F&I: Mike Conlon - Death by 1,000 Cuts: Researcher Burden Up Close & Personal
•Download as PPTX, PDF•
1 like•302 views
The research process is becoming increaingly complex from an administrative perspective. The extent of the problem is well-known yet solutions have been elusive.
More Related Content
What's hot
What's hot (17)
Viewers also liked
Viewers also liked (11)
Similar to F&I: Mike Conlon - Death by 1,000 Cuts: Researcher Burden Up Close & Personal
Similar to F&I: Mike Conlon - Death by 1,000 Cuts: Researcher Burden Up Close & Personal (20)
More from CASRAI
More from CASRAI (20)
Recently uploaded
Recently uploaded (20)
F&I: Mike Conlon - Death by 1,000 Cuts: Researcher Burden Up Close & Personal
- 1. Death by a Thousands Cuts: Researcher Burden Up Close and Personal Michael Conlon, PhD Clinical and Translational Science Institute University of Florida
- 2. Research Process 1974 Hypothesis Experiment Publication
- 3. Research Process 2014 (Simplified version) Hypothesis Consults Assemble Team Get appro vals Negot iate Write proposal Get Funded Set-up Accounts Hire people InfoSec review Create Data systems Get appro vals Experi-ment Audits Publi- Cation Report to sponsor Archive data Progress reports
- 4. Starting a Clinical Trial
- 5. But wait, there’s more … Application to the NIH: 125 pages of science 200 pages of biosketches 50 pages of budget justification 50 pages of research resource descriptions 30 pages of letters of support 50 pages of consortium sub-contract 50 pages of appendix material 278 pages of forms and attachments 833 pages total. 15% science
- 6. Some Domains of Burden • Finance • Accounting • Human Resources • Privacy • Security • Information Security • Risk Management • Environmental Safety • Diversity • Space • Protection of Human Subjects • Protection of Animals • Protection of Intellectual Property • Conflict of Interest • Environmental protection • Sub-Contracting • Purchasing • Effort
- 7. Forms of Burden • Paperwork/forms – Required customized responses • Training – Tied to evaluation, finance • Required use of specific computer systems – Up to 50 different systems required for clinical research at UF • Approvals – Additional process steps. Additional delay • Reporting – Federal, sponsor, state, university, college, department, institute • Required Meetings – For reviews, approvals, custom/new situations
- 9. How Did It Get This Way? • “It’s the law” • “If it can be tracked, it must be tracked” • It’s easier, simpler, safer, requires less thinking, to err on the side of more burden • Every domain is entitled to create burden in support of their mission without regard to total burden • No one is checking the checkers • Efforts to combat burden are easily characterized as being “against compliance”
- 10. What can be done?
- 11. 1. Don’t ignore the problem
- 12. 2. Use a Team Approach to respond to existing burden
- 13. Investigator-Centric • Senior investigators create staffs to handle burden. Isolates the investigator from the burden (good), removes the investigator as an advocate for change (not so good) • Mid-career investigators use whatever resources they can to manage burden • Junior investigators are often bewildered and incapable of managing the burden
- 14. Facilitator-centric • The Clinical and Translational Science Institute provides support to investigators managing research burden: – Human subjects – Clinical trials compliance – IND/IDE assistance – Proposal development
- 15. 3. Lower the Burden via Process Re-engineering
- 16. Clinical Trial Start-up • Offices involved in administering processes come together to redesign clinical trial start-up: human subject approval, budgeting, contracting • Result: U.S. national average for final negotiation of a clinical trial is 55 days, final contract execution is 103 days. At UF, 20 days and 39 days, respectively.
Editor's Notes
- Work the functionaries, the faculty senate, the office of research, the health systems, the provost, the president.
- Work the functionaries, the faculty senate, the office of research, the health systems, the provost, the president.
- Work the functionaries, the faculty senate, the office of research, the health systems, the provost, the president.