Detailed Rules Concerning the Guidelines on Conflict of Interest in Medical Research
The Japanese Society for Helicobacter Research
The Japanese Society for Helicobacter Research (JSHR) has drawn up the Guidelines on Conflict of Interestin Medical Research in order to justly manage all cases of conflict of interest (COI) in which JSHR members
and presenters of research findings may be involved. The purposes of the Guidelines are to ensure theappropriateness and fairness of all medical research activities that take place at the JSHR and to maintain thetransparency of all presentations at academic conferences and social trust, while properly facilitating medical
research activities in industry-academia collaboration projects. The JSHR hereby stipulates these Detailed
Rules Concerning the Guidelines on Conflict of Interest in Medical Research in order to ensure that the
Guidelines are properly and efficiently implemented.

Article 1 Report on COI information concerning presentation of research findings, etc. at the JSHR
Section 1
If any medical research findings are to be presented in a special lecture, educational lecture, or luncheon
seminar at a JSHR-hosted academic lecture event, etc. or at an extension course, etc. that is open to the public,
the presenter must comply with the reporting criteria as specified by the JSHR and report its COI statuspertaining to any economic ties that exist with the private enterprise and other for-profit organizations that are
involved in the medical research project, including spouse, relatives within the first degree of kinship, andthose living in the same household, that existed within the last 3 years (January to December), by submitting
Form 1 to the academic conference secretariat before the day of the academic conference.
Each presenter or lecturer having such COI status must clearly state on the first slide shown in thepresentation or lecture (or on the next slide following the one that introduces the presentation topic, presenteror lecturer, etc.) about the COI using Form 1-A. Even if there is no COI, each presenter and lecturer must
provide COI information using Form 1-B. In regard to each poster presentation topic, the COI information
pertaining to the presentation must be stated at the end by following Form 1-A or 1-B, as the case may be.
Section 2“Private enterprises, corporations, or other for-profit organizations involved in medical research” means
private enterprises, organizations, or groups that have the following types of relationships in regard to the
medical research:
1) relationships in which they requested to conduct the medical research or jointly conducted the medical
research (regardless of whether or not any remuneration was provided for the research);2) relationships in which they jointly own patent rights, etc. pertaining to any treatment method, medication,equipment, etc. being evaluated in the medical research;3) relationships in which any medication, machinery, material, etc. being used in the medical research areprovided by them free of charge or at a particularly steep discount;4) relationships in which they provide a research grant, donation, etc. for the medical research;5) relationships in which they provide any unapproved medical drug, equipment, etc. in the medical research;or6) relationships in which they are sponsoring grant-funded courses, etc.
Section 3“Medical research” in regard to presentation of research findings means any type of medical research
activities in order to improve disease prevention methods, diagnosis methods, and treatment methods; better
understand the causes of various diseases and their pathological conditions; and enhance the quality of life ofpatients in the field of medicine, which involve humans subjects. Medical research projects that involve
humans as the subjects include those that study human-derived samples and data that can be used to identify
the individuals to which they pertain. Any decision as to whether any sample or data is of the type that can beused to identify the individuals shall be made pursuant to the Ethical Guidelines on Medical Research on
Humans stipulated by the Ministry of Health, Labour and Welfare.

Article 2 Self-reporting criteria on COI cases
The monetary amount based on which a COI must be self-reported as well as the type of information to bedisclosed in each type of circumstance are as specified below.
1) Assumption of a post as officer or advisor at any private enterprise, corporation, or other for-profit
organization that is involved in the medical research (hereinafter referred to as “Private Enterprise,
Organization, or Group”): It must be self-reported if the amount of the remuneration provided by any
single Private Enterprise, Organization, or Group is ¥1 million or more.
2) Possession of shares: It must be self-reported if the amount of profit (i.e., the sum of all dividends andcapital gain) achieved by possessing shares of any single Private Enterprise per year is ¥1 million or more,
or if 5% or a larger percentage of all outstanding shares of the Private Enterprise are owned.
3) Payment of patent royalties by the Private Enterprise, Organization, or Group: It must be self-reported if
the amount of royalties paid for the right to use any single patent per year is ¥1 million or more.
4) Payment of allowances (i.e., lecture fee, etc.) made by the Private Enterprise, Organization, or Group to a
researcher to attend or make a presentation at a conference for the time spent or labor expended by the
researcher: It must be self-reported if the amount of the lecture fees paid by any single Private Enterpriseor Group per year is ¥500,000 or more.
5) Payment of manuscript fees by the Private Enterprise, Organization, or Group for authoring text to be
included in a pamphlet, etc.: It must be self-reported if the amount of the manuscript fees paid by any
single Private Enterprise, Organization, or Group per year is ¥500,000 or more.

6) Payment of research fees by the Private Enterprise, Organization, or Group: It must be self-reported if thetotal amount of the fees paid by any single Private Enterprise or Group for the medical research (i.e., in theform of contracted research fee, joint research fee, entrusted government fund that must be accounted for,etc.) per year is ¥5 million or more.
7) Payment of clinical trial fees and scholarship (incentive) donations by the Private Enterprise, Organization,
or Group: It must be self-reported if the total amount of the fees paid by any single Private Enterprise,
Organization, or Group to the reporting individual, the department (course or field) where the reporting
individual is a member, or the individual representing the laboratory is ¥1 million or more per year.
8) If a person is a member of a grant-funded course program provided by the Private Enterprise, Organization,
or Group: Each such instance must be self-reported.
9) Other benefits such as funding of travel expenses, provision of gifts, etc. that are unrelated to the research,educational endeavor, or medical practice: It must be self-reported if the total amount of all monies paid by
any single Private Enterprise, Organization, or Group per year is ¥50,000 or more.
In regard to the types of circumstances that must be reported as set forth above, there may be cases where therecipient of a scholarship donation provided by the Private Enterprise, Organization, or Group is the head ofan organization (head of an academic institution or hospital), head of a course or field, or the self-reporting
individual itself. In any case where such recipient is not the self-reporting individual, no researcher tie at anindividual level is usually assumed. However, if the scholarship donation is distributed to any personpresenting research findings, the department (course or field) where the presenter is a member, or thelaboratory through the head of the organization from the Private Enterprise, Organization, or Group, theamount of money involved must be investigated and confirmed to the extent possible and reported.
As for items to be reported concerning which issues often arise, they involve cases where donations, etc. from
Private Enterprises are provided through not-for-profit entities (e.g., NPOs) and public-interest corporations(e.g., incorporated foundations) in the form of monetary support (i.e., contracted research fee, research grant),
all of which must be self-reported in the same manner as the aforementioned cases. As the amount of financial
assistance becomes higher, outside parties will receive a worse impression as to the objectivity and fairness of
the research findings. Therefore, each person involved in any research activity where assistance is deemed to
be indirectly provided by a concerned Private Enterprise should self-report the COI, in order to avoid any
doubt or social issue that may arise.

Article 3 Publishing of reported information in JSHR journals, etc.
Section 1
If an author that is publishing any research findings (in the form of a review, original paper, etc.) in any JSHR
journal has any economic tie to a Private Enterprise, Organization, or Group as set forth in Article 1, Section 2
hereof regarding publication of those findings, the author must disclose its COI status for the year (January toDecember) preceding the contribution of the text by submitting a report to the editorial committee in advancepursuant to the contribution rules of JSHR journals. Such COI status shall be stated at the end of each such
paper. In cases where there is no COI as defined, an appropriate statement such as “There are no potential
conflicts of interest to disclose.” shall be indicated in the same place instead. In regard to each COI case thatmust be disclosed at the time of publication, the names of the Private Enterprise, Organization, or Groupinvolved must be reported with reference to IV. “Matters that require reporting” of the Guidelines on Conflictof Interest in Medical Research, or Article 2 hereof regarding what sorts of information must be disclosed, etc.
Section 2
In regard to each case of publication of a set of medical practice guidelines, etc. for which the JSHR was
involved in the editorial process, the COI status of respective members of the document preparationcommittee, review committee, and supervising committee that were involved in the process must be
investigated, summarized, and disclosed in the published document. The scope of such information disclosure
shall be limited to the private enterprises, corporations, and for-profit organizations that concern the content ofsuch publications.

Article 4 Submission of COI reports by JSHR officers, committee chairs, and chairs of academic
conferences, etc.
Section 1
Each JSHR officer (president, vice president, trustee, supervisor), secretary, representative, various committee
member, and organizer of academic lectures must report its COI status concerning the circumstances as set
forth in IV. “Matters that require reporting” of the Guidelines on Conflict of Interest in Medical Research bycreating a self-report using Form 2 and submitting it to the secretariat on whether any COI existed over theprevious year (from January to December) at the time of assuming the post and also by the general JSHR
employee assembly each year. As for each chair of an academic conference, it must report its COI status bycreating a self-report using Form 2 and submitting it to the secretariat on whether any COI existed over theprevious year when the decision is made for the person to become the chair. If a self-report on COI has
already been submitted, there is no need to resubmit another self-report. In this connection, the scope of suchself-report on COI shall be limited to the private enterprises, corporations, and for-profit organizations thatconcern any of the JSHR activities or projects.
Section 2
In regard to the COI status to be reported using Form 2, all applicable circumstances as set forth in IV.
“Matters that require reporting” of the Guidelines on Conflict of Interest in Medical Research must be
self-reported. Regarding each circumstance to be disclosed or otherwise made public, the amount of money ator above which a self-report must be submitted as specified in Article 2 hereof in each type of circumstancemust be referred to, based on which an itemized statement must be provided including all monetary amounts

involved, using Form 2. When filling out Form 2, the information for the previous fiscal year must be
provided, while clearly specifying the time period for which the amounts have been calculated.

Article 5 Procedure for handling self-reports on COI
Section 1
Each self-report on COI that is submitted at the time of academic presentation at any JSHR event must be
stored and strictly managed by the secretariat for a period of two years. Likewise, each document, etc. that
contains COI information on a person who has served as an officer or committee chair at the JSHR, or aperson whose nomination as officer or committee chair has been definitively revoked, must be stored andstrictly managed by the corporation office for a period of two years following the expiry of the final term ofassumption or the revocation of the committee member nomination. In regard to each self-report submitted bya member of the JSHR secretariat, it must be stored and strictly managed by the corporation office for theduration of employment of the secretariat member at the JSHR and also for a period of two years following
the date on which the secretariat member leaves employment with the JSHR. All documents that have been
duly stored for their respectively designated two-year periods must be promptly deleted or disposed of under
the supervision of the president. Notwithstanding the foregoing, if the board of trustees should decide that
deletion or disposal of any particular documents would be inappropriate, the deletion or disposal of such
documents containing COI information on the pertinent individuals may be postponed for an extended periodof time to be specified as needed. The COI information on each chair of academic lectures (including the one
for the following fiscal year) shall be treated in the same manner as the COI information on any JSHR officer
should be treated.
Section 2
COI information may be used by any JSHR trustee or concerned individual in a managerial position, etc. fromtime to time as needed pursuant to these Detailed Rules, in order to decide whether any COI exists between
the person to whom the COI information pertains and the JSHR activity or project involved as well as thelevel of COI if it exists, so that the JSHR can properly conduct its activities or project management andimplement any measures based on the decision.
Use of any COI information shall be kept within the necessary scope of use, depending on the purpose of useof the information. In addition, no COI information shall be disclosed to a party to which disclosure of theinformation is not required for the purpose of use of the information (i.e., non-disclosure obligation applies).
Section 3
Excluding the cases as set forth in Article 5, Section 2 hereof, COI information shall be kept confidential andshall not be disclosed to the public, in principle. If it is necessary to disclose or publish any COI information
concerning any activity of the JSHR or any of its various committees, etc. in order for the JSHR to fulfill its
accountability obligation for social or ethical purposes, such disclosure or publication of the COI information

may be allowed, either internally at the JSHR or externally, only to the extent necessary, after a discussion isheld and consent is reached by the board of trustees. Notwithstanding the foregoing, such restrictive procedure
shall not prevent the JSHR from entrusting a particular trustee to handle such issue and asking it to make adecision on the issue for the JSHR, based on the advice of the COI Committee. In such a case, the person towhom the COI information being disclosed or published pertains shall be entitled to express its opinion to theboard of trustees or the trustee that has been entrusted to make the decision. The foregoing procedure,
however, may not be followed if the COI information at issue must be disclosed or published in an urgent
manner and there is not time to hear the opinion of the person to whom the COI information pertains.
Section 4
If a request has been filed to disclose information on any particular member of the JSHR (including statutory
request), and if there is a reasonable ground to consider that such request is valid, the COI Committee shallproperly handle such request while protecting the personal information involved, at the suggestion of thepresident. Notwithstanding the foregoing, if it is deemed impossible for the COI Committee to properly
handle such request, the president shall set up a COI investigation committee consisting of a particular trustee
to be specified, a small number of JSHR members, and at least one outside member, to handle the issue
instead. The COI investigation committee must hold a committee meeting within 30 days of receiving thedisclosure request and make a decision on it as soon as possible.

Article 6 COI Committee
The president must form the COI Committee, which shall consist of a small number of JSHR members, andalso appoint a committee chair. Each member of the COI Committee shall be bound by non-disclosure
obligations as to all COI information that becomes known to it pertaining to the JSHR members. The COI
Committee must work with the board of trustees to conduct proper activities and project management toprevent deterioration of the COI status of any members and also to respond to any non-conformance that has
been identified, pursuant to the COI Guidelines and these Detailed Rules. If a significant COI case shouldarise with any JSHR member in regard to any activity or project being led by the JSHR, or if any self-reporton COI is found to be inappropriate, the COI Committee must notify the person involved in the case andprovide proper instructions by advising correction of the COI report that was previously filed, etc. In regard to
the procedure for reporting COI cases and handling COI information, the provisions of Article 5 hereof shallbe applied, mutatis mutandis.

Article 7 Measures against breaching individuals
Section 1
If any doubt or issue of a social or ethical nature should arise pertaining to the content of any COI self-reportthat has been submitted by an author publishing research findings in a JSHR journal, etc. or by a presenter at a

JSHR-hosted academic conference, etc., the COI Committee shall conduct an investigation, interviews, etc. on
the matter in a thorough manner and implement proper measures accordingly, in order to allow the JSHR tofulfill its obligation of accountability to society. If the JSHR is unable to fulfill its accountability obligation ona critical COI case, the president may consult the COI Committee, discuss the case at the board of trustees
based on the advice of the COI Committee, and implement appropriate measures that may include preventing
the author or presenter from making its presentation at the academic conference or publishing its paper, etc. If
any doubt or issue is raised with a presentation or paper after it has already been delivered or published,
relevant facts must be investigated and proper measures must be reviewed for implementation if theinvestigation indeed detects an infraction, which may include retraction of the published paper. In addition, if
an act of any concerned party is deemed to cause significant damage to the reputation of the JSHR in society,the information must be submitted to the ethics committee for review so that appropriate measures may be
implemented.
Section 2
If any COI information that has been reported by a JSHR officer, the chair of any of various committees,committee member that is required to submit a self-report on COI, or candidate for any of the aforementioned
posts is found to have an issue, before or after such person assumed its post, the chair of the COI Committee
must provide a written report on the case to the president, based on which the president must promptly hold aboard of trustees meeting, and pass a resolution to either approve or deny such claim that there is an issue with
the COI information. If the board of trustees passes a resolution approving the validity of such claim, the
JSHR officer or committee member in question must resign from its post, in which case, the president may
also revoke the nomination of the candidate for the post as officer or committee member, as the case may be.
If any doubt or issue of a social or ethical nature should arise pertaining to the content of any COI self-reportthat has been submitted by a presenter at a JSHR-hosted academic conference, etc., or if an act of any
concerned party could cause significant damage to the reputation of the JSHR in society, the board of trustees
may implement appropriate measures to address the situation.

Article 8 Objecting motions
Section 1 Filing of objecting motions
If a person receives a notification indicating that the person committed an infraction concerning its
presentation or publication with the JSHR pursuant to Article 7, Section 1 hereof, or if a person has been
notified of a decision requiring resignation from its post as officer or committee member, or revoking its
nomination for such post pursuant to Article 7, Section 2 hereof, and if the person does not agree with thedecision, the person shall be entitled to request a review of the case by filling out and submitting to the JSHR
secretariat a review request form addressed to the president, within 14 days of receiving the notification fromthe board of trustees. The person must concisely state in the review request form its specific grounds forrebuttal of and objection to the reasons for the decision as described in the document by the president. In sucha case, the person filing the form may also present addition pieces of information to support its objection
grounds in addition to the information that has been disclosed to the president.
Section 2 Procedure for reviewing objecting motions
1. If a review request has been filed by a person who does not agree with the decision it has been notified of,the president must promptly set up an objecting motion review committee (hereinafter referred to as“Review Committee”). The Review Committee must consist of a small number of JSHR members to beappointed by the president and at least one outside committee member. The committee chair shall bechosen by the members. None of the members of the COI Committee may be appointed to serve on the
Review Committee simultaneously. The Review Committee must hold a committee meeting and conduct
an actual review of the case within 30 days of receiving the review request form.
2. The Review Committee shall be allowed to conduct interviews with the chair of the COI Committee thatconcern the case and also with the person who filed the objecting motion to hear their opinions, unlesssuch person fails to show up on the specified interview date.
3. Unless there is a special circumstance, the Review Committee must draft a decision on the case and submit
it to the board of trustees within one month of the date on which the first committee meeting was held toreview the case.
4. The board of trustees shall make its final decision on how to treat the case based on the judgment made by
the Review Committee based on the objecting motion.

Article 9 Measures against persons who have breached their non-disclosure obligations
To ensure proper management of COI information, each employee working at the JSHR secretariat who
comes to know COI information that is personal in nature shall be bound by the non-disclosure obligations as
set forth in Article 5, Section 2 hereof, in the same manner as each JSHR trustee and concerned person in a
managerial position. If any concerned person or secretariat member is found to have intentionally divulged
any COI information to outside parties without following the specified appropriate procedure, the board oftrustees may enforce a penalty on such person or member by expelling them from the JSHR or terminating
their employment, etc.

Article 10 Modification of the Detailed Rules
Any part of these Detailed Rules may need to be modified on a case-by-case basis to adapt to various social
conditions and statutory changes concerning industry-academia collaboration, etc. Therefore, the board oftrustees may consult the COI Committee to properly review these Detailed Rules and pass resolutions tomodify these Detailed Rules based on the advice of the COI Committee.

Supplementary Provisions

Article 1 Enforcement date
These Detailed Rules shall be enforced from March 16, 2017.

Article 2 Revision of these Detailed Rules
In principle, these Detailed Rules must be reviewed and revised once every few years in order to adapt tovarious social factors, statutory amendments and enactments concerning industry-academia collaboration, andchanges in circumstances surrounding the field of medicine and medical research.

Article 3 Special provision on the application of these Detailed Rules to JSHR officers, etc.
In regard to those persons who had already assumed their posts as JSHR officers, etc. at the time when these
Detailed Rules came into force, these Detailed Rules shall be applied to them, mutatis mutandis, to ensure thatthey promptly submit required reports, etc. accordingly.