Data Management Session Biological and Life Sciences Division Graduate School RCR Workshop

1. Data Management SessionBiological and Life Sciences DivisionGraduate School RCR Workshop Mark Burke, PhD Dept Physiology and Biophysics

2. "Science does not recognize a sliding scale of quality." • OMB directives has issued Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Disseminated Information • Quality is an encompassing term comprising utility, objectivity, and integrity. • Objectivity involves a focus on ensuring accurate, reliable, and unbiased information. • information is presented in an accurate, clear, complete, and unbiased manner and in a proper context • Utility refers to the usefulness of the information to its intended users • Integrity refers to security - the protection of information from unauthorized access or revision, to ensure that the information is not compromised through corruption or falsification.

3. The Telephone Gambit, chasing Alexander Graham Bell's secret • Did Bell invent the telephone? • Bell’s laboratory notebook tells a tale of plagiarism. • a picture in it turns out to have been copied almost exactly from a patent filing made by Bell's main rival Elisha Gray • the patent examiner who was involved in this actually filed an affidavit, in which he admits that he showed Bell Gray's confidential filing and he did so because he was an alcoholic and he owed money to one of the partners in Bell's law firm

4. Data Notebook • Keeping records • Organization • Protecting intellectual property • Ownership of ideas • Validation of results • Need to keep it for up to 5 years after you publish the research • Ensures quality and replicablity of experiments

5. Data Notebook • What goes into the notebook? • Everything: protocols, reagents, experiments, notes, location of samples, results of experiments, references, dates • What can be deleted? • Nothing: how do you know what to do next if you cannot remember what you did yesterday? • Do not think that you will remember an experiment in one week, month, or year.

6. Data and Notebook Ownership • The student? • The lab technician? • The Principle Investigator? • The University?

7. Data and Notebook Ownership • The University under the care of the Principle Investigator • When you leave the lab, all notes, notebooks, and materials that you collected through your blood, sweat and tears belongs to the lab!!!

8. Notebook • It is essential that your notebook is clearly written and concise. • It is essential that any experiment listed has sufficient detail to be replicated. • Any samples produced in the experiment must be clearly labelled and location recorded. • Every member of the lab should keep a detailed notebook and remain in the lab. • Remember that you may not be part of the laboratory when your data is needed most!

9. Misconduct • Examine raw data carefully, the notebook is a great initial place to start. • Inter-rater reliability • Any experiment should be able to be replicated by another researcher. • If there is a question of the reliability of another’s data that must be taken seriously by the student, technician, PI, and University • Discussion Point: how do we do this?

10. BioEthics • Inclusion of humans in studies • Informed consent • Benefits, Risks, and Alternatives • Case: CIA funded electric shock and LSD studies during the 1950’s and 60’s at the Allen Memorial Institute in Montreal • Case: Use of lithium on schizophrenics in France • Case: Tuskegee syphilis experiment- poor black men who had syphilis were not informed of their illness, medical doctors did not give the known treatment in order to determine the natural progression of the disease.

11. Federal Regulations • Risks to subjects minimized • Risks reasonable in relation to anticipated benefits. • Selection of subjects equitable • Provision for safety monitoring • Informed consent documented

12. IACUC Russell and Burch’s the 3 R’s • Replacement refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aim. • Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals. • Refinement refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals still used.

13. Authorship and Intellectual Contribution • Scientific authorship: guests, courtesy, contributions, and harms. • Who stands behind the research • McGill University has formally reprimanded senior professor and researcher Barbara Sherwin for failing to acknowledge a ghostwriter hired by drug company Wyeth Pharmaceuticals in a paper Sherwin wrote in 2000. • Sherwin's name appeared in court documents in a class-action suit launched by 8,400 women against Wyeth. The documents revealed that Wyeth paid a New Jersey professional-writing firm, DesignWrite, to produce a paper on treatment options for ageassociated memory loss that was eventually published in the Journal of the American Geriatrics Society. • Sherwin was listed as the sole author of that paper

14. Authorship and Intellectual Contribution • The other reason people put their names on scientific papers is to claim credit for their work, insights, and contribution • Often funding, tenure, position, and promotion hinge on publications. • Scientific disciplines have different practices as far as what kind of contribution is recognized as worthy of inclusion as an author and the order of the authors

15. Authorship and Intellectual Contribution • Usually the first author made the biggest contribution followed by the second author who made the second-biggest contribution and the last author is usually the principal investigator (PI)-the brains of the operation. • Before entering a project determine what your contribution is and in what order will the authorship be.

16. Nature’s Policy Authors are required to include a statement of responsibility in the manuscript that specifies the contribution of every author. The level of detail varies; some disciplines produce manuscripts that comprise discrete efforts readily articulated in detail, whereas other fields operate as group efforts at all stages. A Nature Editorial describing this policy in more detail, 'Author Contributions', is included in the list of links at the foot of this page. Examples of published "author contributions" statements can be seen at this Nautilus post. Nature journals also allow two coauthors to be specified as having contributed equally to the work being described (most often used for co-first authors), but prefer authors to use the "author contributions" style for reader clarity.

17. Journal of Comparative Neurology All authors listed on the paper must have contributed significantly to the elaboration of the paper and/or to the research that led to preparation of the manuscript. The role of each author must be described in a paragraph after the Acknowledgements and the Conflict of Interest disclosure. It can adopt the following format:All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Names or Initials. Acquisition of data: Names or Initials. Analysis and interpretation of data: Names or Initials. Drafting of the manuscript: Names or Initials. Critical revision of the manuscript for important intellectual content: Names or Initials. Statistical analysis: Names or Initials. Obtained funding: Names or Initials. Administrative, technical, and material support: Names or Initials. Study supervision: Names or Initials.

18. Whats the harm? • Truthful communication is essential and the ability to connect bits of knowledge to the people who contributed is part of how the community does quality control on that knowledge base. • A PI removes a grad student from first authorship to promote a post-doc who had minimal contribution. • Inclusion of a prominent scientist to gain credibility- Gerald Schatten in 2005 paper in Science. Paper had 25 authors with Schatten as the senior authro, the paper was eventually revealed to be fraudulent and Schatten claimed to have writing the paper in good English • Courtesy authorship could be viewed as inflating the value of the actual contribution

19. For more topics of ethical science: http://blogs.scientificamerican.com/doing-good-science/