Responsible Conduct of Research Data Issues

1. Responsible Conduct of ResearchData Issues Karin Ellison, Biology & Society

2. What is data? • Examples • Animal observations or counts • Archival documents • Blood samples • Gels • Instrument read-outs • Interviews • Museum specimens • Photographs, movies, other images • Surveys

3. Responsible Conduct of Research • Issue identification • Relevant standards and norms • University • State • Federal • Disciplinary (Professional Societies) • Critical thinking • Options for action • Consequences • Why one choice might be preferred

4. Data Issues • Should I use/report all of my data? • Who owns research data? • Should I share my research data? • How should data be organized? • How long should data be kept? • When collaborations end, who should use, publish, and do follow up work with the data?

5. The Baltimore Case: Key Players • David Baltimore • Nobel Laureate, Director, Whitehead Institute, MIT • Thereza Imanishi-Kari • Assistant Professor, MIT • Margot O’Toole • Postdoctoral fellow in I-K’s lab

6. Baltimore: The Science • Immune system gene expression in genetically altered mice • Weaver D, Reis MH, Albanese C, Costantini F, Baltimore D, and Imanishi-Kari T. “Altered Repertoire of Endogenous Immunoglobulin Gene-Expression in Transgenic Mice Containing a Rearranged Mu Heavy-Chain Gene.” Cell 45, 2 (Apr. 25, 1986): 247-259.

7. Baltimore: Beginnings and Endings • Beginning • O’Toole joined I-K’s lab and assigned a project building on the Cell paper (June 1, 1985). • Ending • DHHS appeals panel found that DHHS’s Office of Research Integrity had failed to prove 19 charges of fraud by preponderance of evidence (June 21, 1996).

8. Baltimore: The Story • 10 years of investigations • University inquiries (2, MIT, Tufts) • NIH scientists investigate • Congressional hearings (multiple) • Including Secret Service analysis of laboratory records • Letter in Cell with corrections, Cell paper retracted, retraction retracted • NIH misconduct hearings (multiple) • DHHS misconduct finding appeal (1)

9. Baltimore: Ethical Issues • Was there misconduct? • What is an appropriate misconduct investigation process? • Did Baltimore behave appropriately? • What are the responsibilities of co-authors? • Women in science • Data management

10. Data: Key Questions • Do I have to use and report all of my data? • When can data appropriately be eliminated from analysis/reporting? • When is dropping selected data falsification of data?

11. Baltimore: I-K data analysis • O’Toole could not get Bet-1, the antibody used to distinguish between foreign and native antibodies in the mice, to work as reported in the Cell paper. • O’Toole describes meeting with I-K in which I-K analyzed both of their data and eliminated outliners in ways O’Toole thought inappropriate. • In addition, O’Toole differences between lab notes and published figures in the Cell paper.

12. Baltimore: I-K data analysis • I-K appropriate data handling? • I-K had explanation for how she treated data. • I-K explained inability to replicate work as O’Toole’s poor skills.

13. Baltimore: I-K data analysis • Standards? • Research Misconduct (current definition) Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results…. (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…. (d) Research misconduct does not include honest error or differences of opinion. (DHHS, ORI, http://ori.dhhs.gov/misconduct/definition_misconduct.shtml, Accessed 3/26/09) • Honesty

14. Baltimore: I-K data analysis • How should one respond to this kind of concern? • O’Toole approached colleagues at Tufts and later MIT with concerns. • Reasonable choice • Groups of faculty at each institution reviewed the paper and concluded small errors in paper and professional difference of opinion. • These findings should have ended the matter, but didn’t. • Other, better options? • Formal misconduct inquiry?

15. Data: Key Questions • Who owns research data? • Should I share my research data? • What kind of data? • Preliminary • Raw • Analyzed data • Results • Context? • Federally funded research • Human subjects research • Intellectual property (private sponsors, patents) • Classified/military research

16. Baltimore: Circulating lab notes • Another former I-K lab trainee informed Walter Steward and Ned Feder, NIH scientists and self-appointment fraud watchdogs, of O’Toole’s concerns. • Steward and Feder approached Margo O’Toole about her concerns. • O’Toole copied 17 pages of Moema Reis’s laboratory notes and mailed them to Steward and Feder.

17. Baltimore: Circulating lab notes • Standards • Ownership • Federally funded research. • Institution owned data. • I-K as PI was the custodian of the data.

18. Baltimore: Circulating lab notes • Standards • Data sharing • NIH. Data Sharing Policy and Implementation Guidance (Updated: March 5, 2003). • “In NIH's view, all data should be considered for data sharing. Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data. NIH requires that investigators share data.” http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm • Share “final research data,” “Recorded factual material commonly accepted in the scientific community as necessary to document and support research findings…” • Generally computerized datasets, excludes laboratory notebooks • Openness

19. Baltimore: Circulating lab notes • How should one respond to requests for data? • O’Toole could have referred Steward to I-K for data. • University could have impounded the data when O’Toole initially raised questions.

20. Data: Key Questions • How should I keep my data and research materials organized? • Bound notebooks, ink, numbered pages • Computer records • Materials—plates, gels, museum specimens, etc. • Electronic laboratory notebooks • Languages

21. Baltimore: I-K’s record keeping • Did not keep single notebook; had a file with loose pages. • Did not do anything systematic with counter tapes immediately. Sometimes organized materials months after research. • Compiled and annotated materials when sending to Washington for review. • Secret Service forensic analysis of lab records showed that they were not in chronological order.

22. Baltimore: I-K’s record keeping • Standards • Lab notebook standards most formalized in industrial settings and when researchers are concerned with intellectual property • Carefulness • Better options? • Better records might have shortened the investigations substantially.

23. Data Management Questions • Should I use/report all of my data? • Who owns research data? • Should I share my research results? • How should data be organized? • How long should data be kept? • When collaborations end, who should use, publish, and do follow up work with the data?