April 13, 2020
Ethical Review Board of the Japan Society for Hematopoietic Cell Transplantation
The purpose of the Japan Society for Hematopoietic Cell Transplantation (JSHCT) is to promote research on hematopoietic cell transplantation and improve its therapeutic outcomes and safety, thereby contributing to the welfare of patients and donors, and to improve the research, education, and practice of hematopoietic cell transplantation by its staff and member doctors, thereby contributing to public welfare. Society-sponsored clinical trials and research published at academic meetings and in publications include clinical research for the standardization of hematopoietic cell transplantation and clinical research using novel drugs and technologies, some of which are conducted in collaboration with industry and academia. The ultimate goal of all clinical research is to return the results to clinical practice for the benefit of patients, and the promotion of industry-academia collaboration is essential for this purpose. Research results obtained from hematopoietic cell transplantation clinical research through industry-academia collaboration not only provide public benefits by giving back to society, including patients, but may also generate private benefits such as money, status, and interests for researchers and companies resulting from industry-academia collaboration. The existence of these two interests within an individual researcher is called a conflict of interest (COI).
A serious conflict of interest (COI) situation raises suspicion that the research methods, data analysis, interpretation of results, and publication methods may be arbitrarily distorted. Even if the research results are appropriate and genuine, evaluation may be unfair owing to doubts.
Conflicts of interest are inevitable in clinical research conducted through industry-academia collaboration. Therefore, in order to ensure the fairness and credibility of industry-academia collaborative clinical research, it is necessary to manage conflicts of interest appropriately.
The Declaration of Helsinki, the international ethical guidelines for medical research, added a section on conflict of interest disclosure in 2000. In addition, the Ministry of Education, Culture, Sports, Science, and Technology (MEXT) issued "Guidelines for the Formulation of Conflict of Interest Policies for Clinical Research" in 2006, and the Ministry of Health, Labor, and Welfare (MHLW) issued "Guidelines on Conflict of Interest in MHLW Scientific Research” in 2008. Furthermore, in December 2014, MEXT and MHLW issued "Guidelines for the Management of Conflicts of Interest in Clinical Research,” which clearly specify management of conflict of interest in ensuring the credibility of research.
It is important for academic societies to provide clear guidelines on conflicts of interest to their members and actively promote clinical research and academic society projects while ensuring fairness in important research and development through industry-academia collaboration.
As stated in the "Declaration of Helsinki" and the "Ethical Guidelines for Medical Research Involving Human Subjects" (MEXT and MHLW, enacted in 2015, partially revised in 2017), clinical research involving human subjects requires special consideration for the protection of the human rights, life, and safety of human subjects. In light of the social responsibility and high level of ethics required for such activities, the society has established the "Guidelines for Conflicts of Interest in Hematopoietic Cell Transplantation Clinical Research" (hereinafter referred to as the "Guidelines"). The purpose is to contribute to the advancement of hematopoietic cell transplantation for patients by ensuring that the society appropriately manages conflicts of interest among its members and promotes the publication of research results and their implementation in a neutral and transparent manner. Therefore, the Guidelines present the basic idea of conflict of interest (COI) to the members of the society, and require them to disclose their COI appropriately by self-reporting when presenting clinical research conducted by the society and research results at academic conferences, in journals, and at other such venues.
The Guidelines shall be applied to the following subjects who may have conflicts of interest (COI).
1) Members of the society (JSHCT)
2) Those making presentations at academic meetings of academic societies, etc.
3) Officers of the society (Chair of the Board, President of the society, vice-chairs of the board, directors, auditors, and chairs of academic meetings), councilors, chairpersons, members of various committees, and members of provisional task forces (task forces or working groups involved in formulating medical guidelines, etc.)
4) Authors of papers submitted to the official journal of the society
5) Spouses, first-degree relatives, or persons who share income or property with the subjects of 1) to 3)
The Guidelines shall apply to all activities conducted by the society, including the following:
1) Holding of academic meetings (including annual General Meeting), etc.
2) Publication of academic journals, academic books, etc.
3) Conducting research and surveys
4) Encouragement of research and awards for research achievements
5) Liaison and cooperation with related academic organizations
6) Promotion of international research cooperation
7) Accreditation of physicians and facilities
8) Promotion of lifelong learning activities
9) Activities necessary to achieve the other purposes
In addition, special compliance with the Guidelines is required for the following activities in particular:
1) Presentations at academic meetings, etc., sponsored by the society
(2) Publication in academic journals and other publications
(3) Establishment of medical guidelines, manuals, etc.
(4) Work in ad hoc study committees, advisory committees, etc.
(5) Presentations at lectures, luncheon seminars, evening seminars, etc., sponsored or co-sponsored by corporations, organizations, or for-profit entities
The subjects indicated in Section II, Items 1) to 4) shall report the following Items 1) to 11) regarding themselves and Items 1) to 4) regarding the subjects indicated in Section II, Item 5) to the Chair of the Board of the society in the prescribed form. In addition, the subjects indicated in Section II, Item 2) shall report the following Item 12) matters concerning themselves to the Chair of the Board of the society in the prescribed form at the time of academic meeting presentations, etc. The definition of "corporations, organizations, and for-profit entities" subject to reporting, criteria such as the amount of money required to be reported, reporting methods, and handling of the report, shall be specified elsewhere in the detailed regulations.
1) The fact that you are a director or advisor of a corporation, organization, or for-profit group and the amount of your compensation
2) Ownership of shares in a corporation and the profits derived from those shares
3) Investments in corporations or stock options (stock acquisition rights)
4) Royalties paid by corporations, organizations, or for-profit entities for patent rights, etc.
5) Per diem, lecture fees, instructional fees, or other remuneration paid by a corporation, organization, or for-profit entity for attendance at a conference (presentation, advice, etc.)
6) Manuscript fees paid to corporations, organizations, or for-profit entities for writing brochures and other materials
7) Research funds provided by corporations, organizations, or for-profit entities under contract (industry-academia joint research, contract research, clinical trials, etc.)
8) Scholarship (incentive) donations provided by corporations, organizations, or for-profit entities
9) Endowed courses offered by corporations, organizations, and for-profit entities
10) Travel, gifts, or other compensation not directly related to the research provided by a corporation, organization, or for-profit entity
11) History of affiliation with a corporation, organization, or for-profit entity
12) Provision of samples, drugs, equipment, etc., from corporations, organizations, or commercial entities
1. Situations to be avoided by all those subject to the Guidelines
Publication of the results of clinical research and establishment of medical practice guidelines should be based purely on scientific evidence and judgment or public interest. Members of the society shall not be influenced by the arbitrary intentions of the sponsors of clinical research or companies in their decisions to present or not present the results of clinical research at conferences or in papers, or in the content of essential presentations, such as the results of clinical research and their interpretation, or in the development of guidelines and manuals based on the scientific basis of clinical research (diagnosis and treatment). Contracts must not be influenced by the arbitrary intentions of the sponsor of the clinical research or the corporation, nor must contracts be concluded in such a way that such influence cannot be avoided.
In addition, when trainees conduct their own intervention research on human subjects in industry-academia collaborations, all researchers should avoid the following:
1) Obtaining non-contractual incentive payments for brokering or referring research subjects to participate in clinical research
2) Obtaining non-contractual incentive payments for the accumulation of cases within a certain specified period of time
3) Receipt of travel and lodging expenses from funders and companies for participation in academic conferences unrelated to the relevant research
4) Obtaining extra-contractual performance fees for specific research results
2. Situations to be avoided by investigators of hematopoietic cell transplant clinical studies
Principal investigators with decision-making authority over the planning and conducting of clinical research (including clinical trials and studies) who do not have any of the following conflicts of interest should be selected, and they should avoid these conflicts of interest after selection. However, this does not apply to the investigator at each site in a multicenter clinical research project.
1) Shareholding in or appointment as an officer, etc., of the funders or corporations providing funding for the relevant research
2) Obtaining patents and patent fees for pharmaceuticals, treatments, testing methods, etc., for research projects
3) Receipt of money or gifts other than just compensation for the time and effort involved in such research
4) Inappropriate behavior by dispatched researchers, part-time lecturers, and working graduate students affiliated with a corporation dispatched to a research institution to participate in the research, such as redacting the name of corporations in implementation plans or presentations of results
5) Situations that enable funders or corporations to exercise influence over the compilation, storage, statistical analysis, interpretation, and conclusions of research data
6) Entering into agreements that allow funders and interested corporations to exercise influence over decisions to present research results at conferences and publish papers
However, this does not apply to researchers who fall under Item 1) or 2), if they are indispensable personnel in planning and executing clinical research, the clinical research has extremely important social significance, and they ensure fairness, impartiality, and transparency of judgment and hold themselves accountable to society through means such as third-party auditing of the results, interpretation, and publication of research. In addition, when accepting a contract that falls under Item 5) or 6), the details of the funders' roles and involvement must be disclosed at the end of the paper at the time of publication of the results.
The larger the number of patients involved in an invasive, interventional, investigator-initiated, independent clinical study, the greater the research funding required, and private funding (endowments, grants, clinical research support funds, etc.) is often sought. In such cases, from the perspective of conflict of interest (COI) management, the researcher must appropriately disclose funding sources and their role in research through self-reports to the Ethical Review Board, applications for ethical review, and publications. The appropriateness of whether expenses are sufficient to ensure that intervention-type studies are properly conducted must also be considered. In addition, intervention studies should be conducted with the following caveats in mind (see note below).
1. On one hand, results of investigator-initiated clinical studies using post-marketing drugs, especially phase III comparative studies, provide important information and rationale for the development of clinical practice guidelines. On the other hand, companies are highly interested in comparative clinical trials using their own drugs from the viewpoint of sales promotion, and often provide various forms of cooperation and support (funds, services, etc.) to researchers. However, if transparency between industry and academia is not ensured, it is easy to invite suspicion from society. In order to ensure the quality and credibility of research, it is necessary to take exceptional care to disclose the interests of both parties as well as contracts, in principle.
2. It is in the public interest that the results of clinical research be made widely available to health care professionals, patients, and others. Therefore, all clinical trials involving human subjects should be registered through public databases and, in principle, the results should be made publicly available. Both the principal investigator and supporting corporations are responsible for disclosing all relevant interests in the submission or publication of published papers.
3. In preparing articles for publication, authorship should be clearly stated, and if medical writers, statisticians, or others assisting with interpretation or discussion do not meet the criteria for authorship, appropriate acknowledgement should be given for their involvement, and their names, affiliations, sources of funding, and other interests should be listed and disclosed.
4. In addition to investigator-initiated clinical research that is planned and funded by researchers themselves, there are other forms of clinical research, such as clinical research commissioned by companies (contracted or funded research and joint research), investigator-initiated clinical trials funded by donations, and investigator-initiated clinical research conducted under contract after review by companies. The head of the research institution and the researcher must be accountable from the perspective of compliance with research ethics.
Note: If the research falls under specified clinical research, it should be conducted in accordance with the provisions of the Clinical Research Act.
1. Responsibilities of members
When presenting the results of clinical research at academic meetings, in journals, etc., members shall be obliged to appropriately disclose their conflict of interest (COI) related to the implementation of the relevant research through self-reporting. Disclosure shall be made in the prescribed form in accordance with the detailed regulations. If the conflict of interest (COI) is deemed serious, the Board of Directors shall consult the Ethical Review Board and take appropriate measures based on the report by the Ethical Review Board.
2. Responsibilities of officers, etc.
The officers of the society (Chair of the Board, President of the society, vice-chairs of the board, directors, auditors, and chairs of academic meetings), councilors, chairs, members of various committees, and members of provisional task forces (task forces or working groups involved in formulating medical guidelines, etc.) (hereinafter, officers, etc.) have important roles and responsibilities in all activities related to the society, and therefore, shall self-report any conflicts of interest related to such activities in accordance with the prescribed forms specified in the bylaws upon assuming office. In addition, in accordance with the provisions of the bylaws, officers, etc., shall self-report their conflict of interest (COI) annually after assuming office, and shall also self-report any new COI that arises during their term of office.
3. Role of the Board of Directors
The Board of Directors may consult with the Ethical Review Board and instruct remedial measures, etc., based on its report, in the event that officers, etc., have a serious conflict of interest (COI) in the conducting of the activities of the society, or in the event that the self-report of COI is deemed inappropriate. In addition, in the event that any public doubt or allegations of COI arise against any affiliated officers or members, the society will respond appropriately and promptly, and if investigative results show that the allegations or accusations are without merit, the society will fulfill its own responsibility and social accountability as an academic society, and may issue its own opinion and statement regarding the unwarranted accusations.
The Board of Directors shall avoid any contract, agreement, or arrangement with a corporation, organization, or other entity that would constrain or restrict the fairness, neutrality, or appropriateness of research activities or presentations in the course of its activities.
The Board of Directors shall provide educational and training opportunities on research ethics (bioethics, publication ethics, COI management, etc.) and educate members.
4. Role of the Ethical Review Board
The Ethical Review Board shall manage members' conflicts of interest (COI) to prevent them from developing into serious situations. If a member has a serious COI in any activities conducted by the society, or if a self-report of COI by a member is found to be inappropriate and questionable, the society shall conduct a hearing or other investigation to manage the COI of the member and report the results of the investigation to the Board of Directors. In addition, the Board of Directors or the relevant committee will consult with the violator of the Guidelines and, taking into consideration the nature of the violation and the degree of its impact on the society, decide on specific measures to be taken, and then report to the violator.
5. Roles of the chairs of academic meetings, Program Committee members, and Program Review Committee members
When clinical research results are presented at academic meetings, the chairs of academic meetings, Program Committee members, and Program Review Committee members shall verify that the results are in accordance with the Guidelines, and may take measures such as suspending the presentation of abstracts that are in violation of the Guidelines. In such a case, the prospective presenter will be promptly notified with the reason for the decision. These actions will be discussed with the Ethical Review Board and approved by the Board of Directors based on the report before implementation.
6. Role of the Editorial Board
When an original article, review article, editorial postscript, or opinion on the results of clinical research is published in an academic society publication, the Editorial Board may verify that the conducting of the research is in accordance with the Guidelines, and may take measures such as withholding publication if it is contrary to them. In such a case, the contributor of the paper will be promptly notified with the reason for the decision. If, after publication of the article, it becomes clear that the Guidelines have been violated, public notice of the violation may be given in the name of the Editor-in-Chief in the relevant publication or other media. These actions will be taken after consulting the Ethical Review Board and obtaining the approval of the Board of Directors based on the report of the Ethical Review Board.
7. Roles of other committees
Other chairs and committee members shall verify that the implementation of the activities of the society in which they are involved is in accordance with the Guidelines, and if a situation arises that violates the Guidelines, they shall promptly consider measures to remedy the situation. These actions will be discussed with the Ethical Review Board, and based on the report, will be implemented with the approval of the Board of Directors.
8. Conflict of interest (COI) management for the development of medical practice guidelines
When developing guidelines, the Guideline Committee decides to develop new or revised specific guidelines for diagnosis, treatment, and prevention, and establishes task forces for the practical work of developing or revising the guidelines. Treatment guidelines developed by the taskforce will be finalized after public comment by the members and review by the Board of Directors. In order to ensure transparency in the formulation, these tasks will, in principle, be carried out independently of each other.
In addition, to ensure thorough COI management to avoid the risk of bias, the eligibility criteria for participants involved in the development of medical practice guidelines shall be clarified, and the self-reported COI of potential participants shall be screened using the prescribed form. The eligibility criteria for the above participants and the procedures for reviewing the COI of potential participants shall be specified elsewhere in the bylaws.
If an external party (e.g., the mass media, a civic organization, etc.) makes a request for disclosure of the COI of an officer or member of the society, the Board of Directors will consult the Ethical Review Board if the reason for the request seems reasonable. The Ethical Review Board shall investigate the facts and make a report in the shortest possible time with the protection of personal information, and the Board of Directors shall respond to the disclosure requester promptly after receiving the report.
After the publication of a paper on medical research results, if a question concerning industry-academia collaboration is raised concerning the paper, the editorial board and the Ethical Review Board will work together to clarify the question and the Chair of the Board will be held accountable. However, if it is determined that the respective committees are unable to take action, a Conflict of Interest (COI) Investigation Committee will be established as specified in the bylaws. It will also seek the cooperation of the heads of the research institutions involved, investigate the facts and gather information, and take prompt and appropriate action to uncover the truth behind the allegations. The Chair of the Board shall be accountable for responding to the disclosure requester as soon as possible after receiving the report of the committee.
1.Actions to be taken against persons violating the Guidelines
In the event of a violation of the Guidelines, the society’s Board of Directors shall consult with the Ethical Review Board and, upon receiving a report, deliberate the matter. If is determined that there has been a violation of the Guidelines, depending on the severity of the violation, the Board of Directors may take all or some of the following measures for a certain period of time.
1) Suspension of presentations at all academic meetings held by the society
2) Suspension of publication of articles in publications of the society
3) Suspension from office as chair of academic meetings of the society
4) Suspension of participation in the Board of Directors, committees, task forces, etc., of the society
5) Suspension of trusteeship in the society or withholding approval of trusteeship
6) Suspension or withholding of membership in the society
In the event that measures 1 to 6 against a violator of the Guidelines are finalized, the information shall be provided to the heads of other relevant societies.
2. Appeals and reconsideration
Any person who has been subjected to measures 1 to 6, mentioned above, may file an appeal to the society. Upon receipt, the Chair of the Board of the society shall promptly establish an Appeal Review Committee, which shall review the appeal and, after consultation with the Board of Directors, notify the appellant of the results of the review.
3. Publicity and accountability
If the need arises to fulfill social and moral accountability because of the conflict of interest (COI) of a member, the society may disclose or publicize it within and outside the society to the extent necessary through a resolution of the Board of Directors. In such cases, the party whose COI information is to be disclosed or made public shall be provided the opportunity to comment to the Board, unless the urgency of disclosure or publication precludes such comment.
The society will strive to provide opportunities for research ethics education to further deepen understanding of bioethics, publication ethics, and conflict of interest (COI) management, and to incorporate such education into the programs of academic meetings (e.g., educational lectures, symposia, etc.) and into the educational seminars and renewal seminars required for certification and renewal of board certification.
The Ethical Review Board may propose the establishment or revision of bylaws necessary for the practical application of the Guidelines, and may implement such bylaws with the approval of the Board of Directors.
The Guidelines may be periodically reviewed and revised to conform to social factors, changes and developments in laws and regulations concerning industry-academia collaboration, and other conditions surrounding medicine and research. Such amendments shall take effect upon resolution of the Board of Directors and approval of the Board of Trustees.
1. The Guidelines went into effect as of February 26, 2012.
2. The Guidelines were revised and went into effect as of March 9, 2019.
3. The Guidelines were revised and went into effect as of April 13, 2020.
