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Death by a Thousands Cuts: Researcher Burden
Up Close and Personal
Michael Conlon, PhDClinical and Translational Science Institute
University of Florida
Research Process 1974
Hypothesis
Experiment
Publication
Research Process 2014(Simplified version)
Hypothesis
Consults
Assemble Team
Write propos
al
Negotiate
Get approvals
Get Funded
Set-up Account
s
Hire peopl
e
Get approvals
Create Data
systems
InfoSecrevie
w
Experi-ment
Audits
Publi-Cation
Progress
reports
Archive data
Report to sponsor
Starting a Clinical Trial
But wait, there’s more …Application to the NIH:
125 pages of science200 pages of biosketches50 pages of budget justification50 pages of research resource descriptions30 pages of letters of support50 pages of consortium sub-contract50 pages of appendix material278 pages of forms and attachments833 pages total. 15% science
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
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
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”
What can be done?
1. Don’t ignore the problem
2. Use a Team Approach to respond to existing burden
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
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
3. Lower the Burden via Process Re-engineering
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.
Simplifying Recruitment