1. Data Management

2. 2 Data Management Practices RESPONSIBLE CONDUCT IN RESEARCH

3. 3 Data Management Practices Data Ownership Who owns it depends on …. Funding source Government, private company or philanthropic organization Grant (Bayh-Dole) versus contract Research institution? Grants awarded to institution, not individual Institution responsible for budget, regulatory compliance, contractual obligations, data management To ensure compliance, institution exerts ownership RESPONSIBLE CONDUCT IN RESEARCH

4. 4 Data Management Practices Data Ownership Maybe the data source Countries with tropical rain forests Individuals with rare diseases Entities with unique databases RESPONSIBLE CONDUCT IN RESEARCH

5. 5 Data Management Practices Data Ownership Work out in advance - Who owns the data I am collecting? What rights do I have to publish the data? Does collecting these data impose any obligations on me? Preferably in writing. May need institutional approval! RESPONSIBLE CONDUCT IN RESEARCH

6. 6 Data Management Practices Data Collection Four generic but important considerations - 1.Use appropriate and reliable methods 2.Pay attention to detail 3.Obtain authorizations Human / animal subjects, biohazards, copyrighted material, etc 4.Keep permanent record regardless of format What was done / observed / achieved RESPONSIBLE CONDUCT IN RESEARCH

7. 7 Data Management Practices Data Collection Two basic rules to record keeping - 1.Enter data / evidence into numbered, bound notebook Date, order of data collection, results achieved No binders or files, changes without date / reason 2.Electronic evidence should be validated to assure it was recorded on a particular date and not changed later ??? RESPONSIBLE CONDUCT IN RESEARCH

8. 8 Data Management Practices Data Protection Data, as currency of research, represents investment It may be needed later: To confirm findings or to establish priority Or, for re-analysis by others It should be stored in a safe place and backed up if on computers Confidentiality agreements must be honored! RESPONSIBLE CONDUCT IN RESEARCH

9. 9 Data Management Practices Data Protection Data, as currency of research, represents investment Data should be preserved – but for how long? At least 3-7 years? Research data should be shared – but when and with whom?? Preliminary data – not unless … Confirmed / validated data – not before publication Keeping data confidential prior to publication – OK Once published, all relevant information should be available RESPONSIBLE CONDUCT IN RESEARCH

10. 10 Data Management Practices Data Protection Future considerations. Data complexity – e.g. the human genome project How to store efficiently and inexpensively? Control – e.g. large projects Can researchers participating in a large, multi-site study publish their own data, or are they constrained? National security Freedom versus fears of terrorists, enemy nations, etc RESPONSIBLE CONDUCT IN RESEARCH