HCCA's Research Compliance Conference

Sunday, June 3 — Pre-conference
11:30am – 6:00pm	Registration
Pre-Conference Sessions 1:00 – 3:00 pm	P1: IRB Updates This will significantly impact research compliance in your organization This will require a significant "attitude adjustment" on the part of IRBs This is a very big deal! Jeffrey P. Braff, DrPH Director, Human Research Protections, Kaiser Permanente
	P2: Research Billing Compliance Define risk areas with billing for clinical trial services Identify process for integration with research, hospital and clinic teams to get it right Provide audit tools and outcomes from hardwiring research billing module in EPIC system Ruth Krueger, Regional Director of Corporate Compliance, Sanford Health Eve Sakran, Director Clinical Trials Office, Jackson Health System Diana Salinas, Esq., CHC, Corporate Director and Chief Compliance Officer, Jackson Health System
Breakout Sessions 3:30 – 5:00 pm	P3: Implications of Transparency Reports and Updates on Institutional COI Luanna Putney, Ph.D., CHC, CCEP Director of Research Compliance University of California David Vulcano, LCSW, MBA, CIP, RAC AVP & Responsible Executive, Clinical Research, Clinical Services Group HCA
	P4: Research Conflicts of Interest Learn the requirements of COI disclosure for research, clinical and business relationships Review a combined approach to institutional COI policy Experience a one stop approach for annual COI surveys and reports. Janis Anfossi, Associate General Counsel, Rush University Medical Center Tim Cleary, Greenwich Hospital Compliance & Privacy Officer, Yale New Haven Health System Tracy E. Miller, Senior Member, Health Care Group, Cadwalader Wickersham & Taft
5:00 – 6:30 pm	Welcome Reception

Monday, June 4
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	Research Compliance: A Year in Review Lisa Murtha, Esq. Partner, SNR Denton US LLP Rachel Nosowsky, Principal Counsel, University of California David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, Clinical Services Group HCA
9:30 – 10:00 am	Networking Break
Breakout Sessions 10:00 – 11:30 am	101: Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities - The Impact on Clinical Research Sites Recent regulatory requirements for increased transparency will affect researchers Increased government scrutiny on pharmaceutical and medical device manufacturers' R&D activities Actions research sites can take to mitigate risk MaryAnn Northrup, Associate Director, Navigant Consultant Heather M. O’Shea, Partner, Jones Day
	102: Fabrication, Falsification and Plagiarism: Complying with Federal Regulations on ResearchMisconduct Gain an understanding of the Office of Research Integrity and its functions Learn the key components for handling a misconduct allegation Hear actual case examples Randy Mason, Vice President, Research Operations, Beth Israel Deaconess Medical Center
	103: Your Medical Staff is Conducting Clinical Research. Are you Prepared and Protected? Special Challenges for Community Hospitals Risks faced by community hospitals when unemployed medical staff do clinical research How some hospitals attempt to minimize those risks How to get the medical staff to go along Michael C. Roach, Partner, Meade & Roach, LLP

11:30 am – 12:45 pm	Networking Luncheon

Breakout Sessions 12:45 – 2:15 pm	201: Clinical Research Enforcement Initiatives and False Claims Act Update Practical strategies for assessing internal compliance and minimizing False Claims Act risks Kickback, PATH and other initiatives Gary W. Eiland, Partner, King & Spalding LLP
	202: A Successful IRB Model for Handling Noncompliance Cases (Emory's Experience) Learn about a successful, streamlined model for IRB handling of noncompliance! Struggling with how to manage noncompliance reviews by your IRB? This session is for you. How your IRB can efficiently, fairly, and confidentially handle reports of noncompliance Sarah B. Putney, IRB Director, Emory University
	203: Research Compliance Management Project Review & Centralized Research Registration Conducting a pre-review of research projects for billing compliance Using electronic research management system Using a centralized research notification and registration process Kurt Sargent, MBA, CPA, Manager, Sponsored Projects, Allina Health System Carmi Anderson, Research Compliance Specialist, Sponsored Projects, Allina Hospital's Clinics
2:15 – 2:45 pm	Networking Break
Breakout Sessions 2:45 – 4:15 pm	301: Comprehensive Risk Assessments to Fuel Research Compliance Learn the power of a comprehensive risk assessment when optimizing your risk management efforts. This analysis features a wide range of risks: Regulatory agencies, financial requirements, clinical/legal risks. The presentation includes an overall survey of risks plus drill downs on key topics. Daniel E. Ellis, President, 20/20 Healthcare Advisory Services, Ltd.
	302: Clinical Trial Disclosure and the Risk of Non-Compliance Discuss current and future requirements of FDAAA Section 801 and EU Recognize challenges of regulators, academia, industry in clinical trial disclosure Understand impact of noncompliance on the organization Barbara Godlew, President, The Faire Company, LLC
	303: The Dynamics of Cooperative Groups Providing Coverage Analysis: How to Utilize the Information and Make it Work for You! Review rules and understand the complex issues with some Cooperative Group studies. Results from SWOG survey and the needs of members participating in research studies How to make a prepared CA work within your operations and how to work it locally Kelly Willenburg, President, Synergism, LLC Kati Stoermer
4:15 – 4:30 pm	Networking Break
GENERAL SESSION 2 4:30 – 5:30 pm	GS2 Lewis Morris (invited), Deputy Inspector General and Chief Counsel, Office of Inspector General, Department of Health and Human Services

5:30 – 6:30 pm	Networking Reception

Tuesday, June 5
7:15 am – 4:30 pm	Registration
7:15 – 8:30 am	Continental Breakfast
GENERAL SESSION 3 8:30 – 10:00 am	TBD
10:00 – 10:30 am	Networking Break
Breakout Sessions 10:30 am – 12:00 pm	401: Privacy Complexities in Research Compliance Research subjects and privacy: What are the rules? Where is your research data or perhaps where isn't your research data. Practical solutions to protect the privacy & security of research subjects' information Marti Arvin, Chief Compliance Officer, UCLA Health System Mary Thomason, Privacy Compliance Consultant, Intermountain Healthcare
	402: Fair Market Value Issues in Financial Arrangements with Research Physicians Fraud and Abuse laws that apply to research compensation arrangements How to construct compliant compensation arrangements with research physicians Recent cases and settlements Robert Wade, Partner, Krieg DeVault
	403: BioSpecimen/Data Kirk Nahra, J.D., CIPP, Partner, Wiley Rein LLP Rachel Nosowsky, Principal Counsel, University of California
12:00 – 1:00 pm	Networking Lunch
1:00 – 1:15 pm	Break
Breakout Sessions 1:15 – 2:45 pm	501: Successful FDA Inspections: How to Prevent and Respond to Common FDA Observations in a Form 483 or Warning Letter Identify the top 10 issues that are likely to result in a Warning Letter Discuss strategies for preventing FDA from issuing an FDA Form 483 or Warning Letter to you Know how to respond if you are issued an FDA Form 483 or Warning Letter Richelle Little, JD, Regulatory Counsel, Western Institutional Review Board Kara Morgenstern, Associate General Counsel, University of Michigan
	502: Creating Infrastructure Support for Sponsor-Investigators in Academic Health Centers Presentation of some of the common oversights by sponsor-investigators Overview of sponsor-investigator responsibilities under FDA regulation Description of Program to educate sponsor-investigators & promote compliance with FDA regulations Keren Dunn, Manager, Research Compliance and Quality Improvement, Cedars-Sinai Medical Center Karen Hartman, Operations Manager, Mayo Clinic
	503: Effective Financial Research Compliance Management Cover the key elements to financial compliance and managing the layers of complexity Discuss the application of regulatory requirements for a successful audit Discuss opportunities & approaches for ensuring financial compliance and assessing current practices Kathryn Seifert, Consultant, Ernst & Young
2:45 – 3:15 pm	Networking Break
GENERAL SESSION 4 3:15 – 4:30 pm	Why Smart Leaders Do Dumb Things Patrick Kuhse, Speaker, Speaking of Ethics

Wenesday, June 6 — Post-Conference
7:30 – 11:30 am	Registration
7:30 – 8:30 am	Networking Break
Breakout Sessions 8:30 – 11:30 am	W1: Developing and Implementing a Research Compliance Audit Plan Establishing baseline based on government areas of focus and institutional priorities Exercise: Identifying and prioritizing research risks Case studies for addressing areas of indentified risks and control weakness Jodi Ogden, Executive Director, Sponsored Projects Administration, UT Health, The University of Texas Health Science Center at Houston
	W2: Recent Developments in Clinical Trial Regulation and Oversite Hear the latest information about new and proposed changes in regulatory oversight. Find out how the changes will affect the conduct of your studies. Get ideas on processes changes that might help you comply with the changes. Cynthia Gates, RN, JD, CIP, VP Education and Consulting, Western IRB

1:00 – 3:00 pm	CCEP Exam