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