Establishing an Office of Research Compliance: Challenges & Opportunities Dr. Gary K. Ostrander Vice President for Research President, FSU Research Foundation Professor of Medicine Florida State University

PROFESSOR & SENIOR ADMINISTRATOR

3 MOST FACULTY FIND RESEARCH COMPLIANCE TO BE:  Unnecessary  Intrusive  Waste of money  Bureaucratic  Not relevant …….until they have to work with them!!

WHY?  Culture  Training (or lack thereof)  Transparency

WHAT CHANGED?  Funding became more competitive  Technology revolution  More federal oversight  Easier to catch offenders

Establishing Your Office of Research Compliance

DETERMINE YOUR BUDGET  1 – 1.5 FTE  Travel (2-3 meetings/year)  Secure office  Computer, cell phone, etc.  Training  Faculty, Staff, Students & Compliance Office  Website  Reserve/back-stop

SELL THE IDEA TO THE FACULTY  Most to lose and least to gain (in their minds)  You will curtail their current behavior  Make them a partner/advocate  Articulate their role and how the Research Compliance Office will function within your university

SELL THE IDEA TO ADMINISTRATION  Budget  Access to legal counsel  Protection of the University  Protection of the faculty, staff and students

RECRUIT YOUR FIRST DIRECTOR  Experienced compliance officer from another university  Train an internal staff member  “Trainer” needs the understanding/vision  Will need to send them to workshops  Must be respected by faculty and staff

THE SEARCH COMMITTEE MEMBERSHIP  Faculty  Staff  IT  IRB  Animal Care and Use  Tech Transfer  Security  Finance and Administration

THE SECRET TO MAKING THIS WORK!!!  Hire a “good cop”

WHY DOES ALL THIS MATTER?  It is the right thing to do!!  You will develop allies and support for everything you need to do in your office  You will save time and money

WHEN YOU HIRE YOUR FIRST DIRECTOR  Make sure they meet key people in your key departments  Not likely they will have a back log of work  Begin with your policies

WHEN YOU HIRE YOUR FIRST DIRECTOR-CONT.  Policies  Talk to stakeholders in advance  Circulate drafts  Follow your procedures  FSU…….. Legal, CRC Exec, CRC, Faculty Senate Exec, Faculty Senate, Legal, 21-day comment period, Senior Administration

THE RETURN ON INVESTMENT - ROI  Educated faculty, staff and students  Prevent misconduct  Promote integrity

Questions?