Regulation Issues Concerning Conflicts of Interest Management in Clinical Research

ABSTRACT

For universities to receive grants from the National Institutes of Health (NIH), US federal regulations began requiring conflicts of interest management (COI management hereafter) and reporting to the NIH in 1994. A site review conducted by the NIH, however, has shown that universities face problems in the selection of the target areas as well as management after research commences. In addition, an audit of NIH by the Department of Health and Human Services (DHHS), the umbrella organization, revealed that the NIH itself has difficulties grasping the state of COI management at its own grant recipient organizations.

In COI management of clinical research in the US, individual financial interests and university interests are interlocked. It is important that universities – the organizations implementing COI management at the individual level – deal with their own COI management. The Association of American Medical Colleges (AAMC) has recommended that universities develop and implement institutional COI management structures by 2010.

In March 2008, the Japanese Ministry of Health, Labor and Welfare (MHLW) created guidelines for implementing COI management with regards to its Health Labor Sciences Research Grants. Universities must quickly establish COI management structures and regulations for clinical research. The intended research areas for the grants will expand beyond medical, and as a result the impact of this policy will be far-reaching. However, the content of the guidelines is unclear in many areas. For management to function, in addition to creating the guidelines the MHLW must also establish a forum for interested parties to discuss cases and share information and best practices so that the guidelines will work and Japan’s clinical research will develop.