What is Research Misconduct?

1. What isResearch Misconduct? Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

2. Research Misconduct • Fabrication is making up data or results and recording or reporting them. • 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. • Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

3. Research Misconduct Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

4. Research Misconduct Proposing: Grant proposals*, graduate research prospectuses, fellowship applications etc. Performing: Experimental design and execution. Reviewing: Manuscripts, grant proposals, etc. Reporting: Papers*, presentations, notebook entries, lab meetings, computer entries, etc. *Submitted

5. Why do universities investigate research misconduct? ORI [federal Office of Research Integrity] Statutory Authority - 42 U.S.C. § 289b: “(b) Existence of administrative processes as condition of funding for research. The Secretary shall by regulation require that each entity that applies for financial assistance under this chapter for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance – (cont.) https://ori.hhs.gov/ori-statutory-authority

6. Why? (cont.) • assurances satisfactory to the Secretary that such entity has established and has in effect (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or sponsored by such entity; (2) an agreement that the entity will report to the Director any investigation of alleged research misconduct in connection with projects for which funds have been made available under this chapter that appears substantial; and (3) an agreement that the entity will comply with regulations issued under this section.” https://ori.hhs.gov/ori-statutory-authority

7. WSU Policy on Research Misconduct Based on the federal Sample Policy for Research Misconduct (https://ori.hhs.gov/sample-policy-procedures-responding-research-misconduct-allegations) http://research.wayne.edu/integrity/pdf/university-research-misconduct-procedure-policy.pdf

8. What happens when misconduct is alleged? There are two major players. • Complainant: Most misconduct cases start with a “whistleblower”. S/he files a complaint in which research misconduct is alleged. The complainant may be anonymous. • Respondent: The individual(s) accused of research misconduct.

9. Complainant obligations and protections The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. WSU employees and students may not unduly influence or retaliate in any way against complainants, witnesses, or committee members.

10. Allegations Research misconduct allegations should be made to the Research Integrity Officer (RIO, me). Allegations may also be made directly to federal agencies such as the Office or Research Integrity (ORI), funding agencies or others such as journal editors. Allegations made to others regarding WSU personnel should be communicated to the WSU RIO. All WSU research misconduct allegations must come to me (philc@wayne.edu)

11. Process Overview Complaint: Allegations are reported to the Research Integrity Officer (RIO). Pre-inquiry: The RIO determines if there should be an inquiry. Inquiry: A committee determines if there is sufficient evidence to warrant a full investigation. Investigation: A committee evaluates the allegations, examines the evidence in depth, and determines whether misconduct has been committed, by whom, and to what extent. If appropriate, the investigation committee recommends actions to correct the scholarly record.

12. Inquiry Committee The Inquiry Committee consists of at least three members (usually WSU faculty) who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry, including the respondent and who are qualified to evaluate the evidence and issues related to the allegation. The Inquiry Committee determines if there is sufficient evidence to warrant a full investigation.

13. Investigation Committee The Investigation Committee must include at least three members. Two members must be Wayne State University faculty. No member may be affiliated with either the complainant's or the respondent's departments or equivalent units. The RIO may select Committee members from outside Wayne State University.

14. Process Overview Draft Report: The Investigation Committee writes a draft report of its findings which is provided to the respondent for review. The respondent may submit written comments regarding the draft report to the RIO. The comments are considered and included in the final investigation report.

15. Process Overview Final Report: The Draft Report is filed with the Deciding Official (usually the Vice President for Research or designee) for review. The Deciding Official notifies the Investigation Committee in writing of her/his decision to accept, request further clarification of, or disagreement with, portions of the report. If the report is accepted by the Deciding Official, it is designated as the Final Report.

16. Process Overview Notification: The Complainant and the Respondent are notified in writing of the final decision and are provided with a copy of the Deciding Official’s written decision. When appropriate, funding agencies, law enforcement agencies, professional societies, licensing boards, journal editors and others with a need to know may be notified of the findings.

17. Appeal The respondent may appeal the final decision of a finding of research misconduct and the recommendations for appropriate disciplinary action to the Provost and the Vice President for Research.

18. Administrative Actions After a finding of research misconduct has been made and the appeals process is completed, the Vice President for Research in consultation with the Provost will decide on the appropriate administrative actions to be taken.

19. Administrative Actions-WSU Administrative actions may include: • Correction of the scholarly record (retractions etc.). • Restitution of funds to the grantor agency as appropriate. • Removal of the responsible individual(s) from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment.

20. Federal Investigations and Administrative Actions Federal actions may vary according to the funding agency. If the research falls within the jurisdiction of ORI, a federal investigation may be conducted and additional administrative actions may be imposed. Health and Human Services findings and administrative actions are posted on the Public Health Service Administrative Actions Bulletin Board and the ORI web site. https://ori.hhs.gov/case_summary

21. The case of Dong-Pyou Han,an HIV researcher NATURE|VOL523|9JULY2015 p138

22. Spiked Data Han falsified data by spiking blood from HIV immunized rabbits with human HIV antibodies to mislead other researchers to believe that the rabbits had developed immunity to the virus. The Investigation Committee found him guilty of research misconduct and he was forced to resign.

23. Spiked Data A federal investigation was conducted and ORI barred Han from receiving federal grants for three years. Normally, this would have been the end of Dr. Han’s career as a scientist and the extent of his punishment. However….

24. Spiked Data Senator Charles Grassley (Iowa) was outraged and wrote to ORI: “This seems like a very light penalty for a doctor who purposely tampered with a research trial and directly caused millions of taxpayer dollars to be wasted on fraudulent studies.” ~Charles Grassley, February 2014.

25. Escalation: Criminal prosecution In June, 2014, the federal prosecutor in Des Moines, Iowa arrested Han and in February 2015, he pleaded guilty to two felony charges of making false statements to obtain NIH research grants. Making false statements to obtain research grants????

26. Certification on federal grant proposals

27. Sentencing On July 1, 2015, Dong­Pyou Han was sentenced to 4 years and 9 months in prison and fined $7,200,000. He will be subject to three years parole after he leaves prison.

28. Compliance with federal law What are the potential consequences if the federal government determines that a university failed to fulfill its responsibility to adequately investigate allegations of misconduct?

29. Duke’s mishandling of misconduct prompts new U.S. government grant oversight By Alison McCook, Retraction Watch Mar. 23, 2018 “Last week, the U.S. National Institutes of Health (NIH) imposed unusual new requirements on researchers based at Duke University in Durham, North Carolina, who receive federal funds. The changes are a response to concerns over how the institution handled recent cases involving research misconduct and grant management. According to a Duke spokesperson, NIH now requires Duke researchers to obtain prior approval for any modifications to new and existing grants. And any Duke researcher submitting a so-called “modular application” for a grant worth less than $250,000 per year must include “detailed budgets” justifying the costs. Duke faculty learned of the changes on 21 March, in a letter from university administrators. “NIH reports that these new requirements are a result of its concerns about Duke’s management of several research misconduct cases and grant management issues that date back to 2010, some of which have been widely reported like the Anil Potti case,” according to the letter.” https://www.sciencemag.org/news/2018/03/duke-s-mishandling-misconduct-prompts-new-us-government-grant-oversight

30. Duke University to settle case alleging researchers used fraudulent data to win millions in grants By Ivan Oransky, Retraction WatchNov. 19, 2018 Duke University in Durham, North Carolina, is on the verge of settling a case brought by a former employee who claims the university included faked data in applications and reports for federal grants worth nearly $200 million. According to court documents filed last week in the Middle District of North Carolina in Greensboro, former Duke biologist Joseph Thomas, who sued the university in 2015 under a federal law that allows whistleblowers to receive as much as 30% of any payout, is waiting for the U.S. Department of Justice to approve the settlement. Thomas brought his case under the federal False Claims Act (FCA), which could force Duke to return to the government up to three times the amount of any ill-gotten funds. This story was produced under a collaboration between Science and Retraction Watch. doi:10.1126/science.aaw1185