The Guidelines Concerning Conflict of Interest of theJapanese Association of Medical Sciences
Table of Contents
I.

Introduction

II.

Basic thinking

III.

The special character of medical research and COI policy

IV.

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. Items that should be avoided in medical research and their management

V.

The planning of detailed regulations 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 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 data115. Monitoring, abiding by COI policy, and educational training
16. Handling requests for COI disclosure
17. Handling those violating COI policy
18. Response to an appeal

VI.

Accountability to societyVII.

COI management of affiliated societies

VIII.

Questions regarding the Q&A section and the homepage

IX.

Change in policy and detailed regulations2

I. Introduction

The industrial academic cooperation activity in the United States became
strengthened with the introduction of the Bayh-Dole Act in 1980. For the past 30
years this has contributed greatly to practical applications in the fields of prevention,
diagnostics, and therapeutics based on research in preclinical medicine.

Howeverthe more academia becomes involved in profit-related activities and also with
for-profit organizations, the more social responsibilities it shoulders in terms ofeducation and research, and the personal development of individual conflicts ofinterest becomes unavoidable due to such industrial-academic cooperation (Figure1). These conflicts of interest (COI) must be appropriately managed by academic
institutions and societies and the safety and human rights of subjects taking part inclinical research must be zealously guarded. The Gelsinger incident that occurredin a US state university in 1999 was a great warning about the importance of the
management of and supervision of an organization concerning COI regarding not
only ethical aspects, but also state-of-the-art medicine. Since then more than 95%
of all biomedical universities in the United States have established policies
concerning research involving human subjects and have attempted to ensure
appropriate clinical research and clinical trials.

This kind of movement was not limited to large general hospitals or medical
schools who were actively promoting clinical research in association with industry,3but also involved institutions devoted to the publication of their research results tomake them available for society at large, and they were also interested in making
COI policy be understood by all researchers who were involved in clinical researchand educational activities. Furthermore, awareness of the necessity of thedeclaration of COI status of researchers publishing in specialist medical journals
increased, but, although the necessity for individual reporting of COI statusincreased, there is no uniform policy on, or management of, COI, as yet.

In Japan, the "Kagakugijutsu Kihonkeikaku" (Basic Plan for Science andTechnology) was established in 1996. This was intended as an overall response to
the wishes of the general populace regarding state-of-the-art preclinical research
results. Thereafter, the second plan for basic research (2001) followed by the thirdplan (2006) advanced this philosophy and reflected the basic thinking concerning
administration of scientific policies of our country. Furthermore, while attempting toestablish the scientific and technological creativity status of our country, theimportance of industrial-academic cooperation was emphasized. Not only
universities, but also research institutes and scientific groups must return thebenefits of the results of the research to society, thereby providing the Japanese
populace with safety and good outcomes with regard to economic activity, and also
ensure that education and research activity should be promoted. At the same time,the more that industrial academic collaboration increases, the responsibility of
public institutions such as universities and research institutes also increases.

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Therefore, the responsibility of disclosure of COI status concerning individual
researchers and their affiliated institutions or universities becomes extremely
important.

In addition, since medical research involves human beings, it is necessary toensure ethical treatment of patients, who are generally in a weak position, and also
ensure the scientific integrity of any project. Therefore, it is essential that the
ethical aspect of any research be guaranteed. In the “ethical policies regarding
clinical research” of the 2003 Declaration of Helsinki, it is clearly stated that COI
regarding human subject research, especially concerning the individual profit thatmight be derived from research, should be treated with great care.

The first approach taken to COI in Japan was in August 2004 at a panel discussion
sponsored by the Ministry of Education entitled “Clinical Research, Clinical Trials
and Conflict of Interest: How to Handle the Problem”.
importance of the question of COI.

This event established theThereafter, a committee entrusted to performa survey by the Ministry of Education Research Group on the ethics of clinicalresearch and COI was established.

In March 2006 “Guidelines regarding Conflictof Interest Policy and Clinical Research” was published.

These guidelines defined

the regulations concerning universities, research institutes, hospitals and academic
societies concerning clinical research on human beings.

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They also tried toprevent any obstacle to the implementation of research involving human subjects
and strove to establish the social responsibility and regulations for clinical research.
The guidelines attempted to present basic policies on the management of COI
problems involving clinical research and at the same time to promote a high levelof clinical research and assist in the achievement of a high level of research.
Then 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.

One of the major worldwide movements of recent years is to perform preclinicalresearch looking for seedlings that can be passed over by translational research tothe clinical field and many countries use this approach in their national plan.
Because of this background, the research object of COI management is clinicalresearch and clinical studies (including clinical trials). Industrial academic
cooperation has expanded to the field of basic biomedical research and for-profit
businesses, organizations, and groups are increasingly tending to demandfinancial COI status self-disclosures from basic researchers. Therefore, the Japan
Association of Medical Sciences, wishing to improve approaches to prevention andmethods for diagnosis and treatment, is seeking to gain better understanding of thecauses and morphology of diseases and promote industrial academic cooperative
research to improve the quality of life of patients. The biochemical research and6preclinical basic research both extend to human beings, and associated clinicalresearch (including the use of specimens which can identify the individual fromwhich they originated or data which can be used to identify the individuals fromwhich they were generated), and defines all such activities up to and including
clinical research as medical research, and therefore considers all such activities
within this wide range as the target of COI management.

II. Basic thinking
Biochemical science universities, research institutes, hospitals, and similar
institutes, specialists, or academic societies are hoping to help prevent, diagnose
and treat intractable diseases through education and medical research by industrial
academic cooperation. The medical research of these establishments andinstitutions, as well as their scientific educational programs and researchconcerning human beings, require the application of secure ethics and science.
The publication of any results in academic meetings or academic journals requires
transparency and neutrality. It goes without saying that such medical research,clinical research and clinical studies must strictly comply with ethical policies.

The COI status in medical research involves not only human rights, life and safetyof the patient, but also preclinical research and health treatment in the healthcare
environment. Researchers working in such an environment carry out research in7

cooperation with industry, including basic research, clinical studies and trials, andmoreover such researchers are involved with venture capital industries, whichmake commercial products of the treatment methods created by the researchers,
and therefore the presence of COI is unavoidable. However, the fact that a COI
status per se regarding financial aspects exists, is in itself not a problem. The
institutions and organizations have to properly manage those aspects and it isessential that a system be developed in which inappropriate medical research isprevented. In our country, the response to the COI status, which has been taken
up as an extremely important aspect of the Declaration of Helsinki and other ethicalpolicies, has not been as rapidly developed and given as much importance as in
the West.

In medical research, the necessity of transparency, reliability, and specialized
aspects of clinical research and clinical studies in human beings requireappropriate COI management. As reported by the Ministry of Health and Welfare inthis interpretation of the "Ethical Policy in Clinical Research", they state that theconflict of interest of a researcher should not cause any "warping of the essential
nature of the research", while at the same time, based on the status of clinicalresearch in our country, they also state "if research related to for-profit industries
were to be forbidden categorically, this would lead to hindrance in the developmentof drugs." As can be understood from this, even within the field of medical research,clinical medical research and clinical studies have an extremely high level of ethical8and specialized aspects, and since this means that the research concerning
human beings is of a very special nature, this entails that COI status in this field isof a slightly different nature than the COI problem in general. By appropriately
overcoming this problem and in order to prevent the COI status, which can develop
latently to become a serious problem, all medical research regarding humanbeings must be particularly transparent and extremely appropriate.

In the COI management related to medical research, the foundation or organization
which seeks to employ the data provided by the researcher should 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.
In addition, the health science branch of such an organization must ensure thatbasic or preclinical information regarding medical research or clinical medical
research, clinical studies (clinical trials) must be distributed appropriately and theresearcher providing those data should ensure that objective evaluation is given to
those data. In addition, in performing medical research or clinical research, it isimportant to ensure that there is no undue influence of considerations of financial
profit. Furthermore, the individual researcher who is employed in medical researchmust ensure that the research does not lose any validity and that the safety ofparticipants in clinical studies is not threatened. In addition, the researcher should
not receive rights to ownership or profit. In order to attain this goal, the evaluationof the COI status should be enforced or supervised by a third party to ensure that9the appropriateness of the medical research is guaranteed. Furthermore,biomedical-related universities or scientific bodies should disclose appropriately
any financial profit or other related profit.

It therefore is essential to makeprogress based on an appropriate balance of education and research with anindependent, objective and strictly scientific nature.

The guidelines concerning COI management of medical research of the Japan
Association of Medical Science are intended to give guidance to the leaders of thesocieties affiliated with the Japan Association of Medical Sciences and members
related to COI management. Each affiliated society manages all matters related to
COI status, including distinct conflict of interest issues. The appropriateness of the
medical research results should be verified, guaranteed and made public. The
organization and modus operandi of the affiliated societies will differ, as will
particular factors concerning each of the affiliated societies, therefore, we muststate that these guidelines do not have legal power. These guidelines should
consider many conditions related to each of the affiliated societies of the Japan
Association of Medical Science and are intended to provide assistance inestablishing COI policy and detailed regulations concerning medical research.

Ⅲ. The special character of medical research and COI policy
Medical research differs from joint research, or commissioned research (forexample, unlike engineering faculties etc.) and has the following particular features10

which require extreme care in implementation:

1. Many researchers belonging to universities, research institutes, hospitals andother specialist societies are not only related to commercial ventures, but also
are related to, or are involved with, doctor-patient relationships, protection of therights of the subjects and guarantee of the safety of the health and welfare of
the subject.

2. Data from medical research or clinical research are involved with thesubsequent development of new diagnostic or therapeutic methods, therefore itis especially imperative for researchers to ensure the reliability of their data.

3. The publication of research results has a great impact on those involved inhealth care, those listening to presentations, or reading papers. Therefore, theinterpretation of such publicized results has an influence on health care that isby no means small. In order to ensure a neutral objective self evaluation, it isnecessary for the presenters to disclose all pertinent data concerning relatedcommercial organizations and their COI status.

On the other hand, based on the following points of view, medical research andclinical research have the following special characteristics concerning the COI
status of individuals and researchers.

111. Many areas of the most up-to-date medical research is related todevelopments in prevention, diagnosis and treatment.

In many cases, theresearchers themselves are the most appropriate persons to safely
accomplish such basic and clinical research.
2. Concerning the development of new drugs, it would take a long time forsociety to benefit by relying only on technology transfer from existing
commercial entities. Therefore, the role of researchers themselves
regarding venture entities is large.
3. New drugs or new medical devices require basic research and clinicalstudies in order to be developed for clinical use. Therefore, it is very difficult
for the researchers themselves to be completely uninvolved with thisprocess.

In order to appropriately manage COI related to medical research (pre-clinical andclinical) in the environment of industrial-academic cooperation, the social situationin the specialty of each of the affiliated societies, must prepare detailed regulations
concerning COI policy and COI management related to the above comments. As
a result of that, the COI committee under the leadership of each of the affiliatedsocieties should enforce suitable management of COI, thereby contributing to thereturn of benefit to the society, welfare of the people, promotion of health and theovercoming of intractable diseases.

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Ⅳ. The basis of COI management related to medical research

In recent years, COI management related to medical research can be carried out atmedical schools and research institutes and the specialist societies at which
research results are made public can be largely divided into two stages (Figure 2).

1. Implementation of medical research by institutions and organizations
Various medical academic universities and research institutes are promoting theestablishment of COI policies concerning medical research (including pre-clinicaland clinical research and clinical studies and the systemization of managementof COI at those institutions is gradually becoming better organized. In particular,
concerning clinical studies, as in the case of other cooperative projects withindustry, each researcher is required to submit not only clinical research programplans but also COI disclosure statements in order that the universities andresearch institutions can appropriately manage COI.

2. Specialized societies and scientific bodies at which medical research
results are presented.
Specialty medical meetings of societies affiliated with the Japan Association of
Medical Sciences at which the results of research are presented at institutions,
often have duplication of researchers and therefore, it is necessary to establish a
COI policy based on a common philosophy.

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3. Items that should be avoided in medical research and their management

In cases of clinical research (clinical studies and clinical trials) involving humanbeings and the industrial medical cooperation system, the following items should
be avoided by researchers involved in those projects, from the point of view of
COI policy.

(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 remuneration in regard to the results of the specific clinical study or
result(4) Affecting the ability to report on the results at a medical society based on theinfluence of financial supporters or commercial organizations.

On the other hand, the principal investigator involved with clinical research,(including clinical studies and clinical trials) and who is involved with the planningand carrying out of the conditions of the study, must make clear whether thefollowing conditions have been followed regarding the appropriate disclosure of
any financial relationship regarding the financial sponsors or organizations.

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(1) Having responsibility as an executive member or financial support organizationor venture regarding the clinical 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) Receiving payment for travel or accommodation from the commercial societies
or ventures in order to take part in medical meetings related to the research(4) Receiving financial remuneration that considerably exceeds the actual costs
required by the research project reported(5) Having received money or gifts exceeding the actual value of the time or labor
expended on the research.

Ⅴ. The planning of detailed regulations concerning COI policy
Each affiliated society must establish its own policy concerning medical
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 the established policy (detailed rules). In order to implement
management of COI the affiliated societies should have a predetermined policy on

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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 research, all of theresearchers involved in the given research must, in principle, submit aself-reported COI disclosure document to the president of the affiliated society(see appendix 2). The management process of COI concerning medical
research can vary according to the particular conditions of the affiliated society,but basically the concerned researcher must describe the related commercial
entities, foundation organizations, and any other groups which aim to derive
profit, and this should be reported in the self-disclosure COI form which is
submitted to the president of the affiliated society.

2. Businesses and corporate organizations and for-profit groups involved inindustrial academic cooperative activity
Concerning medical research involving universities and research institutions,related to industrial academic cooperation with businesses, corporate
organizations and for-profit groups (hereinafter, businesses, organizations, andgroups) the following activities are included and should be disclosed.
(1) Joint research: Research performed by dividing research funds andresearch personnel, involving businesses, organizations, groups. (withor without recompense or remuneration)16

(2) Commissioned research: businesses, 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: businesses make practical use of the patent rights
and other rights concerning the research results of universities andresearch institutes(4) Technology guidance: researchers of universities and research
institutes

etc.

developtheresearchofbusinesses

and

give

technological advice(5) University ventures: venture organizations are based on the results of
the research of universities and research institutes(6) Donations: unrestricted donations are made to assist universities andresearch institutes by businesses, organizations and groups(7) Endowed departments: Departments are established for the promotionof research enabled by financial donations to universities frombusinesses, organizations, and groups.

3. Those subject to COI management:(1) Whenmemberspresent

theresultsofresearchinscientificpresentations etc., at the time of presentation, they must report the COI
status in relation to the performance of that research and, in17accordance with the per se and detailed regulations of the affiliatedsociety, must make such disclosures using the designated forms. If it isdecided that the presentation in relation to the research is incontravention of the COI policy, then the president of the affiliatedsociety is required to discuss with the COI committee and takeappropriate measures based on the results of such discussion.
(2) When publishing papers in scientific journals of the affiliated societies,
not only members, but all authors, must submit self-disclosure COI
forms.
(3) All officers (chairpersons of the organization, regents, financial
comptroller)

those responsibleforscientificmeetings(meeting

presidents etc.), all committee chairpersons, committee members ofspecial committees (scientific organizing committees, editorial board
committees, ethical committees, COI committees etc.) and temporarygroups (subcommittees, working groups etc.) play a very important roleand have responsibility for their activities in relation to the respective
affiliated society. The COI status in relation to the given activity must be
described by self-disclosure in the designated form at the time of
appointment, and should the COI status change after the appointment,
then according to the regulations of the society, there is a duty to adjust
the form. The above officers and committee members are required to
pay particular attention to the COI management responsibilities.

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(4) Clerical staff employed by the affiliated societies．At the same time,each affiliated society should decide, based on its own individual
situation whether to require COI disclosure of the spouses, immediatefamily or those who share income or property with those listed in 1 to 4
above. However, even if spouses or family are not considered subject
to disclosure of COI, if they have an indirect effect or a non-financial
effect on the implementation or the understanding of the medical
research, or if such a possibility exists, they are required to disclosesuch relationships on the designated forms.

4. Activities subject to COI guidelines
COI policy should be applied to all those who take part in all activities of
the affiliated society. To give individual examples:(1) Academic meetings (annual general meetings included), holding local
or chapter 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 personnel or certifying institutions

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(6) Those promoting continuing medical education(7) Those promoting international research cooperation(8) Those involved with businesses enabling attainment of professional
levels of various sorts.

In particular, the following activities require extreme care and respect for thepolicies of COI:

(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 or advisorycommittees.
(5) Making presentations at lectures, luncheon seminars, evening seminars etc.
sponsored by businesses or for-profit groups

Furthermore, members of the affiliated societies must pay great respect to COI
policies concerning academic activities, even if they are not directly connected tothe activities of the given affiliated societies.

5. Items that must be disclosed

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Among the items that must be disclosed, one of the most problematic andfrequently discussed is that of grant contributions (entrusted funds), especially theirinterpretation and handling. The recipients of grant contributions from businesses,organizations, and groups, can be generally divided into two large groups. One ofthese 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 theinterpretation 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) of a person making a publication, or distributed to a
research laboratory, it is necessary 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 research performed through industrial academic cooperation, if it isconsidered that there was support from a related business, even if it be indirect,
then it is desirable that this should be reported in the COI self-disclosure.

Another disclosure item, concerning which suspicions can easily arise includes
those cases in which financial support (commissioned research, research funds)
are made available from not-for-profit foundations (for example NPOs) or public
foundations (for example public corporations).

If grants from businesses are

distributed to researchers via not-for-profit groups or public corporations then thegreater the amount of the contribution the greater a third party will receive theimpression that the objectivity of the research results might be lacking, thus this21

deserves great attention. Therefore, the COI committees of each of the affiliatedsocieties must consider the nature of the research funds and make an appropriate
response to that.

Self-disclosure forms should be planned to be of three types (1) for officers, (2)those presenting at academic meetings, (3) those publishing in journals. All theabove groups should be included but the above conditions should be made basedon the situation of each individual affiliated societies.

6. COI management of each type of individual(1) Officers
The president of the affiliated society must make it a duty for the individual officers
to submit a self disclosure COI document with regard to their relations tobusinesses, organizations (not-for-profit organizations, foundations etc.), andgroups. The method of disclosure is usually done on a printed form, but it could be
worth considering a self-disclosure system established on a secured website fordisclosure on application by a given day.

Businesses, organizations, and for-profit groups may present or may supply
information on external finances including reimbursement for manuscripts, lectures,
research funds (including clinical trials and clinical studies), commissioned22research, joint research, grant contributions, including trusts, and endowments)
and these are all extremely important items from the point of view of COI
management. It is therefore necessary to consider how to make these clearly
understood by third parties. As a concrete example, for an item that should be
declared by an individual researcher (see appendix 2) if the amount exceeds that
described in the detailed regulations, it is necessary to disclose that to thepresident of the affiliated society.

Furthermore, there should be detailed

regulations concerning the concrete disclosure and method of publication of suchinformation.

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 theaffiliated societies, there are frequently some unavoidable relationships amongauthors and those in the various specialized areas from which reviewers are
selected, extending to even closer relationships between the reviewer and thesubmitting author (mentor-student, joint researcher, receiving grants from the samecommercial entity). However, should it become necessary to request reviewers
from among specialists who have absolutely no COI status problems with regard to
the submitting author the number of potential reviewers could drastically reduceand it is even possible that it would be impossible to find suitable candidates torequest peer reviews, based on this and other considerations, therefore it is23

essential to give very careful consideration to the condition of COI managementwith regard to peer reviewers. As one example, if an editorial board member orreviewer 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 theresponsibility to explain the result of the review, therefore it could be possible forthem to refuse to review. This is one practical way of handling the problem. Be thatas it may, the delivery of information from the results of research in academic
journals is a very important means of the returning of benefit to society therefore itis essential for the COI committee to be closely involved in this process, in order topreserve public transparency and secure neutrality.

(2) Those publishing at scientific meetings
The president of the affiliated society can require all those with names attached tothe publication or just the first presenter, whether they be a member or not, to selfdisclose COI status with regard to businesses, organizations, and groups related tothe contents of the research.

Concerning the amount of money that should be notified in the self-disclosure, thiscan be calculated according to the conditions of the individual affiliated society andstandards should be prepared regarding disclosure. Furthermore, concrete
standards should be established for the researcher’s family (for example,
immediate family etc.) that is, all those who are making a living together with the24researcher and these standards should be calculated and established by each of
the affiliated societies.

(3) Authors publishing in scientific journals
The editorial boards of each of the affiliated societies must, under the leadership of
the president of the affiliated society ensure that all authors, whether they bemembers or not, provide self-disclosure information concerning all publications inthe scientific journals of the affiliated society. Usually the corresponding author
should collect the statements concerning the COI status of all of the authors of thegiven paper and should take responsibility for the content 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 and references.

Even ifthere is no definite rule about COI status reporting, there is usually a statement
about COI status such as “The authors declare they have no conflict of interest”.
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 anddetailed regulations should be clearly stated in the Instructions to Authors.

Recently the International Committee of Medical Journal Editors (ICMJE), in order
to simplify matters for authors of papers, has proposed a standardized COI status
disclosure form. The form for disclosure of potential COI that they are proposing
will not only reveal the COI status of the authors but also require disclosure of the25

COI status of the institutes and institutions to which they belong and, as a new
development in this field, this is attracting much attention. Usually if the impact
factor or citation index of a given journal is high, this has significant effect on thestatus and ability to attract research funds on the part of researchers. At the sametime, the attention paid by society to the research results of medical research andclinical studies supported by business sponsors attracts much attention and has agreat effect on society. Therefore, it is important that the journals and scientificsocieties 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 of that, there also
should be close cooperation between the editorial board and the COI committee, 1)
concerning authors in Japanese language journals, and 2) in English language
journals of the societies. These two categories should be considered separately
and description of the journal COI policy for each of those should be described in
the manual for publication and appropriate handling of each is considereddesirable.

1) Authors of papers in Japanese language journals
Since many of the authors in Japanese language journals of the affiliated society
publishing in the journal are members, it is usually possible for the COI disclosure
forms to have the same items as for the scientific meetings and lecture sessions ofeach of the affiliated societies. However, even in the case of non-members, it is26necessary that they should comply with the COI policy and detailed rules of each of
the affiliated societies and clearly disclose their status using the given forms.

2) Authors in English language journals of affiliated societies
Concerning COI management regarding authors of papers in English language
scientific journals, the COI self-disclosure forms required of the authors are, as in
the case of Western societies, quite different according to the journal and there isas yet no standardization. It is considered that there will be a considerable numberof papers from non-Japanese researchers (non-members) in the English language
journals published by the affiliated societies. Therefore, since the situation in eachcountry is very different from the industrial academic cooperation activity in Japan,① the extent to which disclosure should be made by the authors, ② thedisclosure items③ the criteria for evaluation of the self-disclosure must be

carefully considered and must be clearly described in the journal’s COI policy.

7. Period required for disclosure
The medical research resulting from the industrial academic corporation is varied innature. In preclinical research, it can often be performed within a short time, but forclinical studies, especially clinical trials, long periods of research are necessary.
Therefore, in terms of the nature of the medical research and clinical research, theperiod for which disclosure is required in many cases covers several years. In

27cases in which COI management has just begun to be addressed, it is possible toset the initial period for the preceding one year and then extend it year- by-year. In
affiliated societies that are promoting COI policy and detailed regulations, they are
requiring disclosure for the previous one year for members and employees of theaffiliated society and will be carrying out management based on COI policy over
several years, after which a complete system of several years (for example 3
years) may be required for disclosure as a disclosure period for self-disclosure.
Clinical trial results can have a large influence on society and in cases in whichsuch studies are carried out over long periods of time, extending beyond the limit
defined by the industrial academic cooperation, it is desirable that individuals takeresponsibility to disclose their COI status appropriately.

8. Method of self-disclosure
The method of self-disclosure is clearly stated in the COI policy and detailed
regulations according to subject. (See Figure 3)(1)

Officers

Officers must submit a self-disclosure form on their COI situation pertaining to thebusinesses, 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 period28

(e.g. within 6 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 the affiliated society, and submit the COI self-disclosure form to thepresident of that society, and 2) a discussion will take place concerning theeligibility of the officer candidate at the COI committee meeting, 3) The results(written opinions concerning COI) will be reported to the head of the organization,and 4) The final decision concerning the approval/approval with condition/
disapproval, etc. will be made by the head of the organization to the candidate.

(2)

Authors presenting at scientific meetings

Presenters are obligated to self-disclose COI status with regard to businesses,organizations, and groups related to the theme of presentation using the form
provided, both when submitting abstracts via the Website and also at the time ofpresentation. It would be an idea to construct a system which will not permit thepresenter to submit the abstract via the Website unless all items of the COI form
are answered. Moreover, speakers should disclose all existing and possible COI
situations using the format prescribed by the affiliated society, either on the first or
second slide (see Figure 4), and read the name of the business, organizations, andgroups that are involved.

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(3)

Authors presenting publications in scientific journals

Authors giving presentations on publications in scientific journals are obligated toself-disclose their COI status regarding businesses, organizations, and groups andall coauthors, at the end of the publication in a style set by the committee. In recent
years, some European and American scientific journals (e.g. the New England
Journal of Medicine) have implemented a system whereby the COI status isundeclared at the end of the publication but instead, the reader can voluntarily
access via the Website, the original self-disclosure form filled in by the author withregard to the COI status of all authors. In the future, if international standardizationof the Form for Disclosure of Potential COI progresses along with the advances inelectronic journal publications, this method of disclosure could be one possible
method to consider.

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

30whose term has expired and those who withdraw from the committee or terminate
their commission, until the term has ended or for a fixed time period (e.g. 2-5
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, toplace 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 same manner as COI
information of officers. Methods to store or destroy such information should beclearly described in this policy.

10．Role and responsibility of the board of directors
The board of directors may consult the COI committee, ethics committee, andeditorial committee to direct measures in the event that a serious state of COI
problem arising from the need to accomplish the work of the affiliated 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 board of directors, on31behalf of the affiliated society, will act appropriately and in good time, and in theevent that there is an unjust allegation or indictment, will give an opinion or make astatement to fulfill its social responsibility to explain the results of the verification offacts and to defend the individual member’s rights.

It is clearly stated in the COI policy that the officer and members of the affiliatedsociety, etc. when arranging contracts with businesses, organizations, and groups,
will not agree to any activity or survey activity which may lack public transparency
and appropriateness of research or announcements of the affiliated society.

11． Role and responsibility of the COI committee
The COI committee should be established independently from the ethics
committee, to take measures against those who violate the policy. The COI
committee should be supervised 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, and the need to protect personal information. Moreover,
for COI management to be conducted smoothly, it is recommended that the COI
policy state a specific method in regard to how the COI committee, board of
directors, Ethical Review Board, and the editorial committee should cooperate. The
COI committee should play an advisory role to ensure that COI in medical research,clinical research, and clinical trials within the industrial-academic cooperation is32managed properly, from the researchers’ standpoint.

1)

Items of jurisdiction of the COI committee

The COI committee has jurisdiction over the following:(1) Handling all inquiries from individual members concerning their COI status(includes explanations, advice, and guidance).
(2) Issues concerning COI management and educational activities.
(3) Issues concerning COI investigations, discussions, management, proposals formeasures to be taken, and recommendations.

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 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 research in the environment of industrial-academic cooperation should be
conducted in a proper and publically transparent way, regardless of the fact that the
remuneration and grant support will differ depending on the businesses,organizations, and groups, therefore, a potential state of COI for the researcher isinevitable.

33

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 theaffiliated society that can provide social accountability. An appropriate revision andupdate of this policy and detailed regulations should be done regularly, to improve
handling of COI self-disclosure.

When a 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,there is a possibility that the interpretation and study results will be biased, 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 the monetary sum isover a standard amount, and in such case the corporate name of the sponsor must
be disclosed.

However, regarding COI management of the officers and committee members,
there has been a recent attempt to use a method of disclosure based on astandard amounts prescribed at 2 to 3 levels.

For example, a large scholarship fund with great interest in mass media has
divided acceptance money into 3 levels, 2 million yen or more, five million yen or
more, and 10 million yen or more, to facilitate COI management.

34

Moreover, there has been an attempt to introduce a point system to control
management on different levels, whereby each item of disclosure is given a certain
point, and one must disclose COI based on the total number of points. On theother hand, based on the Sunshine article of the U.S. medical insurance reform law(March 2010), pharmaceutical companies and manufacturing companies related to
medical equipment are now obligated to disclose all payments made to physicians
and medical institutions, and this information be made public via a Website fromfiscal year 2013. If the financial relationship between the business side and theresearcher becomes clear and open to the public, it can of course be expected togreatly affect COI disclosure criteria for researchers, and COI management in ourcountry will need to be revised to meet the global criteria of industrial-academic
cooperation.

It is important to pay attention to the needs of the general public andset the disclosure criteria by selecting and entrusting officers and committee
members so that the COI situation does not become more critical.

Concerning the COI disclosure criteria for overseas members and nonmembers,
there is a need to consider the characteristics of the industrial-academic
cooperation activity of each country, and the currency value in relation to its
economic situation, thereby making it difficult to apply the same judgment criteria
as domestic members.

35

In particular, with the vast increase of scientific speakers from developing countries
experiencing rapid economic development, there is a need to construct anappropriate COI management structure from past cases. For this purpose,exchange of information between affiliated societies, in addition to collaboration,
will be necessary in the future.

3)

Structure of the COI committee

The COI committee will consist of those members who conduct the medical
research, those familiar with 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
is preferred to have a fixed proportion of both men and women, and external
members.

12． Role and obligation of the editorial committee
When scientific journals publish original papers, review articles, clinical guidelines,
editorials, and opinions, the editorial committee of the affiliated society can, withthe collaboration of the COI committee, verify COI policies have been followed, andin the case that there is a violation, can take appropriate measures such as
prohibiting the publishing of such articles. In such circumstances, prompt contact36

should be made with the author involved, to notify the author of the situation andreasons. 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 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 functions independently from the COI committee, however,depending on the situation of the affiliated society, it is possible for the ethics
committee to handle COI matters of committee members. The role and obligationof the ethics committee concerning COI management involves, receiving
consultation from the Chairman of the Board of Directors, deciding on theappropriate measures to be taken by judging and considering the degree ofviolation, its effect on the affiliated society, and reporting this to the Chairman of theBoard of Directors. As COI management deals with difficult ethical issues, daily
exchange of information between the ethics committee, COI committee and theeditorial committee is necessary to promote justifiable medical industrial-academic
cooperative research.

37

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 inprint or electronic data, should be secured by the secretariat of the affiliated society
by an assigned manager, until it can be deleted or destroyed after a certain periodof 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 suchinformation.

If the disclosure of COI status concerning officers and members is requested fromthe 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 involving apersonal legal counsel is necessary, and it is recommended that a manual be38

prepared beforehand.

15． Monitoring, abiding by COI policy, and educational training
All members of the affiliated society and employees are obligated to follow the COI
policy concerning medical studies. At the same time, it is important to implement
COI policy in the training curriculum and programs for continuing education,lectures, and seminars for qualifications, for the purpose of increasing awarenessof COI. In particular, if officers involved in medical research in the environment ofindustrial-academic cooperation have a serious COI status, regular reporting andmonitoring, change in official post and avoiding inappropriate COI behavior, will
ensure minimal effect on the conducted activity. Furthermore, in the event that anindividual member’s COI status is serious and may affect the affiliated society’s
activities, and if fairness and reliability cannot be assured, it is possible toimplement a policy prohibiting all involvement (zero tolerance) in the activity.
However, this kind of situation must be treated very cautiously as it may become afactor 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 affiliated society,the procedure on how to respond should be stipulated from the understanding that39

the request will be made from an external source. If the reason for request seems
appropriate, the COI committee will, with consultation by the president of theaffiliated society, respond to the request as quickly as possible, including
conducting an investigation on relevant facts, and also by protecting theconfidentiality of personal information.

It is recommended that a structure forwhen the COI committee is unable to respond to a situation be made available.

17. Handling those violating COI policy
A serious violation of the policy concerning the affiliated society might cause thesociety 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 those regarding this issue, and to create a COI management systemcentered around the COI committee. In the event that a member violates the policy,
this policy clearly states that the president of the affiliated society will take theappropriate measures according to the degree of violation (e.g. prohibition ofpresenting at scientific meetings, prohibiting of publishing in a scientific journal of
the society, prohibition of assumption of office or dismissal, withdrawal of
qualifications as a member, expulsion from the society, and/or prohibition ofadmittance to the society). However, in the case of a serious violation of COI policy,
the ethics committee (or appropriate committee) will be consulted and discussions

40

will be held, and based on the decisions made by the board of directors,
appropriate measures will be carefully taken.

Generally speaking, since COI management is based on self-disclosure, if
regulations for violations are too strict, there will be hesitation to disclose
information, therefore attention should be paid to expressions used in violation
regulations. On the other hand, it is necessary to state the procedure for appeal
beforehand.

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
the affiliated society will, based on the consultation with the ethics committee,
discuss the situation at the board of directors meeting, and will retract thesubmitted publication or presentation of the author involved, or retract the
publication. A structure such as this, stating the measures to be taken based on thepolicy of the affiliated society, should be prepared beforehand.

On the other hand, handling COI violations of nonmembers is most often difficult. It
can be suggested that when requesting participation each time from a nonmember,each affiliated society should carefully explain the COI policy and the importance offollowing the policy, in writing. It can be assumed that for affiliated societies which41

publish scientific journals in the English language, the number of nonmembers,
especially from foreign countries, will increase and that correspondence in relation
to COI 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 a publication, and publishing an apology
letter be made available 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 statusof their affiliated institutions and individual members, after discussions at the Boardof Director’s meeting. The COI committee should create a system in case amember’s COI situation in the industrial-academic cooperation environment
becomes serious, the related committees can collaborate regarding responding to
the society and the mass media. For example, if a member has a COI situation in42which there is a need to take social and moral responsibility, the president of theaffiliated 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.

In such cases, the member involved will be given an opportunity to present theirown opinion either to the Board of Directors or to the designated officer, however inthe case of an urgent situation leaving no time for consultation, then it will be noted
as such.

VII. COI management of affiliated societies
The ways to handle COI problems of individual members and officers giving
presentations on medical studies has been stated, however, it is important to state
the policy concerning ways to handle serious cases of financial COI between theaffiliated society itself and businesses, organizations, and groups. For example, if
an affiliated society, receiving large remuneration from businesses, organizations,and groups, sponsors activities (such as special symposia, public lectures etc.), a
possible COI status is likely to arise. When giving presentations under suchcircumstances, it can be predicted that COI evaluation and ethical aspects such as
fairness, subjectivity and independence are difficult to maintain. This shows that wehave entered an era in which a way to disclose remuneration and funds theaffiliated society receives from businesses, organizations, and for-profit groups, is43needed. One method would be to have an external evaluation of the affiliatedsociety.

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 COI policy and detailed regulations ② making sure thatmembers and participants abide by the COI policy and detailed regulations isimportant, 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 otherinterested parties.

IX. Change 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.

Appendix 1) Definition of terms

44

① Investigator
The person conducting the medical research/study, or the subject individual.
② Immediate Family
The investigator’s spouse (partner), underage children, children employed by asponsor, a family member who is entitled to share equity (generally, first of kin), or
those who are residing in the investigator’s household.
③ Financial situations and related persons requiring COI disclosure
Since a COI situation may occur for various reasons, judgment may need to bemade 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.
④ Advisor 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.
⑤ Equity (stocks etc.) holder
This applies if a venture company holds stock (includes stock options) whether it isa publicly held stock or unlisted stock, and is involved in investment, licensing, or isa 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 thecorrespondent )45

⑥ Honoraria
A legitimate payment given for services such as giving lectures, seminarpresentations and participation. This applies when the individual disclosing COI isgiven direct payment consisting of honoraria, investments, licensing fees from theauthorities concerned, or from for-profit organizations. However, the maximum limitof lecture honoraria should be set by each affiliated society, in addition to othernominal income.
⑦ Funds for conducting medical researchThis includes all funds related to conducting medical research projects, and applies
even if the fund is paid by an agent hired by the sponsor. In addition, even if it is ascholarship fund from the sponsor of the medical research, with no specified
expenditure, it must still be disclosed if it is over a certain amount. However, thetotal funds and duration when disclosing can be set by each affiliated society.
⑧ Other contributions (gifts, materials etc.)
Gifts and materials which are not directly related to research activity, such as travel
expenses and gifts, are still subject to disclosure if they are received frominvestment, licensing, or for-profit organizations. In addition, disclosure is also
necessary if such in-kind materials were received within a fixed term after the study
activity was initiated.
⑨ COI 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

46

to COI and the extent of corresponding acts, foundation of a COI committee andself-disclosure forms.
⑩ COI management
A system to promote appropriate industrial-academic cooperative activities among
the businesses, organizations, and groups related to medical research. According
to COI policy, employees and members of each affiliated society must submit
self-disclosure forms, to which an investigation is conducted by the COI committee,
and in situations where COI status may cause damage to the corresponding
affiliated society’s activities, the COI committee will take necessary measures toensure that education, research and publicity is conducted properly to society andthe general public.

Appendix 2) Items to check when filling out self-disclosure forms
Items for self-disclosure for officers① State if you have been an officer or consultant in a businesses, corporation or
for-profit group (if the total annual income from the corresponding institution or
facility exceeds a certain 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 byeach institution or facility while considering the situation.
② State the type of equity (stocks etc.) of the industrial-academic cooperative47

activity (e.g. either publicly held or unlisted stock, stock, investment, stock option,
beneficiary rights etc.), and the amount. If the profit (total sum of the dividend or
profit sales) from stocks within a fixed period from 1 organization totals more than acertain amount, e.g. 1 million yen or more, or if 5% or more of all stocks of thecorresponding stock is owned then disclosure is needed.
③ Patent right fees from businesses, organizations and groups, of 1 million yen or
more per patent fee, per year.
④ Remuneration for attending meetings (presentations) from businesses,organizations and groups, paid for the time and effort of the daily activity (lecturesetc.) which is 500,000 yen or more from 1 organization or group per year.
⑤ Regarding manuscript fees paid for writing of pamphlets etc. by businesses,organizations and groups, 500,000 yen or more per organization, business orgroup, per year.
⑥ Regarding research funds for medical studies (trust research funds, joint
research funds, clinical study funds) provided by businesses, organizations andgroups, an annual total of 2 million yen or more for 1 organization or group.
⑦ For scholarship funds granted by businesses, organizations and groups, 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 of the department.
⑧ If the individuals disclosing COI is affiliated with the funded department

48

sponsored by the businesses, organizations and groups.
⑨ Concerning other travel expenses, gifts, or contributions unrelated to theresearch, an annual total of 50,000 yen or more by 1 business, organization orgroup.

However, whether the researcher’s family members are subject to disclosure and if
so, the specific range of disclosure, should be decided after consideration by eachaffiliated society.

Items for self-disclosure for speakers at scientific meetings① For an officer or consultant in a businesses, corporation or for-profit group(hereinafter, businesses, organizations and groups) total annual honoraria of 1
million yen or more from 1 organization, business or group.
② State 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 the amount. If the profit (total sum of the dividend or
profit sales) from stocks within a fixed 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.
③ Patent right fees from businesses, organizations and groups, of 1 million yen or
more per patent fee, per year.

49

④ Remuneration for attending meetings (presentations) from businesses,organizations and groups, paid for the time and effort of the daily activity (lecturesetc.) which is 500,000 yen or more from 1 organization or group per year.
⑤ Regarding manuscript fees paid for writing of pamphlets etc. by businesses,organizations and groups, 500,000 yen or more per organization, business orgroup, per year.
⑥ Regarding research funds for medical studies (trust research funds, joint
research funds, clinical study funds) provided by businesses, organizations andgroups, an annual total of 2 million yen or more for 1 organization or group.
⑦ For scholarship funds granted by businesses, organizations and groups, 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 of the department.
⑧ If the individuals disclosing COI is affiliated with the funded department
sponsored by the businesses, organizations and groups.
⑨ Concerning other travel expenses, gifts, or contributions unrelated to theresearch, an annual total of 50,000 yen or more by 1 business, organization orgroup.

However, regarding ⑥ and ⑦, if there are any research funds or scholarshipgrants received from organizations or groups where a COI situation exists between

50

the results of the study of the first author, the affiliation (department, field) of thefirst author, or the laboratory, disclosure is necessary.

Items for self-disclosure when publishing in a scientific journal① State if you have been part of an activity where there is a possible COI
situation regarding the corresponding clinical study and that business or group (ifthe total annual income from the corresponding institution or facility exceeds thelimit, e.g. 1 million yen), the type of income and amount. The preset limit ofminimum income to determine whether disclosure is necessary should be decided
by each institution or facility while considering the situation.
② Give the same description as item ① for other parties related to theindividual disclosing COI status. However, whether the researcher ’ s family
members (e.g. first of kin) are subject to disclosure and if so, the specific range of
disclosure, should be decided on by each affiliated society.
③ State whether the applicant has been involved with industrial-academic
cooperative activities related to the corresponding medical study (if the total annual
remuneration exceeded a preset limit (e.g. 2 million yen) from the same externalorganization), type of remuneration received (e.g. joint research, funded research,
consortium, conductance approval , transfer of rights, technological training,commissioned committee member, commissioned trips, visiting fellow andpostdoctoral fellow appointment, acceptance of research grants and contributions,51

request examinations and analyses) in the provided period. The preset limit ofminimum income to determine whether disclosure is necessary should be decided
by each institution or facility while considering the situation.
④ State 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 the amount.
⑤ State whether there is mention of COI in the informed consent (if so, attach
explanation), the name of the applicant and personal seal.

52