Guidance on Eligibility Criteria for Clinical Practice Guideline Formulation
The Japanese Association of Medical Sciences COI Committee 2023

Table of Contents
1. Background
2. Those subject to COI management
3. COI disclosure items and self-reported disclosure of COI of participating
individuals and spouses, first-degree relatives, or any persons with whom theparticipant shares income or property assets
1) Self-reported COI self-disclosure of participating individuals
2) COI disclosure by the spouse or first-degree relative, or any persons with whom
the participant shares income or property assets
3) Disclosure of institutional COI regarding the participant’s affiliated organization
or department
4. COI disclosure items and monetary amount category
5. Basic concept of eligibility for CPG participation
1) In principle, if any of the following categories apply to the candidate for CPG
formulation, or his/her spouse, first-degree relative, or any persons with whom theparticipant shares income or property assets, the candidate should not be allowed toparticipate.
2) Evaluation and management of eligibility for participation in CPG formulationaccording to the monetary amount category
6. Structure of the CPG Formulation Committee
7. Responsibilities of the Head of the CPG Formulation Committee
8. Matters to consider when formulating CPG

11. BackgroundIndustrial-academic cooperation is indispensable for promoting clinical development
and clinical research in disease prevention, diagnostics, and therapy.
Clinical research is the source of evidence-based medicine (EBM), as it enables
validation of the efficacy and adverse events of multiple treatment options, and allows asystematic comparison of cost-effectiveness, therefore contributing greatly to theformulation and revision (hereinafter, formulation) of the Clinical Practice Guidelines(CPGs) to suggest optimal medical care and treatment for patients.
However, while the national medical expenditure in 2019 expanded to 44.4 trillion yen,and the total amount for pharmaceutical products was 10 trillion yen, close to a quarterof the total amount, the infrastructure for clinical research in Japan is extremely poor
compared with other countries. Furthermore, the number of clinical epidemiologists,
clinical biostatisticians, and clinical coordinators, establishment of data centers, andpublic funding support are insufficient. The quality, as well as the number of clinicalresearch papers, are unsatisfactory, and it is difficult to say that CPG formulation basedon optimal treatment and medical economics is being carried out adequately.
On the other hand, the interest of pharmaceutical companies is extremely highconcerning how CPG formulation is related to sales promotion and the positioning of
their products. Therefore, it is more likely for pharmaceutical companies to become
deeply involved in clinical research and publishing, and the process of publicizing
results, which form the basis for CPG formulation. In addition, researchers conducting
clinical research develop strong financial ties with for-profit companies. In recent years,
medical-related companies have been providing not only "endowments" to medical
specialty societies, but also large sums of money in the form of "contracts" with theheads of specific research institutes or academic groups (e.g., specialty societies)
selected through public solicitation, for the purpose of supporting education, research,and medical treatment. As a result, if researchers participating in CPG formulation areaffiliated with those institutions or academic groups, there may be a serious situation of
institutional COI. Suspicion is likely to arise in society and raise questions such as,“Can the independence of CPGs be kept?” “Can a fair judgment be made?” and “Will a
certain company be unjustly favored?” For this reason, specialty societies that formulate
CPGs are required to manage any related institutional COI.

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It has been reported that when conducting or publishing intervention research involving
companies, bias, i.e., trial bias (research unfavorable to companies is not conducted),
publication bias (unfavorable results are unpublished), or reporting bias (efficacy isoverrated, side effects are underrated), are likely to occur. Recently, several incidents ofclinical research misconduct involving improper intervention of companies have beenreported in Japan, undermining the international credibility of CPGs, and creating social
problems.
CPGs are widely used by clinical medical societies, patient support organizations,payment agencies, medical specialists, clinicians, and consumers. With the rapid growthin the clinical development of pharmaceutical drugs and medical equipment, efforts tosecure the quality and credibility of CPGs have raised much interest as an urgent issue
both domestically and internationally, and specific rules have been formulated.
To formulate trustworthy CPGs based on EBM methods, it is necessary not only todisclose in detail and make public the conflict of interest (COI) of the relevant
participants and societal organizations involved, but also to clearly state the eligibility
criteria of those taking part in the CPG formulation, and establish a management system
to prevent any risk of bias. In addition, to ensure the quality and credibility of CPGs,
verification must be conducted through regular and appropriate reviews and revisions.
To this end, the CPG Steering Committee, a standing committee of the affiliated society,upon collaboration with the COI Committee, must properly manage the COI of allparticipants involved in CPG formulation.
Therefore, based on the COI Management Guidelines of the Japanese Association of
Medical Sciences, we have established this guidance on the eligibility criteria for
individuals participating in CPG formulation. The purpose of this guidance is to provide
information on the COI status of individuals and/or institutional COI status of affiliatedinstitutions and academic organizations participating in CPG formulation in as muchdetail as possible in the prescribed form, to enable third parties using CPGs to easily
and conveniently view the COI status to appropriately judge whether or not there is bias
in the CPG content. This will help the affiliated society to ensure not only the quality
but also the credibility of CPGs in the process of COI management.

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2. Those subject to COI management
The president of the affiliated society will establish a CPG Steering Committee as astanding committee. To newly formulate or revise CPGs concerning diagnosis,
treatment, and prevention, umbrella committees such as the CPG Formulation
Committee (group for guideline formulation), Systematic Review Team, and External
Evaluators (committee) will be established. All individuals (including committee
members affiliated with patient groups) who participate in these committees, groups,
and teams, in addition to spouses, first-degree relatives, or any persons with whom theparticipant shares income or property assets are subject to COI disclosure.
On the other hand, following the Intractable Diseases Act of 2014, the Ministry of
Health, Labour and Welfare (MHLW) has been intensively promoting research on rarediseases as part of the Intractable Diseases Policy Research Project and has publishedseveral guidelines for patients and families struggling with the diseases. Members of theJapan Medical Association who participate in the formulation of such guidelines are
required to disclose their COI status in the form prescribed by this guidance.
3. COI disclosure items and self-reported disclosure of COI of participating
individuals and spouses, first-degree relatives, or any persons with whom theparticipant shares income or property assets
Participants who are engaged in CPG formulation are required to disclose the COI
status for the following items using the self-reported COI form for CPG formulation
participants (Fig. 1-A) for the past 3-year period starting from the previous year, foreach year (from January 1 to December 31) from when the individual takes office and
CPG is announced.
1) Self-reported COI disclosure of participating individuals(1) Position as an officer or advisor of a company or for-profit organization, and amountof remuneration.
(2) Stock ownership and profit from stock (profit from stock for the previous year)(3) Remuneration received for patent royalties or licensing fees from companies or forprofit organizations.
(4) Honoraria such as lecture fees, attending conferences (presentations, providing
advice, etc.) received from a single company or for-profit organization.
4(5) Manuscript fees received for writing articles, pamphlets, roundtable discussion
articles, etc. from a single company or for-profit organization(6) Research funds (joint research, commissioned research, clinical trials, etc.) provided
by a single company or for-profit organization(7) Scholarship (incentive) donations provided by a single company or for-profit
organization(8) Endowed departments established through donations by a company(9) Other remuneration (travel expenses, gifts, etc. not directly related to research)
The amount reported in (6) and (7) is the amount actually allocated by the head of
the research institution to which the researcher belongs and should be expenses anddonations that can be substantially determined by the researcher.
2) COI disclosure by the spouse or first-degree relative, or any persons with whom theparticipant shares income or property assets(1) Executive or advisory positions in a company or for-profit organization, and theamount of remuneration.
(2) Stock ownership and profit from stock (profit from stock for the previous year)(3) Remuneration received for patent royalties or licensing fees from companies or forprofit organizations.
Fig. 1-A. Base amount and monetary amount category of self-reported COI disclosure
items for CPG formulation participants and first-degree relatives
3) Disclosure of institutional COI regarding the participant’s affiliated organization or
department
Two items subject to institutional COI disclosure are education and research funds(publicly solicited or not), and scholarship (incentive) donations accepted by the head of
the organization or division (research institution, hospital, department or center, etc.)with which the participant is affiliated in relation to the research content. This isapplicable if the participant disclosing the COI is currently or was a collaborator or joint
researcher with the head of the research institution or department for the current or past
3 years (Figure 1-B).
Fig. 1-B. Base amount and monetary amount category of institutional COI disclosure
items for affiliated organizations related to CPG formulation participants.

54. COI disclosure items and monetary amount category
Participants involved in CPG formulation will disclose COI using the form prescribed,
by entering the corresponding number for the item category (Form 1).
5. Basic concept of eligibility for CPG participation
The basic concept in determining eligibility for CPG participation is that if the COI
status of the candidate for CPG formulation is found to exceed a socially acceptable
range, or if, after CPG formulation, there is a possibility of a large financial benefit for
third-party institutions and organizations from recommending the CPG for the CPG
participant, spouses, first-degree relatives, or any persons sharing income or property
assets either directly or indirectly with the participant, then in principle, the candidate
should not be allowed to participate in CPG formulation.
1) In principle, if any of the following categories apply to the candidate for CPG
formulation, or his/her spouse, first-degree relative, or any persons with whom theparticipant shares income or property assets, the candidate should not be allowed toparticipate.
(1) Income as an executive or advisor of a company or for-profit organization(1,000,000 yen or more /company /year)(2) Profit from shareholding and profit income from stock (5% or more of all shares/company, or 1 million yen or more/company/year)(3) Remuneration received for patent royalties or licensing fees from a company or forprofit organization (1 million yen or more/company/year)(4) Affiliation with endowed departments provided through donations from a company
or for-profit organization
Participants taking part in CPG revision work, and their spouses, first-degree relatives,and any persons with whom the participant shares income or property assets must avoid
the above-mentioned conditions while participating in the formulation task.
2) Evaluation and management of eligibility for participants in CPG formulationaccording to the monetary amount category
The following illustrates the procedure for the CPG Supervisory Committee to manage
the COI of participants in the CPG Formulation Committee and Systematic Review
Team (Fig. 2). Eligibility for participation is determined according to the base and rangeof amount category items disclosed based on self-reported COI disclosure for the past 3
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years (Table 1). In principle, eligibility is given to those who have items to disclose inmonetary amount category②, and those who have items to disclose in monetary amount
category③, should not be allowed to participate in work related to CPG formulation.
(2) Criteria and management of eligibility for participation in CPG development bymonetary amount category
Table 1. Eligibility criteria and base amount per item for those participating in the CPG
Supervisory Committee, CPG Formulation Committee, and Systematic Review TeamSpecifically,(1) Eligibility for participation as Head of the CPG Formulation Committee is based on
self-reported COI disclosure and disclosure of institutional COI. If none of the items
apply to monetary amount categories②, ③ it is possible to participate as the Headof the CPG Formulation Committee and have voting privileges. However, taking
into consideration the great influence the position as Head will have on theformulation of CPGs, in cases where there are multiple items disclosed in monetaryamount category①from a specific company or for-profit organization as individual
and/or institutional COI that could be considered to be perceived to significantly
affect the promotion of its pharmaceutical drugs and medical supplies, measures
such as having the Deputy Head, who has less conflicting interests, act on behalf of
the Head, but without voting privileges and the Head may be given the authority tomake recommendations, should be taken. This fact should be disclosed at the
beginning of the CPG main text using the prescribed form (Table 3).
(2) Eligibility for participation as a Committee Member may be considered if each itemin the monetary amount category②does not exceed the base amount. If this is thecase, it is possible to participate in the CPG formulation with voting privileges.
*The president of the society concerned shall have participants in the CPG
formulation promptly report the occurrence of any items that fall under the monetaryamount category②(Head or Deputy Head) or③(Committee Member) during theformulation period, and take appropriate measures.
(3) Participants in CPG formulation shall promptly report to the head of the relevantsociety if an item falls under monetary amount category②(Head or Deputy Head) or③(Committee Member) during the period of CPG formulation, who will take7

appropriate action.
6. Structure of the CPG Formulation Committee
Participants for the CPG Formulation Committee will be selected as members based on
eligibility criteria but the following points should be noted in the structure of thecommittee.
1) The number of members having items to disclose in monetary amount category②
should not exceed the majority of the total number of members.
2) The committee should be structured so that diversity of the participant’s area ofexpertise is emphasized, including epidemiologists and statisticians, and should not
be biased toward members who have conflicting interests with a specific company
or for-profit organization.
3) Since CPGs serve as a source of information to support the decision-making by
patients and healthcare workers in the medical field, those representing patients andcivic groups should be invited as members of the CPG Formulation Committee andaim for a committee that is structured so that different values can be shared.
7. Responsibilities of the Head of the CPG Formulation Committee
1) At the time of CPG publication, the head must disclose the COI status of eachparticipant including the affiliation and title for the past 3 year-period starting from theprevious year, by classifying the participants into CPG Supervisory Committee, CPG
Formulation Committee, and Systematic Review Team and External Evaluators, using
the prescribed form (Table 2). This information must be placed either at the beginningor end of the CPG main text and made public.
Table 2. Example of COI disclosure for participants of CPG formulation
2) However, if a situation arises that a member of the Formulation Committee has items
in monetary amount category② that exceeds the base amount and are relevant to theamount in category③, if the individual is indispensable to the formulation of CPG, andif the transparency and neutrality can be ensured, participation can still be granted in the
CPG formulation process.
However, the president of the affiliated society must take measures such as not having
the authority in the final decision-making in CPG formulation and fulfill obligations tofulfill accountability to society by disclosing COI and the names of those who abstained
from voting for each CQ number at the beginning of the CPG main text (including
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updates), as shown in Table 3.
Table 3. Disclosure for abstention at CPG formulation meetings to select clinicalguidelines (example)
3) In addition, the source of the funding used for CPG formulation must also be
disclosed. That is, at the time of CPG publication, 1) the name of the company thatprovided funding (donations, etc.) for activities of the affiliated society (academic
lectures, etc.), and 2) the name of the company that provided funding (includes labor)
concerning the formulation of CPG, must be disclosed using the designated form (Table3) for the past 3 year-period starting from the previous year.
The institutional COI of the affiliated society itself related to the contents of the clinicalguidelines to be established (including revisions) must be disclosed in the prescribed
form (Table 4). That is, at the time of CPG publication of the CPG, the names of thirdparty organizations and groups that have provided funds (educational or researchsupport funds, donations, joint research funds, etc.) to the affiliated society concerned
for the past 3-year period, their breakdown, and the names of the business activities
covered must be described and disclosed. However, the amount paid by a company tothe relevant affiliated society for an event (academic seminars, exhibition halls, etc.) cosponsored by the company in connection with the holding of an academic meeting is not
subject to disclosure.
4) When recommendations of the CPG are publicized through media, the COI status ofparticipants in the formulation should be disclosed. In particular, the same applies topublications in company-related promotional brochures and/or commercial magazines.
5) In the case of COI disclosure, the COI status of individual participants and theirresearch institutions and academic organizations related to the contents of theformulated CPG must be disclosed in the CPG main text in the prescribed format.
However, if the volume of disclosure is large, Tables 2, 3, and 4 may be substituted byincluding a URL or QR code (viewable by smartphones) in the CPG text that will allow
easy access to the disclosed information on the relevant society's website, instead ofincluding them in the CPG.

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8. Matters to consider when formulating CPG
To improve the quality of CPG content and ensure credibility, the head of the committee
involved in CPG formulation should handle the following items appropriately.
1) Obtaining the name of the company or for-profit organization involved with the
manufacturing and sales of pharmaceutical drugs or medical equipment mentioned
in the CPG before CPG formulation.
2) Assessment of CPG contents with a cost-effective perspective3) Verifying and securing the neutrality and fairness of CPG contents
4) Managing and recognizing any COI between the participant in CPG formulation(including external evaluators), spouses, first-degree relatives, or any persons withwhom the participant shares income, and the company or for-profit organization
involved.
5) The sharing of COI information of each participant by all those participating in the
CPG Formulation Committee.
6) Acceptance and appropriate handling of comments received from other related
institutions and organizations of which a COI exists7) Acceptance of an external evaluation to improve the credibility of CPG
8) Disclosure of funding sources related to expenses required for CPG formulation andpublication
9) Disclosing the contents of any financial support from a company etc. involved in thecontents formulated, to the related organization
10) Acceptance of advice etc. for CPG formulation (revisions) based on evaluation
results of a third-party organization (e.g. Japan Council for Quality Health Care,
Medical Information Network Distribution Service (Minds))
11) Establishing disciplinary rules and regulations for violators of the guidelines

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The Japan Association of Medical Sciences Conflict of Interest Committee
Vice-President in Charge
Takashi Kadowaki

Head of Committee
Saburo Sone

Committee Members
Chikashi Ishioka

Director, Toranomon Hospital (Federation of National Public Service
Personnel Mutual Aid Associations)

Professor Emeritus, Tokushima University

Professor, Department of Clinical Oncology, Tohoku University
School of Medicine

Kojiro Ueki

Director, Diabetes Research Center, National Center for Global Healthand Medicine

Kanae Karita

The Japan Association of Medical Sciences Executive Committee
Officer
Professor, Department of Hygiene and Public Health, Kyorin University
School of Medicine

Shuji Terai

Professor, Division of Gastroenterology and Hepatology, Graduate
School of Medical and Dental Sciences, Niigata University

Yuichiro DokiProfessor, Department of Gastroenterological Surgery, Graduate Schoolof Medicine, Osaka University

Masaomi Nangaku

The Japan Association of Medical Sciences Executive Committee
Officer
Professor, Division of Nephrology and Endocrinology, The Universityof TokyoSeji Yano

Professor, Division of Medical Oncology Cancer Research Institute,
Kanazawa University

External Committee Members
Fumikazu Asai
Director, Medical Journalists Association of Japan, Former Editorial
Board Member, The Asahi Shimbun
Saiko Ogasawara

Attorney, Nanboku Law Office

Takako Kojima

Professor and Director, Center for International Education and Research,
Tokyo Medical University

Liaison Committee Member
Kiyoshi KitamuraHead, Japan Association of Medical Journal Editors

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The Japan Association of Medical Sciences Conflict of Interest Committee(Term: September 1, 2023～June 2025 Board of Councilors Ad Hoc Meeting of the Japan Association of Medical Sciences)

Vice-President in Charge
Masaomi Nangaku

Professor, Division of Nephrology and Endocrinology, Graduate Schoolof Medicine and Faculty of Medicine, The University of Tokyo

Head of Committee
Yuichiro DokiCommittee Members
Chikashi Ishioka

Professor, Department of Gastroenterological Surgery, Graduate
School of Medicine, Osaka University

Professor, Department of Clinical Oncology, Tohoku University
Graduate School of Medicine

Kohjiro Ueki

Director, Diabetes Research Center, National Center for Global Healthand Medicine

Kanae Karita

The Japan Association of Medical Sciences Executive Committee
Officer
Professor, Department of Hygiene and Public Health, Kyorin University
School of Medicine

Shuji Terai

Professor, Division of Gastroenterology and Hepatology, Graduate
School of Medical and Dental Sciences, Niigata University

Yasuo Terauchi

Professor, Department of Endocrinology and Metabolism, Graduate
School of Medicine, Yokohama City University

External Committee Members
Fumikazu Asai
Director, Medical Journalists Association of Japan, Former Editorial
Board Member, The Asahi Shimbun
Saiko Ogasahara

Attorney, Nanboku Law Office

Takako Kojima

Professor and Director, Center for International Education and Research,
Tokyo Medical University

Liaison Committee Member
Kiyoshi KitamuraHead, Japan Association of Medical Journal Editors12