1. MUSC College of Graduate Studies Postdoctoral Retreat on the Responsible Conduct of Research “Misconduct & Whistleblower Protection” Ed Krug BioE 101 876-2404 krugel@musc.edu 052512

2. Common Principals of Research Integrity: Honesty in all aspects of researchHonesty in all aspects of research Accountability in the conduct of researchAccountability in the conduct of research Professional courtesy and fairness in working with othersProfessional courtesy and fairness in working with others Good stewardship of research on behalf of othersGood stewardship of research on behalf of others Singapore Statement on Research Integrity 2010 (51 countries represented) http://www.singaporestatement.org

3. Common lapses in research integrity in human subjects research Failure to report all data Failure to report all data Fabrication of data to match number of reported subjects Fabrication of data to match number of reported subjects Falsification of data on study report forms Falsification of data on study report forms Failure to report all adverse events/reactions or serious adverse events/reactions related to the study Failure to report all adverse events/reactions or serious adverse events/reactions related to the study Titus et al. Nature 453:980-982 "A large percentage of allegations of misconduct received by ORI involves clinical research.” John Dahlberg, HHS Office of Research Integrity

4. 1981 Congressional Interest (Gore et al.) in response to several high profile cases 1987 Health Research Extension Act - institutional processes to review scientific fraud 1989 Office of Scientific Integrity established 1992 NAS Report 1993 OSI became ORI - moved from NIH to HHS 1995 Ryan Commission - established RCR educational programs and whistleblowers protection 1999 HHS required RCR training of all research staff (repealed in 2001 on technicality - regulation vs. policy) 2005 ORI initiated training program of institutional research integrity officials Evolution of RCR Training

5. MUSC Code of Conduct http://academicdepartments.musc.edu/uco/code _conduct.htmExpectations IntegrityIntegrity ComplianceCompliance ConfidentialityConfidentiality Reporting possible violationsReporting possible violations

6. ”Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. (d) Research misconduct does not include honest error or differences of opinion." According to the US HHS Office of Research Integrity … http://ori.hhs.gov/

7. A. Gawrylewski (2009) The Scientist 23:67. What do I do if I suspect misconduct?

8. Process for Addressing an Allegation of Research Misconduct: 1.Research Integrity Officer receives complaint. 2.Complainant interviewed by the inquiry committee. 3.Respondent notified in writing of the allegation and pertinent data records sequestered. 4.Respondent interviewed by, and present evidence to, inquiry committee. 5.Deciding Official receives inquiry report and determines if an investigation is warranted, and if so notifies PHS ORI within 30 days. 6.Complainant interviewed by the investigation committee. 7.Respondent interviewed by the investigation committee. 8.Any individuals pertinent to the investigation interviewed. 9.Investigation committee submits findings and recommendations to Research Integrity Officer, who reports to the Deciding Official. 10.If misconduct has been found, the Deciding Official determines what administrative actions are appropriate and reports to the PHS ORI. 11.The PHS ORI determines whether or not to accept the Deciding Officials report. If the report is not acceptable, the investigation continues until the PHS ORI is satisfied. 12.The PHS ORI may post findings of research misconduct on their website 12.The PHS ORI may post findings of research misconduct on their website.

9. MUSC Confidential Hotline 800-296-0269 Report any activity reasonably believed in violation of any law or regulation, any MUSC policy, or any Federal or State healthcare requirement by means of the Confidential Hotline: 1-800-296-0269 (toll free, available 24 hours, 7 days a week). The Confidential Hotline is monitored by a third-party vendor.

10. The Research Integrity Committee Investigates Potential Research Misconduct http://academicdepartments.musc.edu/research/ori/ric/

11. The PHS Office of Research Integrity Is a Great Resource http://ori.hhs.gov

12. 1) whistleblowers are free to disclose lawfully whatever information supports a reasonable belief of research misconduct as it is defined by PHS policy, 2) institutions have a duty not to tolerate or engage in retaliation against good-faith whistleblowers, 3) institutions have a duty to provide fair and objective procedures for examining and resolving complaints, disputes and allegations of research misconduct, 4) institutions have a duty to follow procedures that are not tainted by partiality arising from personal or institutional conflict of interest or other sources of bias, 5) institutions have a duty to elicit and evaluate fully and objectively information about concerns raised by whistleblower, 6) institutions have a duty to handle cases involving alleged research misconduct as expeditiously as possible without compromising responsible resolutions, and 7) at the conclusion of proceedings, institutions have a responsibility to credit promptly, in public or private as appropriate, those whose allegations are substantiated. Principles of ORI Whistleblower’s Bill of Rights http://ori.hhs.gov/misconduct/Guidelines_Whistleblower.shtml

13. http://ori.dhhs.gov/education/ National Center for Professional & Research Ethics http://nationalethicscenter.org/ US Dept. Health & Human Services Office of Research Integrity MUSC Office of Research Integrity http://research.musc.edu/ori/index.html

14. Take home messages

15. The goal of training in the responsible conduct of research is to promote a general awareness of professional norms in scientific research, as well as encourage a life-long attention to the ethical underpinnings from which they are derived. It is much more than simply following the rules!

16. Issues or Points of Conflict What are the situations in which the rights or obligations of interested parties are in conflict?What are the situations in which the rights or obligations of interested parties are in conflict? Who other than those directly presented in the conflict have an interest?Who other than those directly presented in the conflict have an interest? Interested Parties Consequences of Action Identify those that have the highest probability of occurring or the greatest impact firstIdentify those that have the highest probability of occurring or the greatest impact first Obligations What are the responsibilities of each individual to other interested parties?What are the responsibilities of each individual to other interested parties? Are these grounded in moral considerations or are they a rationalization?Are these grounded in moral considerations or are they a rationalization? Emotion can detect problems, but logic is a much better approach to resolve them

17. Be cognizant of ASSUMPTIONS – then validate, refute or modify as needed!

18. http://walt.foreignpolicy.com/files/in tegrity51417692.jpg http://nickshell1983.files.wordpress.com/2010/09/g0130 09blago1_cst_feed_20090129_16_28_37_1500h400w3 06.jpeg VS. “The truth of the matter is that you always know the right thing to do. The hard part is doing it.” – General Norman Schwarzkopfdf

19. Research “norms” can vary due to local culture and are sometimes questionable when viewed in a larger contextResearch “norms” can vary due to local culture and are sometimes questionable when viewed in a larger context True “research norms” evolve over timeTrue “research norms” evolve over time Individual Integrity public/society community of practice institution department or division staff & trainees PI

20. "Innovation provides the seeds for economic growth, and for that innovation to happen depends as much on collective difference as on aggregate ability. If people think alike then no matter how smart they are they most likely will get stuck at the same locally optimal solutions. Finding new and better solutions, innovating, requires thinking differently. That’s why diversity powers innovation.“ - Scott E. Page, Professor, University of Michigan Successful teams are diverse

21. If problems arise… “May I speak with you confidentially?” “Thank you for being able to speak with you confidentially.”

22. MUSC Postdoctoral Retreat CITI RCR Certification Requirement Due by 11 PM Friday December 19, 2014 (80% minimum score to pass) 1. Go to 1. Go to www.musc.edu/cgi-bin/citi/login.cgiwww.musc.edu/cgi-bin/citi/login.cgi 2. Log in with your NetID and password 3. Select “Biomedical Responsible Conduct of Research Course 1” 4. Email an electronic version of your certificate of completion to me () 4. Email an electronic version of your certificate of completion to me (krugel@musc.edu)krugel@musc.edu