In recent years, there has been tremendous growth in federal and industry sponsored biomedical research. As more money is being spent on biomedical research, the boundary between public and private research has become less distinct. With the growing commercialization of research, there is concern about the potential for financial conflicts of interest on the part of investigators and research institutions. These conflicts may affect the overall objectivity of the research process and could potentially harm study subjects. A number of recently published studies have found variability and lack of specificity in how major research institutions define financial conflicts of interest. There is limited empirical evidence however, about whether financial conflicts of interest are growing, the nature of these conflicts, and how they are actually being managed by institutions. Additionally, little attention has focused on institutional conflicts of interest. In this session, the U.S. General Accounting Office will discuss findings from our recent review of federal and institutional financial conflict of interest policies. We conducted case studies of five universities that receive significant NIH funding, to determine how financial conflicts of interest on the part of both investigators and institutions were managed and addressed. In addition to our case study findings, this session will suggest areas for improvement in federal policy and oversight.
Learning Objectives: At the end of this session, the participant will be able to: 1. describe federal policy on financial conflicts of interest in clinical research and how this policy is being implemented and monitored. 2. describe the types of policies and procedures that some research institutions have for minimizing and managing financial conflicts of interest among investigators and IRBs and how they are being implemented. 3. describe some of the types of policies and procedures that research institutions have for minimizing and managing their own financial conflicts of interest and how they are being implemented. 4. recommend how financial conflicts of interest in clinical research can be addressed by federal and institutional policy.
Keywords: Research Ethics, Federal Policy
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.