Promoting Integrity in the Next Generation of Researchers

1. Promoting Integrity in theNext 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 InterestTHANK YOU!