1. Promoting Integrity in the Next Generation of Researchers A Curriculum for Responsible Conduct of Research in Occupational Therapy (2005) Funded by the Office of Research Integrity through the American Association of Medical Colleges

2. Conflicts of Interest

3. Objectives  Define conflicts of interest, and discuss how it applies to personal, financial, political, and other perceived or real influences.  Recognize situations in which protections should be established to control the appearance of conflict of interest or true conflict of interest.  Discuss how professionals and institutions can avoid or minimize the impact of conflicts of interest.  Differentiate between conflict of interest and conflict of commitment.  Feel empowered to prevent or address conflicts of interest.

4. Definition  Conflicts of interest are situations in which a person’s or an institution’s objectivity, ethics, or responsibility is compromised or appear to be compromised by a “competing financial, personal, or political obligation, gain, desire, loyalty, or bias”. ( Shamoo & Resnick, 2003, pg. 139)  The conflict is between a gain or an “interest and a duty”. ( Shamoo & Resnick, 2003, pg. 139)

5. Everyday Examples of Possible Conflicts of Interest  Financial: A Governor who owns 20 recreational vehicles proposes elimination of the state tax on that type of vehicle.  Personal: A mother who judges a beauty contest which her daughter wins.  Political: A doctoral student who teaches part-time in an occupational therapy master’s curriculum gets permission to take a doctoral exam several days after her peers, without penalty. (Based on examples in Shamoo & Resnick, 2003)

6. Research Examples of Potential Conflicts of Interest  Financial: A researcher studying the effects of a new device holds stock in and accepts funding for trips from the manufacturer.  Personal: A researcher studies the effects of a treatment developed by and strongly endorsed by a friend. The researcher reports glowing results.  Political: A researcher reviewing an article recommends against its publication. She is currently researching the same question and hopes to publish results soon.

7.  “…it is often difficult to determine (or know) whether a person has a conflict of interest, because we may not know how their personal, financial, or political interests are affecting… their judgment, reasoning, motivation, or behavior.” (Shamoo & Resnik, 2003, pg. 141)  Therefore, researchers must manage both real and perceived conflicts of interest

8. In Summary:  Having a conflict of interest is not unethical and does not imply that someone is doing anything wrong. It indicates that the situation could create bias.  It is unethical and unprofessional to ignore a real or apparent conflict of interest.

9. Control Conflict of Interest by  Disclosure  Management  Avoidance (Shamoo & Resnick, 2003)

10. Controlling conflict of interest by: Disclosure  Faced with a real or apparent conflict of interest, the researcher or institution should disclose the conflict to an objective party who is independent but interested party, such as : The journal editor The grant manager The article’s readers A Conflict of Interest Review Board

11. Controlling conflict of interest by: Management  Informed of the conflict of interest, the interested but independent party establishes safeguards to control the conflict. These include: Added oversight or vigilance:  External review of study design  Analysis of data before unmasking group assignment  Review of article or grant by additional persons

12. Controlling conflict of interest by: Management (continued)  The federal government has defined financial conflict of interest.  It allows a maximum of $10,000/year in salary, gifts, or services to the researching individual, spouse, or children. Accepting less than $10,000/yr in salary, gifts or services does not constitute a conflict of interest. (National Institutes of Health, 1999)

13. Controlling conflict of interest by: Avoidance (continued)  Avoiding a service activity is a last resort, and is used only when disclosure and management are insufficient to control the real or apparent conflict of interest.  It removes the researcher or institution from the research or review being performed.  Avoidance should be selective (i.e., to a specific study or review)  It should not be used as an excuse to withdraw from performing all reviewing.

14. Definition  Conflict of Commitment describes a situation where a person’s or an institution’s resources (including time and efforts) are unbalanced by competing demands.

15. Resolving Conflicts of Commitment  Determine the required commitments  Set clear goals and priorities related to those commitments.  Limit or remove additional commitments that are optional and not within capabilities. (Shamoo & Resnik, 2003)

16. Resources  Association of American Universities, Task Force on Research Accountability. (2001, October). Report on individual and institutional financial conflict of interest. Washington, DC: AAU. Retrieved August 20, 2005, from http://www.aau.edu/research/COI.01.pdf.  Magnus, P. D., & Kalichman, M. (2002, September). Conflicts of interest. Retrieved August 20, 2005, from RCR Education Resources, Online Resource for RCR Instructors: http://rcrec.org/r/index.php?module=ContentExpress &func=display&meid=76&ceid=42.

17. Resources (continued)  National Institutes of Health, Office of Extramural Research (1999). NIH initiative to reduce regulatory burden: identification of issues and potential solutions, Chapter III: Financial conflict of interest - workgroup report. http://grants.nih.gov/grants/policy/regulatoryburden/ conflictofinterest.htm  Shamoo, A. E., & Resnik, D. B. (2003). Responsible conduct of research. New York: Oxford University Press.

18. This completes the presentation on Conflicts of Interest THANK YOU!