Managing Conflict of Interest (COI). (In this Issue).

In response to global competitiveness, Congress passed two laws in 1980 that expanded opportunities to commercialize research discoveries supported with federal funds. Most U.S. policy strategists credit these laws with the escalation of the potential for research conflict of interest. (DHHS/NIH, 2001)

All research activities must strive for truth and objectivity through the recognition of researcher's bias and the elimination of bias from data elements and analyses, the reduction and management of conflict of interest, and the balance of risks and benefits for subject safety. Conflicts of interest are ubiquitous and situational and as we witnessed vividly in the business sector this year, legal and legislative action are means to correct problems but proactive individual, professional, and corporate ethical practices must rely on consistent institutional interpretation and self-judgment. Each research project advances because of the investigators and/or the sponsor's belief that it will increase knowledge or improve current applications but perceptions of conflict of interest or actual misconduct weaken the public trust. Hence, considerable effort continues to be expended at research institutions and in federal agencies to identify and manage potential conflict of interest that may compromise research inte grity or human safety.

The research integrity literature dealt with conflict of interest over this decade through increasing media attention, professional guidance, and government regulations, especially focused on faculty research and publication, and more recently on institutional action. In our theme papers, the authors present excellent references for your re-reading. In addition there are Government Accounting Office (GAO) reports, draft 2001 guidelines and comments on federal regulations related to financial COI, and extensive Internet sources. For instance, the Office of Research Integrity (ORI), Department of Health and Human Services' (2000) first conference on research integrity presented thoughtful papers on policy drivers (Shohara and Rennie). ORI, along with three Midwestern universities, co-sponsored an April 2002 two-day conference on conflict of interest and research integrity. Dr. Bert Spilker listed several factors not equated directly with finances which might conflict faculty such as academic advancement, abilit y to expand their research effort, tenure, prestige and additional grant awards, as well as institutional conflict arising from desires for fame and glory, recruitment of top scientists and graduate students, premier publications, enhanced capability to receive more research grants, royalties from licenses and patents, and increased valuation of stock (slides 10, 11). Also in these conference materials, Lee Stokes cautions us that "You CANNOT determine whether your own activities or relationships create a COI. Assessment requires objective review...."

Laws, regulations, and guidelines only go so far in the ethical application of research principles and the management of conflict of interest. In this issue, three theme contributors present different approaches to how we might manage research conflict. The 2001 revised policies at Northwestern University relate to affirming the institution's values and creating processes that manage conflict of interest and conflict of commitment throughout the university. Drs. Villa-Komaroff and Edwards present the background behind the university's revision and describe first-year implementation of the new policies. Lee Stokes of the Office of the Inspector General at the National Science Foundation summarizes actions based on that agency's operating policies and presents real-life examples of both internal and external breaches of adherence to COI regulations. Dr. Gaylen Bradley of Penn State provides a commentary about his recommendations to help manage conflict emanating from technology transfer in the university enviro nment. The journal team encourages you to react to these papers before September 30 so wider member views can be shared in the third journal issue of 2002; send your correspondence to [e-mail]

References

Cho, M.R, Shohara, R, and Drummond, R. (2000). What is driving policies on faculty conflict of interest? Considerations for policy development. In Steneck, N.H. &: M.D. Scheetz (Eds.) Investigating Research Integrity: Proceedings of the first ORI research conference on research integrity. November 2000. Retrieved on 17 May 2002 from http://www.hhs.gov/multimedia/acrobat/papers/cho.pdf

U.S. Department of Health and Human Services, National Institutes of Health. (2001). NIH response to the [FY 2001 DHHS Appropriation] conference report request for a plan to ensure taxpayers' interests are protected. Retrieved on 17 May 2002 from http://www.nih.gov/news/070101wyden.htm

Washington University. (2002). Ed. Conflict of Interest and Research Integrity Conference, St. Louis, 16-17 April 2002. Materials compiled by the office of the Vice Chancellor for Research, include slide presentations by Bert Spilker, MD, PhD and Lee Stokes, JD as well as other presenters and recent national association materials and federal regulations. St. Louis, MO: Washington University. [Copy is available for $20 through Rose Kettler, Assistant to the VC Research, Phone: [phone]]

Molly A. Anthony, PhD, Managing Director, psPORA, recently completed her contract as the Director of Research and Grants Administration, Department of Radiology, University of Virginia. Dr. Anthony focuses on program development, organizational design, and research management for organizations serving the public interest in health and human services. Her career in public health included research, teaching, nutrition leadership, program evaluation, perinatal consultation and federal project officer; she also has hospital and hospital association experience. Dr. Anthony received her PhD from Michigan State University, College of Social Science, in research methods, public administration and health policy. She is a member of the SRA Editorial Review Board and currently serves as journal editor.