JGOG COI Policy - JGOG Japanese Gynecologic Oncology Group

Guidelines Regarding Conflict of Interest of Japanese Gynecologic Oncology Group (JGOG)

Introduction

The Japanese Gynecologic Oncology Group (JGOG), a specified non-profit-making organization, conducts clinical research and development through academic-industrial partnerships using new medical drugs, equipment, and technologies to establish standards for anti-cancer treatment. Since cancer research findings generated through academic-industrial cooperation have many applications in clinical settings, this relationship has become increasingly more important and significant.

Clinical research involving academic-industrial partnerships yields not only public profits (those made by fulfilling academic and ethical responsibilities and applied to society) but also personal profits, including money, status, and interests. Conflict of interest (COI) is a situation in which research is affected by these two incompatible interests. Today, COI is inevitable in our complex social activities, and some legal restrictions have been imposed on certain activities.

However, a COI situation may occur in activities not governed by such legal restrictions. A high level of COI could affect research methods and findings as well as data analysis, or even interfere with the appropriate evaluation of research results. Necessary management measures should be taken to prevent these COI situations. In this context, the JGOG has defined the guidelines on COI for its members to further promote research and development in academic-industrial cooperation and clinical studies while maintaining their validity.

1. Basic Policy

Management measures shall be taken to prevent COI from interfering with objectivity and reliability in JGOG research or minimize the fear of their potential compromise among the public.
In this document, “COI report” means the provision of COI-related information by JGOG researchers to the COI Committee. Publication of information on COI according to the guidelines within the JGOG is referred to as “disclosure”, and allowing those other than JGOG researchers to know such information is referred to as “publication”.
The JGOG has adopted the “Declaration of Helsinki”, “Ethical Guidelines on Clinical Research (Public Notice No. 255, 2003, and No. 415, 2008, issued by the Ministry of Health, Labour and Welfare), revised on July 31, 2008”, and “Guidelines on the Management of COI in Health and Labour Sciences Research (No. 0331001, science, issued on March 31, 2008, and approved by the Chief of the Health Sciences Division)” as normative standards. If a certain degree of COI occurs, relevant information shall be disclosed in accordance with these standards and the guidelines.
If interference with (or a possible compromise of) objectivity and reliability in research is recognized by the COI Committee, the committee shall suggest to the president of the JGOG Steering Committee that the relevant researchers and committee members should be relieved of their responsibilities or their roles should be limited.
The amount of money shall not be disclosed or published for viewing by any person or organization other than the COI Committee unless a legitimate request for its disclosure has been made.
The management of researchers from medical institutions shall be excluded from COI management by the JGOG; each medical institution shall have the right and responsibility for management. The COI Committee shall have the authority to manage researchers from health care facilities that have no management section.

2. Subjects

The guidelines shall be applied to the following groups or persons who might be affected by a COI situation:

1)	Research group: study chair, Co-study chair, Research Head Office
2)	President, vice president, executive board members, supervisors, and committee members
3)	Staff of data centers and JGOG Head Office
4)	Researchers from medical institutions in which COI management is not implemented

3. COI Report

I. Initial report: for all concerned

1)	“JGOG Format for an Initial COI Report” shall be submitted to report whether “you” or “your spouse or first-degree relative living in the same house (also see Appendix)” receives one or more of the following:
	(1)	A salary for an executive or adviser of a company or profit-making organization: The annual salary from one company or organization exceeds one million yen.
	(2)	Stocks and dividends: The annual profit of one company is more than one million yen / You hold more than 5% of the stocks issued by one company.
	(3)	Patent royalty paid by a company or profit-making organization: The annual patent royalties paid by one company or organization exceed one million yen.
	(4)	Lecture fees and other monetary rewards paid by a company or profit-making organization to a researcher for his/her time and effort: The annual lecture (or other) fees exceed 500,000 yen.
	(5)	Fees for writing brochures or other manuscripts: The annual fees paid by one company or organization exceed 500,000 yen.
	(6)	Research funds provided by a company or profit-making organization: The annual research funds provided by one company or organization exceed two million yen.
	(7)	Other rewards (including travel expenses and gifts not related to research activity): The annual rewards paid by one company or organization exceed 50,000 yen.
2)	The form shall be submitted in April of each year to report the total amount paid during the preceding year (between January and December).

II. Secondary report

If one or more of the above-mentioned seven items apply, a secondary report shall also be submitted to disclose the total amount and other detailed information.

III. Management

Information included in initial and secondary reports shall be stored and managed by the COI Committee. Information shall only be disclosed or publicized if such a request is considered to be appropriate by the COI Committee.

IV. Update

Information included in initial and secondary reports shall be updated in April of each year. Modifications shall be reported on a need-to-know basis.

4. COI Committee

1)	The COI Committee shall supervise and ensure the appropriate implementation of tasks, including initial and secondary COI reports and responding to requests for disclosure or publication, and provide suggestions, guidance, and advice to the steering committee, researchers, data centers, and the JGOG head office as needed.
2)	If COI is considered to have interfered with objectivity and reliability in research, the COI Committee shall advise the Board of Supervisors of the JGOG to restrict a researcher’s or committee member’s authority.
3)	The president of the JGOG Board of Supervisors shall appoint the president and vice president of the COI Committee. The president of the COI Committee shall appoint committee members.

5. COI Report Formats

1)	For an initial report on COI: JGOG Format for an Initial COI Report shall be used.
2)	For a secondary report on COI: JGOG Format for a Secondary COI Report shall be used.

JGOG-COI-Report-1st.pdf (PDF)
JGOG-COI-Report-2nd.pdf (PDF)

6. Methods for the Implementation of COI Management

1)	If a severe COI situation occurs in relation to a board member (president, vice president, executive board member, and director) in any of the JGOG projects, or a self-report on COI is considered to be inappropriate, the Board of Supervisors may consult the COI Committee and provide instructions on improvement measures based on the responses.
2)	Prior to a presentation of clinical research results by the JGOG, the president of the board may examine whether the presentation complies with the guidelines. If a scheduled presentation is not considered to be in line with the guidelines, the president may notify the presenter of the cancellation and reason by mail. The above-mentioned measures shall be implemented based on the results of a discussion by the COI Committee and the approval of the Board of Supervisors.
3)	Other executives of the committee shall examine whether the implementation of each project that they are in charge of complies with the guidelines, and develop and take necessary improvement measures if any project is considered not to be in line with the guidelines. The above-mentioned measures shall be implemented based on the results of a discussion by the COI Committee and the approval of the Board of Supervisors.
4)	Those who have been given instructions as mentioned in the preceding paragraphs shall be allowed to file a complaint with the JGOG. If the JGOG accepts a complaint, the COI Committee shall re-examine it in good faith, and the result will be sent to the person who has filed the complaint following the approval of the Board of Supervisors.

7. Penalties for the Offender and Accountability

1) Penalties for those who fail to comply with the guidelines

The Board of Supervisors of the JGOG shall have the right to discuss a violation of the guidelines in accordance with the rules defined elsewhere by the JGOG. If a serious violation is recognized by the Board of Supervisors following a discussion, the board may impose the following penalties for a certain period depending on the degree of violation:

I)	Banning of any presentation at conferences organized by the JGOG
II)	Banning of the publication of articles in journals issued by the JGOG
III)	Banning of participation in the Board of Supervisors, Committee, and Working Group of the JGOG
IV)	Removal of the status of a JGOG executive, or prevention of the person from being an executive
v)	Removal of JGOG membership, or prevention of the person from being a member

2) Filing a complaint

Those who have received a penalty shall be allowed to file a complaint with the JGOG. If the JGOG accepts a complaint, the COI Committee shall re-examine it in good faith, and the result will be sent to the person who has filed the complaint following the approval of the Board of Supervisors.

3) Accountability

If the JGOG identifies and recognizes a serious violation of the guidelines in a presentation of clinical research made at a site, including a conference, participated in also by the JGOG, the organization shall fulfill its accountability to the society following the approval of the COI Committee of the JGOG and the Board of Supervisors.

8. Establishment of Detailed Rules

The JGOG may define detailed rules to implement the guidelines while taking into consideration the originality and specificity of the JGOG.

9. Date of Implementation and Revision Methods

The guidelines shall be implemented following approval at the 8th JGOG Annual (General) Conference on December 4, 2009. It is expected that partial modifications to the guidelines will be required to address specific cases due to social influences and the revision of rules in relation to academic-industrial cooperation. The COI Committee of the JGOG may revise the guidelines following the approval of the Board of Supervisors and the General Conference and a joint discussion.

Established on December 4, 2009