Management of Conflict of Interest (COI) regarding HSR

Introduction

Management of Conflict of Interest (COI) is included in the review in the HSRRC as a required item for research integrity. The COI disclosure statement shall be submitted to the OIST COI Committee for review (started in October 2010). To conduct human subjects research, approval by the both committees is required.

<Guidelines that stipulate COI>
Entire research: "Guidelines for Managing Conflicts of Interest in Health, Labor and Welfare Science Research”
Clinical research: "Clinical Research Act"
Medical research: "Ethical Guidelines for Medical and Health Research involving Human Subjects”

<Recommendation by Ministry of Health, Labor and Welfare (MHLW)>
COI of entire research and COI of individual researchers are reviewed and monitored by the ethics committee or COI management committee, which is another organization.

Submission of COI Disclosure Statement

Download the form from the COI Website of the Compliance Section and fill it in, then submit it to the Section. The OIST COI Committee shall review and the review result shall be reported to the applicant. Please include the review result in the hsr application.

<Submission Timing>
When applying for a new research and any changes arises in the already approved research. Also, at the end of the every fiscal year after one year passed from the first approval.

<Subject for COI Disclosure Statement>
All individuals who are listed as research personnel are subject to submit the statement.

Implementation Plan in FY2020 is as follows:

  • Ongoing research: At the timinig of creating the Progress Report
  • New application: Right before the review by the HSRRC (submit your application to the Secretariat on EAS to obtain a reference number and then create a COI Disclosure Statement.)

Conflic of Interest Website

Guidelines and Reference Materials

Policy regarding Mangement of Conflict of Interest (COI) in Health and Labour Science Research  <English translation of 厚生労働科学研究における利益相反(Conflict of Interest: COI)の管理に関する指針>
Questions and Answers about "Policy regarding Management of Conflict of Interest (COI) in Health and Labour Science Research" <English translation of「厚生労働科学研究における利益相反(Conflict of Interest: COI)の管理に関する指針」についてのQ&A」>

利益相反ワーキンググループ報告書(平成14年11月1日科学技術・学術審議会・技術・研究基盤部会・産学官連携推進委員会・利益相反ワーキンググループ)(Japanese only)