[About Us] Basic Guidelines on Reporting a COI in Medical Research through Industry-Academia Collaboration

Japan Neuroscience Society

(1) Objective

The objective of these Guidelines is to enable the Japan Neuroscience Society (hereinafter, the “Society”) to fulfill its obligations to the general public by contributing to progress in medical research by properly promoting the presentation of research results, as well as dissemination, awareness-raising and related activities, while maintaining neutrality and impartiality, through the Society’s appropriate management of conflict-of-interest situations involving its members and related persons. Toward that end, these Guidelines explain the basic concept of COI to the members, and require them to disclose their own COI through self-reporting in an appropriate manner and to comply with these Guidelines when making presentations or participating in various events.

(2) Definition of COI

COI is defined as a situation in which the responsibilities of academic institutions and societies, namely education and research, conflict with the interests of individuals associated with industry-academia collaboration in medical research.
Medical research means “research conducted through industry-academia collaboration with the aim of improving methods of disease prevention, diagnosis or treatment, increasing understanding of the causes or pathology of diseases and improving patients’ quality of life, and includes life science research and basic medical research as well as clinical medical research on humans (including research on specimens from humans or data that enable individuals to be identified) and clinical trials” (Guidelines concerning Management of Conflict of Interest, 2013, The Japanese Association of Medical Sciences).

(3) Persons subject to the Guidelines

  1. Officers (President, Vice President and Directors), Annual Meeting Chairperson, Annual Meeting Executive Committee Chairperson, Annual Meeting Program Committee Chairperson, Next Annual Meeting Chairperson and chairpersons of various committees, Neuroscience Research Editorial Committee Chairperson and members of the Ethics and COI Committee of the Society;
  2. Spouses and first-degree family members of the persons listed in 1, as well as persons who share their income and/or assets with the persons listed in 1;
  3. Persons who make presentations at the Annual Meeting of the Society (including non-members); and
  4. Persons who publish articles in the academic journal published by the Society (including non-members).
Activities subject to the Guidelines
  1. The holding of the Annual Meeting and other conferences;
  2. The issuance of academic journals, academic books and similar publications;
  3. The operation of the Society’s home page; and
  4. Other affairs necessary for the achievement of the objectives of the Society.
In particular, in carrying out the following activities, particularly careful adherence to the Guidelines is required:
Presentation at the Annual Meeting or other conferences hosted by the Society (including the luncheon seminar); and
Presentation through Neuroscience Research and other publications.

(4) Matters to be declared

When the value exceeds the criteria provided in the detailed regulations (Operational Guidelines) for any of the following items 1 through 9 in connection with an individual, the individual subject to these Guidelines shall declare the precise circumstance to the President of the Society. Note that the specifics on how the declared contents should be disclosed and announced are provided separately by the detailed regulations.
  1. Assuming the position of officer, advisor or employee of a business enterprise, corporate organization or for-profit group;
  2. Holding shares of a business enterprise;
  3. Receiving royalties for patent rights or other similar fees from a business enterprise, corporate organization or for-profit group;
  4. Receiving per-diem compensation (such as lecture fees) from a business enterprise, corporate organization or for-profit group for the researcher’s time and labor associated with attending a meeting (presentation);
  5. Receiving manuscript fees paid by a business enterprise, corporate organization or for-profit group for the authoring of pamphlets, etc.;
  6. Receiving research fees (such as those for clinical trials and clinical studies) provided by a business enterprise, corporate organization or for-profit group;
  7. Receiving research fees (such as those for funded research, joint research, and donations) provided by a business enterprise, corporate organization or for-profit group;
  8. Accepting endowed lectures sponsored by a business enterprise, corporate organization or for-profit group; and
  9. Receiving travel expenses (for participating in a conference, etc.) and gifts other than the above.

(5) Matters to be avoided in relation to COI situations

Matters to be avoided by all persons subject to these Guidelines
Members of the Society shall not be influenced, in relation to the contents of announcements of the results of medical research through industry-academia collaboration and interpretations thereof, by the arbitrary intentions of the individuals or businesses that fund such medical research through industry-academia collaboration, and shall not enter into contracts with funding providers that make such influence unavoidable.
Matters to be avoided by persons responsible for medical research through industry-academia collaboration
Persons with the general responsibility for, and the decision-making power in, planning and implementing medical research through industry-academia collaboration shall be selected from among researchers who are publicly assessed as not having any major COI in relation to the following items, and such persons shall maintain such status after their selection:
1) Holding shares in the business enterprise commissioning the medical research through industry-academia collaboration;
2) Acquiring patent royalties, patent rights, etc. for products or technologies derivable from the results of medical research through industry-academia collaboration; and
3) Assuming the position of officer, director, advisor, etc. of a business enterprise or other for-profit group commissioning the medical research through industry-academia collaboration (excluding scientific consulting without compensation).
Exclusions
However, even researchers to whom 1) through 3) apply may assume the position of the person responsible for the relevant research, if such researchers are indispensible to the planning and execution of the relevant research and if the research has extreme medical significance, on the condition that the fairness, impartiality and transparency of their judgments and measures taken are clearly secured.

(6) Method of implementation

Responsibilities of members
When presenting medical research results through industry-academia collaboration that involves a COI situation at the Annual Meeting or through academic journals, members of the Society shall properly disclose in a specified form the fact that the execution of such research involves a COI situation in accordance with the COI Operational Guidelines of the Society. If there is any indication that these Guidelines have been violated in connection with presentation of research, etc., the Chairperson of the Board of Directors shall request a review to a committee that is authorized to handle COI-related matters (hereinafter simply referred to as the “Ethics and COI Committee”), and shall take appropriate measures based on the Committee’s findings.

Responsibilities of officers, etc.
Officers (President, Vice President and Directors), Annual Meeting Chairperson, chairpersons of various committees and members of the COI Committee and Neuroscience Research Editorial Committee of the Society have important roles and obligations in relation to the activities of the Society, and therefore such persons shall declare any COI situations related to such activities at the time they assume their office in accordance with the specified form of the Society. Furthermore, if new COI situations arise after assuming their office, an amended declaration shall be submitted in accordance with the relevant provisions.

Role of Ethics and COI Committee
If, in carrying out any project of the Society, any serious COI situation arises involving a member, or a question of the inappropriateness of a COI declaration is raised, the Ethics and COI Committee shall conduct an investigation via hearing or other means in order to manage the COI situation of the relevant member and report the results of the investigation to the President of the Society.

Role of the President of the Society
If a serious COI situation arises involving an officer, etc., in carrying out a project of the Society, or if it is deemed that a COI self-declaration is inappropriately made, the President of the Society may consult with the Ethics and COI Committee and direct improvement measures, etc., may be taken based on the Committee’s findings.

Role of the person responsible for the Annual Meeting
When results of research through industry-academia collaboration are presented at an academic conference, the person responsible for the Annual Meeting shall verify that such presentations are in accordance with these Guidelines, and he/she may take appropriate actions if they are found to be noncompliant, including cancellation of the presentation. In such cases, the person responsible for the Annual Meeting shall promptly inform the scheduled presenter of such fact along with the reasons therefor. Note that in taking these measures, the above person responsible may consult with the Ethics and COI Committee and direct improvement measures, etc., to be taken based on the Committee’s findings.

Role of Neuroscience Research Editorial Committee
When original research papers on research results, review papers, editorials, opinion pieces or other articles are to be published in academic journals or other printed publications, the Neuroscience Research Editorial Committee shall verify that such publication is in accordance with these Guidelines, and if found to be noncompliant, he/she may take appropriate actions, including cancellation of publication of any article that violates these Guidelines. In such cases, the Committee shall promptly inform the relevant submitter of the research paper of such fact along with the reasons therefor. If it is discovered that a research paper has violated these Guidelines after its publication, such fact may be announced publicly under the Editorial Committee’s chairperson’s name in the relevant printed publication. Note that in taking these measures, the Editorial Committee’s chairperson may consult with the Ethics and COI Committee and direct improvement measures, etc., to be taken based on the Committee’s findings.

Miscellaneous
Other chairpersons and members of committees shall verify that the execution of activities of the Societies in which they are involved is in accordance with these Guidelines, and if found to be noncompliant, promptly consider taking appropriate actions to improve the situation. Note that such persons may consult with the Ethics and CIO Committee concerning these actions, and that the President of the Society may direct improvement measures, etc., based on the Committee’s findings.

(7) Measures against Violators of the Guidelines and Accountability

Measures against Violators of the Guidelines
The President of the Society is authorized to review any act that may violate these Guidelines, and if he/she considers, upon referring the matter to the Ethics and COI Committee and obtaining its findings and further having the matter reviewed by the Board of Directors, that there is a serious violation of these Guidelines, then he/she may take the following actions against the violator, in whole or in part, for a certain period, depending on the degree of the violation:
  1. Prohibit from making presentations at any conferences hosted by the Society;
  2. Prohibit from publishing articles in publications issued by the Society;
  3. Prohibit from assuming the position of the Chairperson of the Annual Meeting of the Society;
  4. Prohibit from participating in the Standing Committee and other committees of the Society;
  5. Dismiss from the office of director of the Society or prohibit from assuming the office of director; and/or
  6. Suspend membership, remove from the Society roster or reject membership application.

Appeal
Persons against whom measures are taken may appeal the decision to the Society. The President of the Society shall, upon receipt of the same, promptly form the Appeal Review Committee (a provisional advisory committee), delegate a review to the Committee, confer on the findings within the Board of Directors, and inform the person who filed the appeal of the result.
Accountability
If there is deemed to be a serious violation of these Guidelines in connection with the results of medical research through industry-academia collaboration announced at a venue the Society is involved with, the Society shall immediately fulfill its accountability to the general public through discussions of the Board of Directors.

(8) Establishment of detailed regulations

The Society may establish detailed regulations (Operational Guidelines) necessary to operate these Guidelines.

(9) Revision of the Guidelines

These Guidelines shall be reviewed and revised on a periodical basis to adapt to social conditions, amendment and establishment of laws and regulations related to industry-academia collaboration, and conditions associated with research.

(10) Effective date

These Guidelines shall come into effect as of October 1, 2014.

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