1The JAMS Guidelines on COI Management in Medical Research
Revised March, 2017
Table of Contents
I.
II.
III.
IV.

V.

Introduction
Basic thinking
The special character of medical research and COI policy
The basis of COI management related to medical research
1. Implementation of medical research by institutions and organizations
2. Specialized societies and scientific bodies at which medical research results
are presented
3. Precautions concerning medical science research, particularly
investigator-initiated clinical research
4. Items that should be avoided in clinical research conducted by the principal
investigator and their management
Rgulations concerning COI policy
1. The procedure of COI management
2. Businesses and corporate organizations and for-profit groups involved inindustrial academic cooperative activity
3. Those subject to COI management
4. Activities subject to COI guidelines
5. Items that must be disclosed
6. COI management of each type of individual
7. Period required for disclosure
8. Method and timing of self-disclosure
9. Handling of COI self-disclosure forms submitted by officers
10. Role and responsibility of the board of directors
11. Role and responsibility of the COI committee
12. Role and obligation of the editorial committee
13. Role and obligation of the ethics committee
14. Storage and release of personal data
15. Monitoring, abiding by COI policy, and educational training of COI policy
16. Handling requests for COI disclosure
17. Handling those violating COI policy
18. Response to an appeal

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VI.
VII.
VIII.
IX.

Accountability to society
COI management of affiliated societies
Questions regarding the Q&A section and the homepage
Change in policy and detailed regulations

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I. Introduction
The industrial-academic cooperative activity in the United States became
strengthened with the introduction of the Bayh-Dole Act in 1980. For the past 35
years this has contributed greatly to practical applications in the fields of prevention,
diagnostics, and therapeutics based on research in preclinical medicine. However, themore heads and researchers in research institutions become involved in profit-related
activities and also with for-profit organizations, the more social responsibilities itshoulders in terms of education and research, and the personal development of
individual conflicts of interest becomes unavoidable due to such industrial-academic
cooperation (Figure 1). These situations are called conflicts of interest (COI) and has
causes some concern in the loss of independence of medical science research studies,publication of biased results in favor of industry (research bias, publication bias,
reporting bias) and has become a social problem at times. The Gelsinger incident that
occurred in a US state university in 1999 raised an alert about the importance of the
management of and supervision of an organization concerning COI regarding not only
ethical aspects in research, but also state-of-the-art medicine.
There is a great demand for the heads of research institutions and academicorganizations to ensure the safety and human rights of subjects taking part in medical
science research is guarded, in addition to managing any COI of corresponding
researchers (physicians) that may be embedded as an organization, so that medical
science research is carried out appropriately by maximizing prevention of any bias risks
in publication of results for constructing evidence-based medicine (EBM).
This kind of movement is not limited to research institutions who are actively
promoting medical science research in association with industry, but also academicorganizations involved in educational activities and medical journal publishers toappropriately manage the COI of researchers who are devoted to the publication ofresearch results. Furthermore, the International Committee of Medical Journal Editors(ICMJE) which is a group of prominent international journal editors (Lancet, NEJM etc.)
introduced the ICMJE Recommendations for the Conduct, Reporting, Editing andPublication of Scholarly Work in Medical Journals in 2013, which provides a common
format for COI management by recommending specific instructions on how to prepare
and publish a medical manuscript. This ensures not only the quality of research but thescientific integrity of the research, and a large number of medical journals adhere to
the ICMJE Recommendations.
In Japan, the "Kagakugijutsu Kihonkeikaku" (Basic Plan for Science andTechnology) was established in 1996. This was intended as an overall response to the4wishes of the general populace regarding state-of-the-art preclinical research results.
Thereafter, the plan which has been carried over every 4 years, has advanced thisphilosophy and reflected the basic thinking concerning administration of scientificpolicies of our country. Furthermore, in 2014, the Japan Agency for Medical Researchand Development (AMED) was established under national policies such as the “Healthand Medical Promotion Strategy Act” and “Research and Development of Medical
Organization as Independent Administrative Institution Law”. The AMED emphasizes
the importance of industrial-academic cooperation by developing groundbreaking
pharmaceutical products, biologics, and medical equipment.
In medical science research involving human subjects, it is necessary to ensureethical treatment of patients, who are generally in a weak position, and also ensure thescientific integrity of any project. In the Declaration of Helsinki (revised in 2013) andthe “ethical policies regarding clinical research” by the Ministry of Health, Welfare andLabor, in 2003, it is stated that COI regarding human subject research, especiallyconcerning the individual profit (Conflict of Interest) that might be derived fromresearch, should be disclosed, and subjects or legal guardians of the research mustreceive sufficient explanations and understand fully about the study to be conducted
or continued, and informed consent should be obtained based upon their free will.
A full-scale approach taken to COI in Japan began when by a committee
entrusted to perform a survey by the Ministry of Education known as the “Researchgroup on the ethics of clinical research and COI” was established and “Guidelines
regarding Conflict of Interest Policy and Clinical Research” was published in March 2006.
These guidelines defined the COI regulations concerning universities, research
institutes, hospitals and academic societies concerning clinical research on humansubjects. They also tried to prevent any obstacle to the implementation of clinicalresearch involving human subjects and strove to establish the social responsibility andregulations for clinical research. The guidelines attempted to develop basic policies on
the management of COI problems involving clinical research and at the same time topromote a high level of clinical research and assist in the achievement of a high level ofresearch. In 2008 the Ministry of Health and Welfare of Japan published their policy on
the management of welfare, labor and health research concerning COI and clearlystated the duties of researchers in the field of clinical research who are receiving
research grants.
The 2011 guidelines concerning COI management of medical research of theJapan Association of Medical Science are intended to give guidance to the leaders of
the societies affiliated with the Japan Association of Medical Sciences (JAMS) and5members related to COI management. Each affiliated society manages all mattersrelated to COI status, including distinct conflict of interest issues. The neutrality of
medical science research results should be verified, guaranteed and made public.
Furthermore, these guidelines are intended to provide assistance so that results ofmedical science research activities can be published appropriately from the perspectiveof industrial-academic cooperation.
Amid such circumstances, a large-scale comparative clinical study on Valsartan (Diovan)
conducted at five universities in Japan reported allegations of misconduct resulting
from specific company intervention, and as a result of violations of COI disclosure anddata manipulation in the interest of corporations, multiple articles were retracted.
In response to the publication of " Clinical Study Cases of Hypertension
Treating Drugs and Measures to Prevent Recurrence" by the Review Committee, theMinistry of Education, Culture, Sports, Science and Technology and the Ministry of
Health, Labor and Welfare, publicly announced the "Ethical guidelines on Medical
Science Research Conducted in Human Subjects" in December 2014, that integrates
ethical guidelines and epidemiological guidelines in order to clarify the responsibilitiesof the head of the research institution in addition to the researcher, and to seek strict
compliance with them.
On the other hand, the Japan Pharmaceutical Industry Association, as a resultof research fraud cases concerning Diovan, announced in April 2014, that in general,
for clinical studies involving in-house pharmaceutical drugs, funding and support inproviding goods would be carried out under a contract, and that donations would not
be used as a method of support. It also made public the “Guidelines on Support for
Investigator-initiated Clinical Research Using In-house Pharmaceutical Drugs”, inJanuary 2016. As far as procedure, the pharmaceutical company will conduct anin-house review of the investigator-initiated clinical research protocol proposed by the
researcher, and based on the " investigator-initiated Clinical Research Contract(sample)" proposed by the pharmaceutical company legal research Group and theJapan Pharmaceutical Society, will draw up a contract, to clearly state how researchfunding can be made. However, because this way of forming a contract (model) can
enable a company to have influence over an investigator-initiated clinical study and its
results, from the viewpoint of maintaining neutrality and independence of the clinicalresearch for the researcher, preventing bias is one major concern. For that purpose,compliance with research ethics and describing the details of corporate involvement in
the publication are required in order to ensure the reliability and transparency of theresearch.

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The Japanese Association of Medical Sciences (JAMS) has made extensive
revisions to the Japanese Association of Medical Sciences’ “Guidelines on COI
Management in Medical Research” established in 2011, in order to incorporate bothinternal and external trends in COI management, revisions to ethical guidelines andother relevant guidelines.
II. Basic thinking
Academic organizations such as medical research institutions and specialist
societies are hoping to help prevent, diagnose and treat intractable diseases througheducation and medical research by industrial academic cooperation. The medical
research of these institutions, as well as their scientific educational programs andresearch concerning human beings, require the application of secure ethics and sciencein order to protect the quality and integrity of the research. The publication of any
results in specialist societies or academic journals require ensuring transparency andneutrality. It goes without saying that such medical science research must strictly
comply with ethical policies.
For researchers conducting medical science research, the first step to be taken
is for the foundation or organization which seeks to employ the data provided by the
researcher to ensure that any financial profit deriving from the research (financial etc.)
or other related profits (status or authority etc.) should be disclosed appropriately
within the organization. The COI status in medical research involves not only humanrights, life and safety of the patient, but also preclinical research and health treatmentin the healthcare environment. Researchers working in such an environment carry out
research in cooperation with industry, including basic research, clinical studies andtrials, and moreover such researchers are involved with venture capital industries,
which make commercial products of the treatment methods created by the
researchers, and therefore the presence of COI is unavoidable. However, the fact thata COI status per se regarding financial aspects exists, is in itself not a problem. It isextremely important for research institutions and heads of specialist organizations, inaddition to researchers, to properly manage those aspects and to amend any
situations in which bias may be suspected, and to establish a structure which does notcreate any misunderstandings without reason regarding the researcher and research
institution, to promote industrial-academic cooperation.
The supervision of research institutions and heads of academic societies
becomes necessary to ensure that the medical and health, as well as clinical researchand its results indicate no undue influence of considerations of financial profit in favor

7of the industrial side, as the COI situation of researchers is becoming an increasingly
serious problem. In order to attain this goal, the evaluation of the COI status should be
enforced to prevent serious COI situations, or be supervised by a third party to ensurethat the quality and integrity of the medical science research is guaranteed.
Furthermore, research institutions and heads of specialist societies should disclose andpublicly release appropriately any financial profit or other related profit to create anenvironment which allows to make progress based on an appropriate balance of
education and research with an independent, objective and strictly scientific nature.
In medical science research, clinical studies involving human beings as
subjects and involving invasive procedures, and are expected to be the foundation of
the development of clinical guidelines, demand an extremely high level of ethical andspecialized aspects. Furthermore, since this means that the research concerning
human subjects is of a very special nature, this entails that COI status in this field is of aslightly different nature than the COI problem in general. For instance, a COI status candevelop latently to become a serious problem, which can increase the risk of bias of
the funding organization, and may lead to cause scientific misconduct, Furthermore,
the individual researcher who is employed in medical science research must ensurethat the research does not lose any validity and that the safety of participants in clinicalstudies is not threatened. In addition, the researcher should not receive gifts, material
compensation or profit. Needless to say, researchers must adhere to COI policies andany other policies of research institutions or academic societies of which they are
members.

Ⅲ. The special character of medical science research and COI policy
Medical science research differs from joint research, or commissioned research (forexample, unlike engineering faculties etc.) and has the following particular features
which require extreme care in implementation:
1. Many researchers in medical science research belonging to research institutions
and other specialist societies are not only related to commercial ventures, but also
are related to, or are involved with, doctor-patient (subject) relationships, therefore
the protection of the rights of the subjects and safety of the health and welfare of
the subject must be guaranteed.
2. Data from medical science research are involved with the subsequent developmentof new diagnostic, therapeutic, or preventive methods, due to the Pharmaceutical

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Affairs Law enacted in November 2014, therefore it is especially imperative forresearchers to ensure the reliability of their data.
3. The publication of research results has a great impact on those involved in healthcare, participating as an audience, or reading papers. Therefore, the interpretationof such publicized results has an influence on health practice that is by no means
small. In order to determine whether there is a risk of bias or not in the content
presented, it is necessary for the presenters to disclose all pertinent data
concerning related commercial organizations and their COI status at the time of thepresentation.
On the other hand, based on the following points of view, relevant medical science
research has the following special characteristics concerning the COI status ofindividuals and researchers.
1. Many areas of the most up-to-date medical science research is related todevelopments in prevention, diagnosis and treatment. In many cases, theresearchers themselves are the most appropriate persons to safely accomplish
such relevant research.
2. Concerning the development of new drugs and medical equipment, it may bedifficult for or take a long time for society to benefit by relying only on technology
transfer from existing commercial entities. Therefore, there are many cases inwhich the role of researchers themselves regarding venture entities is large.
3. New drugs or new medical devices require basic research, and medical science
research in order to be developed for clinical use. Therefore, it is very difficult for
the researchers themselves to be completely uninvolved with this process.
IV. The Basis of COI management related to medical science research
In recent years, COI management related to medical science research can be
carried out at (1) research institutes and (2) conferences and medical journals of
specialist societies at which research results are made public, and can be largely
divided into two stages (see Fig. 2).
Implementation of medical research by institutions and organizations
Various research institutions have developed COI policies concerning medical
science research (pre-clinical and clinical research involving human beings as subjects)
and the systemization of management of COI at those institutions is managed by theheads to ensure the quality and integrity of medical science research when such

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research is conducted. In particular, concerning research involving human beings as
subjects, each researcher is required to submit not only clinical research program plans(protocol) but also COI disclosure statements so that the head of the research
institution can appropriately manage COI as an organization. The Guidelines forinvestigator-initiated Clinical Trials introduced in 2015 by the National Associate ofJapan Medical Colleges Council explains the methods and steps of COI management
for clinical studies at research institutions.
2. Specialized societies and scientific bodies at which research results are presented.
Specialty medical meetings of societies affiliated with the Japanese
Association of Medical Sciences (JAMS) at which the results of research are presented
at institutions, often have duplication of researchers and therefore, it is necessary toestablish a COI policy based on a common philosophy.
3. Precautions concerning medical science research, particularly investigator-initiatedclinical research
When conducting investigator-initiated intervention-type clinical researchwhich involves invasive procedures, the need to ask private sectors for financial
support (donations, research grants, financial support for clinical research) increases as
more research funding becomes necessary as the number of target cases increases.
In such situations, from the perspective of COI management, the relative researcher
must self-disclose this COI to the COI Committee and in addition to making anapplication to the Ethics committee. Furthermore, the funding source and its purpose
should be disclosed or published through publications.
For intervention-type research to be conducted appropriately, the validity of whether
or not the expenses are sufficient must be considered.
1) Investigator-initiated clinical research using drugs after marketing, particularly
results of phase IV comparison tests, provide important information and grounds forthe formulation of clinical practice guidelines. On the other hand, from the viewpointof sales promotion, companies have a high interest in comparative clinical trials using
in-house pharmaceutical drugs, therefore in many cases various forms of cooperationand support (funding, work positions, etc.) are often given to the researcher. However,
if transparency between academia and industry is not secured, it can easily cause
suspicion from society. Therefore, in order to ensure the quality and reliability of the10research, it is essential for not only the contract, but COI disclosure of both sides to bemade public.
2) Making the results of clinical research widely available to healthcare professionals,
patients, and others will lead to public benefit. Therefore, it is necessary to register all
clinical trials for human subjects via a public database, and test results should be, in
principle, made public. When publishing the results, both the corresponding
researcher and the supporting company involved are responsible for disclosing andpublishing all relevant COI related to the publication or presentation of the study.
3) When preparing the publication, it is necessary to clearly state the authorshipcriteria and if help was obtained from medical writers, statisticians, and any otherpersons regarding the interpretation and discussion, this should be mentioned. If suchpeople do not satisfy authorship criteria, their contributions should be acknowledgedin the Acknowledgement section by stating their names, affiliations, funding sources,
and all COI.
4) In addition to investigator-initiated clinical research that is planned and financial
sources obtained independently by the researcher, although there are other types ofinvestigator-initiated clinical research, such as those requested by company(commissioned or entrusted research, joint research), and those contracted by acompany after in-house reviews, from the perspective of complying with research
ethics, the head of the research institution and the researcher must fulfill their
responsibility to be accountable for the research.
4. Items that should be avoided in clinical research conducted by the principal
investigator and their management
In cases of research involving human beings conducted as an interventional study by
the researcher for industrial-academic cooperation, the following items should be
avoided by researchers involved in those projects.
(1) Being an intermediary or providing an introduction to the clinical study for thepatient for which you will receive monetary remuneration(2) Receiving financial remuneration for accumulation of patients within a specified
period of time(3) Receiving payment for travel or accommodation from commercial societies or11ventures in order to take part in medical meetings unrelated to the research(4) Receiving remuneration in regard to the results of the specific study or result
On the other hand, the principal investigator or research director (on behalf ofcollaborative research in multiple institutions) involved with clinical research, and who
is involved with the planning and carrying out of the conditions of the study, must
make clear whether the following conditions have been followed regarding theappropriate disclosure of any financial relationship regarding the financial sponsors ororganizations.
(1) Having responsibility as an executive member or financial support organization or
venture regarding the relevant study(2) Having obtained any right to patent rights or patent fees regarding the medical
products, diagnostic products or examination methods concerning the research
topic(3) Having received money or gifts exceeding the actual value of the time or labor
expended on the relevant research.
(4) If the relevant research includes participation of temporary researchers, part-time
instructors and graduate (working) students who belong to companies, are being
dispatched to the research institution, suppressing the name of the relevant
company in the research plan and published results.
(5) Affecting the ability in the collection and storage of data, statistical analysis,
interpretation, and conclusion based on the influence of financial supporters orcommercial organizations.
(6) Affecting the ability to report on the results at a medical society based on influenceof financial supporters or commercial organizations
However, even if (1) and (2) are relevant to the researcher, in a case where
the researcher is essential to the planning and conducting of the medical science
research, and that the research is of extreme significance in society, based on theunderstanding that the integrity and transparency are ensured, it is possible tonominate the researcher as the principal investigator or representative of the research.
However, the head of the research institution has a duty to clearly state this fact tosociety. In addition, if accepting a contract whereby (5) and (6) are relevant, thefunding source and its role must be disclosed at the end of the text of the manuscript
at the time of publication.
Ⅴ. Regulations concerning COI policy

12Each affiliated society must establish its own policy concerning medical
science research-related COI and make that policy public, as well as establishing amanagement system based on that. In addition to making clear the extent of any profit
to any individual taking part in this research, the management systems should also take
into account the prevention of any breach of the COI policy, especially concerning theestablished policy. In order to implement management of COI the affiliated societies
should have a predetermined policy and penal regulations on how to deal with any
breaches of the COI policy.
1. The procedure of COI management
Concerning the publication of the results of the medical science research, allresearchers involved in the given research, must, in principle, submit a self-reported
COI disclosure document to the president of the affiliated society at the time ofpresentation (Fig. 4). If it is pointed out that there is a violation of the COI guidelines inrelation to the presentation, the researcher must understand and cooperate fully. If
appointed as officers, chairpersons of committees, members of designated committees
and members of working groups, the COI status in relation to the given activity must be
described by self-disclosure in the designated form (Form B) at the time of
appointment, and undergo appropriate evaluation, as they play a very important roleand have responsibility for their activities in relation to the society.
2. Businesses and corporate organizations and for-profit groups involved in industrial
academic cooperative activity
Concerning medical science research involving research institutions related toindustrial-academic cooperation with businesses, corporate organizations andfor-profit groups (hereinafter, businesses, organizations, and groups) the following
activities are included and should be disclosed.
(1) Joint research: Research performed by dividing research funds andresearch personnel, involving companies, organizations, groups. (with orwithout recompense or remuneration)(2) Commissioned research: companies, organization, and groups commit
themselves to contracts concerning methods of treatment, drugs anddevices, and research is performed on the basis of such contracts(3) Technology transfer: companies make practical use of the patent rights andother rights concerning the research results of research institutions(4) Technology guidance: researchers of research institutions etc. conduct13

business development and give technological advice(5) Research institute ventures: venture organizations are based on the resultsof the research of universities and research institutions and supported by
the research institution(6) Donations: unrestricted donations are made to assist universities andresearch institutions by companies, organizations and groups(7) Endowed departments: departments are established for the promotion ofresearch enabled by financial donations to research institutions fromcompanies, organizations, and groups.
3. Those subject to COI management:(1) Both members and non-members presenting the results of research inscientific presentations and publications etc., must report the COI status in relation to
the performance of that research and, in accordance with the per se and detailed
regulations of the affiliated society, must make such disclosures for the past 3 years (Fig.
4, Ref. 2) using the designated forms at the time of presentation. If it is decided thatthe presentation in relation to the research is in contravention of the COI policy, thenthe president of the affiliated society is required to discuss with the COI committee andtake appropriate measures based on the results of such discussion.
(2) All officers (chairpersons of the organization, regents, financial comptroller)
those responsible for scientific meetings (meeting presidents etc.), all committee
chairpersons, committee members of special committees (CPG steering committee,
scientific organizing committees, editorial board committees, ethical committees, COI
committees etc.) and temporary groups (committees, working groups, teams etc.) playa very important role and have responsibility for their activities in relation to therespective affiliated society. The COI status in relation to the given activity must be
described by self-disclosure in the designated form (Fig. 1) at the time of appointment,
and undergo appropriate evaluation. Should the COI status change after theappointment, then according to the regulations of the society, there is a duty todisclose any additional information, and such cases should be managed quickly andappropriately.
Whether to include spouses, first degree relatives, or subjects who shareincome or financial benefits (inherited benefits) of those above subjects should bedetermined depending on the situation of each affiliated society. However, in cases
where the spouses, first degree relatives are not included as subjects of COI disclosure,if there is possibility of COI due to indirect or uneconomical factors that might affect14

the carrying out or interpretation of the results of the medical science research, they
may be required to disclose such COI using the designated form.

4. Activities subject to COI guidelines
COI policy should be applied to all those who take part in all activities of the affiliatedsociety. To give individual examples:(1) Academic meetings (annual general meetings included), holding local orchapter meetings of the society(2) Publication of the academic journal of the society or academic publications(3) Implementing research or questionnaires(4) Those who provide encouragement for research or reward academic
achievements(5) Certifiers of board-certified physicians, board-certified specialists ，board-certified trainers or certified institutions(6) Those promoting continuing medical education(7) Those promoting international research cooperation(8) Those involved with businesses enabling attainment of professional levelsof various sorts.
In particular, the following activities require extreme care and respect for COI policies:(1) Making presentations at academic meetings held by affiliated societies,(2) Publication in scientific journals or affiliated society journals(3) Those planning health care guidelines or manuals(4) Work involving temporarily established investigation committees oradvisory committees.
(5) Making presentations at lectures, luncheon seminars, evening seminars
etc. sponsored or co-sponsored by businesses or for-profit groups
Furthermore, members of the affiliated societies must disclose all COI situations using
the designated form (Fig. 4) according to COI policies of the affiliated societies,
concerning academic activities (regardless of being sponsored or co-sponsored bybusinesses etc.), even if they are not directly connected to the activities of the given
affiliated societies.

5. Items that must be disclosed
Among the items that must be disclosed, we have established 9 items (Ref. 1,

152）concerning relations with industry. One of the most problematic and frequently
discussed is that of grant (incentive) contributions, especially their interpretation andhandling. The recipients of grant contributions from businesses, organizations, andgroups, can be generally divided into two large groups. One of these includes the
directors of institutions (school presidents or hospital directors) and department heads.
In the case of the former, there is a tendency to make the interpretation that the grant
is not related to individual researchers, but if the grant contributions are passed
through the heads of an institution to an individual or to the section (department,
field) of a person making a publication, or distributed to a research laboratory, it isnecessary to clearly describe this in the disclosure. In order that there should be no
suspicion or doubt on the part of society concerning the medical science research
performed through industrial-academic cooperation, if it is considered that there was
support from a related business, even if it be indirect, then it should be reported in the
COI self-disclosure. In the latter situation, it has already been stated that COI
self-disclosure is necessary.
Another disclosure item, concerning which suspicions can easily arise includes
those cases in which financial support (commissioned research, research funds) aremade available from not-for-profit foundations (for example NPOs) or public
foundations (for example corporations, foundations) and investigator-initiated clinical
trials are conducted. If grants from pharmaceutical companies are distributed toresearchers via not-for-profit groups or public corporations then the greater theamount of the contribution the greater a third party will receive the impression thatthe objectivity of the research results might be lacking, thus this deserves great
attention. Therefore, the name of the funding company must also be listed in the COI
disclosure form.
Self-disclosure forms should be of three types (1) for officers, committee
members (2) those presenting at academic meetings, (3) those publishing in journals
and used accordingly.
6. COI management of each type of individual
The subjects of COI management in affiliated societies include speakers(members, nonmembers), officers, committee members (including external members),
and COI must be self-disclosed. All names of organizations and research institutions ofwhich they hold full time positions must be listed during self-disclosure of COI whensubjects are appointed as officers or committee members.

16(1) Officers
Members and non-members who are affiliated with research institutions must
disclose all related COI when publishing or presenting academic achievements,
however members who are only affiliated with companies will not be targets of COI
management. However, if the presenter is a fulltime employee of a company but holds
simultaneously a part-time position at a university or research institution etc. (e.g.
lecturer, visiting professor etc.), temporary researcher, graduate student (working),
then the name of the affiliation where the presenter holds a fulltime position(including affiliation and title) should be given, or as another option, both the names ofresearch institutions etc. where both fulltime and part-time positions are held. In
principle, for the presenter, if the funding provider of the research funding of thepresentation is company-affiliated, then only the name of the company (including
affiliation and title) need to be listed. If the funding is provided by a different company,
the name of the related company should be disclosed in the self-disclosure form. The
president of the affiliated society can require all those with names attached to the
publication or just the first presenter, whether they be a member or not, to selfdisclose COI status with regard to companies, institutions, and organizations related tothe contents of the research.
On the other hand, if a member who is affiliated with a research institution
has changed workplace in the past 5 years from a designated company or NPO to a
fulltime or part-time position at a research institution (adjunct professor etc.) but the
research theme is ongoing, the name of the present research institution to which thepresenter is affiliated in addition to the previous affiliation (corresponding company
name) related to the research must both be mentioned when presenting research
results.
（２）Officers and Committee Members
The president of the affiliated society must, in principle, make it a duty for theindividual officers and committee members to submit a COI self-disclosure documentwith regard to their relations to businesses, organizations (not-for-profit organizations,foundations etc.), and groups（Ref.1）. Furthermore, if the subject was affiliated withrelated companies, institutions (not-for-profit organizations, foundations etc.), andorganizations in the past 5 years, this (period, name of company, position etc.) must bereported to the president of the affiliated society. The method of disclosure is usually
done on a printed form, but a self-disclosure system established on a secured website
for disclosure on application by a given day can also be used for convenience.

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Companies, organizations, and for-profit groups may present or may supply
information on external finances including reimbursement for manuscripts, lectures,
medical science research funds (including clinical trials and clinical studies),
commissioned research, joint research, clinical trial funding, grant contributions,
including trusts, and endowments) and these are all extremely important items fromthe point of view of COI management. It is therefore necessary to consider how tomake these clearly understood by third parties. As a concrete example, for an item thatshould be declared by an individual researcher who is an officers or committee
member if the amount exceeds that described in the COI regulations, it is necessary tofill out the amount classification (3 levels) designated form (Ref. 1) and accurately
disclose the situation to the president of the affiliated society. The president of theaffiliated society must, in collaboration with the COI subcommittee, determine theseverity of the COI situation presented in the COI self-disclosure forms submitted by
officers or committee members when selecting presidents or members for therespective committees.
1) Editorial Board Members
There has also been much discussion whether editorial board members orreviewers should be subject to COI management, although the Editor-in-Chief andmembers of the editorial board now have the duty to self-disclose COI. In the affiliatedsocieties, there are frequently some unavoidable relationships among authors andthose in the various specialized areas from which reviewers are selected, extending toeven closer relationships between the reviewer and the submitting author(mentor-student, joint researcher, receiving grants from the same commercial entity)
and many result in a COI situation. However, should it become necessary to request
reviewers from among specialists who have absolutely no COI status problems withregard to the submitting author, the number of potential reviewers could drastically be
reduced and it is even possible that it would be impossible to find suitable candidates
to request peer reviews, based on this and other considerations, therefore it isessential to give very careful consideration to the condition of COI management withregard to peer reviewers. As one example, if an editorial board member or reviewer
feels reluctance to perform a review because of a COI issue with regard to the author
or the individual reviewing peers they might not be able to take the responsibility to
explain the result of the review, therefore it could be possible for them to refuse toreview. This is one practical way of handling the problem. Be that as it may, the deliveryof information from the results of research in academic journals is a very important

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means of the returning of benefit to society therefore it is essential for the COI
committee to be closely involved in this process, in order to preserve public
transparency and secure neutrality.
2) Participants involved in the establishing of clinical practice guidelines
The CPG is widely used not only by clinical societies, clinicians but also patient
support organizations, funding institutions, medical experts, lawyers, and consumers.
Recently, the clinical development of drugs and medical equipment is rapidly growing,
and therefore the quality and credibility of CPG has brought much attention
internationally. Based on the EBM technique, in order to formulate a trustworthy CPG,
those involved in the establishing of the guidelines and the specialist societies as anorganization must disclose COI situations and make them available publicly. Not only
that, the criteria for those participating in the establishment of CPG must be madeclear and COI management to avoid any bias risks is strongly desired.
The president of the affiliated society will establish a CPG steering committee
as a standing (permanent) committee. If new plans are established in the CPG
regarding diagnosis, treatment, or prevention, and if revisions are to be made,measures such as budget and establishment of a systemic review team; SR team, andexternal evaluation (committee) should be established as part of the task to establish
or revise CPG. It is possible for members of the CPG control committee, guideline
establishment committee, SR team, to overlap partially, but in principle, thecommittees should be independent of each other to secure transparency of guideline
establishment (Minds CPG development guide 2014). The president of the affiliatedsociety will have participants involved with CPG establishment to self-disclose any COI
using the designated form and will cooperate together with the COI committee
beforehand to evaluate and manage this so that the most eligible members are chosen(Fig 3).
In general, the COI of those involved will not only include financial COI but
expertise, preferences, promotions, and any other intellectual COI that might beconsidered to affect career development, or if the COI situation with the affiliatedresearch institution or society and the specific company is strong, this can be seen as
potentially affecting CPG formulation. In particular, when selecting the CPG
establishment committee members, president (vice president), it is necessary to take amultifaceted approach and requires exceptional care. The Japanese Association of
Medical Sciences (JAMS) Guidance on Participants Involved in the Establishing ofClinical Guidelines (2017) can be used as referential material for specific measures to19

be taken in such situations.
In addition, if guidebooks, discussion articles, and special feature articles areto be published from member societies, any related COI must be disclosed byparticipants using the COI form and the information should be published at the end of
the article.

7. Period required for disclosure
The medical science research resulting from the industrial academic
corporation is varied in nature. In preclinical research, it can often be performed withina short time, but for medical and health studies which require ethical approval, and inparticular, interventional studies, long periods of research are necessary. Therefore, interms of the nature of such research, the period for which disclosure is required inmany cases covers several years. Since it has been 6 years since the JAMS introduced
COI management guidelines, we recommend that the period of previous 3 years be
required for COI disclosure for members and staff of affiliated committees.
Specifically, when a member publishes the results of a research, and when
he/she is appointed as an officer, the period for the previous three years from thepreceding year, is the target of COI disclosure. Furthermore, if the COI status haschanged during the year of appointment as officer, or after that, additional COI
disclosure must be made to the president of the affiliated society within 8 weeks using
the designated form (Ref. 1).
Clinical research using funds provided by a company, particularly large-scaleinvasive intervention type research, are often conducted over a long period of time,even after the time limit described in the research plan (protocol) approved by the
Ethics Committee. Since COI self-disclosure is required according to the COI policy ofthe society or journal at the time of submission, it is desirable to keep records of thefunding source and amount by year, from the time of publication. In particular, theamount of donations and research support funding related to clinical trials should berecorded as part of the data together with the contract.
8. Method and timing of self-disclosure
The method of self-disclosure is clearly stated in the COI policy and detailed regulations
according to subject. (See Fig. 3)(1) Officers

20

Officers must submit a self-disclosure form on their COI situation pertaining to
the businesses, organizations, and groups every year at a set date (e.g. April 1) so thatit may be updated for evaluation. In the event that a new COI situation occurs during
the study period, there is an obligation to report this within a set time period (e.g.
within 8 weeks).
The following states the specific reporting process when commissioning
officers to do research.
1) Candidates for director must follow the format and procedure determined by theaffiliated society, and submit the COI self-disclosure form to the president of thatsociety, and 2) a discussion will take place concerning the eligibility of the officer
candidate at the COI committee meeting, 3) the results (written opinions concerning
COI) will be reported to the head of the affiliated society, and 4) the final decision
concerning the approval/approval with condition/ disapproval, etc. will be made by thehead of the affiliated society to the candidate.
(2) Authors presenting at scientific meetings
The president of the affiliated society can require all those with names
attached to the publication or just the first speaker, whether they be a member or not,to self- disclose COI status with regard to businesses, organizations, and groups related
to the contents of the research.
Speakers should disclose all existing and possible COI situations using theformat prescribed by the affiliated society, either on the first or second slide (see Fig. 4a, b). In addition to showing the slide for a certain amount of time, reading the namesof businesses, organizations, and groups in which a COI situation exists, is one
significant way to manage COI. In addition, if a member participates in educationalseminars or training seminars for the purpose of acquisition or renewal of professional
qualifications/credits, and if handout materials which include contents of presentations
are to be distributed, the COI information of the presenter should be disclosed using
the designated form.
(3) Authors publishing in scientific journals
The editorial boards of each of the affiliated societies must, under theleadership of the president of the affiliated society ensure that all authors, whether
they be members or not, provide self-disclosure information concerning all
publications in the scientific journals of the affiliated society.
Usually the corresponding author should collect the statements concerning

21

the COI status of all authors of the given paper and should take responsibility for thecontent of the paper. The information concerning the COI status of all the authors
appears after the main body of the text, usually before the acknowledgment andreferences. Even if there is no definite rule about COI status reporting, there is usually astatement about COI status such as “the authors declare they have no conflict ofinterest”. Measures to be taken concerning those violating the principle of COI
disclosure should be determined by each of the affiliated societies and the COI policy
and detailed regulations should be clearly stated in the Instructions to Authors.
For researchers, if the impact factor or citation index of a given journal is high,this has significant effect on the status and ability to attract research funds on the partof researchers. In particular, the attention paid by society to the research results ofmedical science research and clinical studies supported by business sponsors attracts
much attention and has a great effect on society. Therefore, it is important that thejournals and scientific societies not only ensure the transparency and the reliability of
the COI status disclosures of the authors themselves; they must strive as much as
possible for the security of the objectiveness and neutrality of the data. Because ofthat, there also should be close cooperation between the editorial boards of eachaffiliated society and the COI committee, 1) in English language journals of the societies,
and 2) concerning authors in Japanese language journals. These two categories should
be considered separately and description of the journal COI policy for each of thoseshould be described in the manual for publication and appropriate handling of each isconsidered desirable.
Authors giving presentations on publications in scientific journals are obligatedto self-disclose the COI status with businesses, organizations, and groups for a periodof 3 years from the preceding year of the time of submission, in addition to any
additional COI disclosures at the time of acceptance, for all coauthors. This should be
disclosed at the end of the manuscript in the designated style (Ref. 2).
Even if there is no definite COI status to be reported, there should be a statement suchas “The authors declare they have no conflict of interest”.
The COI regulations should clearly state that usually the corresponding author
should collect the statements concerning the COI status of all authors of the given
manuscript and should take responsibility for the content and information, such as theaffiliations of all authors. Information concerning the COI status, funding, and role of all
authors should be given for each author in the Acknowledgment section after the maintext.
The following points should be brought to attention if there is a22company-affiliated researcher among the authors.
①Name of the affiliated company of the researcher, department name, job title②Description of the contribution to the research③Investment amount from the company④Where or whom the research results belong⑤Whether or not a contract exists that allows a relevant company to exercise
influence regarding the presentation and publication of research results⑥Confirm whether there was labor provided from companies that may affect theresults of the research, and publication of a manuscript should be a comprehensive
decision made after considering whether the reliability and quality of the research are
secured or not. Furthermore, measures to be taken by the affiliated society against
those who violate COI policy, should also be stated in the COI guidelines andInstructions to Authors.
1) Authors of manuscripts in English language journals
Concerning COI management regarding authors of papers in English language
scientific journals, the COI self-disclosure forms required of the authors are, as in thecase of Western societies, quite different according to the journal and there is as yet nostandardization.
The policy of the "Guidelines for Support of Investigator-initiated ClinicalResearch Using Pharmaceutical Drugs" established by the Japan Pharmaceutical
Manufacturers Association (abbreviated as Pharmaceutical Cooperative ClinicalResearch Support Guidelines) in January 2016, is that no research support by donation
will be conducted, and research support will be provided as stated in the contract
between the research institution.
According to the content of this contract, the principal researcher will proposea research plan, and if the company finds it is advantageous for the company after
review, it will approve the research which will be conducted through full responsibilityof the research institution. It is obligatory to submit the details of the research results
to the contract company, before publicizing them. The company will conduct a reviewof the results from an ethical, medical and scientific point of view, and will respond to
the principal researcher. The principal researcher will take into account the response
from the company, and will be responsible for making the final decision as to whether
to make the content public. Furthermore, in the event that it is not made public, thecontract allows the company to use or publish the research results, with a possibility ofrisk of bias towards the company side. In order to ensure the fairness and reliability of23

research, principal researchers should make efforts to clearly state at the end of the
publication any role or involvement of funding supporters (company related persons) inthe planning, protocol making, conducting, monitoring, auditing, data compiling,statistical analysis, data interpretation, manuscript preparation, and review, to avoid
this risk.
Please refer to the example statement for English and Japanese manuscripts(Fig. 5), in reference to the ICMJE Recommendations created by the International
Committee of Medical Journal Editors.
Fig. 5 How to give descriptions of research results for research support obtained fromcontract pharmaceutical companies at the time of publication
Even if there is no definite COI status to be reported, there should be astatement about COI status such as “The authors declare they have no conflict ofinterest”.
It is considered that there will be a considerable number of papers from
non-Japanese researchers (non-members) in the English language journals publishedby the affiliated societies. Concerning the COI disclosure criteria for overseas members
and nonmembers, there is a need to consider the unique characteristics of theindustrial-academic cooperation activity of each country, and the currency value inrelation to its economic situation, thereby making it difficult to apply the same
judgment criteria as domestic members. In particular, with the vast increase ofscientific speakers from developing countries, it is possible that ① the extent to which
disclosure should be made by authors, ② disclosure items③ criteria for evaluation of
the self-disclosure, may vary. Recently the International Committee of Medical Journal
Editors (ICMJE), in order to simplify matters for authors of papers, has developed astandardized COI status disclosure form. Many international medical journals haveadopted this form. Medical journals belonging to the affiliated societies, particularly
those that receive many foreign submissions, should consider adopting the ICMJE COI
disclosure form under the author's own responsibility. In addition, the ICMJE suggests
not only disclosing the author’s COI status but also the COI status of the affiliatedresearch institutions, and this may be an area to be discussed in the future.
2) Authors of manuscripts in Japanese language journals
It is mandatory for member authors of Japanese journal articles (originalarticles, reviews, etc.) to comply with COI policy of the affiliated society for any

24non-member contributions, and must disclose COI status using the designated form
(Ref. 2). For publications in Japanese journals, including roundtable discussion articles,
each author must disclose COI status with companies if it exceeds the base amount asshown in Fig. 6. Furthermore, if there is company involvement in the research contract,the details must be mentioned in the Acknowledgments, as shown in Fig. 5.
Fig. 6 Examples of COI disclosure by authors for Japanese publications
9. Handling of COI self-disclosure forms submitted by officers
As COI self-disclosure forms submitted by officers may include very important
personal information, they should be handled very carefully and a highly securemanagement by the secretariat of the affiliated society is needed to secure theprotection of classified and personal information. A specific example would include,the necessity to keep and secure all COI related documents of those officers whoseterm has expired and those who withdraw from the committee or terminate theircommission, until the term has ended or for a fixed time period (e.g. 2-4 years), under
the supervision of the president of the affiliated society. Once a fixed time period has
passed, the documents should be deleted or destroyed under the supervision of the
Chairman of the Board of Directors. However, if the Chairman of the Board of Director
decides that information should not be deleted or destroyed, a certain time period will
be given, as necessary, to place a hold on such action. It is recommended that all COI
information with regard to the president (including the president-elect), and the
Chairman and organizing committee of the scientific meeting is handled in the samemanner as COI information of officers.
10. Role and responsibility of the board of directors
The president of the affiliated society may consult the COI committee, ethics
committee, and clinical practice guideline steering committee, to and based on the
response, the board of directors may consult to direct measures in the event that a
serious state of COI problem arising from the need to accomplish the work of theaffiliated society, may lead to a loss of social reliability, or if the COI self-disclosure of
authors presenting at scientific meetings and in scientific journals is found to be
improper. If an officer or member is accused of a suspected COI problem, the presidentof the subcommittee, on behalf of the subcommittee, will act appropriately and ingood time, and in the event that there is an unjust allegation or indictment, will give an
opinion or make a statement to fulfill self and social responsibility to explain the resultsof the verification of facts and in response to excessive accusations of the individual

25

member.
The president of the affiliated society, etc. should avoid arranging contracts
with businesses, organizations, and groups that will not agree to any activity or survey
activity which may lack public transparency, neutrality and appropriateness of researchor announcements of the affiliated society.
The president of the affiliated society should provide educational training on
research ethics (bioethics, publication ethics, COI management, etc.) at academic
meetings and lectures, and should make it mandatory to participate in order toeducate members. Furthermore, attending a session on research ethics is mandatory
and credits are given to board-certified physicians, board-certified specialists, orboard-certified trainers when obtaining and renewing qualifications. If a member
participates in research ethics training at different affiliated societies or research
institutions, there is a need for a compatible system to recognize the credits earned at
different locations.
11. Role and responsibility of the COI committee
The COI committee should be established independently from the ethics committee, totake measures against those who violate the policy. The COI committee should besupervised by the president of the affiliated society, taking into consideration that COI
management must deal with the nature of the distinct content of self-disclosure, andthe need to protect personal information. Moreover, for COI management to be
conducted smoothly, it is recommended that the COI policy state a specific method inregard to how the COI committee, board of directors, Ethical Review Board, editorialcommittee and the Clinical Practice Guideline Steering Committee should cooperate.
1) The role of the COI committee
The COI committee should play an advisory role to ensure that COI which may
affect the publishing of study results is disclosed appropriately to promote medical
science research in industrial-academic cooperation, and that it is managed properly,
from the member (researcher’s) standpoint. In addition, if in the event that amember’s COI status is considered to be serious, or if the COI self-disclosure is found to
be inappropriate or suspicious, a hearing will be conducted, and the results will bereported to the president of the affiliated society.
The COI committee has jurisdiction over the following:(1) Handling all inquiries from individual members concerning their COI status(creating Q & A).

26(2) Judgment, management, and guidance concerning COI status of officers andpresenters (including non-members) with risk of bias in business related activities(particularly, establishment of clinical practice guidelines)(3) Cooperation and educational activities for the planning of training in research
ethics and publication ethics(4) Investigation activities and recommendations for improving measures in theevent of suspicions raised concerning COI disclosure of individual members.
(5) Gathering of information for revisions of COI policy and bylaws. The presidentof the affiliated society must provide an opportunity for commissioned external
officers of the committee to participate in training of COI management andresearch ethics.
2) Criteria for judgment of COI disclosure
Neither standard judgment criteria nor standard evaluation criteria exist in COI
management since the COI status regarding medical science research varies greatly
according to the situation of the study in industrial-academic cooperation activity,
social background, the patent and intellectual property, facilities and the situation the
researcher is in (domestic or nondomestic residents). Medical science research in theenvironment of industrial-academic cooperation should be conducted in a proper andpublicly transparent way, regardless of the fact that the remuneration and grantsupport will differ depending on the businesses, organizations, and groups, therefore, apotential state of COI for the researcher is inevitable. Therefore, the criteria regarding
the content of the activity and the finances involved with the affiliated industry should
be set, based on a policy decided by the affiliated society that can provide social
accountability. An appropriate revision and update of this policy and detailed
regulations should be done regularly, to improve handling of COI self-disclosure. Whena researcher is offered a large sum of money by businesses, organizations, and groups,
either in the form of an honorarium, editing fee, or scholarship fund, or research fundthere is a possibility that the interpretation and study results will be biased in favor ofindustry, and will be pointed out by the mass media since there is an increasing
concern in society. At present, the need for disclosure is decided upon whether themonetary sum is over the base amount, and in such case the corporate name of thefunder must be disclosed. In this guideline, the base amount for disclosure has been
set and proposed in order to prevent COI status from becoming severe for its members,
officers, and when selecting committee members or commissioned personnel (Ref. 1,2). It should be noted that, Disclosure Item 1 which states "officers and advisors of

27

companies and for-profit organizations" refers to researchers affiliated with research
institutions who are appointed as officers and advisors of a specific company, and isengaged in a contract where the researcher is regularly and continuously engaged
receives remuneration.
If advice was requested by the other party (company) on a single occasion then thisshould be disclosed under Disclosure Item 4 “remuneration and daily wages received
for attending meetings (presentations, advice etc.) from companies and for-profit
organizations for the time and effort for which the researcher was detained.
Furthermore, concerning the criteria for judgment of disclosure for research funding
and donations provided by companies, etc., the actual amount that the researcher
could have actually used, is shown based on the actual amount allocated from the total
annual amount provided by the head of the research institution.
On the other hand, the Japan Pharmaceutical Manufacturers Association
announced its "Transparency Guidelines for the Relation Between Corporate Activities
and Medical Institutions" in January 2011, which obligates disclosure of all payments
made by pharmaceutical companies to doctors, and medical institutions, etc. Fromfiscal year 2013, the description of the total amount of scholarship donations, total
amount of writing and lecture remuneration fees (amount and number of payments forindividual researchers can be found from fiscal year 2014) for the previous fiscal year
can be found on the website. If the financial relationship between the business sideand the researcher becomes clear and open to the public, it can of course be expected
to greatly affect COI disclosure criteria for researchers, and therefore this will need tobe revised periodically.
3) Structure of the COI committee
The COI committee will consist of those members who conduct the medical science
research, those familiar with research ethics and COI problems, and those with legal
knowledge concerning related laws and policies. However, concerning the nature ofconfidentiality of personal information, the number of members who handle thisinformation should be limited (e.g. total of 5-7 committee members). In addition, it ispreferred to have a fixed proportion of both men and women, and expert external
members.
12. Role and obligation of the editorial committee
When publishing medical science research results in scientific journals as original
papers, review articles, clinical guidelines, editorials, and opinions, the basic principle is28

to secure ethics and science in order to protect its neutrality. The editorial committee
of affiliated societies regarding results of intervention studies, for example①Whether the medical science research is an invasive intervention study (clinical
trial), ②For intervention studies, whether it is a registered clinical trial, ③Whether it
is a contract or commissioned research, or an independent research, ④Whether the
research funding is public or corporate (foundation grant, including nonprofit
organization NPO), ⑤CONSORT（Consolidated Standards of Reporting
Trials: Confirmation that it adheres to CONSORT (Consolidated Standards of Reporting
Trials: Integrated criteria for clinical trial report). If funds from companies are used forthe research, the author must disclose information about the funding source (provider)and the role of the provider in the process of designing, data collection, analysis,
interpretation, and manuscript preparation, of the research. In particular, forresearchers who conduct intervention studies, if research support funding is obtained
through contract with the company to conduct the research, this information must be
disclosed regardless of what type of contract it may be (Fig. 5). This will in fact be one
way to manage COI for third parties. For the basic way of thinking regarding medical
editing, please refer to the Japanese Association of Medical Sciences Editorial
Guidelines (2015).
The editorial committee, with the cooperation of the COI committee whichclearly states the following, will confirm that COI related to the research contents aredisclosed appropriately using the designated form (Ref. 2). The editorial committee ofthe affiliated society can, with the collaboration of the COI committee, verify COI
policies have been followed by checking to see if any COI related to the particularresearch has been disclosed appropriately using the designated form (Fig. 2), and in thecase that there is a violation, can take appropriate measures such as prohibiting of the
publishing of such articles or retraction. In such circumstances, prompt contact should
be made with the author involved, to notify the author of the situation and reasons. If
a violation occurred after the article was published, the editor-in-chief can publicize
this fact in the scientific journal, and the editor-in-chief can consult the COI committee
and take necessary measures based on discussions.
In addition, for affiliated societies which publish English language journals, it isrecommended that a separate COI policy (in English) be made available, stating clearly
the specific measures to be taken for those who violate the policy.
13. Role and obligation of the ethics committee
The ethics committee is a third-party organization that reports to the29consultation of the president of the affiliated society and functions independently fromthe COI committee. The role and obligation of the ethics committee concerning COI
management involves, receiving consultation from the presidents of the affiliatedsocieties deciding on the appropriate measures to be taken by judging and considering
the degree of violation, its effect on the affiliated society, and reporting this to thepresident of the affiliated society. As COI management deals with difficult ethical issues,
daily exchange of information between the ethics committee, COI committee, editorialcommittee and the clinical practice guideline steering committee is necessary to
promote justifiable medical and health industrial-academic cooperative research, andthat each committee is established as an independent committee.
However, depending on the situation of the affiliated society, it is possible forthe ethics committee to handle COI matters of committee members as an interim
measure.
14. Storage and release of personal data
The COI disclosure form of members and officers contain confidential personal
information which must be stored securely. All personal information either in print orelectronic data, should be secured by the secretariat of the affiliated society by anassigned manager, until it can be deleted or destroyed after a certain period of time.
This system allows the president of the affiliated society as well as the head of
the COI committee to be able to access personal COI information of the member
involved, at all times, in the event that measures need to be taken by the affiliatedsociety in regard to COI management. However, access to this information should not
be more than necessary, and information should not be disclosed for members, or for
any other purposes, other than those who are required to disclose such information.
If the disclosure of COI status concerning officers and members is requested
from the public (e.g. mass media), the appropriate information will be disclosed after
carefully considering the confidentiality of individual information and privacy of themember. Furthermore, if disclosure of COI status is requested for specific officers
and/or members through legal means, a board of directors meeting taking into accountlegal points of view is necessary, and it is recommended that a manual be prepared
beforehand.
15. Monitoring, abiding by, and educational training of COI policy
All members of the affiliated society and employees are obligated to follow
the COI policy concerning medical and health studies. At the same time, it is important

30

to implement COI policy in the training curriculum and programs for continuing
education, lectures, and seminars for qualifications.
As part of research ethics education, a system that includes educational plans
to deepen understanding of bioethics, publication ethics, and COI management, andacademic meetings (e.g. educational lectures, symposia etc.) where board-certified
physicians, board-certified specialists, and board-certified trainers can earn credits
necessary for acquiring and renewing certificates, should be established. Furthermore,in order to enhance the convenience of members belonging to multiple affiliatedsocieties, it is also necessary to issue a common certificate for attending research
ethics training sessions and credits among affiliated societies should be compatible.
In particular, if officers involved in medical science research in theenvironment of industrial-academic cooperation have a serious COI status, regular
reporting and monitoring, change in official post and avoiding inappropriate COI
behavior, is essential for minimal effect on the conducted activity. Furthermore, in theevent that an individual member’s COI serious status may result in affecting theaffiliated society’s activities, and if fairness and reliability cannot be assured, it ispossible to implement a policy prohibiting all involvement (zero tolerance) in theactivity. However, this kind of situation must be treated very cautiously as there is apossibility that it may become a factor which hinders the general industrial-academic
activity.
16. Handling requests for COI disclosure
If a request is made for disclosure of COI status of a member of an affiliatedsociety, the procedure on how to respond should be stipulated from the understandingthat the request will be made from an external source (e.g. mass media, publicorganization etc.). If the reason for request seems appropriate, the COI committee will,with consultation by the president of the affiliated society, respond to the request as
quickly as possible, including conducting an investigation on relevant facts, and also by
protecting the confidentiality of personal information. It is recommended that after
consultation with the president of the affiliated society, the response is quickly passed
onto the person requesting the disclosure.
If suspicions or doubt about industrial-academic collaboration are pointed out
after the results of the medical science research have been published, the editing
committee and the COI committee will work together to clarify the situation, and it is
the responsibility of the president of the affiliated society to give an explanation.

31

However, if it is decided that it cannot be dealt with by each committee, aninvestigation committee including external committee members (experts) will beestablished, and the committee will seek cooperation from the relevant university
presidents to investigate the situation and to collect information. The committee will
respond rapidly to clarify the alleged suspicion, and after receiving a response, thepresident of the affiliated society will be responsible for informing the person
requesting the disclosure.
17. Handling those violating COI policy
A serious violation of the policy concerning the affiliated society might cause
the society to lose its reliability and moral standing in society. In order to prevent thisfrom happening, it is necessary to increase the awareness of COI policy beforehand
through publicity, scientific meetings and other activities that may educate thoseregarding this issue, and to create a COI management system centered around the COI
committee. In the event that a member violates the COI policy, the policy should
clearly state that the president of the affiliated society will take the appropriate
measures according to the degree of violation (e.g. prohibition of presenting at
scientific meetings, prohibiting of publishing in a scientific journal of the society,prohibition of assumption of office or dismissal, withdrawal of qualifications as amember, expulsion from the society, and/or prohibition of admittance to the society).
However, in the case of a serious violation of COI policy, the ethics committee (orappropriate committee) will be consulted and discussions will be held, and based on
the decisions made by the board of directors, strict measures will be taken. On theother hand, it is necessary to state the procedure for appeal beforehand.
Generally speaking, since COI management is based on self-disclosure,
however, in fiscal year 2013, in accordance with the transparency guidelines, it was
decided that pharmaceutical companies would disclose the amount of scholarship
donations made to every research institution. In fiscal year 2014, it was decided thatdetails of writing fees, and lecture fees for each researcher would be disclosed,
therefore it is possible that the information concerning disclosure may be different
from that of self-disclosure. It may also be assumed that members of affiliatedsocieties who are at question, may be considered to be problematic or a violator.
If a doubtful, social or moral problem arises concerning a society member, the
COI committee will conduct a thorough investigation and hearing. If there is a serious
COI situation, and if no explanation or responsibility can be taken, the president of theaffiliated society will, based on the consultation with the ethics committee, discuss the32situation at the board of directors meeting, and will retract the submitted publicationor presentation of the author involved, or retract the publication. A structure such as
this, stating the measures to be taken based on the policy of the affiliated society,should be prepared beforehand and stated in the COI policy.
On the other hand, handling COI policy violations of nonmembers is mostoften difficult. It is necessary that when requesting participation each time from anonmember, each affiliated society should carefully explain the COI policy and theimportance of following the policy, in writing beforehand. It can be assumed that foraffiliated societies which publish scientific journals in the English language, the numberof nonmembers, especially the number of speakers from foreign countries, will
increase and that correspondence in relation to COI policy violations can be expected
to be more complicated than expected. It is recommended that a correspondence
manual including measures such as prohibition of a presentation, retraction of apublication, and publishing an apology letter for those violating the policy, be madeavailable to guarantee the integrity of the international society.
18. Response to an appeal
If an appeal is made, the president of the affiliated society must promptly set
up a screening committee (hereinafter, the screening committee). The structure of thescreening committee, in addition to the appeal procedure, is stated in the COI policy.
VI. Accountability to society
The presidents of affiliated societies are responsible for disclosing the COI
status of their affiliated institutions and individual members after discussions at theBoard of Director’s meeting, and providing explanations to society as an organization to
fulfill self-responsibility and ensure accountability. The COI committee should create asystem, in advance, so that in case a member’s COI situation as a result ofindustrial-academic cooperation becomes serious, the related committees cancollaborate regarding responding to various organizations and the mass media. For
example, if a member has a COI situation in which there is a need to take social andmoral responsibility, the president of the affiliated society may disclose or publicize
that information either within or outside the society after a final decision has been
made by the Board of Directors.
VII. COI management of affiliated societies
The ways to handle COI problems of individual members and officers giving

33

presentations on medical and health studies has been stated, however, it is important
to state the policy concerning ways to handle serious cases of financial COI between
the affiliated society itself and businesses, organizations, and groups. For example, if anaffiliated society, receiving large remuneration from businesses, organizations, andgroups, sponsors activities (such as special symposia, public lectures etc.), a possible
COI status is likely to arise. When giving presentations under such circumstances, it canbe predicted that COI evaluation and ethical aspects such as fairness, subjectivity andindependence are difficult to maintain. In the future, the detailed amount of
remuneration and funds the affiliated society receives from businesses, organizations,and for-profit groups, should be disclosed in accordance with the format of the"Transparency guidelines for the relation between Corporate Activities and Medical
Institutions" of the Japan Pharmaceutical Manufacturers Association in the homepageof the affiliated society.
One method of COI management for affiliated societies as an organization
would be to have an external evaluation of the affiliated societies. We will continue topursue measures for COI management as the JAMS and also as a member of theaffiliated societies.
VIII. Questions regarding the Q&A section and the homepage
The basis of COI management for each affiliated society is ① Informing
members and participants of the development of COI policy ②making sure thatmembers and participants abide by the relevant COI policy is important, however,questions and problems concerning the interpretation may arise. In that case, the COI
committee should create a Question & Answer (Q&A) section in the society homepage,and make sure that each question is answered, in addition to publicizing the Q&A
section of the homepage to members and other interested parties.
IX. Changes in policy and detailed regulations
COI policy and detailed regulations should, generally, be updated every few
years, in order to meet the revisions made to laws for social factors andindustrial-academic cooperation, and various changes related to equipment, medicine,and clinical research.
X. Current guidelines were established in February, 2011.
1. Revised in February, 2014
2. Partially revised in March, 2015

34

3. Revised March 31, 2017

Appendix 1) Definition of terms
The definition of terms related to medical science research are, in principle, based on the Japanesetranslation of the Helsinki Declaration prepared by the Japanese Medical Association, in reference
to the "Ethical Guidelines on Medical Science Research Involving Human Subjects" (2014) of the
Ministry of Education, Culture, Sports, Science and Technology, and the Ministry of Health, Laborand Welfare "Ethical Guidelines on Medical Research for Humans" (2014). We have attempted totry to ensure consistency with the content of our guidelines as much as possible.
1. Medical science research refers to activities involving human subjects (including specimens andinformation) carried out to investigate the etiology of the disease (including the frequency anddistribution of various health-related events and factors affecting them) and its pathology, and to
gain knowledge that will contribute to maintaining and promoting public health and improving
patient prognosis or quality of life through improvements in diagnostic and therapeutic methods
and verifying such measures. In this Guideline, for the term "human subjects" used in the Helsinki
declaration published by the World Medical Association, we have used the Japanese term "humanbeings" translated by the Japan Medical Association.
2. Clinical Research
Medical science research that is conducted for the purpose of disease prevention, improvement of
diagnostic and therapeutic methods, understanding the etiology and pathological condition of
diseases, and improving the quality of life of patients, and is subject to ethical review.
①Interventional studies concerned with the prevention, diagnosis or therapeutic methods using
pharmaceutical drugs or medical devices.
②Interventional studies (excluding those relevant to ①)③Studies without intervention using specimens etc. that do not include epidemiologic research(to clarify the frequency and distribution of various health-related events appearing in a clearlyspecified human group and the factors affecting them) (observational research).
3. Clinical Trials
Research with intervention designed and conducted in accordance with scientific principles, inhuman subjects, for the purpose of evaluating clinical effects of medical supplies (including
vaccines, biologics), radiotherapy, psychotherapy, surgery, medical devices, alternative therapies.
Classification of clinical trials according to purpose (general guidelines for clinical trials) include①Clinical pharmacology trials，② Exploratory trials，③Confirmatory trials (comparative efficacy
trials, randomized parallel dose-response studies, safety studies, evaluation of mortality / morbidity

endpoints, large scale clinical trials, comparative trials) ④Evaluation of therapeutic use(comparative efficacy trials, evaluation of mortality / morbidity) endpoints, tests for additional
endpoints, large-scale clinical trials, and medical economics examinations
4. InvasivenessTo cause stimulation for research purposes that exceeds the range covered by daily life such as
puncture, incision, irradiation, and questions related to psychological trauma. “Minor invasiveness”
refers to invasiveness that has little effect on the body and psychological state of the researchsubject.
5. Intervention
The act or practice for research purposes to control the presence or absence of factors which canaffect a variety of events that occur in relation to human health (including actions maintain andpromote good health, medical practices, medication, and examinations etc.) for the prevention,
diagnosis, or treatment of diseases. (This includes medical practice beyond the usual level,
conducted for research purposes).
6. Research subject
An individual (the individual asked to be enrolled in the research) about whom an investigator
conducting research obtains existing data or information to constitute research.
7. Investigators etc.
This refers to the principal investigator and other individuals who are engaged in conducting the
research (including collecting and providing specimens and information at organizations that collectand distribute specimens and information), excluding those who do not belong to research
institutions but only engage in distributing existing data and information, and those who are partly
engaged in entrusted research work.
8. Principal Investigator
An individual who is responsible for conducting the research, such as preparing the research plan,
and who oversees all work related to the research at the affiliated research institution.
9. Research Director
An individual who is responsible for conducting the research, such as preparing the research plan,
and who oversees all work related to the collaborative research at multiple facilities.

10. Head of the Research Institution
An individual who is a representative of a corporation, head of an administrative organization or anindividual business owner, who is ultimately responsible for the research.
11. Sponsor
An individual, company, institution or organization having responsibility for the starting,administrating, managing and funding etc. of the medical science research. The Japanese
Association of Medical Journal Editors has translated “sponsor” as "president" in Japanese anddistinguishes it from Funder (funding provider).
12. Funding Provider
An individual, company, corporation, institution or organization that provides necessary funding for
conducting medical science research. It also includes providing labor.
13. Serious Adverse Events
An event that
① results in death ② is life-threatening ③ requires hospitalization or causes
prolongation of existing hospitalization ④ results in permanent or persistent disability or
impairment ⑤is a congenital anomaly or birth defect
14. Unanticipated Serious Adverse Events
Among severe adverse events, those not documented in the research plan, or informed consent
documents, etc., or those that are described but whose nature and severity do not agree with thecontents described.
15. Interventional Research
An invasive clinical trial involving human beings as subjects. A clinical trial conducted to collect datanecessary for application for obtaining approval for the manufacturing and sales of new drugs iscalled a "trial". Interventional research that is initiated by the investigator to validate the clinicalefficacy and safety of an approved drug is called an investigator-initiated clinical trial.
16. Randomized Controlled Trial
A type of research method of a large-scale comparative clinical trial which enables an objective
evaluation of the efficacy of treatments by eliminating frivolous bias in evaluation.

17. Research Institution
A corporation, administrative institution or individual business owner that conducts the research,
excluding cases where only a part of the work related to the storage of samples / information,
statistical processing and other research is entrusted.
18. Joint Research Institution
A research institution that jointly conducts research based on a research plan, including institutions
that acquire new specimens / information from research subjects and provide them to otherresearch institutions for the research.
19. Informed Consent
Voluntary consent that is given by research subjects or their legal representatives etc. (hereinafter“research subjects”) regarding the research (including the handling of samples and information) tobe conducted or continued after receiving adequate explanations about the purpose andsignificance of the research, procedures, any discomforts research subjects may experience, andpredicted results (including risks and benefits).
20. Informed Assent
The process whereby research subjects who are objectively considered unable to give informed
consent regarding the research to be conducted or continued due to lack of cognitive maturity tounderstand, are informed of the research in words suited to meet their ability to understand, andexpress consent to participate in the research to be conducted or continued.
21. Legal representative, legal representatives etc.
An individual who can speak on behalf of the research subject’s will and interests. If an occasion
arises where the research subject is judged objectively that he/she does not have the ability to giveinformed consent to the research, the legal representative is able to give informed consent onbehalf. In cases where the research subject is deceased, the term “legal representatives etc.” will be
used.
22. Industrial-Academic Cooperative Activities
Research institutions cooperate with companies, corporations, and for-profit organizations(hereinafter referred to as companies, etc.) related to the medical science research. The following
activities are included.

1) Joint Research: Research performed by dividing research funds and research personnel,
involving companies, organizations, groups. (with or without recompense or remuneration)2) Commissioned Research: companies, organization, and groups commit themselves to contracts
concerning methods of treatment, drugs and devices, and research is performed on the basis ofsuch contracts3) Technology Transfer: companies make practical use of the patent rights and other rights
concerning the research results of research institutions4) Technology Guidance: researchers of research institutions etc. conduct business development
and give technological advice
5) Research Institute Ventures: venture organizations are based on the results of the research ofuniversities and research institutions and supported by the research institution.
6) Donations: unrestricted donations are made to assist universities and research institutions bycompanies, organizations and groups
7) Endowed Departments: departments are established for the promotion of research enabled byfinancial donations to research institutions from companies, organizations, and groups.
25. Monitoring
The principal investigator (research supervisor) will appoint an individual to determine whether aclinical trial is conducted properly in compliance with the research plan, and that progress, ethics
and science of the research based on the research plan are ensured.
24. Audit
The principal investigator (research director) will appoint an individual to determine whether theclinical trial was properly conducted in order to assure the reliability of clinical trial results.
25. Definition of Terms Related to Conflict of Interest (COI)①Economic COI or related persons who need disclosure
Financial situations and related persons requiring COI disclosure
Since a COI situation may occur for various reasons, judgment may need to be made on an
individual basis. For those employed, or in a position of leadership, regardless of whether it may be
full-time or part-time, disclosure is required of all investment and licensing companies, all executive
board members of for-profit organization, and officers.

②Advisor or Consultant
This applies to those who act as advisors. For example, if a person acts as advisor or consultant in
an investment, licensing, or for-profit organization, and receives income such as consulting fees etc.
within a fixed term.
③Equity (stocks etc.) holder
This applies if a venture company holds stock (includes stock options) whether it is a publicly heldstock or unlisted stock, and is involved in investment, licensing, or is a for-profit organization, if it
receives profit from such stocks (unless it is operated by a multilateral fund which cannot be
managed or controlled by the correspondent)④Honoraria
A legitimate payment given for services such as giving lectures, seminar presentations andparticipation. This applies when the individual disclosing COI is given direct payment consisting ofhonoraria, investments, licensing fees from the authorities concerned, or from for-profit
organizations. However, the maximum limit of lecture honoraria should be set by each affiliatedsociety, in addition to other nominal income.
⑤Funds for Conducting Medical Science ResearchThis includes all funds related to conducting medical science research projects, and applies even if
the fund is paid by an agent hired by the sponsor. In addition, even if it is a scholarship fund fromthe sponsor of the medical science research, with no specified expenditure, it must still be disclosed
if it is over a certain amount. However, the total funds and duration when disclosing can be set byeach affiliated society.
⑥Other Contributions (gifts, materials etc.)
Gifts and materials which are not directly related to research activity, such as travel expenses andgifts, are still subject to disclosure if they are received from investment, licensing, or for-profit
organizations. In addition, disclosure is also necessary if such in-kind materials were received withina fixed term after the study activity was initiated.
⑦COI Policy
A structure which includes a basic system of COI management, such as, the basic policy related to
COI of each affiliated society, the definition of COI, those subject to COI and the extent ofcorresponding acts, foundation of a COI committee and self-disclosure forms.

⑧COI Management
A system to promote appropriate industrial-academic cooperative activities among the businesses,organizations, and groups related to medical science research. According to COI policy, employees
and members of each affiliated society must submit self-disclosure forms, to which an investigationis conducted by the COI committee, and in situations where COI status may cause damage to thecorresponding affiliated society’s activities, the COI committee will take necessary measures toensure that education, research and publicity is conducted properly to society and the generalpublic.
⑨Disclosure is disclosing COI status of an individual and transmitting the information to research
institutions and members of academic organizations. Public COI disclosure means disseminating
information to society as a whole, such as publishing this information in a manuscript in a journal.

Appendix 2) Items to check when filling out self-disclosure forms
1) Sample self-disclosure items for officers① State if you have been an officer or consultant in a company, institution or for-profit
organization (if the total annual income from the corresponding institution or facility exceeds acertain limit, e.g. 1 million yen), the type of income and amount. The preset limit of minimum
income that must be disclosed should be decided by each institution or facility while considering
the situation.
②State the type of equity (stocks etc.) of the industrial-academic cooperative activity (e.g. either
publicly held or unlisted stock, stock, investment, stock option, beneficiary rights etc.), and theamount. If the profit (total sum of the dividend or profit sales) from stocks within a fixed period
from 1 organization totals more than the standard amount e.g. 1 million yen or more, or if 5% ormore of all stocks of the corresponding stock is owned then disclosure is needed.
③Patent right fees from companies, institutions and organizations, of 1 million yen or more perpatent fee, per year.
④Remuneration for attending meetings (presentations) from companies, institutions andorganizations, paid for the time and effort of the daily activity (lectures etc.) which is 500,000 yen ormore from 1 organization or group per year.
⑤Regarding manuscript fees paid for writing of pamphlets etc. by companies, institutions andorganizations, 500,000 yen or more per organization, business or group, per year.
⑥Regarding research funds for medical science studies (trust research funds, joint research funds,
clinical study funds) provided by companies, institutions and organizations, an annual total of 2
million yen or more for 1 organization or group.
⑦For scholarship funds granted by companies, institutions and organizations, anannual total of 2 million yen or more from 1 organization or group, to the individual disclosing COI
or to the affiliated department of the individual disclosing COI (department, field) or to the head ofthe department.
⑧If the individuals disclosing COI is affiliated with the funded department sponsored by thecompanies, institutions and organizations.
⑨Concerning other travel expenses, gifts, or contributions unrelated to the research, an annual
total of 50,000 yen or more by 1 company, institution or organization.
However, whether the researcher’s family members are subject to disclosure and if so, the specificrange of disclosure, should be decided after consideration by each affiliated society.

2) Items for self-disclosure for speakers at scientific meetings①For an officer or consultant in a companies, institutions and organizations (hereinafter,
companies, institutions and organizations) total annual honoraria of 1 million yen or more from 1
organization, business or group.
②State the type of equity (stocks etc.) of the industrial-academic cooperative
activity (e.g. either publicly held or unlisted stock, stock, investment, stock option, beneficiary rightsetc.), and the amount. If the profit (total sum of the dividend or profit sales) from stocks within afixed period from 1 organization totals more than 1 million yen or more, or if 5% or more of all
stocks of the corresponding stock is owned then disclosure is needed.

③Patent right fees from companies, institutions and organizations, of 1 million yen or more perpatent fee, per year.
④Remuneration for attending meetings (presentations) from companies, institutions andorganizations, paid for the time and effort of the daily activity (lectures etc.) which is 500,000 yen or
more from 1 organization or group per year.
⑤Regarding manuscript fees paid for writing of pamphlets etc. by companies, institutions andorganizations, 500,000 yen or more per organization, business or group, per year.
⑥Regarding research funds for medical science studies (trust research funds, joint research funds,
clinical study funds) provided by companies, institutions and organizations, an annual total of 2
million yen or more for 1 organization or group.
⑦For scholarship funds granted by companies, institutions and organizations, anannual total of 2 million yen or more from 1 organization or group, to the individual disclosing COI
or to the affiliated department of the individual disclosing COI (department, field) or to the head ofthe department.
⑧If the individuals disclosing COI is affiliated with an endowed department where funding isprovided by companies, institutions and organizations⑨Concerning other travel expenses, gifts, or contributions unrelated to the research, an annual
total of 50,000 yen or more by 1 business, organization or group.
However, regarding ⑥ and ⑦, if there are any research funds or scholarship grants received fromorganizations or groups where a COI situation exists between the results of the study of the firstauthor, the affiliation (department, field) of the first author, or the laboratory, disclosure isnecessary.

Appendix 3) Websites that allow you to view relevant policies, guidelines, recommendations, etc.
①Helsinki 宣言：http://www.med.or.jp/wma/helsinki08_j.html②CONSORT 2010
http://www.consort-statement.org/checklists/view/32-consort/66-title③日本製薬工業協会「企業活動と医療機関等の関係の透明性ガイドライン」2011年

２月 http://www.jpma.or.jp/about/basis/tomeisei/④ICMJE(International Committee for Medical Journal Editors): ICMJE
Recommendations for the Conduct, Reporting, Editing and Publication of
Scholarly Work in Medical Journals. 2013
⑤文部科学省・厚生労働省「人を対象とする医学系研究に関する倫理指針」2014年
12月 http://www.lifescience.mext.go.jp/files/pdf/n1443_01.pdf⑥日本学術会議「我が国の研究者主導臨床試験に係る問題点と今後の対応策」 平
成26年３月 http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-22-t140327.pdf⑦文部科学省「研究活動における不正行為への対応等に 関するガイドライン」2014
年８月
http://www.mext.go.jp/b_menu/houdou/26/08/__icsFiles/afieldfile/2014/08/26/1351568_02_1.pdf⑧一般社団法人全国医学部長病院長会議 「研究者主導臨床試験の実施にかかるガ
イドライン」2015年 https://www.ajmc.jp/pdf/guideline_01.pdf⑨日本医学会 医学雑誌編集ガイドライン 2015年３月
http://jams.med.or.jp/guideline/jamje_201503.pdf⑩日本製薬工業協会「医療用医薬品等を用いた研究者主導臨床研究の支援に関する指針」2016年１月
http://www.jpma.or.jp/about/basis/clinical_research/pdf/guideline.pdf⑪Minds 診療ガイドライン作成の手引き2014．
http://minds4.jcqhc.or.jp/minds/guideline/handbook2014.html

(Form Reference 1)
COI Disclosure Form for Committee Members( 20.01.01〜12.31: Disclosure period is for the past 3 years for each year from a year prior to the time of

office)Name of Individual Disclosing COI: (Member Number)：

（

―

）

Affiliation (Institution, Department, Hospital Department), Title:
Official Title in Society:
President
Board member Supervisor
Congress President
Next Congress President Academic Conference President
Name of Designated Committee:
Committee, Section Head
Academic Meeting Steering Committee
Committee for Lifelong Education
Journal Editorial Board Committee
Committees Related to Clinical Practice Guideline Formulation
Ethics/Medical Safety Committee
COI Committee
Working Group

Staff

Other

A. Items for COI self-disclosure
1. Position as an officer or advisor of a company or for-profit organization, and amount of remuneration（ Applicable ・
Not Applicable）(Give amount if remuneration exceeds 1,000,000 yen or more from a single company or for-profit organization)
Title (Officer, Consultant
AmountName of Company/Organization
etc.)
１
２
３

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more
2. Stock ownership and profit from stock (profit from stock for the previous year)（ Applicable ・
Not Applicable）(Give amount if annual profit from stock from a single company exceeds 1,000,000 yen, or if ownership is 5% or moreof total shares.)
Name of Company
Number of Shares Share Price (per share)
Amount１
２

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

3. Remuneration received for patent royalties or licensing fees from companies or for-profit organizations.
（ Applicable ・
Not Applicable）(Give amount if royalties or licensing fees exceeds 1,000,000 yen per year for a single patent.)
Name of Company/Organization
Name of Patent
Amount１
２

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

4. Honoraria such as lecture fees, attending conferences (presentations, providing advice etc.) received from acompany or for-profit organization for the time and labor given by the researcher（ Applicable ・
Not Applicable）(Give amount if annual honoraria from a single company or organization exceeds 500,000 yen)
Name of Company/Organization
Amount
１
２
３
４
５
６
７
８
９

Amount: ①500,000 yen or more ②1,000,000 yen or more ③2,000,000 yen or more

5. Manuscript fees received for writing articles for pamphlets, roundtable discussion articles, etc. from a single company
or for-profit organization（ Applicable ・
Not Applicable）(Give amount if annual manuscript fees from a single company or organization exceeds 500,000 yen)
Name of Company/Organization
Amount１
２

Amount: ①500,000 yen or more ②1,000,000 yen or more ③2,000,000 yen or more

Not Applicable）
6. Research funding provided by a company or for-profit organization（ Applicable ・(Give amount if research funding from a single company or organization allocated for medical science research (joint
research, commissioned research, clinical trials etc.) exceeds 1,000,000 yen)
Name of company/Organization
Research classification
Amount１
２
３

Research classification: ①Industrial-academic cooperative research, ②commissioned research, ③clinical trials, ④otherAmount: ①1,000,000 yen or more ②10,000,000 yen or more ③20,000,000 yen or more

7. Scholarship (incentive) donations provided by a company or for-profit organization（ Applicable ・
Not Applicable）(Give amount if scholarship (incentive) donations provided by a single company or organization to the affiliateddepartment or division allocated for use exceeds 1,000,000 yen)
Name of Company/Organization
Amount
１
２
３
４
５
６
７
８
９
10

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

8. Endowed departments established through donations by a company （ Applicable ・(Give amount if affiliation is with an endowed department)
Name of Endowed Department
Name of Company/Organization

Not Applicable）
Installation
Period１
２*Give amount if funding allocated for research is 1,000,000 yen or more.

9. Other remuneration (not directly related to research such as gifts etc.)（ Applicable ・
Not Applicable）(Give amount if annual remuneration received from a single company or organization exceeds 50,000 yen)
Name of Company/Organization
Details of Remuneration
Amount１
２
３

Amount: ①50,000 yen or more ② 200,000 yen or more

B. COI disclosure for spouse, first degree relatives or any persons who share income or property assets with thedeclarer.
Please check the box applicable.
□No items to disclose: There is no need to fill out the rest of this form
□Items to disclose: Please check the following items. If not applicable, check ‘Not Applicable’.
1. Position as an officer or advisor of a company or for-profit organization, and amount of remuneration（ Applicable ・
Not Applicable）(Give amount if remuneration exceeds 1,000,000 yen from a single company or organization)
Name of Corresponding Person
Name of Company/Organization

Relationship with Declarer
Title
Amount(Officer, Consultant etc.)

１
２
３

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

2. Stock ownership and profit from stock (profit from stock for the previous year)（ Applicable ・
Not Applicable）(Give amount if annual profit from stock from a single company exceeds 1,000,000 yen, or if ownership is 5% or moreof total shares.)
Name of Corresponding Person
Relationship with Declarer
Number of
Declared share Price
AmountName of Company
Shares(per share)
１
２

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

3.Remuneration received for patent royalties or licensing fees from companies or for-profit organizations.
（ Applicable ・
Not Applicable）(Give amount if annual royalties or licensing fees exceeds 1,000,000 yen for a single patent.)
Name of Corresponding Person
Relationship with Declarer
Name of Company/Organization
Name of Patent
Amount１
２

Amount: ①1,000,000 yen or more ②5,000,000 yen or more ③10,000,000 yen or more

Pledge: I hereby declare that there is no discrepancy in my conflict of interest status described above. I have noother COI that may impede my work for the ◎◎ Society other than those I have stated. I agree that the contents ofthis disclosure form may be made public if subject to social or legal requests.
Date:

/

/

(month / date / year)

Signature:
Receipt Number:(This form will be archived for 3 years after expiration or retraction from office)Use this form if you require more space to disclose items.

(Additional Form)

Name of Individual Disclosing COI:
＜Items to Declare＞
1.
2.
3.
4.
5.
6.
7.
8.
9.

Position as an officer or advisor of a company or for-profit organization, and amount of remuneration.
Stock ownership and profit from stock (profit from stock for the previous year)
Remuneration received for patent royalties or licensing fees from companies or for-profit organizations.
Honoraria such as lecture fees, attending conferences (presentations, providing advice etc.) received from a single
company or for-profit organization
Manuscript fees received for writing articles for pamphlets, roundtable discussion articles, etc. from a single
company or for-profit organization
Research funding (joint research, commissioned research, clinical trials etc.) provided by a single company or
for-profit organization
Scholarship (incentive) donations provided by a single company or for-profit organization
Endowed departments established through donations by a company
Other remuneration (travel expenses, gifts etc. not directly related to research)
Name

(A・B)

Disclosure
NumberName of Company/Organization

Applicable (Title, Patent name,
Type of research etc.)*If #2, give the total number ofshares and share priceAmount(refer to each item)

*Please make copies if more space is required