Foreword

The purpose of the Japan Society of Clinical Oncology (JSCO) and the Japanese Society of Medical Oncology (JSMO) is to contribute to the advancement of the prevention, diagnosis and treatment of cancer, and public well-being through member education activities, the provision of venues for the presentation of research findings, and public awareness activities.

Much of the research presented via JSCO/JSMO academic conferences and publications is clinical research aimed at either the standardization of treatment methods for cancer patients or the use of new pharmaceuticals, medical devices, and techniques; basic medical research, including translational research and industry-academic collaborative research and development, is also conducted. As the results of such research provide benefits on the front lines of clinical medicine, the importance of oncology research involving industry-academic collaboration is increasing every day.

In some cases, industry-academic collaborative oncology research entails benefits to society (public interest) from the fruits of discharging academic and ethical responsibility, as well as money, status, rights, and other benefits (private interest) acquired attendant on industry-academic collaboration. When these two types of benefit are in conflict within an individual researcher, it is called a "conflict of interest." The occurrence of conflict of interest is unavoidable in today’s complex social activities, and legal restrictions apply to certain activities.

Nevertheless, conflicts of interest may occur in activities outside the framework of legal regulation. In cases of serious conflicts of interest, the risk of distortion of research methods, data analysis or results interpretation arises. A situation may also occur whereby fair assessment is not made, even though research findings are appropriate. Many academic societies in Europe and North America have established conflict of interest guidelines covering research in order to ensure the appropriate conduct of industry-academic collaborative research and impartiality in academic presentations. In recent years, against a backdrop of increasingly globalized research and development activities concerning the prevention, diagnosis, and treatment of cancer on the basis of Japanese, North American, and European joint research have been actively pursued, and the establishment of conflict of interest policy in Japan has become an indispensable task. In the undertakings of JSCO/JSMO as well, it is important to actively conduct research after having clearly indicated conflict of interest policy to members and ensured fairness in important industry-academic collaborative research and development projects.

I. Purpose of Guideline Establishment

As has been mentioned in the Helsinki Declaration, the Ethical Guidelines for Clinical Studies, and the Ethical Guidelines for Epidemiological Research, clinical research differs greatly from research in other academic fields in that, as the research subjects are human beings, special consideration to protect the rights and lives of subjects and safely conduct research is required.

Pharmaceutical agents and medical instruments shall be developed through basic medical research. Data from basic medical research are critical both for decisions on whether to carry out subsequent clinical research and for judgments of the subject matter under consideration based on the Pharmaceutical Affairs Law. Therefore, confidence in basic medical research represents a serious matter affecting human life.

JSCO/JSMO, in view of the fact that social responsibility and high ethics are required in their activities, hereby establish the Oncology Research Conflict of Interest Policy (hereinafter abbreviated as the “Policy"). The purpose for establishment of these Policy is for JSCO/JSMO to ensure that the presentation and dissemination of research findings, and public awareness activities are appropriately conducted in circumstances where neutrality and impartiality are maintained by means of appropriate management of member conflicts of interest, as well as to discharge social responsibility by contributing to the advancement of the prevention, diagnosis, and treatment of cancer.

The crux of the Policy is to indicate the basic concepts of conflict of interest to JSCO/JSMO members and to ensure that conflicts of interest are appropriately disclosed by self-declaration in cases where members participate and make presentations at JSCO/JSMO undertakings. JSCO/JSMO will require members to observe the Policy set forth below.

II. Covered Individuals

The Policy applies to all of the following covered individuals for whom a conflict of interest may arise.

• (1) JSCO/JSMO members
• (2) JSCO/JSMO employees
• (3) Persons who make presentations at JSCO/JSMO meetings
• (4) Persons who attend JSCO/JSMO Board of Directors meetings, committee meetings, or working group meetings

III. Covered Activities

The Policy applies to activities in all undertakings concerned with JSCO/JSMO. In particular, observance of the Policy for all research concerning the prevention, diagnosis, and treatment of cancer is required of researchers who make presentations at any JSCO/JSMO academic conference, symposium, or lecture meeting, or who publish presentations in any JSCO/JSMO bulletin, article, or book. Especially rigorous observance of the Policy is required of lecturers who conduct educational lectures for JSCO/JSMO members or who conduct open lectures for the general public, in view of the powerful social influence of these undertakings.

IV. Matters Requiring Disclosure

If any of items (1) to (7) below exceeds separately stipulated criteria with respect to a covered individual, the individual shall have the obligation to accurately disclose by self-declaration the circumstances of the conflict of interest in accordance with the prescribed form. In addition, if any of items (1) to (3) below exceeds separately stipulated criteria with respect to a covered individual’s spouse, a relative in the first degree, or any other person who shares income or assets, the individual shall have the obligation to report the exact circumstances to JSCO/JSMO. The declarer himself shall bear responsibility for the self-declaration and the declared content. Specific methods of disclosure and publication are separately stipulated in the bylaws according to the covered activity.

• (1) Position as an officer or advisor of a company or for-profit organization
• (2) Ownership of stock
• (3) Patent royalties or licensing fees from a company or for-profit organization
• (4) Honoraria (such as lecture fees) from a company or for-profit organization paid as compensation for the time or labor of a researcher engaged for conference attendance (presentation)
• (5) Manuscript fees paid by a company or for-profit organization as compensation for writing for a pamphlet or other publication
• (6) Research funding provided by a company or for-profit organization
• (7) Advisory fees or remuneration paid by either a company or a for-profit organization in exchange for testimony in a lawsuit
• (8) Acceptance of researchers from a company or for-profit organization
• (9) Endowed chairs offered by a company or for-profit organization
• (10) Other remuneration (travel, gifts, or other in-kind payments not directly related to research)

V. Avoidance of Conflict of Interest

1) Matters to Be Avoided by All Covered Individuals
Publication of research findings should be on the basis of purely scientific judgment or the public interest. A JSCO/JSMO member must not be influenced by the arbitrary intentions of a company or entity providing funding for research in decisions whether to present research findings at conferences or in research papers or the essential presentation content, namely the research findings or their interpretation, and must not enter into any contracts under which such influence cannot be avoided.

2) Matters to Be Avoided by Clinical Oncology Research Principal Investigators
Persons who have none of the following conflicts of interest should be selected as principal investigators who have the right of decision over the planning and conduct of clinical research (including clinical trials and treatment). This does not apply to principal investigators of institutions for clinical research conducted at multiple institutions. These conflicts of interest should also be avoided after selection.

• (1) Ownership of stock in a company sponsoring the clinical research
• (2) Acquisition of intellectual property rights for pharmaceutical agents or medical instruments obtained from clinical research findings
• (3) Position as an officer, board member, or advisor of a company or for-profit organization sponsoring the clinical research (except as an unremunerated scientific advisor)

It is provided, however, that it in the case where an individual is essential to the planning and conduct of the clinical research concerned, and the clinical research is extremely significant, even from a global perspective, it is possible for even a person to whom items (1) to (3) above apply to serve as a principal investigator for the clinical research concerned.

VI. Method of Enforcement

1) The Role of Members
Members shall have the obligation to appropriately disclose any conflict of interest in connection with the conduct of the research in question when presenting research findings at academic conferences or other venues. Members shall disclose conflicts of interest using the form prescribed in the bylaws. Violations of the Policy shall be discussed at the JSCO/JSMO committees with jurisdiction over conflicts of interest (hereinafter the "committees with jurisdiction") and reports submitted to the Boards of Directors.

2) The Role of Officers
The chairmen of the boards of directors, directors, presidents, vice-presidents, auditors, and committee chairmen of JSCO/JSMO have important roles and responsibilities for all undertakings and activities in connection with their respective societies, and have the obligation to make self-declarations concerning conflicts of interest in connection with said undertakings by means of the prescribed form at the time they assume office.

If a serious conflict of interest has occurred in an officer (chairman of the board of directors, president, vice-president, and auditors) in the execution of any JSCO/JSMO business or an officer’s conflict of interest self-declaration has been judged inappropriate, the Board of Directors of the society in question may refer the matter to the committee with jurisdiction and prescribe remedial measures on the basis of the findings.

When clinical research findings are presented at JSCO/JSMO venues, program committee chairmen, committee members and program referees verify that the conduct of the presentation is in accordance with the Policy, and may prohibit presentations about subjects that violate the Policy. In such cases, the program committee chairman, committee members, and program referees of the society in question promptly notify the individuals planning the presentations to that effect and provide reasons. These measures are discussed by the committee with jurisdiction and implemented following approval of the Board of Directors on the basis of the findings.

When clinical research findings are presented in JSCO/JSMO publications, the Editing Committee of the society in question verifies that the conduct of the presentation is in accordance with the Policy and may prohibit presentations about subjects that violate the Policy. In such cases, the Editing Committee promptly notifies the individuals planning the presentations to that effect and provides reasons. These measures are discussed by the committee with jurisdiction and implemented following approval of the Board of Directors on the basis of the findings.

Other committees and their members verify that the conduct of academic undertakings with which they are involved is in accordance with the Policy and promptly consider remedial measures in cases of activities that violate the Policy. These measures are discussed by the committee with jurisdiction of the society in question and implemented following approval of the Board of Directors on the basis of the findings.

3) Filing of Objections
A person who has been subject to remediation instructions or prohibition in accordance with 1) or 2) above may file an objection with the society in question. When a society has received an objection, the committee with jurisdiction promptly discusses the matter and notifies the objecting individual of its findings following consultation with the Board of Directors.

VII. Measures Against Guideline Violators and Accountability

1) Measures Against Guideline Violators
The respective Boards of Directors of JSCO/JSMO have the authority to deliberate actions that violate the Policy as per regulations that each society separately sets down and, when as the result of deliberation the Board of Directors of the society in question has judged that an action falls under the category of a serious breach of the Policy, the Board may take one or more of the following measures for a fixed period of time in accordance with the seriousness of the breach.

• (1) Prohibition from presenting at all conferences held by JSCO/JSMO
• (2) Prohibition from publication of papers in JSCO/JSMO publications
• (3) Prohibition from serving as chairman of JSCO/JSMO academic conferences
• (4) Prohibition from participation in JSCO/JSMO boards of directors, committees, or working groups
• (5) Expulsion from the JSCO/JSMO Council or prohibition from becoming a councilor
• (6) Expulsion from JSCO/JSMO or prohibition from becoming a member

2) Filing of Objections
When a society has received an objection, the committee with jurisdiction conscientiously reexamines the matter and notifies the individual subject to measures of its findings following consultation with the Board of Directors.

3) Accountability
When a society has judged there has been a serious violation of compliance with the Policy in clinical research presented at a venue in which the society is involved, the society will discharge its accountability to society following discussion by the committee with jurisdiction and Board of Directors.

VIII. Establishment of Bylaws

JSCO/JSMO can establish necessary bylaws for the actual implementation of the Policy taking into consideration their independence and special characteristics.

IX. Date of Enforcement and Method of Amendment

The Policy come into effect in April 2008. The need to amend the Policy due to individual cases arising from social influences or laws concerning industry-academic collaboration is anticipated. The JSCO-JSMO Ethics Committees may jointly discuss and amend the Policy by means of resolutions of the respective Boards of Directors, Councils, and General Committees of the societies.