Conflict of Interest/Conflict of Commitment NCURA Region VI & VII Spring Meeting Chandler, AZ April 2005

Panelists Ann Pollack, Assistant Vice Chancellor – Research, UCLA Anne Hannigan, Associate Vice President, Office of Research Administration, Stanford University Christina Hansen, Assistant Vice Chancellor for Research, UC Irvine

Agenda Conflicts of Interest and Conflict of Commitment– What are they? What is at Stake? Discussion Case Studies

Conflicts of Interest and Conflicts of Commitment – What are they? Situations in which there are: Competing Interests Competing Values Competing or Overlapping Commitments

Conflict of Interest in Science “The term ‘conflict of interest’ in science refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research.” AAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research

Conflict of Interest in Science “Individual Conflicts of Interest in science … refer to situations in which financial considerations may compromise or have the appearance of compromising an investigator’s professional judgment in conducting or reporting research.” AAU Task Force on Research Accountability – 2001

Conflict of Commitment “A conflict of commitment involves a situation in which an employee engages in an outside activity that interferes, or appears to interfere, with fulfillment of the employee's obligations to the University, even if the outside activity is valuable to the University or contributes to the employee's professional development and competence.” University of Iowa Operations Manual

Conflict of Commitment “… Whether professional or non- professional, compensated or uncompensated, an outside activity that interferes with the successful performance of the faculty member’s University obligations represents a conflict of commitment.” UC Policy on Conflict of Commitment and Outside Activities of Faculty Members

What is at Stake? Integrity of the researcher and the research Public trust and confidence in science Individual and institutional reputations Rights and welfare of human subjects Give rise to questions about self dealing Compromise ability to fulfill obligations to the institution Other?

Statement on Conflicts of Interests “Conflicts of interest are unavoidable and pervasive. Some are stated or implied, such as the conflict of interest between professional advancement; academic position; salary; professional status and/or power, on the one hand and research integrity on the other; or the conflict between scientific integrity and extra- institutional interests such as religious, political or social beliefs.” UCLA Statement of Principles on Financial Conflicts of Interest in Research

Recent Controversy at NIH In December 2003, the LA Times Times article “Stealth Merger: Drug Companies and Government Medical Research,” identified 6 high level NIH researchers who received consulting fees and, in some cases, stock or stock options ranging in worth from $150K to $1.4M In February 2005 NIH issued rules prohibiting full time employees from consulting with pharmaceutical companies. Certain NIH employees cannot own stock in pharmaceutical or biotech firms Some think it is unfair and needs to be revised

Food for Thought Should NIH rules be applied to the academic community? Should all financial interests be prohibited or can some be managed? Should all Universities treat similar situations in the same way?

More Food for Thought 2003 GAO Report recommended expansion of disclosure requirements to all federal sponsors Is this a good idea?

Conflict of Financial Interest in Research “…severe restrictions on financial benefits to investigators for their research products may inhibit or prevent research developments. This may be more deleterious to the progress of science and of medicine than any potential loss of objectivity.” UCLA Statement of Principles on Financial Conflicts of Interest in Research

Discussion Case Studies Questions