Conflict of Interest / Background Information for the new Disclosure Form

Background
The increase in partnerships between universities and industry has led to the expectation at all levels of government that universities function as engines of socio-economic development.  These relationships will in some cases have the potential for creating financial conflicts of interest.  These financial ties are occurring in the context of increased public sensitivity to and concern about financial conflict of interest in the academic setting.

Both the federal government and the academic community have been active in defining their respective responsibilities to assure the integrity of their research activities.  These growing and increasingly complex conflicts of interest in interactions with industry lead to the modification of the University of Kentucky’s administrative regulation on Research Conflict of Interest and Financial Disclosure Policy (AR II-4.0-4) in December, 2007.   
The following recent reports, notices, and bills in Congress reflect the increased scrutiny of conflict of interest policies in the University setting:

  • The Association of American Medical Colleges and the Association of American Universities’ report, “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research”, Feb 2008; www.aamc.org/jointcoireport
  • The Institute of Medicine’s report, “Conflict of Interest in Medical Research, Education, and Practice”, April 2009 http://www.nap.edu/catalog.php?record_id=12598
  • Federal Register Proposed Rules: 42 CFR Part 50 and 42 CFR Part 94: Advance notice of proposed rulemaking, Department of Health and Human Services, “Responsibility of Applicants  for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors; Request for Comments”  Vol. 74, No.88 Friday May 8, 2009
  • Physicians Payment Sunshine Act – Introduced in 2009- Bill pending in Congress- Purpose: to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers. The extensive list of reporting requirement includes grants.

Therefore, the University of Kentucky has amended the Research Financial Interest Disclosure Statement to incorporate these increased concerns and public sensitivity to conflict of interest issues, particularly those related to human subjects. 

The Office of Sponsored Projects Administration (OSPA) is announcing that the revised Research Financial Interest Disclosure Statement (required form for externally funded projects along with the Internal Approval Form) is now available on the OSPA web site http://www.uky.edu/eForms/forms/discfin.pdf  Please start using this new form immediately.  The new form’s substantive changes include a second set of questions to be answered for research projects that involve human subjects.