Pre Conference Agenda

Monday, October 20

9:00 – 11:45 am
Pre-Conference: Concurrent Breakout Sessions

P1 Building a Compliant Research Operation: The Rush University Medical Center Experience

Handout 1         Evaluation

Lisa Pitler, JD, MS, RN
Senior Director, Research and Clinical Trials Administration Office
Rush University Medical Center

Janis Anfossi, JD, MPH, RN
Associate General Counsel
Rush University Medical Center

Anthony M. Gibbs
Director, Healthcare Finance
Rush University Medical Center

• CMS’s Clinical Trial Policy and application
  
• Billing for Clinical Trials
  
• Code of Federal Regulations applicable to research
  
• Questions to ask to determine if your program is compliant
  
• Methods to use if your program is noncompliant

P2 Consistency in IRB/Privacy Board Submissions: Does It Really Matter?

Handout 1         Evaluation

Dawn Diehl
Sr. IRB Compliance Auditor
University of Louisville

Marian Hughlett
Deputy Privacy Officer
University of Louisville

• Pre-submission evaluation
  
• Post-submission evaluation
  
• Education to improve quality of submissions
  
• Submission resources
  
• Reviewer resources

P3 Research Misconduct: Handling Allegations of Research Misconduct

Handout 1         Evaluation

Debbi Gilad, JD
Executive Director
Office of Research Compliance and Integrity
University of Pennsylvania School of Medicine

Lisa Murtha, JD, CHC
Managing Director
Huron Consulting Group, LLC

• What is research misconduct?
  
• Description of the process for handling allegations—including tips from beginning to end
  
• Examples of real instances of research misconduct
  
• How to help faculty and students stay out of trouble

1:15 – 4:15 pm
Pre-Conference: Concurrent Breakout Sessions

P4 Research Quality Improvement Program

Handout 1         Evaluation

Kate Gottfried
Senior Director
Office of Research Integrity and Regulatory Affairs (ORIRA)
Rush University Medical Center

Juliann Tenney, JD
Institutional Research Compliance Officer
University of North Carolina at Chapel Hill

• How to design and grow an effective quality improvement program
• Templates and tools to help standardize your process
• Effective ways to utilize your data/findings to understand progress
• Managing the politics of self-assessment

P5 Implementing a Clinical Trial Management System in support of Research Billing Compliance

Handout 1, Handout 2         Evaluation

Pam Joy
Director
Office of Research Compliance & Education
Seattle Children’s Hospital Research Institute

James A. Moran
Assistant Dean Clinical Trials
Washington University

Sara Kukuljan, RN
Washington University in St. Louis  
Center for Applied Research Sciences

• Practical, real world experience of what it takes for successful deployment
  
• Manage research billing compliance with greater accuracy and fewer resources
  
• Centralize documentation of research visits
  
• Identify study procedures as either “Standard of Care” or “Research Care” events
  
• Facilitate auditing of research activities

P6 Establishing and Managing an Effective Conflicts of Interest Policy

Handout 1         Evaluation

Nancy LeGros
Partner
King & Spalding LLP

Kendra Dimond
Director
Daylight Forensic & Advisory, LLC

• The importance of implementing an effective conflicts of interest policy
  
• An overview of the federal regulatory scheme for monitoring and reporting potential conflicts of interest
  
• Current industry guidance for evaluation and management of potential conflicts of interest
  
• Illustrative scenarios that represent common legal risks for providers
  
• Practical strategies for identifying the existence of a conflict of interest and mitigating compliance risks