Monday, October 19
8:30 am – 9:30 am
General Session: ORI and OH RP Compliance Oversight: Recent Cases and Initiatives
handout
evaluation survey
JoAn Rochez, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services
Laura Odwazny, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services
- Overview of interrelationship between ORI and OHRP compliance oversight jurisdiction
- Update on ORI and OHRP compliance activities, including illustrative case studies
- Discussion of new agency initiatives relating to compliance
9:30 am – 10:30 am
General Session: Hot Topics: Just When You Thought It Was Safe to Go Outside...
handout evaluation survey
Ryan Meade, JD, CHRC, Partner, Meade & Roach, LLP
- Recent developments in clinical research coverage rules
- Impact of Medicare developments on clinical research reimbursement
- Overview of clinical research compliance enforcement
11:00 am – 12:15 pm Concurrent Breakouts
101 Our Bodies? Compliance Challenges and Solutions for Body and Specimen Donation for Research
handout evaluation survey
Rachel Nosowsky, Esq., CHRC, Senior Counsel, Miller Canfield Paddock & Stone, PLC
- Legal primer: anatomical gift laws, Medicare COPs, and human research regulations
- Informed consent: issues for human and cadaver donation for research
- Tissue banking for research: policy and governance options
102 Developing a Comprehensive Program for Managing Conflicts of Interest
handout
evaluation survey
David S. Hefner, Senior Advisor, Association of American Medical Colleges (AAMC)
Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
- Bringing together key stakeholders
- Articulating the issues and development of common questionnaires
- Automating the dissemination and collection of questionnaires
103 Managing a Centralized Research Compliance Program in a Decentralized Environment
handout
evaluation survey
Luanna Putney, Systemwide Director of Research Compliance, University of California
Andra M. Popa, JD, LLM, CHC, CHRC, Consultant, Meade & Roach, LLP
- Identify goals, priorities, gaps and overlaps in systemwide and campusbased compliance programs
- Learn processes to support and integrate conflict of interest and other research compliance goals in a distributed system
- Learn practical ways to incorporate AAHRPP accreditation requirements, VA research, Stark, anti-kickback, and research billing requirements
1:15 pm – 2:30 pm Concurrent Breakouts
201 The Three Cs of Billing Compliance: Collaborations, Challenges and Compromises
handout evaluation survey
Kelly Willenberg, CHRC, President, Synergism, LLC
Ryan Meade, JD, CHRC, Partner, Meade & Roach, LLP
- Overview and demonstration of billing compliance training module
- Practical challenges facing administration now in billing
- Compromises to meet demands of billing compliance issues and change
202 Selecting, Planning, and Surviving the Implementation of an Online Compliance System
handout 1, handout 2, handout 3, handout 4
evaluation survey
Yvonne Rumsey, Senior IRB Specialist, Allina Hospitals & Clinics
Carmi Anderson, Research Compliance Specialist, Allina Hospitals & Clinics
- Setting the criteria for vendor selection and engaging stakeholders in the process
- Planning for integration of office information and implementation
- Implementing the system while maintaining daily work
203 Overview of Privacy Requirements and Compliance Issues in International Clinical Trials (European Law, Canadian Law—and others)
handout 1, handout 2, evaluation survey
Paul Demuro, JD, CPA, MBA, FHFMA, CHC, FACMPE, Partner, Latham & Watkins LLP
John Steiner, Chief Compliance Officer, UK Healthcare of the University of Kentucky
- Uses and Disclosures of identifiable information in clinical research: national and international considerations
- The challenge of protecting health information in the clinical trial process and U.S. and foreign privacy protection
- The Data Transfer Agreement, The De-identification of Information, and conducting Global Clinical Trials—formulation of Good Clinical Practices
3:00 pm – 4:15 pm Concurrent Breakouts
301 A Bag of HIPAA Tricks: For Moving Your Research Forward Consistent With Federal Law
handout evaluation survey
Dianne J. Bourque, Esq., Attorney, Mintz Levin
- Authorization, waiver, and other common approaches for using patient information
- Business associate agreements and less common approaches for using patient information
- Impending changes under ARRA 2009
302 Composition of an Animal Care and Use Program
handout evaluation survey
John Chinn, Director, Office of Research Compliance Administration, East Carolina University
- Regulations covering use of animals in teaching and research
- Composition of IACUC
- Role and responsibilities of IACUC, Institution, and Investigators
303 A Seamless Research Compliance Program for Small Health Care Institutions
handout 1, handout 2, evaluation survey
Pat Connell, RN, MBA, CHE, CBHE, CIP, CHC, Vice President of Behavioral Health, Research, Compliance, and Government Relations for Boys Town National, Research Hospital and Boys Town
- Learn how to start compliance activities before grant submission, including techniques for using existing office software to track and document research compliance activities
- Explore various strategies for incorporating multiple departments into research compliance programs
- Learn how a seamless system approach from pre-grant submission to post-grant review can improve the effectiveness of your research compliance program
4:30 pm – 5:45 pm Concurrent Breakouts
401 Bridging the Gaps: Understanding and Managing the Regulatory, Financial, and Clinical Risks through Implementation of a Sustainable Clinical Trial Management System (CTMS )
handout evaluation survey
James Moran, Director, Huron Consulting Group
Salman Shah, Manager, Huron Consulting Group
- Assessing and understanding your institution’s clinical trial management and billing compliance landscapev
- Navigating the CTMS marketplace
- Planning for a successful system implementation
402 Managing Healthcare Regulatory Risk in Clinical Research
handout evaluation survey
Jana Kolarik Anderson, Attorney, Epstein Becker & Green, PC
Carole A. Klove, RN, JD, CHRC, Chief Compliance Officer, UCLA Medical Sciences
- Recent developments in industry and regulatory guidance
- Contracting issues including consulting arrangements with health care professionals
- Investigator initiated research
403 Auditing & Monitoring
handout 1, handout 2, handout 3, handout 4, handout 5,
evaluation survey
Dwight Claustre, Director, Huron Consulting Group
Yvonne Brinson, Assistant Dean, Research Administration and Compliance, University of Florida
- Discuss the need and importance of auditing and monitoring in the research arena
- Identify those areas that should be audited and monitored
- Provide practical and usable strategies and tools for auditing IRB’s, Research Operations, Clinical Trial Billing and Grants accounting
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Tuesday, October 20
8:15 am – 9:00 am
General Session: Legal Discussion Panel
handout
evaluation survey
Moderator: Juliann Tenney, Institutional Research Compliance Officer, Director of the Institutional Research Compliance Program and Privacy Officer, University of North Carolina at Chapel Hill
Gary Eiland, Partner, King & Spalding LLP
Gabriel Imperato, Managing Partner, Broad and Cassel
Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
9:30 am – 10:45 am Concurrent Breakouts
501 Behavioral Research
handout evaluation survey
Patrick Tolan, PhD, Professor, University of Virginia
- Basic areas of compliance risk for behavioral research
- Understanding of how behavioral researchers view compliance
- Opportunities to facilitate compliance for behavioral research
502 Clinical Research Fiscal Compliance: Developing In-H ouse Training
handout evaluation survey
Angelique Dorsey, Research Compliance Director, MedStar Health
Rebecca Scott, Clinical Research Compliance Manager, UK Healthcare
- Strategies for curriculum development
- Reaching your target audience
- Training Program Assessment
503 Negotiating Clinical Trial Agreements: The Hospital’s Perspective
handout evaluation survey
David Vukadnovich, Senior Counsel, Catholic Healthcare West
- Risk areas under Stark and kickback laws
- Practical solutions for insurance and indemnification provisions
- Two verses three party agreements/including PIs as parties to contracts
11:00 am – 12:15 pm Concurrent Breakouts
601 Role of the Compliance Officer in Regulatory Visits, Audits and Investigations
handout evaluation survey
Juliann Tenney, Institutional Research Compliance Officer, Director of the Institutional Research Compliance Program and Privacy Officer, University of North Carolina at Chapel Hill
Carole A. Klove, RN, JD, CHRC, Chief Compliance Officer, UCLA Medical Sciences
- Address the distinct roles of counsel and the compliance officer of investigations
- Provide tools for conducting audits and investigations
- Define how audits and investigations are reported and built into ongoing risk assessments
602 The Challenges of Research Collaborations
handout 1, handout 2 evaluation survey
Kristen Rosati, Partner, Coppersmith Schermer & Brockelman PLC
James Moran, Director, Huron Consulting Group
- Data and biospecimen sharing among research collaborators
- IRB review of multi-institutional research
- Operational and political challenges in establishing collaborative structures within a research site and across research sites
603 Contract Research Organizations: Who is Conducting Your Research Studies
handout evaluation survey
Bret Bissey, FACHE, MBA, CHC, CMPE Director, Regulatory Compliance Practice, IMA Consulting
- Overview of the expansion and growth of CROs
- CROs for-profit business model
- IRB’s role to assess who is conducting research
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