Clinical Research Resources
Financial Conflict of Interest
Rules regarding financial conflict of interest have been published by NIH to cover NIH grantees and are available from a website established by the NIH Office of Extramural Research (http://grants1.nih.gov/grants/policy/coi/index.htm). Additional information and links to other resources related to conflict of interest are also available from this site.
The FDA's March 26, 2001 Guidance for Industry on Financial Disclosure by Clinical Investigators (http://www.fda.gov/oc/guidance/financialdis.html) incorporates the February 2, 1998 final rule (which took effect on February 2, 1999), the December 31, 1998 amended final rule, and the October 26, 1999 draft guidance. It requires anyone who submits a marketing application of any drug, biological product or device to submit information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies that are submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective, and any study in which a single investigator makes a significant contribution to the demonstration of safety. The applicable regulations include 21 CRF Parts 54, 312, 314, 320, 330, 601, 807, 812, 814, and 860. The Guidance includes a section on frequently asked questions.
Institutional Review Boards (IRBs) are required to consider investigator and institutional conflicts of interest in their assessment of the protection of human subjects and the informed consent process in the protocols they review. On January 10, 2001 the Office of Human Research Protection of the Department of Health and Human Services published the National Human Research Protection Advisory Committee's advice and views as a Draft Interim Guidance on Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing with Issues of Financial Interests and Human Subjects Protection (http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/finguid.htm). The guidance was designed to assist IRBs to function in a way that will facilitate informed, unbiased discussion and properly informed research subjects.
The Association of American Medical Colleges (AAMC) is an organization of the U.S. Medical Schools. It has produced two reports on financial conflict of interest, one on Individual Financial Interest in Human Subjects Research and the other on Institution's Financial Interests in Human Subjects Research (http://www.aamc.org/members/coitf/).
Institutions have their own conflict of interest policies and the Rockefeller University policy can be accessed through http://www.rockefeller.edu/policypdf/Conflict_Investigator060706.pdf