HCCA's Research Compliance Conference

Pre-Conference Wed 4/21
Conference Thurs 4/ 22
Conference Fri 4/23
Post Conference Sat 4/24

Wednesday, April 21 — Pre-conference

Breakout Sessions

12:00 – 2:00 pm

P1: Research Compliance 101
Kevin Eskew, Managing Director, Sonnenschein, Nath & Rosenthal, LLP; Fred Herman, Manager, Research Compliance, University of Maryland Medical System, Department of Finance

handout | evaluation

Provide overview of research compliance (dynamics, accountabilities, regulations)
Identify the common areas of risk and compliance concerns that health care organizations must face if they choose to nurture research activities
Summarize what some of the strategic options are for managing research compliance

P2: FDA’s New Enforcement Agenda: What It Means to Clinical Investigators and I RBs
Rachel Nosowsky, Esq., CHRC, Principal Counsel, University of California;
Jeffrey Layne, Partner, Fulbright & Jaworski L.L.P.

handout | evaluation

FDA’s enforcement tools and best practices for preparing for and responding to FDA inspections
Other enforcement options for federal authorities: criminal and civil exposure for investigators and research sites
Advanced risk evaluation and mitigation strategies for compliance professionals overseeing FDA-regulated activities

Breakout Sessions

2:30 – 4:30 pm

P3: Faculty Training for Research Compliance Professionals
Angelique Dorsey, Research Compliance Director, MedStar Health

handout | evaluation

Challenges in establishing effective faculty education programs
Developing a curriculum
Maximizing utilization and participation

P4: Raising the Bar on Adequate Human Subject Protection
Cynthia Gates, VP Operations,Western Institutional Review Board; Jeffrey A. Cooper, MD, MMM, Director, Huron Consulting Group

handout 1, handout 2 | evaluation

Principal investigator vs. physician: Avoid therapeutic misconception & ensure proper delegation
How do we best protect subjects when there’s a conflict of interest?
Maximize human subject protection while minimizing workload and regulatory oversight

Thursday, April 22
7:30 – 8:30 am	Breakfast
GENERAL SESSION 8:30 – 9:45 am	GS1: 2010 Update from OHRP and ORI 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 handout \| evaluation Overview of interrelationship between ORI and OHRP compliance oversight jurisdiction Update on ORI and OHRP compliance activities Discussion of illustrative case studies
Networking Break	9:45 – 10:15 am
Breakout Sessions 10:15 – 11:45 am	101: How ARRA HITECH Rule Affects Research Data Joy Hardee, Administrator, UHS Privacy Officer/Research Compliance, University Health Systems of Eastern Carolina; Carole A. Klove, RN, JD, CHRC, Special Projects, UCSF Medical Center handout 1, handout 2, handout 3, handout 4, handout 5 \| evaluation The importance of HITECH breach notification requirements and how it affects research data Education to PIs on encrypting research data and why as it relates to breach notification laws Why your research protocol needs to mirror what you do to secure research data
	102: Case Studies in Clinical Research Fraud Enforcement Jesse Witten, Partner, Drinker Biddle & Reath LLP; Gary W. Eiland, Partner, King & Spalding LLP handout 1, handout 2, handout 3 \| evaluation Review leading enforcement theories In-depth analysis of selected, representative fraud enforcement matters involving clinical research Lessons learned from the government’s enforcement actions
	103: Developing a Research Compliance Program in the Context of Corrective Actions to an OHRP Investigation Michael Roach, Partner, Meade & Roach, LLP; Ronald R. Sagritalo, JD, MBA, CHC, CPC-A, Chief Compliance Officer, Hospital Group, Spectrum Health handout 1, handout 2 \| evaluation An experience with a recent OHRP for-cause audit Lessons learned from using an external IRB Revising aspects of the human subjects protection program during the audit

Lunch 11:45 am – 12:30 pm	Networking Luncheon

Breakout Sessions 12:45 – 2:15 pm	201: Managing Regulatory Compliance for Investigator-Initiated Research Leah R. Kendall, Senior Associate, Epstein Becker & Green; Thomas Bechert, Manager, Huron Consulting Group handout 1, handout 2 \| evaluation Key regulatory compliance responsibilities related to investigator-held IND or IDE research Risk-management strategies for institutions whose investigators hold INDs/IDEs Internal processes and written agreements for managing investigator-initiated research
	202: Ensuring a Sound, Compliant Animal Care and Use Program in a Changing (and Challenging) Landscape Kathy Wadsworth, Director, Office of Animal Research Oversight (OARO), University of California, Los Angeles handout \| evaluation Overview of animal research compliance Hot topics & updates in regulatory oversight, compliance and risk assessment Anticipating challenges from animal rights extremists
	203: Data Security in Research: Is the IRB Responsible? Russell Opland, Systemwide Privacy Officer, University of California; Marian Hughlett, Deputy Privacy Officer, University of Louisville handout \| evaluation Review data breach trends and drivers Discuss IRB and investigator obligations to safeguard data Present solutions, strategies, and tools for data security in research
Networking Break	2:15 – 2:45 pm
Breakout Sessions 2:45 – 4:15 pm	301: Conflicts of Interest in Research: Ethical, Regulatory, and Practical Considerations Suzanne M. Rivera, PhD, MSW, Vice President, Research Administration, UT Southwestern Medical Center; Ann N. James, PhD, JD, Senior University Counsel, OGC, Stanford University handout 1, handout 2 \| evaluation What is an “interest” and why interests can create real or apparent conflicts What kinds of measures are required by regulation to protect research subjects from potential conflicts and to maintain scientific integrity What steps your institution can take to prevent, identify and manage conflicts of interest in research
	302: Developing an Effective Anti-Bribery and Corruption Compliance Program in an Environment of Heightened Enforcement Jay Perlman, Director, Daylight Forensic & Advisory LLC; Joel Rush, Associate, Epstein, Becker & Green handout \| evaluation The Elements of an Effective FCPA Compliance Program Using Technology to Address Third-Party Risk Responding to Investigative Findings
	303: The Learnings of a Developing Clinical Trials Office Within an Established Teaching Hospital Eve Sakran, MS, Director, JHS Clinical Trials Office, Jackson Health System, Miami, FL; Ljudmila Hadzikadunic, RN, JD, Compliance Manager, Jackson Health System handout \| evaluation The hospital established a requirement for 3-party agreements Working with financial systems to create a bill hold and audit process Creating collaborative relationships with the University’s PIs and research administration
Networking Break	4:15 – 4:30 pm
GENERAL SESSION 4:30 – 5:30 pm	GS2: International Research Dr. Melody Lin, Deputy Director, Office for Human Research Protection, U.S. Department of Health and Human Services handout \| evaluation
Networking Reception	5:30 – 6:30 pm

Friday, April 23
Continental Breakfast	7:30 – 8:30 am
GENERAL SESSION 8:30 – 9:45 am	GS3: Research Compliance: A Year in Review Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP handout \| evaluation Updates in laws, regulations, and settlements in research compliance
Networking Break	9:45 – 10:15 am
GENERAL SESSION 10:15 – 11:15 am	GS4: An FDA Report: Physician Initiated Device Studies at Academic Medical Centers Anne T. Hawthorn, JD, Chief, Special Investigations Branch, Division of Bioresearch Monitoring, Office of Compliance, CDRH, FDA handout, handout 2 \| evaluation Overview of FDA Device Research Inspection Program Review of Device Physician Initiated studies Case study
Networking Luncheon	11:30 – 12:30 pm
Breakout Sessions 12:30 – 2:00 pm	401: Compliance Challenges in Establishing and Using Clinical Databases Melissa (Lisa) Thompson, JD, MPH, Adelman, Sheff & Smith, LLC; Betsy Hall, Director of Corporate Compliance, Privacy and Information Security, Jewish Hospital & St. Mary’s HealthCare, Inc. (JHSMH) handout \| evaluation Understanding the regulatory requirements for clinical research databases Overcoming compliance challenges when linking clinical information and research databases Avoiding pitfalls when setting up databases
	402: Unanticipated Problems in Human Subject Research: Beyond Adverse Events Keren Dunn, CIP, Manager, Research Compliance& Quality Improvement, Cedars-Sinai Medical Center; Andra M. Popa, JD, LLM, CHC, CHRC, Consultant, Meade & Roach, LLP No handout available \| evaluation Overview of OHRP and FDA regulations and guidance on reporting adverse events and unanticipated problems Discussion of events that may occur in clinical research and how to determine whether they are reportable Learn how one institution streamlined adverse event reporting to maximize value
	403: Research Misconduct: Detection and Risk Mitigation Solutions Susan S. Night, Health Policy and Ethics Fellow, Baylor College of Medicine; Sheryl Tatar Dacso, Partner, Brown McCarroll handout \| evaluation Decisions made by each investigator is the “front line” of research compliance. Training investigators in responsible conduct of research is not enough for compliance. Creating a culture of research integrity is the road to successful compliance in research
Networking Break	2:00 – 2:30 pm
Breakout Sessions 2:30 – 4:00 pm	501: Export Controls Compliance Don Fischer, Fischer & Associates, Export Control Consulting handout \| evaluation Identifying compliance risks in U.S.-based research and international collaborations Current U.S. government enforcement efforts in biomedical research involving sensitive materials and equipment Pragmatic tools and solutions for remaining compliant: minimizing individual and institutional risk
	502: Off-Label Drugs and Devices: The Woes of Their Use, Promotion and Payment Neil O’Flaherty, Principal Attorney, Olsson Frank Weeda Terman Bode Matz PC; handout \| evaluation What are the legal criteria and requirements for appropriate off-label use of devices? How does such off-label use differ from clinical trial use of devices? How does one avoid confusing the concepts and minimize enforcement risks?
	503: The Ten Steps to an Effective Research Compliance Program: A Practicum for Research Compliance Professionals Luanna Putney, CHC, CCEP, Systemwide Director of Research Compliance, University of California; Juliann Tenney, CHRC, Institutional Research Compliance Officer, Director of the Institutional Research Compliance Program and Privacy Officer, University of North Carolina at Chapel Hill handout \| evaluation Key steps necessary to foster an effective compliance program Understanding importance of prioritizing steps for different research compliance areas Recognizing and leveraging opportunities to build an effective compliance program

Saturday, April 24 — Post-Conference
Beverages	7:30 – 8:30 am
Breakout Sessions 8:30 – 11:30 am	W1: Research Risks: What’s the Assessment? Margaret Hambleton, MBA, CPHRM, CHC, Senior Vice President, Ministry Integrity for St. Joseph Health System; Rebecca Scott, Clinical Research Compliance Manager, UK handout 1, handout 2 \| evaluation Why should you be concerned? How to identify the risk Is a risk assessment the answer?
	W2: The Closer: Resolve the Risky Business of Billing Compliance Kathleen Hurtado, RPh, President and CEO , Health Research Association, Inc., A subsidiary of the University of Southern California; Kelly Willenberg, CHRC, President, Synergism, LLC handout 1, handout 2 (xlsx document) \| evaluation Provide attendees with an understanding of current key billing compliance areas including device studies and how to find solutions to challenges Highlight common success strategies for bill holds, expand the compliance billing network Make an affordable investment and provide ways to link performance improvement into the billing compliance model

1:00 – 3:00 pm	CCEP Exam