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. Research Misconduct & Whistleblowing

3. Objectives  Define and differentiate research misconduct and research misbehavior.  Define whistle-blowing.  Discuss the steps that are required for responsible whistle-blowing.  Discuss protections and risks associated with whistle-blowing.

4. Research Usually Occurs  Without direct supervision of data collection, data entry, data analysis, or fiscal reporting.  The research community, participants, and consumers trust that: Research is being conducted as approved by institutional review boards (IRBs) IRB is informed regarding deviations from protocol Data are analyzed as reported and in an unbiased manner Findings are accurately reported Financial actions conform to funder/institution’s rules and policies

5. Research Misconduct  The federal Office of Scientific and Technology Policy (OSTP) narrowly defines research misconduct as: Fabrication – making up data or results Falsification – manipulating materials, process, or changing or omitting data to inaccurately represent research Plagiarism – using another person’s ideas or words without appropriate credit when proposing, performing, reviewing, or reporting research. (Office of Science and Technology Policy, n.d.)

6. Research Misconduct (continued)  Those who accept the OSTP’s narrow definition use the term research misbehavior to describe other irresponsible actions related to research, such as: Unethical authorship practices Irresponsible use or report of funds Irresponsible behaviors when gaining informed consent  Many researchers and non-federal agencies do not accept the OSTP definition and instead use the term research misconduct to characterize all irresponsible research behaviors. This slide presentation uses both misconduct and misbehavior.

7. Error vs. Misconduct or Misbehavior  To be research misconduct or misbehavior, the behavior needs to be performed Knowingly Intentionally Recklessly (Office of Science and Technology Policy, n.d.)

8. Errors That Occur in Spite of Rigorous Effort Are Not Misconduct or Misbehavior  It is misconduct to select a research design or practice that is known to be inadequate Choosing a practice that has limitations because there is none better is not misconduct  It is misconduct if one intentionally fails to gather data on a known or suspected adverse side-effect Failing to gather data on an unknown or unsuspected adverse side-effect is not misconduct

9. Whistleblowing  Is defined as the act of revealing “wrongdoing within an organization to the public or to those in positions of authority.” ( American Heritage Dictionary of the English Language 3 rd ed, 1992, pg. 2035)  May include revelation of : Research misconduct Financial misconduct Sexual misconduct Other misconduct prohibited by the institution or funder

10. Whistleblowing (continued)  The most likely person to know of research misconduct is a person working on or closely with the research  Although protected by law, whistleblowers take risks At least 2/3 of whistleblowers have had an adverse experience because of their action (Lubalin, Ardini, and Matheson, 1995)

11. Common Adverse Experiences  Pressure to drop allegations  Threat or actual lawsuit  Ostracism by colleagues  Guilt by association  Loss of job or own research funding  Loss of job recommendations  Emotional stress and reduced health (Lubalin, Ardini, and Matheson, 1995)

12. Steps Before Deciding Whether to Act on Perceived Misconduct  Know that whistleblowing is likely to cost a whistleblower  Examine your own motivation: others will.  Write down the facts: what was done, when, by whom. Do not speculate

13. Steps Before Deciding Whether to Act (continued)  Discuss with a respected other, to check perceptions before making allegations  Know your institution rules and procedures for handling allegations of misconduct. Who is told? Who reviews allegation? Who obtains evidence? What protections are afforded to a whistleblower? (Columbia University, 2003–2004; Magnus and Kalichman, 2002)

14. If a Whistleblower Decides to Act  If an allegation is appropriate, follow the chain of command Discuss the allegation with the administrator above the questionable researcher Follow-up with a written request for investigation If no action, file a written request for action with the institution’s office of research integrity

15. If a Whistleblower Decides to Act (continued)  Only as a final resort should someone with a misconduct allegation seek media coverage or directly inform a funder of an allegation. An exception: if there is widespread misconduct involving federal funds, whistleblowers are encouraged to report directly to the federal government. (Department of Justice, 2005)

16. When Investigating a Whistleblower’s Allegations, an Institution should  Keep researcher’s & whistleblower’s input confidential  Treat researcher and whistleblower fairly and with respect. Whistleblower should not fear retribution Until allegations proven, researcher should:  Be allowed to continue his/her research,  Receive timely written notification and description of the allegations  Have access to appeals. (Magnus and Kalichman, 2002)

17. Resources  American Heritage Dictionary of the English Language (3rd ed.). (1992). Boston: Houghton Mifflin.  Columbia University. (2003–2004). Responsible conduct of research: Courses portal. Course 4: Research misconduct. Retrieved September 10, 2005, from http://www.ccnmtl.columbia.edu/projects/rcr/index.html. http://www.ccnmtl.columbia.edu/projects/rcr/index.html  Lubalin, J. S., Ardini, M. E., & Matheson, J. L. (1995, October). Consequences of whistleblowing for the whistleblower in misconduct in science cases (Final Report). Washington, DC: Research Triangle Institute. Retrieved September 10, 2005, from http://ori.dhhs.gov/documents/consequences.pdf.

18. Resources (continued)  Magnus, P., & Kalichman, M. (2002, September). Whistle blowing. Retrieved September 10, 2005, from RCR Education Resources, Online Resource for RCR Instructors: http://rcrec.sdsc.edu/r/index.php?module=ContentExpress&fu nc=display&meid=82&ceid=48. http://rcrec.sdsc.edu/r/index.php?module=ContentExpress&fu nc=display&meid=82&ceid=48  Department of Justice (2005). Parent organization of Mayo Clinic pays U.S. $6.5 millionto settle grant fraud investigation. Retrieved September 19, 2005, from http://www.usdoj.gov/opa/pr/2005/May/05_civ_292.htm. http://www.usdoj.gov/opa/pr/2005/May/05_civ_292.htm  Office of Science and Technology Policy. (n.d.). Federal policy on research misconduct. Retrieved September 10, 2005, from http://www.ostp.gov/html/001207_3.html.http://www.ostp.gov/html/001207_3.html

19. This completes the presentation on Research Misconduct and Whistleblowing THANK YOU!