Policy on Conflicts of Interest (COI) in Clinical Research
Japanese Society for Clinical Nutrition and Metabolism
In Japan, the Basic Act on Science and Technology was enacted in 1995 with the aim of building a nation that is creative in science and technology, and the “Basic Plan for Science and Technology” was formulated in 1996 as a national strategy to strengthen collaborative activities between industry and academia. From the latter half of the twentieth century to the twenty-first century, progress in medical science and healthcare has been remarkable, and targets of medical research have shifted from individuals to organs, cells, and molecules. Furthermore, the relationship between genetic abnormalities and disease, developments in regenerative medicine, and other developments have been applied to elucidate unknown pathological conditions, discover new drugs, and develop treatments and preventive methods based on completely new concepts. It is extremely important that the results of medical research be appropriately returned to society and patients so that the people of Japan can enjoy safe, secure, and comfortable lives. Needless to say, it also has great significance in stimulating education and research as well as the economy.
The research results presented at academic meetings and in publications organized by the Japanese Society for Clinical Nutrition and Metabolism (hereafter referred to as “the Society”) include a wide variety of clinical research for the development of diagnostic, therapeutic, and preventive methods for various diseases, as well as clinical research using new drugs, medical devices, and medical technologies. The promotion of such research is based on industry-academia collaboration activities (joint research, contract research, technology transfer and guidance, scholarship donations, endowed courses, etc.) with pharmaceutical companies, venture companies, and others.
As clinical research through industry-academia collaboration becomes more active, universities, research institutions, and academic organizations that are public entities become more deeply involved in the activities of specific companies. As a result, there are inevitably and unavoidably conflicts between the responsibilities of academic institutions and academic organizations in terms of education and research, and the benefits that individuals gain from industry-academia collaborative activities. A situation such as this is called a “conflict of interest (COI),” and the appropriate management of such conflicts of interest by an academic institution or group as an organization is an important issue that must be overcome in order to properly promote industry-academia collaboration activities. In addition, unlike industry-academia collaborative research in other areas, the participation of healthy people, patients, and others as subjects and participants in clinical research is essential. For those involved in clinical research, the more serious the conflict of interest with funding and profit providers, such as corporate organizations and groups, the more likely it is that the human rights of subjects and the safety and security of their lives will be compromised, and that the research methods and interpretation of data analysis results will be distorted. Furthermore, even though research results may be appropriate, they may not be fairly evaluated or presented. However, it has been pointed out that in many cases accumulated in the past, the problem was not the conflict-of-interest situations themselves (that accompanied industry-academia collaboration) but rather the lack of appropriate management of such conflicts. In recent years, many medical facilities and academic organizations in Japan and abroad have established conflict-of-interest policies for clinical research in order to maintain fairness and impartiality in clinical research, maintain transparency and social credibility in conference presentations, and promote appropriate clinical research through industry-academia collaboration. These medical facilities and academic organizations are making efforts to return research results to society through appropriate COI management.
The Society has established a COI policy in order to properly manage the conflicts of interest of its members and others associated with the Society and to fulfill its accountability to society by requiring its members and associates to disclose their financial relationships with sponsors with whom there are conflicts of interest in the Society's business presentations and other activities under certain conditions.
Ethical principles for medical research involving human subjects have already been described in the “Declaration of Helsinki” and the “Ethical Guidelines for Clinical Research (Ministry of Health, Labour and Welfare Notification No. 255, revised in 2008),” but special consideration is required to protect the human rights and lives of subjects and to conduct the research safely. In light of the social responsibility and high level of ethics required in its activities, the Society has established the “Policy on Conflicts of Interest (COI) in Clinical Research” (hereinafter referred to as the “Policy”). The objective of the Policy is to ensure that the Society appropriately manages its members' conflicts of interest, thereby contributing to the prevention, diagnosis, and treatment of nutrition-related diseases and fulfilling its social responsibility by appropriately promoting the publication of research results and activities such as dissemination and awareness-raising while maintaining neutrality and openness. Therefore, the Policy presents the basic concept of conflicts of interest to the Society's members and others, and requires them to appropriately disclose their own conflict-of-interest status through self-reporting and comply with the Policy when they participate in various activities and make presentations.
The Policy applies to the following subjects who may have a conflict of interest:
(1) Members of the Society
(2) Persons who make presentations at academic meetings of the Society
(3) Officers of the Society (president, directors, and auditors), persons in charge of academic meetings (chairpersons, etc.), and various committee chairpersons, committee members, and members of interim working groups (working group hereinafter referred to as “WG,” working team “WT,” and project team “PT”)
(4) Administrative staff of the Society
(5) Spouses, first-degree relatives, or persons who share income or property with those in (1) through (4)
III. Target Activities
The Policy will apply to all activities conducted by the Society.
(1) Convening of member research presentations, academic meetings, etc.
(2) Publishing of the organization's journals (including electronic journals), research papers, etc.
(3) Liaison and cooperation with related academic organizations in Japan and abroad
(4) Research and investigation on nutrition and subjects related to nutrition
(5) Promotion and quality improvement of nutrition support teams (NSTs)
(6) Incentives for research and recognition of outstanding achievements
(7) Provision of information and guidelines on nutrition and nutrition-related topics
(8) Provision of information and education on nutrition to the public
(9) Proposals on medical policies
(10) Accreditation-related activities
(11) Educational activities
(12) Other activities necessary to achieve the objective of the preceding article
In particular, special compliance with the Policy is required for the following activities:
(1) Presentations at academic meetings organized by the Society and its branch societies
(2) Presentations in publications such as an academic society journal
(3) Formulation of guidelines, manuals, etc.
(4) Work in ad-hoc investigation committees, advisory committees, etc.
IV. Items to Report
If, for an individual, any of the following items in (1) to (9) exceed the criteria specified in the Bylaws, the subject will report the exact circumstances to the president of the Society. The specific method for disclosing and releasing the reported content will be stipulated separately in the Bylaws. For (1) to (3), the status of relatives (spouse, first-degree relatives, or persons with whom the subject shares income or property) will also be reported.
(1) Appointment as an officer, advisor, or employee of a company, corporation, or for-profit organization
(2) Ownership of company stock
(3) Royalties from companies, corporations, or for-profit organizations for patents, etc.
(4) Daily allowances (lecture fees, etc.) paid by companies, corporations, or for-profit organizations for time and effort spent by the researcher in attending (making presentations at) meetings
(5) Manuscript fees paid by companies, corporations, or for-profit organizations for writing pamphlets or other documents.
(6) Clinical research expenses (clinical trials, clinical study expenses, etc.) provided by companies, corporations, or for-profit organizations
(7) Research expenses (funded research, joint research, endowments, etc.) provided by companies, corporations, or for-profit organizations
(8) Endowed courses sponsored by companies, corporate entities, or for-profit organizations
(9) Other, including reimbursement of travel expenses (such as for participation in academic conferences), receipt of gifts, etc., other than those listed above
V. Potential Conflict-of-Interest Situations to Avoid
1. Situations that all subjects should avoid
Publication of clinical research results and establishment of guidelines should be based purely on scientific evidence and judgment or public interest. The Society's members and others must not be influenced by the arbitrary intentions of clinical research funders or companies, and must not enter into agreements with funders or other parties where such influence cannot be avoided. This applies to the content of publications, such as results and interpretations of clinical research, and the preparation of guidelines and manuals for medical care (diagnosis and treatment) based on scientific evidence from clinical research.
2. Situations that clinical trial investigators should avoid
When selected as a principal investigator with authority to make decisions on the planning and implementation of clinical research (including clinical trials and clinical studies), a researcher should have a good reputation in the community and have no significant conflicts of interest (minimal relationships with sponsors) with respect to the following items, and should maintain such status after being selected:
(1) Own stock in a company that requests clinical research.
(2) Obtain royalties, patent rights, etc., for products or technology derived from the results of clinical research.
(3) Be an officer, director, advisor, etc., of a company or for-profit organization that requests clinical research (excluding free scientific advisors).
However, even researchers who fall under (1) through (3) may be appointed as principal investigators of a clinical study if they are indispensable in planning and executing the clinical study and the study has great medical significance, as long as the impartiality, fairness, and transparency of their judgment and measures are clearly guaranteed.
VI. Implementation Method
1. Responsibilities of members
When presenting results of clinical research at an academic meeting, for instance, members will appropriately disclose their conflict-of-interest status related to the performance of such research in the prescribed form in accordance with the Bylaws of the Society at the time of the presentation. If a violation of the Policy has been indicated in connection with research or other presentation, the Board of Directors will ask the committee responsible for conflicts of interest (hereinafter referred to as the “Ethics and Conflicts of Interest Committee”) to deliberate on the issue and take appropriate measures based on its report.
2. Responsibilities of officers
The officers of the Society (president, directors, and auditors), persons in charge of academic meetings (chairpersons, etc.), various committee chairpersons, committee members, and working group members have important roles and responsibilities in all activities related to the Society. They will self-report their own conflicts of interest and those of their relatives upon assuming office, using the prescribed form. Furthermore, if a new conflict-of-interest situation arises after assuming office, they will file an amended report in accordance with the regulations.
3. Role of the Ethics and Conflicts of Interest Committee
If a member has a serious conflict of interest in any activity conducted by the Society, or if a member's self-report of a conflict of interest is found to be inappropriate and questionable, the Ethics and Conflicts of Interest Committee will conduct an interview or other investigation to manage the member's conflict of interest, and report the results to the president of the Society.
4. Role of the Board of Directors
If an officer or other person has a serious conflict of interest in conducting the Society activity, or if a self-report of a conflict of interest is deemed inappropriate, the Board of Directors may consult with the Ethics and Conflicts of Interest Committee and, based on its report, may specify remedial measures or other actions.
5. Role of the person in charge of an academic meeting
When the results of clinical research are presented at an academic meeting, the person in charge of the meeting (chairperson, etc.) will verify that the implementation is in accordance with the Policy, and may take measures such as suspending the presentation if the topic violates the Policy. In such a case, the prospective presenter will be promptly notified and given the reason for the decision. In taking these measures, the above-mentioned person in charge may consult with the Ethics and Conflicts of Interest Committee and specify remedial measures based on the Committee's report.
6. Role of the Editorial Board
When an original paper, review article, guideline, editorial article, or opinion of research results is published in an academic society journal or other publication, the Journal Editorial Board will verify that the implementation is in accordance with the Policy, and may take measures such as withholding publication if it violates the Policy. In such a case, the paper's contributor will be promptly notified and given the reason for the decision. If a violation of the Policy is found to have occurred after publication of the paper in question, public notice of the violation may be given in the name of the editorial board chairperson in the relevant publication. In taking these measures, the editorial board chairperson may consult with the Ethics and Conflicts of Interest Committee and specify remedial measures based on the Committee's report.
The other committee chairpersons and members will verify that the Society activity in which they are involved is implemented in accordance with the Policy, and if a violation of the Policy occurs, they will promptly consider measures to remedy the situation. The Ethics and Conflicts of Interest Committee will be consulted on how to deal with these issues, and the Board of Directors may specify remedial measures based on the report.
VII. Measures and Accountability for Violators of the Policy
1. Measures for violators of the Policy
The Society's Board of Directors has the authority to deliberate on violations of the Policy in accordance with the rules separately stipulated. After consulting with the Ethics and Conflicts of Interest Committee (or the appropriate committee), receiving a report, and deliberating, the Board may take all or part of the following measures for a certain period, depending on the degree of the violation, if it determines that there has been a serious violation of the Policy.
(1) Prohibit violators from making presentations at all academic meetings held by the Society.
(2) Prohibit violators from publishing papers in the Society's publications.
(3) Prohibit violators from assuming the chairmanship of the Society's academic meetings.
(4) Prohibit violators from participating in the Board of Directors, committees, and working groups of the Society.
(5) Remove delegates or academic councilors of the Society, or prohibit violators from becoming delegates or academic councilors.
(6) Suspend, expel, or prohibit violators from membership of the Society.
When measures against a Policy violator have been determined, the information will be provided to the heads of other relevant academic societies to which the member belongs.
The aggrieved party may file an appeal with the Society. Upon receipt, the president of the Society will promptly establish an appeal review committee (provisional advisory committee) to review the appeal, discuss it with the Board of Directors, and notify the appellant of the results.
If the Society determines that there has been a serious violation of the Policy in the results of clinical research presented at a location where it is involved, the Society shall promptly hold itself accountable to society through consultation with the Board of Directors.
VIII. Establishment of Bylaws
The Society may establish Bylaws as necessary to administer the Policy.
IX. Policy Revisions
The Policy may be periodically reviewed and revised to conform to social factors, changes and developments in laws and regulations concerning industry-academia collaboration, and conditions surrounding medical care and research.
X. Effective Date
The Policy came into effect on February 26, 2014. The Policy came effect on September 4, 2020.
Japanese Society for Clinical Nutrition and Metabolism
Bylaws of the Policy on Conflicts of Interest in Clinical Research
The purpose of the activities of the Japanese Society for Clinical Nutrition and Metabolism (hereafter referred to as “the Society”) is to promote the advancement of nutritional science and contribute to the development of science in Japan by presenting research, exchanging knowledge, encouraging lifelong learning among its members, and cooperating with fellow members and with related societies in Japan and abroad in the area of nutrition and its applications, which widely covers internal medicine, surgery, dentistry, nursing, pharmacology, and rehabilitation studies.
The Society has developed a “Policy on Conflicts of Interest (COI) in Clinical Research.” In order to fairly manage the conflict-of-interest status of the Society's members and others, the following “Bylaws of the Policy on Conflicts of Interest in Clinical Research” have been established.
Article 1 (Reporting COI Matters at Academic Meetings of the Society)
When presenters, whether members or non-members, give a presentation or lecture on clinical research at an academic meeting sponsored by the Society, an academic meeting sponsored by a branch, or a public lecture, the lead presenter, including his/her spouse, first-degree relative, or a person with whom he/she makes a living, shall in connection with this presentation self-report on Form 1 at the time of abstract registration whether or not he/she has had any conflicts of interest in the past year involving financial relationships with companies or for-profit organizations related to clinical research.
The lead presenter will disclose the relevant COI status at the beginning of the presentation slide (or after the slide introducing the topic, presenter, etc.) or at the end of the brochure.
A “clinical research-related company, corporation, or for-profit organization” is defined as a company, organization, or group that has any of the following relationships involving clinical research:
(1) Relationship in which the entity requests clinical research or performs it jointly (with or without compensation)
(2) Relationship in which the entity shares patents or other rights related to therapies, drugs, or devices evaluated in clinical research
(3) Relationship in which the entity provides drugs or equipment used in clinical research free of charge or at a particularly advantageous price
(4) Relationship in which the entity provides research grants or donations for clinical research
(5) Relationship in which the entity provides unapproved drugs or medical devices for clinical research
(6) Relationship in which the entity sponsors an endowed course
“Clinical research” as it relates to the presented topic means medical research conducted on human subjects for the purpose of improving methods of prevention, diagnosis, and treatment of diseases, understanding causes and pathological conditions of diseases, and improving the quality of life of patients in medicine. Medical research involving human subjects includes research on individually identifiable samples of human origin and individually identifiable data. Criteria for being an individually identifiable sample or data are established in the “Ethical Guidelines for Clinical Research” of the Ministry of Health, Labour and Welfare.
Article 2 (Criteria for COI Self-Reporting)
The monetary amount necessary for COI self-reporting will be based on the following criteria for items to be disclosed.
(1) For officers and advisors of companies, corporations, and for-profit organizations/groups related to clinical research (hereinafter referred to as “companies, organizations, or groups”), the amount of remuneration from one company, organization, or group is at least 1,000,000 yen per year.
(2) For shareholdings, annual profit (sum of dividends and gains on sales of shares) from shares in a company is at least 1,000,000 yen, or the party owns at least 5% of all shares in the company.
(3) For patent royalties from companies, organizations, or groups, the annual royalty fee for each patent is at least 1,000,000 yen.
(4) For daily allowances (such as lecture fees) paid by companies, organizations, or groups for time and effort spent by the researcher to attend (make a presentation at) a conference, the total annual lecture fee from a single company or group is at least 500,000 yen.
(5) For manuscript fees paid by companies, organizations, or groups for writing pamphlets or other documents, the total annual manuscript fee from a single company, organization, or group is at least 500,000 yen.
(6) For research funds provided by companies, organizations, or groups, the total amount paid by a single company or group for clinical research (for funded research expenses, joint research expenses, etc.) is at least 2 million yen per year.
(7) For scholarship (incentive) donations provided by companies, organizations, or groups, the total amount paid from one company, organization, or group to a donation-reporting individual or a representative of the department (course or field) or laboratory to which the donation-reporting individual belongs is at least 2 million yen per year.
(8) The donation-reporting individual or other party is affiliated with an endowed course offered by a company, organization, or group.
(9) For other travel, gifts, and such that are not directly related to the research, the total amount received from a single company, organization, or group is at least 50,000 yen per year.
However, for items (6) and (7), it is necessary to report when the individual lead presenter or the department (course or field) or laboratory to which the lead presenter belongs receives money for research expenses, such as a scholarship donation, from a company or group where there is a conflict-of-interest relationship that must be disclosed in connection with the presentation of research results.
Article 3 (Publication of Notifications in Journal of the Society)
All authors of publications (review articles, original papers, etc.) in the official journal of the Society (The Journal of Japanese Society for Parenteral and Enteral Nutrition) shall provide advance notice to the Society Secretariat of the COI status for any financial relationship regarding the publication content (that has existed within the year prior to submission) with a company, organization, or group stipulated in Article 1, Section 2, of these Bylaws, using a COI Self-Report (Form 2), the form stipulated in the submission rules.
As for the COI status, the matters specified in “IV. Items to Report” of the “Policy on COI in Clinical Research” shall be self-reported. For each of the items to be disclosed, the monetary amount necessary for self-reporting will be as specified in Article 2. COI reports will not be disclosed to research paper reviewers.
Article 4 (Submission of COI Reports by Officers, Committee Chairs, Committee Members, and Others)
The officers of the Society (president, vice president, chairperson, directors, and auditors), chairperson-elect, branch leaders, branch academic meeting chairpersons, persons responsible for educational seminars, workshops, and other activities, all chairpersons of various committees, committee members, working group members, and employees of the Society shall, for the items to report in IV of the “Policy on COI in Clinical Research”, submit a COI self-report to the Board of Directors at the time of new appointment and every year thereafter, in accordance with prescribed Form 3, as to whether any COI conditions existed during the year before he/she assumed office. If the COI self-report has already been submitted, there is no need to submit it. However, self-reporting of COI is limited to those who are affiliated with companies, corporations, and for-profit organizations related to activities conducted by the Society.
For the COI status to be described on Form 3, self-report the “Items to Report” specified in section IV of the “Policy on COI in Clinical Research”. For each item to be disclosed and made public, the amount that must be self-reported will be the standard amount specified in Article 2, and the amount classification will be clearly indicated for each item according to Form 3. Form 3 should be filled in for the year period preceding the fiscal year of appointment, and the period for which it was calculated should be clearly indicated. However, officers and others are obliged to report any new COI conditions that arise during their term of office using Form 3 within 8 weeks.
Article 5 (Handling of COI Self-Reports)
The COI self-report submitted at the time of abstract registration for a conference presentation or at the time of paper submission to the Society journal shall be kept in strict confidence at the Society office under the supervision of the president for two years from the date of submission. Similarly, COI information documents concerning persons who have completed their term as an officer or persons confirmed to have withdrawn their appointment as a committee member shall be kept in strict confidence at the Society office under the supervision of the president for two years from the date of final expiration of their term of office or withdrawal of appointment as a committee member. After a period of two years, the documents will be promptly deleted and disposed of under the supervision of the president. If, however, the Board of Directors recognizes that it is not appropriate to delete or dispose of the COI information, it may defer the deletion or disposal of the reporting party's COI information for the period of time necessary. COI information concerning the chairperson (including the next chairperson), academic meeting chairperson, and academic meeting director (person in charge of the Secretariat) will be handled in the same manner as that of an officer.
In accordance with these Bylaws, the directors and related officers of the Society may use the COI information of the individual concerned at any time to determine whether and to what extent the individual concerned has a conflict of interest based on the self-report submitted and to manage and take measures in accordance with the Society's determination. However, it shall not exceed the limit necessary for the purpose of use, nor shall it be disclosed to persons other than those to whom disclosure is required in light of the above-mentioned purpose of use.
In principle, COI information will not be disclosed except in the case of Article 5, Section 2. After the Board of Directors has been consulted, COI information regarding the activities of the Society, activities of committees (including the activities of affiliated standing WGs, WTs, PTs, etc.), and activities of ad-hoc committees may be disclosed or published inside or outside the Society to the extent necessary when it is necessary for the Society to fulfill its social and moral accountability. However, this does not preclude the Board of Directors from delegating a specific director to handle such issues and to make its decisions under the advice of the Ethics and Conflicts of Interest Committee. In such cases, the party whose COI information is to be disclosed or made public may express his or her opinion to the Board of Directors or to the director delegated to make the decision. However, this will not apply when there is an emergency and there is no time to hear opinions regarding disclosure or publication.
If there is a request for disclosure (including a legal request) from a non-member naming a specific member, the COI Committee, in consultation with the president and while protecting personal information, will respond appropriately if there is a reason to believe that it is reasonable. If, however, it is determined that the COI Committee cannot take action, a COI Investigation Committee, consisting of a few members of the Society appointed by the president and at least one external committee member, will be established to consult. The COI Investigation Committee will meet within 30 days of receipt of the disclosure request and make its report as soon as possible.
Article 6 (Ethics and Conflicts of Interest Committee)
The Ethics and Conflicts of Interest (COI) Committee will consist of a few members of the Society appointed by the president and at least one external committee member. The chairperson will be appointed by the Board of Directors. COI Committee members are obligated to maintain the confidentiality of COI information of members that comes to their knowledge. The Ethics and Conflicts of Interest Committee, in cooperation with the Board of Directors, will manage and respond to violations as stipulated by the conflict-of-interest policy and these Bylaws in order to prevent the COI status of members from developing into a serious situation. The provisions of Article 5 will apply correspondingly to the reporting of COI matters and the handling of COI information for the committee members.
Article 7 (Measures against Violators)
If any doubts or social or moral problems arise with regard to the COI self-report items submitted by authors who make presentations in the official journal of the Society (“JSPEN”) or by persons who are scheduled to make presentations at the Society's academic meetings, the Ethics and Conflicts of Interest Committee will conduct sufficient investigations and interviews and then take appropriate measures to fulfill the social accountability of the Society. If there is a serious COI situation and accountability cannot be fulfilled, the president will consult with the Ethics and Conflicts of Interest Committee. Based on the resulting report, the Board of Directors may, after deliberation, take measures such as suspending the conference presentation or paper publication by the person scheduled to make the presentation. If doubts or other problems arise with regard to a paper after it has been published, the president will investigate the facts and take measures such as withdrawing the paper if there is a violation. Furthermore, if the nature of the violation seriously undermines the social credibility of the Society, the president will also take measures such as those that will affect the author's membership in accordance with the Society's Articles of Incorporation.
If a problem is pointed out with regard to COI matters reported before or after the assumption of office by an officer of the Society, chairperson of a committee, committee member who is required to submit COI self-reports, or a candidate for such a position, the chairperson of the Ethics and Conflicts of Interest Committee will report in writing to the president, who shall promptly convene a meeting of the Board of Directors and vote on whether to approve the findings. If the findings are approved, a person who is an officer or officer candidate must leave their position. If the person is another committee member or candidate for committee membership, he/she will be consulted and may withdraw their appointment.
Article 8 (Appeals)
Section 1: Appeal Request
A person who has been notified of a violation and decision to take measures against the person's presentation at the Society activity (in an academic society journal, at an academic meeting, etc.) in accordance with Article 7, Paragraph 1, or a person who has been removed as an officer or a candidate who had a committee appointment withdrawn in accordance with Article 7, Paragraph 2, may, if dissatisfied with the result, request a review of the decision by submitting a written request for appeal review to the president via the Society Secretariat within seven (7) days of receiving notification of the Board of Directors decision. The request for review will include a brief, specific rebuttal or objection to the reasons for the withdrawal given in writing by the chairperson. In such cases, in addition to the information disclosed to the chairperson, relevant information that forms the basis of the objection may be presented in writing.
Section 2: Appeal Review Procedures
1. Upon receipt of a request for appeal review, the president shall promptly establish an appeal review committee (hereinafter referred to as the “Review Committee”). The Review Committee will consist of a few members of the Society appointed by the president and at least one external committee member, and the chairperson will be appointed by the Board of Directors. A member of the Ethics and Conflicts of Interest Committee may not also serve as a member of the Review Committee. The Review Committee will convene a meeting within 30 days of receipt of a written request for review in order to examine the request.
2. The Review Committee may, when necessary, conduct interviews with the chairperson of the Ethics and Conflicts of Interest Committee and the appellant regarding the appeal.
3. The Review Committee will compile a written report on the appeal and submit it to the president within one month from the date of the first meeting of the Committee regarding the review, unless there are special circumstances.
4. The decision of the Review Committee will be final.
Article 9 (Changes to Bylaws)
It is anticipated that some changes to these Bylaws may be necessary in individual cases due to social factors or changes in laws and regulations concerning industry-academia collaboration. In addition, in order to adapt to changes in the conditions surrounding medical care and clinical research, the Bylaws will, in principle, be reviewed every few years. These Bylaws may be amended by resolution of this Committee and the Board of Directors.
Article 1 (Effective Date)
- These Bylaws were implemented on a trial basis for a period of two years on April 1, 2013, after which they have been fully implemented.
- These Bylaws were revised and came into effect without a trial period on February 26, 2014, with the incorporation of the Society.
- These Bylaws were revised and came into effect without a trial period on April 25, 2014, with the incorporation of the Society.
Article 2 (Special Provisions Concerning Application to Officers)
Persons who were already serving as officers of the Society when these Bylaws came into effect would have promptly made the necessary reports, etc. in accordance with these Bylaws.
Article 3 (Revision Date)
These Bylaws came into effect on September 4, 2020.
These Bylaws came into effect on May 30, 2022.