HCCA's Research Compliance Conference

Pre-Conference Sun 6/12
Conference Mon 6/13
Conference Tues 6/14
Post Conference Wed 6/15

Sunday, June 12 — Pre-conference
11:30am – 6:00pm	Registration
Pre-Conference Sessions 1:00 – 3:00 pm	P1: FCPA 3rd Party Due Diligence for Health Entities presentation 1, presentation 2, evaluation Human research protections: Review differences between FDA and ICH-GCP requirements Examine strategies for domestic IRBs to evaluate local research context Discuss Foreign Corrupt Practices Act – 3rd Party Due Diligence John Heldens, Director, UCSF Human Research Protection Program Ryan Morgan AML/CA, Anti-Corruption Specialist, World Compliance, Inc.
	P2: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for Engagement: PART 1 presentation, evaluation Review of the applicable regulations and standards that govern federally funded research, from effort reporting to F & A; Building or refining your program to assure compliance Juliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA, Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal regulations, Duke University
Breakout Sessions 3:30 – 5:00 pm	P3: Sponsor Agreements: Perspectives of the Parties – Hospital, Sponsor and University presentation 1, presentation 2, presentation 3, evaluation Compliance of clinical trial agreements with Stark and anti-kickback statutes Structuring of clinical trial agreements with non-employed physicians, with particular focus on indemnification and insurance provisions Negotiating budgets David Vukadinovich, Senior Counsel, Catholic Healthcare West Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health Joaquina M. Lazaro, JD, Senior Attorney, Global Clinical Trial Legal Group, Pfizer Inc.
	P4: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for Engagement: Part 2 presentation, evaluation Enforcement and agency Updates What to expect from a regulatory review or investigation Juliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA, Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal regulations, Duke University
5:00 – 6:30 pm	Welcome Reception

Monday, June 13
7:00am – 6:00pm	Registration
7:00 – 8:15 am	Breakfast
8:15 – 8:30am	Opening Remarks
GENERAL SESSION 1 8:30 – 9:30 am	Conflicts of Interest in Biomedical Research presentation, evaluation OIG studies of the identification and management of conflicts of interest among federal grantees NIH rules governing the grantee conflicts of interest Update on regulatory requirements governing NIH grantees Lewis Morris, Deputy Inspector General and Chief Counsel, Office of Inspector General, Department of Health and Human Services
9:30 – 10:00 am	Networking Break
Breakout Sessions 10:00 – 11:30 am	101: MSP Mandatory Reporting - Implications in the Clinical Trial Context presentation, evaluation Overview of the MSP laws, including a summary of the mandatory reporting requirements (and potential penalties for non-compliance) History of the issues surrounding potential application of the MSP laws to clinical trials and a summary of the recent CMS Alert Options for negotiating clinical trial agreements; and special considerations in investigator-initiated trials Holley Thames Lutz, Partner, SNR Denton, LLP
	102: Accounting for those Grants: Medical Schools, Federal Dollars and Patient Costs presentation, evaluation The Ins and Outs of Grant Accounting Medicare Reimbursement when you have federal dollars in the mix Medical School Grants and Patient Care Costs Kelly Willenberg, CHRC, President, Synergism, LLC Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health
	103: Research Misconduct: The ORI and Institutional Perspectives presentation, evaluation ORI's research misconduct oversight process Nuts and bolts of shepherding an institutional research misconduct proceeding Update on research misconduct cases and lessons learned Jo An Rochez, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services Debbi Gilad, J.D., Executive Director Office of Research Compliance and Integrity, University of Pennsylvania’s School of Medicine

11:30 am – 12:45 pm	Networking Luncheon

Breakout Sessions 12:45 – 2:15 pm	201: The Role of Medical Affairs in Late Phase Product Development presentation, evaluation Rick Munschauer, MD., CM., VP, Global Head, Medical Affairs, Biogen Idec The role of Medical Affairs in a Biotech company and how this function serves to address the "unmet medical need" How Medical Affairs operates in the context of Late Phase studies and how this function is structured to ensure ongoing compliance Explore the tensions between achieving scientific goals and the development and marketing of new products
	202: Conflicts of Interest - What's new and on the Horizon? presentation, evaluation NPRM on Financial COI for Public Health Service Funding - What this means for you and your institution (final rules hopefully will be out) COI policies and how to comply with them Let the sun shine in: triangulating investigator attestations with Pharma company lists Jeffrey Braff, Director of Human Research Protections, Kaiser Permanente Joy Hardee, CHRC, Administrator/UHS Privacy Officer/Research Compliance, University Health Systems of Eastern Carolina
	203: PI and AMC Held INDs/IDEs: Responsibilities and Resources presentation, evaluation Responsibilities and Risk Mitigation Challenges and Lessons Learned Potential Best Practices and Resources Kara Morgenstern, Assistant General Counsel, University of Michigan Kay Fuller, RAC, President, Medical Device Regulatory Solutions
2:15 – 2:45 pm	Networking Break
Breakout Sessions 2:45 – 4:15 pm	301: Evolution and Growth of a Research Compliance and Education Program presentation, evaluation Discuss the value of building a quality improvement based research monitoring and education program Outline the key steps in the evolution and growth of a research compliance and education program Analyze the evolution of research compliance through quality improvement initiatives Luanna K. Putney, Ph.D., CHC, CCEP, Director of Research Compliance Office of Ethics, Compliance and Audit Services, University of California, Office of the President Carol Fedor, ND, CCRC, Clinical Research Manager, Office of Research Compliance and Education, Center for Clinical Research and Technology, University Hospitals Case Medical Center
	302: Data Security / FISMA presentation, evaluation Review of Harvard's recently adopted Harvard Research Data Security Policy (HRDSP) which covers all types of research data from public information to extremely high risk information. HRDSP rollout and verification, the role of the IRBs The intractability of FISMA in the real world Scott Bradner, University Technology Security Officer, Office of the CIO, Harvard University
	303: Discussion of 5 Scenarios of Research Billing Challenges: Law & Operations presentation, evaluation Review 5 common research billing scenarios Examine compliance risks for each scenario Propose operational solutions to manage the compliance risk for each scenario Ryan Meade, CHRC, CHC, Attorney, Meade & Roach, LLP Dwight Claustre, Healthcare Compliance Professional
4:15 – 4:30 pm	Networking Break
GENERAL SESSION 2 4:30 – 5:30 pm	What Every Compliance Professional Should Know About Dealing with the FDA presentation, evaluation Do's and Don'ts For Interacting with FDA How to Prepare For Meetings and Discussions with FDA What are the Various Modes of Interaction With FDA and When is Each Appropriate What is New in the Current FDA Regulatory Environment Neil F. O'Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz P.C.

5:30 – 6:30 pm	Networking Reception

Tuesday, June 14
7:15 am – 4:30 pm	Registration
7:15 – 8:30 am	Continental Breakfast
GENERAL SESSION 3 8:30 – 10:00 am	Research Compliance: A Year in Review presentation, evaluation Join us to learn about the new laws, regulations and best practices related to clinical research This session will also provide an overview of the most interesting investigations and settlements in the clinical research area covering HRP, research billing, conflicts of interest, accounting for research studies and mush more This session will address the primary focus areas for research compliance professionals for 2011 and beyond including prime training areas, risk assessment and auditing and research program design and implementation Lisa Murtha, JD, CHC, CHRC, Partner, SNR Denton US LLP Kendra Dimond Campbell, University of Central Florida, Office of Research & Commercialization
10:00 – 10:30 am	Networking Break
Breakout Sessions 10:30 am – 12:00 pm	401: Successfully Navigating an OHRP Site Visit presentation, evaluation Overview of OHRP's compliance oversight process and conduct of site visits Anatomy of a site visit: the institutional perspective Lessons learned from a recent OHRP site visit and recommendations as to best practices Laura Odwazny, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services (Invited) Rebecca D. Armstrong, D.V.M , Ph.D., Director, Research Subject Protection, University of California at Berkeley
	402: Enhancing Research Compliance through Organizational Structure presentation, evaluation Learn how the organizational structure of your research administration function greatly impacts compliance activities Discuss how effective reporting relationships and span‑of‑control help to improve key items like effort reporting, cost transfers and FSRs Learn about the roles of Vice President - Research Admin, Institutional Official (IO) and Research Integrity Officer (RIO) and discuss their functions related to research compliance Randy Mason, Vice President, Research Operations, Institutional Officialfor Research, Beth Israel Deaconess Medical Center
	403: An Inside Look at Clinical Trial Billing in a Multi-Institutional System presentation, evaluation Complexity of regulations governing clinical trial billing The University of Texas System principles and practice for clinical trial billing Collaborating to develop common policies Developing site-specific procedures C.J.Wolf, MD, CHC, CPC, CPC-H, Assistant Systemwide Compliance Officer, The University of Texas System, Systemwide Compliance Office Beth Belt, CHRC, Manager, Deloitte & Touche
12:00 – 1:00 pm	Networking Lunch
1:00 – 1:15 pm	Break
Breakout Sessions 1:15 – 2:45 pm	501: Tissue Issues presentation, evaluation Current and pending privacy rules governing research with human tissue Human research protection regulations and policies Landmark cases and lessons learned Guidelines and best practices Kristen B. Rosati, JD, Partner, Coppersmith Schermer & Brockelman PLC David Vulcano, AVP, Clinical Research, HCA
	502: Gene Transfer Research presentation, evaluation James D. Hearn, General Counsel, DS Ventures/Harridge Development The History of Gene Transfer Research Learning from Past-Failures: Costly Lessons Learned from the Death of Jesse Gelsinger, et. al. The Special Ethical Challenges Presented by such Research: Informed Consent and Conflicts of Interest
	503: Clinical Research Enforcement Initiatives, Off-Label Use Settlements, and False Claims Act Update presentation, evaluation Recent amendments to the federal False Claims Act and other compliance and enforcement authorities addressed in the healthcare reform legislation Off-label use and other research and academic medical center related settlements Federal enforcement initiatives relevant to the research and academic medical center communities including the OIG FY 2011 Work Plan, enforcement efforts relating to cost allocation, effort reporting, indirect cost rates, and Medicare secondary payor issues, and selected FDA enforcement initiatives Gary W. Eiland, Partner, King & Spalding LLP
2:45 – 3:15 pm	Networking Break
GENERAL SESSION 4 3:15 – 4:30 pm	Trends in Oversight of Human Research Protections presentation, evaluation Summary of laws and regulations that cover human research protections and any updates thereto Discussion of recent OHRP inquiries, investigations, findings etc. that research compliance professionals should understand What types of auditing and training should research compliance professionals be doing for 2011 and beyond? Greg Koski, PhD, MD, Associate Professor, Harvard Medical School

Wenesday, June 15 — Post-Conference
7:30 – 11:30 am	Registration
7:30 – 8:30 am	Networking Break
Breakout Sessions 8:30 – 11:30 am	W1: New Developments in Privacy & Research presentation 1, presentation 2, evaluation Understanding the amendments to the HIPAA Privacy Rule, including authorizations for future research, the new prohibition on the "sale" of protected health information, and clarification on when business associate agreements are necessary in research Writing "informed" consent documents for research involving genetic analysis or for future research Implementing adequate security to protect health information in research and conducting breach reporting Managing privacy in multi-party research, including investigator departures and data collaborations Kristen Rosati, Partner, Coppersmith Schermer & Brockelman PLC Paula Bistak, RN, MS, CIP, CHRC, Executive Director, Human Subject Protection Program, University of Medicine and Dentistry, NJ
	W2: Developing and Implementing a Research Compliance Audit Plan presentation 1, handout 1, handout 2, evaluation Establishing baseline through a comprehensive risk assessment, common risk areas, and institutional priorities Tips and advice with executing the plan Case studies for addressing areas of indentified risks and control weakness Matthew Lester, MBA, MHA, Managing Director, Huron Consulting Group Jodi Ogden, MBA, CRA, Executive Director, Sponsored Projects Administration, The University of Texas Health Science Center at Houston

1:00 – 3:00 pm	CCEP Exam