1. Ethical Issues in Research William S. Messer, Jr., Ph.D. Vice President for Research

2. Recent Misconduct Examples: In 2010, Anil Potti resigned from Duke University after his cancer research was called into question. In 2011, a lawsuit was filed against Duke and Dr. Potti, who had retracted 11 research papers focused on the use of genetic information in the treatment of cancer. The lawsuit was settled recently.

3. Recent Misconduct Examples: On July 1, 2015 Dong-Pyou Han, an Iowa State University scientist, was sentenced to 57 months in prison for fabricating and falsifying data in HIV vaccine trials. Han received fines of $7.2M and will be subject to three years of supervision after release from prison.

4. Results of Misconduct: Destroys careers and reputations Wastes public funds Harms/distorts research record and process Adversely impacts public health and safety Undermines public trust –“ The public will support science only if it can trust the scientists and institutions that conduct research. ” Integrity in Scientific Research National Academies

5. Pressures on Researchers Prestige and personal advancement –Grades and degrees –Admittance/acceptance into advanced schools –Professional productivity (publish or perish) –Tenure/advancement Deadlines – deadlines – deadlines Personal wealth Increased administrative burden Sloppiness / laziness

6. Why Is This Important? To help you become an excellent scholar Keep you out of jail Curb growing prevalence of ethical problems Improve the overall quality of research

7. What Is Research Integrity Honesty –Conveying information truthfully and honoring commitments Accuracy –Reporting findings precisely and taking care to avoid errors Efficiency –Using resources wisely – avoiding waste Objectivity –Letting the facts speak for themselves and avoiding improper biases

8. Responsible Conduct in Research Data Management Mentor/Trainee Relationships Publication Practices Peer Review Collaborative Science Human Subjects Animal Welfare Research Misconduct Conflict of Interest and Commitment Environmental Safety (radiation, biohazard) Export Control Laws Intellectual Property Rights

9. Responsible Conduct in Research Data Management Mentor/Trainee Relationships Publication Practices Peer Review Collaborative Science Human Subjects Animal Welfare Research Misconduct Conflict of Interest and Commitment Environmental Safety (radiation, biohazard) Export Control Laws Intellectual Property Rights

10. Responsible Conduct in Research Data Management Mentor/Trainee Relationships Publication Practices Peer Review Collaborative Science Human Subjects Animal Welfare Research Misconduct Conflict of Interest and Commitment Environmental Safety (radiation, biohazard) Export Control Laws Intellectual Property Rights

11. Data Management Obligations of the Researcher –Appropriate authorization –Attention to detail Accuracy, precision, consistency, confidentiality and repeatability –Appropriate recording of data Numbered, dated & documented bound lab notebook Validated & dated electronic recording –Data protection Safe storage of notebooks, computer files, samples Retain for appropriate period of time

12. Worst Practices Recording experimental data on anything temporary with the intention of later transferring or copying it. Failing to retain data or records on published results Failing to keep original and copied data in safe and secure place Failing to record all pertinent experimental information

13. Data Ownership Who owns your research data? –NOT YOU!! Who does own the data? –Follow the money Government funding Private companies Philanthropic organizations

14. Mentoring Clear understanding of mutual responsibilities Commitment to maintain productive and supportive research environment Proper supervision and review Understand that main purpose is to prepare trainees to become successful researchers Professional, technical and ethical training

15. Mentoring Best Practices Trainee is frequently observed performing research and work is critiqued Frequent professional discussions on a multitude of subjects Trainee is treated as a peer in assignment of authorship, presentations, and other credit

16. Mentoring Worst Practices Allowing the trainee to “ learn the hard way ” Exploiting the trainee for resources Not conferring due credit Maintaining a star system Allowing the relationship to expand beyond the professional

17. Publications Purpose is to communicate your research effort accurately, completely and objectively Methods –Full and fair description of the work undertaken Results –Accurate report of the data Discussion –An honest and open assessment of the findings

18. Authorship Requirements of Authorship –Intimately involved in the conception and design of the research; and /or –Assumed responsibility for data collection and interpretation; and /or –Participated in drafting the publication; and /or –Approved final version of the publication

19. Authorship Worst Practices Honorary authorship –Department chair, lab director, major professor, funder, leading researcher in field, providers of resources Salami publications –Dividing one piece of research into 2 or more pieces Duplicate publications –Reporting identical data in two or more publications Premature public statements –Bypasses critical peer review process

20. What is Research Misconduct? Fabrication –Making up data or results and recording and reporting them Falsification –Manipulating research material, equipment or processes or changing or omitting data or results Plagiarism –Appropriation of another ’ s ideas, process, results or words without giving appropriate credit

21. Research Misconduct ViolationNumberPercentage Fabrication2922% Falsification5340% Plagiarism86% Combinations4332% Totals133100% Public Health Service Findings 1994-2003

22. Research Misconduct To Prove Research Misconduct: 1. Must represent a “ significant departure from accepted practices ” 2. Must have been “ committed intentionally or knowingly or recklessly; and 3.Must be “ proven by a preponderance of evidence ”

23. Attitudes Toward Misconduct Action1992 Kalichman1996 Eastwood Past misconduct (yes)15.1%12% Future misconduct (yes)14.8%- Modify data for paper7.3%15% Fabricate data for a paper or grant application 1.3%2% Select or omit data for paper or grant application 14.2%27% List an undeserving author-41%

24. What is Conflict of Interest? I am actually, or potentially, in a situation in which it would be reasonable for others to wonder whether certain interests of mine might compromise my ability to exercise good judgment Can be both positive or negative Types of COI –Conflicts of the wallet –Conflicts of the heart –Conflicts of conscience

25. COI Disclosures Researchers have an obligation to fully disclose Formal disclosure –Annual disclosure to university –Disclosure submission with each new proposal Informal disclosure –Document statement or recusing oneself from decision Positive disclosures are not necessarily bad –Conflicts need to be managed

26. Export Control Laws Violations of trade sanctions and export controls can result in criminal penalties: –Heavy institutional fines (up to $1 M per violation) –Individual prison terms (up to 20 years per violation)

27. Export Control Objectives Implement foreign policy objectives Prevent terrorism Inhibit the proliferation of weapons of mass destruction Fulfill multilateral obligations –(UN sanctions, various trade agreements)

28. What is an Export? Exports: The shipment or transfer of items, information software outside the U.S. or; the release or sharing of restricted technology or data –Items – Tangible things, equipment or hardware –Information – “ Technical Data ” such as models, formulae, engineering designs or technical assistance such as training or instruction –Software – Computer programs in either “ Source Code ” (programming statements) or “ Object Code ” (machine-readable instructions)

29. Prohibited Countries Subject to U.S. Trade Embargoes –Burma –Iran –North Korea State Sanctioned Countries –Balkans –Iraq –Zimbabwe Commerce Sanctioned Countries –Afghanistan –Liberia –North Korea Arms Embargoed Countries –China –Rwanda –Sudan

30. Summary Practice everything you learned in kindergarten Work hard and do things right Be aware of rules and regulations that effect you