Ethical issues in data management Joe giffels jgiff001@umaryland.edu

1. University of Maryland School of Pharmacy Ethical issues indata managementJoe giffelsjgiff001@umaryland.edu Research Integrity Office - Academic Affairs

2. Responsible Conduct of Research • Data acquisition, management, sharing, and ownership • Mentor/trainee relationships • Publication practices and responsible authorship • Peer review • Collaborative science • Human subjects • Research involving animals • Research misconduct • Conflict of interest and commitment Research Integrity Office - Academic Affairs

3. Never try to walk across a river just because it has an average depth of four feet. -- Martin Friedman Research Integrity Office - Academic Affairs

4. Research Generates… • Data • Publications (the scientific literature) • Intellectual Property (technology transfer) • Training (tomorrow’s investigators) Research Integrity Office - Academic Affairs

5. Research Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Research Integrity Office - Academic Affairs

6. Investigator An Investigator is anyone involved in designing, conducting or reporting research Research Integrity Office - Academic Affairs

7. Laboratory The laboratory is anywhere research is conducted Research Integrity Office - Academic Affairs

8. Data Data are observations collected or generated during the conduct of research Research Integrity Office - Academic Affairs

9. Data Formats (examples) • Written observations, journals Research Integrity Office - Academic Affairs

10. Research Integrity Office - Academic Affairs

11. Data Formats (examples) • Written observations, journals • Computer print-outs • E-files (wherever and however they are stored) • Audiotapes or files, CDs • Transcriptions • Gels • Photographs or digital images • Quantitative representation of scanned data • Video files, DVDs • Specimens Research Integrity Office - Academic Affairs

12. The first rule of intelligent tinkering is to save all the parts. -- Paul R. Erlich Research Integrity Office - Academic Affairs

13. Data Issues • Validity • Ownership • Access • Confidentiality Research Integrity Office - Academic Affairs

14. Why Keep a Research Notebook? • Good scientific practice • Satisfy regulations • Aid in documenting results • Establish, protect credit for intellectual property development • Respond to allegations of scientific misconduct Research Integrity Office - Academic Affairs

15. Notebook Entriesfrom Stanford University Office of Technology Licensinghttp://otl.stanford.edu/inventors/resources/inventors_labnotebooks.html • Make in permanent medium • Use consecutive pages • Date entries • Identify subject matter • Include sketches, diagrams, etc • Explain sketches, etc • Photos, drawing, etc., should be identified and permanently attached • Avoid erasures • Don't change entries; make new entry • Periodically have someone look over entries and witness same by applying signature and date Research Integrity Office - Academic Affairs

16. Examples of Ethical Concerns in Data Management • Replicability of results • Analysis of data sets • Data sharing / public use data sets • Fabricated, falsified, plagiarized (ie, stolen) data • Stewardship of data • Ownership of data • Social or political unacceptability Research Integrity Office - Academic Affairs

17. Replicability of Results • How do you respond to another scientist who says she cannot replicate the results of an experiment you have published? • Are you responsible for the replicability (or lack thereof) of the results of a collaborator/coauthor if you were not involved in conducting “their” experiments? • Can you think of changes you might make in the way you plan, document and publish your research in order to maximize the replicability of your results? Research Integrity Office - Academic Affairs

18. Analysis of Data Sets • When, if ever, is it acceptable to alter your plan for analysis of a data set in order to “improve” the results? • How do you respond to a reader of an article you authored who suggests a different method of analyzing the data you collected? • How do you respond to a reviewer of a manuscript who suggests a different method of analyzing the data you collected? • How do you respond to a reviewer of a grant application who suggests a different method of analyzing the data you plan to collect? Research Integrity Office - Academic Affairs

19. Stewardship of Data • How long do you keep data you collected? • What measures do you take to assure the security of data you collected? Research Integrity Office - Academic Affairs

20. Fabricated, Falsified, Plagiarized Data • What responsibility do you have for publications you have coauthored which contain allegedly fabricated, falsified or plagiarized data? • What responsibility do you have when you discover evidence of fabricated, falsified or plagiarized data? • Under what circumstances (if any) would you fabricate, falsify or plagiarize data in a manuscript you intend to submit for publication? • Could you successfully defend yourself from (wrongful) allegations of fabrication, falsification or plagiarism of data in your most recently coauthored publication? Research Integrity Office - Academic Affairs

21. Data Sharing / Public Use Data Sets • Under what circumstances would you consider not sharing data you have collected? Research Integrity Office - Academic Affairs

22. Data Sharing • NIH Data Sharing Policy http://grants.nih.gov/grants/policy/data_sharing/ Research Integrity Office - Academic Affairs

23. Ownership of Data • Who owns data you collected? • In what sense should human research participants own data collected about them? Research Integrity Office - Academic Affairs

24. Politically or Socially Unacceptable Data • Is it ethical to conduct and, presumably, publish data from research supporting the hypothesis that moderate alcohol consumption is correlated with certain health benefits? • How should the publication of data from research on anthrax vaccinology be controlled? Research Integrity Office - Academic Affairs

25. Information Resources • NIH Guidelines on Data Sharing • http://grants.nih.gov/grants/policy/data_sharing/ • N Illinois Univ Data Mgt Module • www.ori.dhhs.gov/education/products/n_illinois_u/datamanagement/dmmain.html • ORI RCR Data Mgt Web Site • http://www.ori.dhhs.gov/education/products/rcr_data.shtml Research Integrity Office - Academic Affairs

26. Information Resources (cont’d) • Stanford’ s Lab Notebooks Guidelines • http://otl.stanford.edu/inventors/resources/inventors_labnotebooks.html • Council of Science Editors Guidelines on Image Manipulation • www.councilscienceeditors.org/editorial_policies/whitepaper/3-4_digital.cfm Research Integrity Office - Academic Affairs