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University of Maryland School of Pharmacy. Ethical issues in data management Joe giffels jgiff001@umaryland.edu. Responsible Conduct of Research. Data acquisition, management, sharing, and ownership Mentor/trainee relationships Publication practices and responsible authorship Peer review

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university of maryland school of pharmacy
University of Maryland School of Pharmacy

Ethical issues indata managementJoe giffelsjgiff001@umaryland.edu

Research Integrity Office - Academic Affairs

slide2

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

slide3

Never try to walk across a river

just because it has an average depth

of four feet.

-- Martin Friedman

Research Integrity Office - Academic Affairs

research generates
Research Generates…
  • Data
    • Publications (the scientific literature)
    • Intellectual Property (technology transfer)
    • Training (tomorrow’s investigators)

Research Integrity Office - Academic Affairs

slide5

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

slide6

Investigator

An Investigator is anyone involved in designing, conducting or reporting research

Research Integrity Office - Academic Affairs

slide7

Laboratory

The laboratory is anywhere research is conducted

Research Integrity Office - Academic Affairs

slide8

Data

Data are observations collected or generated during the conduct of research

Research Integrity Office - Academic Affairs

slide9

Data Formats (examples)

  • Written observations, journals

Research Integrity Office - Academic Affairs

slide11

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

slide12

The first rule of intelligent tinkering is

to save all the parts.

-- Paul R. Erlich

Research Integrity Office - Academic Affairs

slide13

Data Issues

  • Validity
  • Ownership
  • Access
  • Confidentiality

Research Integrity Office - Academic Affairs

slide14

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

slide15

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

slide16

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

slide17

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

slide18

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

slide19

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

slide20

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

slide21

Data Sharing / Public Use Data Sets

  • Under what circumstances would you consider not sharing data you have collected?

Research Integrity Office - Academic Affairs

slide22

Data Sharing

  • NIH Data Sharing Policy http://grants.nih.gov/grants/policy/data_sharing/

Research Integrity Office - Academic Affairs

slide23

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

slide24

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

information resources
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

information resources cont d
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