Research Integrity and Misconduct

1. RESPONSIBLE CONDUCT IN RESEARCH(supported in part by a grant from the National Postdoctoral Association) Research Integrity and Misconduct RCR – Research Integrity created April, 2009

2. Short pre-test • Presentation Objectives • comment • background • definition • challenges • responsibilities • pitfalls • ethical considerations • available resources • References • Faculty Presentation • Case Study and Discussion • Short post-test Presentation content RCR – Research Integrity created April, 2009

3. “Advances in science, engineering and all fields of research depend on the reliability of the research record, as do benefits associated with them in areas such as health and national security….Sustained public trust in the research enterprise requires confidence in the research record and in the processes involved in its ongoing development.” (1) “The Federal Register-December 6, 2000” comment RCR – Research Integrity created April, 2009

4. On December 6, 2000, after an almost 10 year process, the Office of Science and Technology Policy issued a “…unified definition of misconduct” in The Federal Register. • Research misconduct became a public issue in the United States in 1981 when then Representative Albert Gore, Jr., chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, held the first hearing on the emerging problem. The hearing was prompted by the public disclosure of research misconduct cases at four major research centers in 1980. Some twelve cases of research misconduct were disclosed in this country between 1974-1981. Congressional attention to research misconduct was maintained throughout the 1980s by additional allegations of research misconduct and reports that the National Institutes of Health (NIH), universities, and other research institutions were inadequately responding to those allegations. (2) • -- The Office of Research Integrity Background RCR – Research Integrity created April, 2009

5. Congress took action in 1985 by passing the Health Research Extension Act. The Act, in part, added Section 493 to the Public Health Service (PHS) Act. Section 493 required the Secretary of Health and Human Services to issue a regulation requiring applicant or awardee institutions to establish "an administrative process to review reports of scientific fraud" and "report to the Secretary any investigation of alleged scientific fraud which appears substantial." The Section also required the Director, NIH, to establish a process for receiving and responding to reports from institutions. This legislation complemented existing authority under which the PHS pursued research misconduct in the 1970s and early 1980s. Guidelines were published in the NIH Guide for Grants and Contracts in July, 1986; the Final Rule, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science", was published in the Federal Register on August 8, 1989 and codified as 42 CFR Part 50, Subpart A.(2) • -- Office of Research Integrity Background (cont.) RCR – Research Integrity created April, 2009

6. definition • “Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. • 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 • Research misconduct does not include honest error or differences of opinion” (3) • -- Federal Policy on Research Misconduct RCR – Research Integrity created April, 2009

7. Operate in an increasingly ‘business-like/bottom-line’ environment while maintaining academic integrity • Respond to increasing amount of regulation and reporting associated with misconduct in the face of economic challenges • Encourage disclosure and reporting of known or suspected misconduct but discourage frivolous accusations • Protect the accused and the accuser until resolution • Train and maintain training for the research community in issues related to misconduct challenges RCR – Research Integrity created April, 2009

8. Develop university policy and process to address allegations of suspected research misconduct • Conduct fair & objective investigation of any allegations of research misconduct according to university policy • Train campus community on duties and rights as they pertain to research misconduct • Promote a ‘culture of compliance’ by emphasizing university’s commitment to established policy and process • Protect the accused and accuser in any allegations of research misconduct • Report any research misconduct according to university policy and process responsibilities RCR – Research Integrity created April, 2009

9. When research integrity goes astray: • Tuskegee Study of Untreated Syphilis in the Negro Male” • -- Between 1932 and 1972, 400 Black males, who were known to be infected with syphilis, participated in a study that withheld treatment for the disease • Medical research conducted during World War II at Auschwitz • -- women sterilized without anesthesia; bones broken without anesthesia to study healing rates; repeated immersion in ice-water to study hypothermia • Louis Pasteur’s failure to accurately attribute source of vaccine • -- failed to cite that he used the vaccine against anthrax made by a competitor, saying instead that he used his own vaccine to inactivate the bacilli by oxygen (4) • “Columbia University RCR Program” • Thereza Imanishi-Kari/David Baltimore/Margaret O’Toole • -- case took 10 years to resolve, involved the Secret Service and ruined 3 careers. pitfalls RCR – Research Integrity created April, 2009

10. “Someone who would knowingly lie about research data or steal someone else’s ideas, according to bioethicist Arthur Caplan, suffers from lapsed morals. All the information in the world about research misconduct and the responsible conduct of research probably wouldn’t change his or her behavior…In fact, a scoundrel taking part in training programs dedicated to these issues might actually get better ideas about performing misdeeds.” • -- Columbia University – “RCR Research Misconduct” • Universities have unique and particular responsibilities • elevated level of public trust accorded to universities • responsible for training next generation of scientists and leaders • creating the technologies and products used/consumed by the public Ethical considerations RCR – Research Integrity created April, 2009

11. Provost and University Vice President • 4th Floor, EAS • 201.216.5263 • Dr. George Korfiatis • Office of Human Resources • 7th Floor, Howe Center • 201.216.5218 • Mark Samolewicz, Vice President • Office of Sponsored Research • 9th Floor, Howe Center • 201.216.8762 • Barbara DeHaven, Executive Director • -- Potential funding sources for postdoctoral fellows transitioning to independence • Office of Institutional Risk, Compliance and Audit • Chuck Shaw – 3rd Floor Howe Center – 201.216.8568 Available resources RCR – Research Integrity created April, 2009

12. STEVENS’ APPLICABLE POLICIES • Code of Ethics • http://www.stevens.edu/provost/fileadmin/provost/pdf/Code_of_Ethics.pdf • Conscientious Employee Disclosure Policy • http://www.stevens.edu/provost/fileadmin/provost/pdf/ConscientiousEmployee.pdf • Conflict of Interest • http://www.stevens.edu/provost/policies/institutional_governance/conflict_of_interest.html • Policy on Research Misconduct • http://www.stevens.edu/provost/fileadmin/provost/pdf/Integrity_in_Research_and_Scholarship_10oct2008_PL.pdf • FEDERAL POLICIES • Federal Research Misconduct Policy • http://ori.dhhs.gov/policies/fed_research_misconduct.shtml Available resources RCR – Research Integrity created April, 2009

13. 1. “The Federal Register –12-6-2000; Science & Technology Policy Office” • -- http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=00-30852-filed • 2. “The Office of Research Integrityhttp://ori.dhhs.gov/about/history.shtml • 3. “Federal Policy on Research Misconduct” • --http://www.ostp.gov/cs/federal_policy_on_research_misconduct • “Columbia University RCR Program” • -- http://ccnmtl.columbia.edu/projects/rcr/rcr_misconduct/foundation/#1_B_1 • “Columbia University RCR Program” • -- http://ccnmtl.columbia.edu/projects/rcr/rcr_misconduct/introduction/index.html • “42 USC 216, 289b-1 and 299c-3” • -- http://www.law.cornell.edu/uscode/uscode42/usc_sec_42_00000216----000-.html • “42 CFR 50” • -- http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm • 7. “Federal Policy on Research Misconduct” • -- http://www.ostp.gov/cs/federal_policy_on_research_misconduct Reference material RCR – Research Integrity created April, 2009

14. Faculty presentation Dr. George Korfiatis Provost and University Vice President RCR – Research Integrity created April, 2009

15. Dr. X, a distinguished structural engineer at Local University, receives a phone call from a former engineering student of his. The former student studied in Dr. X’s lab and helped him develop a revolutionary new building design as a result of sponsored funding from XYZ Engineering Foundation. At the time, the student was puzzled by some of Dr. X’s design elements of load bearing walls as the student could not replicate Dr. X’s test results. He shared his concern with Dr. X, who refused to review the student’s data and dismissed the conversation as a ‘waste of his time.’ The student was disturbed and suspicious of Dr. X’s reaction but decided not to push the issue. Since graduation, the former student has become a successful structural engineer in his own right and now regrets he wasn’t more forceful in voicing his misgivings. CASE STUDY RCR – Research Integrity created April, 2009

16. (CONT.) Dr. X dismisses the phone call but remembers having trouble with the results on those load-bearing walls at the time and the fact the results weren’t as strongly supportive of his design as he knew just had to be the case. Dr. X sifts through his data again and realizes the former student is indeed correct! Worse, a recently completed building is based on Dr. X’s design. Strong winds could cause this landmark to topple and in the process kill thousands of people. Rectifying the problem would be no small task and would require notifying the building’s owners, city officials, the news media and might negatively impact Dr. X’s professional reputation. He’s undecided on a course of action. CASE STUDY RCR – Research Integrity created April, 2009

17. Q: What is the immediate action or inaction that is the cause for concern? CASE STUDY(cont.) A: The cause for concern is that the building Dr. X designed could potentially topple in strong winds and kill many people. RCR – Research Integrity Q: Considered from another perspective, what is the action or inaction that is a cause for concern? A: Dr. X’s indecision on a possible course of action when people could be killed if the building falls is a definite concern. created April, 2009

18. Q: Who will be affected if the building falls, and how? CASE STUDY(cont.) A: -- The building’s owners will be subject to multiple lawsuits and probably ruined -- The building’s occupants could be killed or injured -- People in the area surrounding the building could be killed or injured -- Businesses in the surrounding area could be destroyed or damaged -- City infrastructure will be damaged and require funds to repair or restore -- Families of those killed will be affected long after the event -- Dr. X’s professional reputation and career would be ruined and he would undoubtedly face multiple lawsuits and possibly prison RCR – Research Integrity created April, 2009

19. Q: Are there any laws, regulations (written or unwritten) or other considerations that may apply? CASE STUDY(cont.) A: -- Dr. X would probably be indicted for manslaughter at a minimum and could be indicted for murder if knowing malfeasance or negligence is proved -- Professional ethics Society of Structural Engineers -- Dr. X’s university’s policy and process on “Misconduct in Science” -- Dr. X’s university’s policy on “Professional Practices” RCR – Research Integrity created April, 2009

20. Q: What are the possible courses of action that can be taken, or not, and what are the associated consequences? CASE STUDY(cont.) A: Dr. X can inform the building owners of the problem, the risks and possible solutions. The consequences could be lawsuits from the building owners and possible professional disgrace. Alternatively, Dr. X could decide not to do or say anything and hope for the best. If the building does fall, he could be sued, charged with murder, professionally disgraced and possibly be terminated by his university. RCR – Research Integrity created April, 2009

21. Q: If the building falls, what are the implications if the former student’s suspicions at the time turn out to have been correct? -- for the people in the building? -- for Dr. X? -- for the former student? CASE STUDY(cont.) RCR – Research Integrity Q: If the building falls, what are the implications if the former student’s suspicions at the time aren’t correct ? -- for the people in the building? -- for Dr. X? -- for the former student? created April, 2009

22. created April, 2009