With permission from the Japan Society of Clinical Oncology (JSCO) and Japanese Society of Medical Oncology (JSMO), the common policy (effective April 2008) used jointly by both societies (JSCO/JSMO) has been used in the initial version of this policy. This vouches that this policy is based upon the JSCO/JSMO policy, with the acronyms JSCO/JSMO in the body of the text having been changed to JSCC (Japanese Society of Clinical Cytology). Both JSCO and JSMO have granted permission to JSCC to use this policy. Moreover, this “Cytopathological Medical Research Conflict of Interest Policy” defines medical research in keeping with “The Guidelines Concerning Conflict of Interest of the Japanese Association of Medical Sciences,” established in February 2011, as all activities up to and including clinical research “wishing to improve approaches to prevention and methods for diagnosis and treatment [and] seeking to gain better understanding of the causes and morphology of diseases and promote industry-academic collaborative research to improve the quality of life of patients, [including] biochemical research and preclinical basic research both [of which] extend to human beings, and associated clinical research (including the use of specimens which can identify the individual from which they originated or data which can be used to identify the individuals from which they were generated).”
Much of the research presented via Japan Society of Clinical Oncology (JSCC) academic conferences and publications is medical research on cytomorphological diagnosis, molecular cytological research on genetic mutation during cancer or atypical expression of cancer genes, and medical research conducted using new medical devices and techniques, and there are cases when industry-academic collaborative research and development is conducted.
In some cases, industry-academic collaborative medical 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’ 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 medical research in order to ensure the appropriate conduct of industry-academic collaborative medical research and impartiality in academic presentations. In recent years, against a backdrop of increasing globalization, 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 a conflict of interest policy in Japan has become an urgent task. Given these circumstances, the Japan Society of Clinical Oncology (JSCO) and Japanese Society of Medical Oncology (JSMO) released an “Oncology Research Conflict of Interest Policy” in April 2008 that was the joint product of their Oncology Research Conflict of Interest Policy Joint Formulation Committee. Because JSCC, like JSCO/JSMO, needs to provide its members with a clear conflict of interest policy for JSCC activities and because medical research should be actively promoted with the assurance that important industry-academic collaborative research and development is undertaken with integrity, JSCC has released this policy, with some modification, based on the existing policy produced by the JSCO/JSMO Conflict of Interest Policy Joint Formulation Committee.
As has been mentioned in the Declaration of Helsinki and Ethical Guidelines for Clinical Studies (Public Notice of the Ministry of Health, Labour and Welfare No. 255, 2003), medical 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.
Like JSCO/JSMO, JSCC, in view of the fact that social responsibility and high ethics are required in their activities, hereby establish the Cytopathological Medical Research Conflict of Interest Policy (hereinafter abbreviated as the “Policy”). The purpose for establishment of the Policy is for JSCC 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 JSCC members and to ensure that conflicts of interest are appropriately disclosed by self-declaration in cases where members participate and make presentations at JSCC undertakings. JSCC will require members to observe the Policy set forth below.
The Policy apply to all of the following covered individuals for whom a conflict of interest may arise.
The Policy apply to activities in all undertakings concerned with JSCC. In particular, observance of the Policy for all cytopathological medical research is required of researchers who make presentations at any JSCC academic conference, symposium, or lecture meeting or who publish presentations in any JSCC bulletin, article, or book. Especially rigorous observance of the Policy is required of lecturers who conduct educational lectures for JSCC members or who conduct open lectures for the general public in view of the powerful social influence of these undertakings.
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 JSCC. 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) Matters to Be Avoided by All Covered Individuals
Publication of clinical research findings should be on the basis of purely scientific judgment or the public interest. A JSCC member must not be influenced by the arbitrary intentions of a company or entity providing funding for medical research in decisions whether to present medical research findings at conferences or in research papers or the essential presentation content, namely the medical 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 Medical 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 medical research. 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.
(except as an unremunerated scientific advisor) It is provided, however, that 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 may sometimes be possible for even a person to whom items (1) to (3) above apply to serve as a principal investigator for the clinical research concerned. Such cases must be discussed in advance by the COI Committee and approved by the Board of Directors on the basis of the committee’s findings.
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 medical 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 JSCC COI Committee, which has jurisdiction over conflicts of interest, and reports submitted to the Board of Directors.
2) The Role of Officers
The JSCC president, vice-president, directors, auditors, congress presidents, and other committee chairs have important roles and responsibilities for all undertakings and activities in connection with the society, 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 (president, vice-president, directors, or auditors) in the execution of any JSCC business or an officer’s conflict of interest self-declaration has been judged inappropriate, the Board of Directors may consult with the COI Committee and prescribe remedial measures on the basis of its findings.
When medical research findings are presented at JSCC venues, the congress president 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 scheduled presenters will be promptly notified to that effect and given reasons for the decision. These measures are to be discussed in advance by the COI Committee and implemented following approval of the Board of Directors on the basis of the findings.
When medical research findings are presented in JSCC publications, the editorial committee 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 publication authors will be promptly notified to that effect and given reasons for the decision. If the work is discovered to be in violation of the Policy subsequent to its publication, the editorial committee chair may make a public announcement to that effect in the publication, etc. These measures are to be discussed in advance by the COI Committee 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 to be discussed in advance by the COI Committee 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 JSCC. When JSCC has received an objection, the president convenes an Objection Review Committee that promptly discusses the matter and notifies the objecting individual of its findings following consultation with the Board of Directors.
1) Measures Against Policy Violators
The JSCC Board of Directors has the authority to deliberate actions that violate the Policy in accordance with regulations established separately by the society and may, when an action is judged to be a serious breach of the Policy as a result of deliberations, take one or more of the following measures for a fixed period of time in proportion to the seriousness of the breach.
2) Filing of Objections
A person who is subject to such measures may file an objection with JSCC. When JSCC has received an objection, the COI Committee conscientiously reexamines the matter and notifies the individual subject to measures of its findings following consultation with the Board of Directors.
1) Accountability
When JSCC has determined that medical research presented at a JSCC-related event is in serious violation of compliance with the Policy, JSCC will discharge its accountability to society following discussion with the COI Committee and Board of Directors.
Taking into consideration its independence and special characteristics, JSCC can establish necessary bylaws for the actual implementation of the Policy.
The Policy is effective from May 29, 2010. The need to amend the Policy based on individual cases as a result of societal influences or revisions to laws concerning industry-academic collaboration is anticipated. The JSCC COI Committee may jointly deliberate and amend the Policy following a resolution by the Boards of Directors.
Supplementary Provision
The Policy was partly amended on June 1, 2012.
The Policy was partly amended on April 1, 2013 as a result of the restructuring of JSCC from a specified nonprofit corporation into a public interest corporation.