Activity involving human subjects (including specimens and information acquired
from them) carried out for the purpose of obtaining knowledge contributing to maintainand promote national health and improving the prognosis and quality of life of patients,
through identification of causes of diseases (including the frequency and distribution ofvarious health-related incidents and factors affecting them), understanding ofpathological conditions, prevention of diseases, and verification and improvement of theeffectiveness of diagnostic and therapeutic methods in healthcare.
2. Clinical research
Medical research listed below that is conducted for the purpose of improving methodsof prevention, diagnosis, and treatment of diseases in healthcare, of understanding thecauses of diseases and their pathology, and of improving the quality of life of patients,
and is subject to ethical screening.
(1) Clinical research that involves interventions and that is related to the use ofdrugs or medical equipment or devices in preventive, diagnostic, or therapeutic
method(2) Clinical research that involves interventions (other than (1) above)(3) Clinical research using samples and the like and does not involve interventions.
Epidemiological research (scientific research to elucidate the frequency anddistribution of various health-related incidents in a clearly defined humanpopulation and factors affecting them; also called observational study) is
excluded.
3. Clinical trial
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Research involving human subjects designed and conducted according to appropriatescientific principles for the purpose of evaluating clinical effectiveness of drugs(including vaccines and biological drugs), radiation therapies, psychotherapies,
surgeries, medical equipment and devices, complementary and alternative medicine, etc.
Clinical studies can be classified according to their objectives (General Considerations
for Clinical Trials) as follows: (1) human pharmacology studies, (2) exploratory
therapeutic studies, (3) confirmatory therapeutic studies (comparative studies toestablish efficacy, randomized parallel dose response studies, clinical safety studies,studies of mortality/morbidity outcomes, large simple trials, comparative studies), (4)studiesontherapeuticuse(comparative

effectivenessstudies,studiesofmortality/morbidity outcomes, studies of additional endpoints, large simple trials,
pharmacoeconomic studies)
4. InvasivenessTo cause stimuli exceeding those which research subjects may experience in their
daily lives or injuries or distress to research subjects’ body and/or mind by conducting aprocedure for investigational purpose, such as puncture, incision, administration ofdrugs, irradiation, questions related to the subject’s mental trauma, etc. Of various typesof invasiveness, one causing minor effect on the research subjects’ body and/or mind iscalled “minor invasiveness.”
5. Intervention
A practice, conducted for investigational purposes, to control the presence of, or thelevel of the presence of, factors influencing various human health-related events(including activities to maintain and promote health and preventive, diagnostic, andtherapeutic medication and examinations). Intervention may also include medical
techniques beyond usual medical practice that are conducted for investigational
purposes.
6. Research subject
Any individual on whom research is conducted (including individuals asked to beenrolled in the research) and any individual from whom existing specimen or
information is obtained for use in the research.
7. Investigator, etc.
Principal investigator and other related persons engaged in the conduct of research(including collecting and providing samples or data at an organization engaging in such
22

activities). Individuals who do not belong to research implementing entities and areengaged only in the provision of existing samples or data or individuals who have beencommissioned by another to take part in a portion of the research are excluded.
8. Principal investigator
Any individual engaged in the conduct of research, such as writing the research
protocol, as well as in overseeing the research at the research implementing entity
he/she belongs to.
9. Research representative
Any individual who, in addition to writing the research protocol and otherwise
engaging in the conduct of research as a principal investigator, oversees joint researchwith other entities.
10. Head of the research implementing entity
A representative of an incorporated entity, a head of an administrative organ, or anindividual business owner who carries out research and with whom the final
responsibility for the research rests.
11. Sponsor
Any individual, company, institution, or organization that has responsibility over the
initiation and management of clinical research and over funds for the research.
12. Institutional COI
A state where an individual making the COI disclosure is a co-investigator or
research collaborator with the research institute the individual is affiliated with or withthe head of the affiliated research institute or division (e.g. university, hospital, faculty,
center, etc.), and as a result, it can be anticipated that such relations may influence theactivities that the individual is involved in.
13. Funder, funding agency
Any individual, company, an incorporate entity, institution, or organization thatprovides the necessary funds for conducting clinical research.
14. Serious Adverse Event
Any adverse event that (i) results in death, (ii) is life-threatening, (iii) requires
hospitalization or prolongation of hospitalization; (iv) results in persistent or significant
disability or incapacity; or (v) causes congenital anomaly.
15. Unexpected serious adverse event
Of the above-defined serious adverse events, any event that is not listed in the23research protocol, the informed consent document, etc. or even if it is listed, is not listed
at the specificity or severity stated therein.
16. Intervention research
Invasive clinical trial involving human subjects. Clinical trial conducted to collectdata necessary for making an application for authorization of manufacture and sale of
new drugs is called “chiken.” Intervention research designed by a research to verify theclinical efficacy and safety of approved drugs is called “researcher-led clinical study.”
17. Randomized controlled trial
Large-scale comparative clinical trial that enables objective assessment of therapeutic
effect by eliminating arbitrary bias in the assessment.
18. Research implementing entity
Any incorporated entity, administrative organ, or individual business owner who
carries out research. Those commissioned to take part in a portion of the research, suchas storage of samples and data and statistical processing, are excluded.
19. Collaborative research implementing entity
A research implementing entity collaboratively conducting research in accordancewith the research protocol. It includes entities to collect samples and data from researchsubjects for the research and to provide such samples and data to other research
implementing entities.
20. Informed assent
Informed assent is given by a research subject who is objectively deemed incapableof giving informed consent. After such a subject is given an explanation, in language
understandable to the subject, and made to understand about research that is about to becommenced or continued, informed assent may be given by the subject to express
agreement to the commencement or continuation of the research.
21. Informed consent
Consent given voluntarily by a research subject or his or her legally acceptable
representative (hereinafter collectively referred as “research subject, etc.”) with respect
to whether the research may commence or continue (including handling of samples anddata), having enough understanding after receiving adequate prior information withregard to the purpose and significance of the research, research methods, burdens on the
research subjects, and predicted results of the research (including both risks andbenefits).
2422. Legally acceptable representative
Any individual expected to speak for the will and benefit of a research subject when
the research subject is considered objectively unable to give informed consent. Such anindividual can give informed consent to investigators, etc. on behalf of the researchsubject. When such a legally acceptable representative is speaking on behalf of any
deceased research subject, the legally acceptable representatives for both living anddeceased research subjects will collectively called “legally acceptable representatives,etc.”
23. Academic-industry collaboration
Academic-industry collaboration between a research implementing entity and any
company, incorporated organization, and/or for-profit organization (hereinaftercollectively referred as the “company, etc.”) in medical research, including:(1) Joint research: research conducted by the research implementing entity and thecompany, etc., with each contributing research expenses and researchers(regardless of whether or not payment will be made for the research)(2) Commissioned research: Agreement-based research on therapies, drugs,
equipment and devices of the company, etc.
(3) Technology transfer: Commercialization by the company, etc. of results ofresearch conducted by the research implementing entity, including the use ofpatents and other rights(4) Technical guidance: Technical guidance provided by researchers from theresearch implementing entity or research and development of the company, etc.
carried out by researchers from the research implementing entity(5) Venture business originating in research implementing entity: Establishment of aventure business based on the results of research conducted by the research
implementing entity and with the support of the research implementing entity(6) Donation: Research grant from the company, etc. to the research implementing
entity without any restriction on the use of the grant(7) Endowed chair: Chair established using donations from the company, etc. to theresearch implementing entity for the purpose of promoting research
24. Monitoring
Any act of overseeing the progress of research, and of determining whether a clinical
trial is being conducted in compliance with the research protocol in ways that guarantee
25the ethical and scientific integrity of the trial, in order to ensure that the clinical trial isproperly conducted. Such an act is performed by an individual appointed by theprincipal investigator (research representative).
25. Audit
Any examination, performed by an individual appointed by the principal investigator(research representative), to determine whether a clinical trial has been properly
conducted, in order to assure the reliability of results of the clinical trial.

26

February 24, 2021

Organization of Japan Digestive Disease Week
“Bylaws of the Guidelines on Conflict of Interest in Medical Research”
The Organization of Japan Digestive Disease Week adopted the “Guidelines on Conflictof Interest in Medical Research” (hereinafter referred to as “the Guidelines”) in order tofairly manage conflicts of interests (COI) of JDDW officers and presenters. The
Guidelines were created based on the JDDW conference guidelines to maintain thefairness and neutrality of medical research, ensure the transparency and social
accountability of presentations, and promote proper collaboration on medical research
between industry and academia. The Bylaws of the Guidelines on Conflict of Interest in
Medical Research (hereinafter referred to as “these Bylaws”) are stipulated as follows tofacilitate proper and efficient implementation of the Guidelines.
Article 1. COI Reporting by Presenters at JDDWWhen submitting an abstract on medical research at JDDW, all presenters andlecturers must disclose to the secretariat of the affiliated academic society, all financial
relationships of self, a spouse, first degree relatives and other dependents withbusinesses or commercial enterprises associated with the medical research held over the
past three years. The COI also has to be disclosed at the time of presentation using aslide or poster as per the bylaws of the affiliated academic society.
Prior to presenting or lecturing at educational lectures and other events planned bythis Organization, the lead presenter or lecturer must disclose COI to this Organization
using Form 1 as per reporting rules stipulated by this Organization, if a COI exists forany of presenters or lecturers, including co-presenters/co-lecturers. Similarly, the COI
must be disclosed at the time of presentation as per the rules of this Organization.
Presenters and lecturers must disclose such COI using Form 1-A in the first slide (thatimmediately after the slide that introduces the title, presenter/lecturer, etc.) of theirpresentations or lectures. Lead presenters must similarly disclose their COI situation
using Form 1-C even if no such COI exists.
For poster presentations, COI must be disclosed using Form 1-B at the end of thepresentation.
Article 2. Submission of Disclosure Statement on COI by Officers, Committee
27

Chairpersons, Vice Chairperson, and Members, Chairpersons of Participating Academic
Societies, Etc.
Clause 1
The officers (president, directors, auditors, staff and advisors), chairpersons ofstanding committees and special committees, vice chairpersons and members ofstanding committees of this Organization, the persons in charge of academic
conferences of societies participating in JDDW (the annual chairpersons of member
societies and participating societies) and members of secretariats of JDDW member
societies and participating societies must prepare and submit to the president of thisOrganization personal disclosures on COI over the past three years immediately prior toassuming their post and every year thereafter, regarding “V. Matters for COI Disclosure
and Disclosure Standards” indicated in the “Guidelines on Conflict of Interest in
Medical Research,” using Form 2. The chairpersons of member societies andparticipating societies must prepare and submit to the president of this Organization
personal disclosure on COI over the past three years immediately prior to assuming
their post at the time the Executive Committee is launched each year, using Form 2.
Submission is unnecessary if the personal statement on COI has already been received.
These personal disclosure statements on COI are limited to the relationships withbusinesses, incorporated organizations or commercial enterprises that are associatedwith projects or activities of this Organization.
Clause 2
Personal disclosure statements must report all matters stipulated in Article V. Matters
for COI Disclosure and Disclosure Standards of the Guidelines as COI in Form 2. The
standard amounts stipulated in Article 2 of these Bylaws apply to all disclosure
requirements and must be itemized as per Form 2. The disclosure should cover a periodof the last three years prior to the year of appointment, and a period of the last three
years for each year thereafter, and the calculation period must be included in Form 2.
Officers and others of this Organization are required to report any new COI that arises
during their current term no later than eight weeks from such event, using Form 2.
Article 3. Handling of Personal Disclosure on COI
Clause 128Personal disclosure statements on COI that are submitted at the time of abstract
registration for presentation at JDDW must be retained under the strict supervision of
the chairpersons of the respective societies for a period of two years. Personal disclosurestatements on COI that are submitted for an educational lecture or other event plannedby this Organization must be retained under the strict supervision of the president of thisOrganizations for a period of two years. Similarly, documents with COI information on
persons who have finished the terms as officer or committee member of thisOrganization or persons whose appointment as officer or committee member iswithdrawn, must be retained under the strict supervision of the president of thisOrganization for a period of two years from the date that the final term ends or theappointment is withdrawn. In addition, personal disclosure statements that are submitted
by the secretariats of JDDW must be retained under the strict supervision of thechairperson of JDDW for a period of two years after the date of retirement including
incumbent periods. At the end of the two-year period, documents shall be promptly
deleted and destroyed under the strict supervision of the president of this Organization.
However, if document deletion or destruction is deemed inappropriate by the presidentof this Organization, a necessary extension may be granted to allow deletion anddestruction of the COI information of the concerned person to be kept on hold. The COI
information of persons in charge of academic conferences (annual chairpersons ofmember societies and participating societies) shall be handled in the same way as that ofofficers of this Organization.
Clause 2
The directors and officers of this Organization may use as necessary the COI
information as permitted by these Bylaws in order to determine the existence or degreeof COI between concerned persons and activities of JDDW, manage the said
information, and take necessary action based on the said determination. The COI
information must not be used beyond the intended objective of use and must not be
disclosed to anyone other than those who require the said information for the said
objective (obligation of confidentiality).
Clause 3
With the exception of the cases described in Article 4 Clause 2, COI information
29

shall not be disclosed in principle. COI information may within the necessary scope be
disclosed and released within and outside this Organization after discussion andapproval by the Board of Directors, if and when necessary towards demonstrating thesocial and ethical accountability of this Organization in pursuit of activities of thisOrganization or its committees. However, it is not precluded in this case that a special
director is tasked with handling the concerned issue and bases any decisions made on
the advice of the COI Committee. In such case, the concerned person whose COI
information is to be disclosed or released may express his/her opinions to the Board of
Directors of this Organization or the director tasked with making the said decision. This
is not, however, imperative if disclosure or release is urgent and there is not adequate
time to hear the opinions of the concerned person.
Clause 4
If a request for disclosure (including legal requests) is made to a specific officer, thepresident of this Organization shall consult the COI Committee, and given an adequate
reason the Committee would respond in appropriate manner while protecting thepersonal information of the concerned person. If deemed that the matter cannot be
handled by the COI Committee, the president of this Organization shall form a COI
Inquiry Commission consisting of the one special director tasked with handling theconcerned issue, a few participants of this Organization and one or more outside persons.
The said COI Inquiry Commission shall convene no later than thirty days from the datethat the request for disclosure is received, and shall provide a response as soon as
possible.

Article 4. Conflict of Interest Committee
The president of this Organization shall form a Conflict of Interest (COI) Committee
consisting of a few Organization members and shall appoint a person to chair thecommittee. The members of the COI Committee are obliged to keep confidentiality of
COI information they handle as committee members. The COI Committee shall manage,
in coordination with the president of this Organization and in line with the Guidelines
and these Bylaws, the COI of members so as to prevent development of serious
situations, and shall deal with violations. The COI Committee shall, in the event of30

serious COI associated with projects or activities of this Organization or inappropriate
disclosure of COI, notify the concerned person to that effect either through theassociated academic society or directly, and instruct that person to take necessary action,i.e., to correct their personal disclosure statement. The reporting and handling of COI
information shall comply with the stipulations of Article 3.
Article 5. Action against Violators
Clause 1
In the event that social or ethical issues are suspected or arise in the personalstatement on COI submitted by a candidate presenter for JDDW, the COI Committee
shall contact the associated academic society and request appropriate action to be taken
in order to demonstrate the social accountability of this Organization. Moreover, theBoard of Directors of this Organization may take appropriate action if acts by concerned
persons significantly damage the social responsibilities of this Organization.
Clause 2
The chairperson of the COI Committee must, in the event suspicion is indicated overa personal disclosure on COI of an officer, committee chairperson, a committee member
with a duty to submit personal statement on COI, or any candidate to any of the above
posts prior to or after assuming the said post, notify the president of this Organization
thereof in writing. The president of this Organization must then promptly convene theBoard of Directors, which must then determine whether to acknowledge or disavow thesaid indication. If the said indication is acknowledged, the president must notify theparent society that nominated the said person of the issue and, after sufficient discussion
with the said society, take appropriate action, i.e., demanding that the nomination bewithdrawn and membership revoked.
Article 6. Action against Violators of the Obligation of Confidentiality
Personnel of the secretariat of this Organization have the same obligation ofconfidentiality stipulated in Article 3 Clause 2 for the directors and concerned officersof this Organization with regards to COI information of individuals learned in thecourse of managing COI cases. The Board of Directors may punish concerned persons
and secretariat personnel who deliberately release COI information to outsiders by31

expulsion and dismissal etc. without following proper procedure.
Article 7. Amendments to the Bylaws
These bylaws may need to be amended in part in line with social factors, amendment
to laws and regulations governing cooperation between industry and academia, etc. The
Board of Directors may seek the counsel of the COI Committee with regard to reviewsof these Bylaws and determine amendments based on their recommendations.
Supplementary Provisions
Article 1. Date of Enforcement
These Bylaws shall come into force as of April 19, 2013.
Article 2. Amendments to These Bylaws
These Bylaws shall be reviewed, as a rule, every few years to keep pace with social
factors, the establishment of or amendment to laws and regulations governing
cooperation between industry and academia, and the various situations surrounding
medical care and medical research.
Article 3. Special Provision for Officers, etc.
Persons serving as officers or other posts of this Organization at the time these Bylaws
go into force shall promptly submit reports, etc., in compliance hereto.
Partial Revisions:・These Bylaws shall be revised on July 28, 2015 to take effect as of January 1, 2016.
・These Bylaws shall be revised on March 2, 2018 to take effect as of the same day.
・These Bylaws shall be revised on February 24, 2021 to take effect as of the same day.

32