ReseaRch Compliance Conference October 18–20, 2009 Minneapolis, MN | hyatt Regency Minneapolis Register online at www.hcca-info.org This is the research conference you cannot miss if you work for a research site, a cRO or sMO, a hospital or hospital system, a sponsor, or for clinicians/investigators who conduct research. Learn about updates to the new cMs clinical Trials Policy (replacing the Medicare NcD for clinical Trials), latest trends on compliance with research accounting standards, clinical trial billing and process improvements, effort reporting, scientific misconduct, conflicts of interest, off-label use issues, FDa compliance, and government enforcement trends. hear directly from representatives from NIh, OhRP, ORI, and the FDa and from other industry experts who can provide practical perspectives for handling research compliance risks. ConfeRenCe SuppoRteRS Join the ReseaRch compliance pRe‑confeRence conveRsation: http://community.hcca-info.org
This is the research conference you cannot miss if youwork for a research site, a cRO or sMO, a hospital orhospital system, a sponsor, or for clinicians/investigatorswho conduct research. Learn about updates to the newcMs clinical Trials Policy (replacing the Medicare NcD forclinical Trials), latest trends on compliance with researchaccounting standards, clinical trial billing and processimprovements, effort reporting, scientific misconduct,conflicts of interest, off-label use issues, FDa compliance,and government enforcement trends. hear directly fromrepresentatives from NIh, OhRP, ORI, and the FDa andfrom other industry experts who can provide practicalperspectives for handling research compliance risks.
P1 effectively preparing for and Responding to an fDa audit: the Research team’s perspective
Stephanie C. Guzik, Assistant Director, Research Integrity and Regulatory Affairs, Rush University Medical Center
Kate-Louise Gottfried, JD, MSPH, Senior Director, Research Integrity, Rush University Medical Center
Alina Denis Jarjour, VP, Chief Compliance Officer & Deputy General Counsel, Medarex, Inc.
xx Being FDA audit ready and audit procedures and communications with the FDAxx Investigator/research team response to an impending auditxx Minimizing the potential of an audit
P2 grant accounting complianceGabe Turner, Associate Director, Health Care Dispute, Compliance and Investigation, Navigant Consulting, Inc.
Mike Vernick, Partner, Hogan & Hartson
xx Overview of the sources of grant accounting compliance rules, including OMB circulars and sponsor-specific guidance such as the NIH Grants Policy Statementxx Learn about key areas of grant accounting compliance, including effort
reporting, cost transfers, cost sharing, service centers and distinguishing between direct and indirect chargesxx Discuss recent federal enforcement activity related to the financial
administration of federal grants
12:15 pm – 1:30 pm
lunch Break (on Your own)
1:30 pm – 4:45 pm
afteRnoon pRe‑confeRence
P3 Research compliance: a Year in ReviewLisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
xx A detailed overview of the most recent cases and administrative actions relating to research matters and research compliancexx A description of relevant laws, regulations or government guidance
on research compliance in the areas of human research protections, scientific misconduct, research billing, conflicts of interest, effort reporting and much morexx Guidance on how to update your organization’s research compliance
program to ensure that all critical areas are covered in appropriate detail including updates to training, auditing and monitoring, and policies and procedures
P4 Relationships with iRBsCynthia Gates, VP Operations, Western Institutional Review Board
David Vulcano, AVP, Clinical Research, HCA
Part 1: adverse events: What should Be Reported to the iRBsxx Definition of unanticipated problemsxx How adverse events, IND safety reports fit within definitionxx What should be included in the report
Part 2: conducting a Basic audit of an iRBxx Learn identifiable danger signs that an IRB is potentially negligentxx Create an audit tool to identify sentinel signs that an IRB is on the right
or wrong trackxx Learn ways of off-site review to decrease travel
monday, october 197:30 am – 7:00 pm
Registration
7:30 am – 8:15 am
continental Breakfast
8:15 am – 8:30 am
opening Remarks
8:30 am – 9:30 am general session: oRi and ohRp compliance oversight: Recent cases and initiatives
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
xx Overview of interrelationship between ORI and OHRP compliance oversight jurisdiction xx Update on ORI and OHRP compliance activities, including illustrative
case studiesxx 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...
Ryan Meade, JD, CHRC, Partner, Meade & Roach, LLP
xx Recent developments in clinical research coverage rulesxx Impact of Medicare developments on clinical research reimbursementxx Overview of clinical research compliance enforcement
10:30 am – 11:00 am
Break
agenda
www.hcca-info.org | 888-580-8373 3
monday, october 19 (continued)11:00 am – 12:15 pm
concuRRent BReakouts
101 our Bodies? compliance challenges and solutions for Body and specimen Donation for Research
xx Legal primer: anatomical gift laws, Medicare COPs, and human research regulationsxx Informed consent: issues for human and cadaver donation for researchxx Tissue banking for research: policy and governance options
102 Developing a comprehensive program for managing conflicts of interest
David S. Hefner, Senior Advisor, Association of American Medical Colleges (AAMC)
Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
xx Bringing together key stakeholdersxx Articulating the issues and development of common questionnaires xx Automating the dissemination and collection of questionnaires
103 managing a centralized Research compliance program in a Decentralized environment
Luanna Putney, Systemwide Director of Research Compliance, University of California
Andra M. Popa, JD, LLM, CHC, CHRC, Consultant, Meade & Roach, LLP
xx Identify goals, priorities, gaps and overlaps in systemwide and campus-based compliance programsxx Learn processes to support and integrate conflict of interest and other
research compliance goals in a distributed systemxx Learn practical ways to incorporate AAHRPP accreditation requirements,
VA research, Stark, anti-kickback, and research billing requirements
12:15 pm – 1:15 pm
networking lunch
1:15 pm – 2:30 pm
concuRRent BReakouts
201 the three cs of Billing compliance: collaborations, challenges and compromises
Kelly Willenberg, CHRC, President, Synergism, LLC
Ryan Meade, JD, CHRC, Partner, Meade & Roach, LLP
xx Overview and demonstration of billing compliance training module xx Practical challenges facing administration now in billing xx Compromises to meet demands of billing compliance issues and change
202 selecting, planning, and surviving the implementation of an online compliance system
Carmi Anderson, Research Compliance Specialist, Allina Hospitals & Clinics
xx Setting the criteria for vendor selection and engaging stakeholders in the process xx Planning for integration of office information and implementation xx 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)
John Steiner, Chief Compliance Officer, UK Healthcare of the University of Kentucky
xx Uses and Disclosures of identifiable information in clinical research: national and international considerationsxx The challenge of protecting health information in the clinical trial
process and U.S. and foreign privacy protectionxx The Data Transfer Agreement, The De-identification of Information, and
conducting Global Clinical Trials—formulation of Good Clinical Practices
2:30 pm – 3:00 pm
Break
3:00 pm – 4:15 pm
concuRRent BReakouts
301 a Bag of hipaa tricks: for moving Your Research forward consistent With federal law
Dianne J. Bourque, Esq., Attorney, Mintz Levin
xx Authorization, waiver, and other common approaches for using patient informationxx Business associate agreements and less common approaches for using
patient informationxx Impending changes under ARRA 2009
302 composition of an animal care and use programJohn Chinn, Director, Office of Research Compliance Administration, East Carolina University
xx Regulations covering use of animals in teaching and researchxx Composition of IACUC xx Role and responsibilities of IACUC, Institution, and Investigators
303 a seamless Research compliance program for small health care institutions
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
xx Learn how to start compliance activities before grant submission, including techniques for using existing office software to track and document research compliance activities xx Explore various strategies for incorporating multiple departments into
research compliance programs xx Learn how a seamless system approach from pre-grant submission
to post-grant review can improve the effectiveness of your research compliance program
agenda
4 www.hcca-info.org | 888-580-8373
monday, october 19 (continued)4:15 pm – 4:30 pm
Break
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)
James Moran, Director, Huron Consulting Group
Salman Shah, Manager, Huron Consulting Group
xx Assessing and understanding your institution’s clinical trial management and billing compliance landscape xx Navigating the CTMS marketplacexx Planning for a successful system implementation
402 managing healthcare Regulatory Risk in clinical ResearchJana Kolarik Anderson, Attorney, Epstein Becker & Green, PC
Carole A. Klove, RN, JD, CHRC, Chief Compliance Officer, UCLA Medical Sciences
xx Recent developments in industry and regulatory guidancexx Contracting issues including consulting arrangements with health care
professionals xx Investigator initiated research
403 auditing & monitoringDwight Claustre, DirectorHuron Consulting Group
Yvonne Brinson, Assistant Dean, Research Administration and Compliance, University of Florida
xx Discuss the need and importance of auditing and monitoring in the research arenaxx Identify those areas that should be audited and monitored xx Provide practical and usable strategies and tools for auditing IRB’s,
Research Operations, Clinical Trial Billing and Grants accounting
5:45 pm – 7:00 pm
networking Reception
tuesday, october 207:30 am – 12:30 pm
Registration
7:30 am – 8:15 am
continental Breakfast
8:15 am – 9:00 am
general session: legal Discussion panelModerator: Juliann Tenney, Institutional Research Compliance Officer, Director of the Institutional Research Compliance Program and Privacy Officer, University of North Carolina at Chapel HillGary Eiland, Partner, King & Spalding LLP
Gabriel Imperato, Managing Partner, Broad and Cassel
Lisa Murtha, JD, CHC, Partner, Sonnenschein, Nath & Rosenthal, LLP
9:00 am – 9:30 am
Break
9:30 am – 10:45 am
concuRRent BReakouts
501 Behavioral ResearchPatrick Tolan, PhD, Professor, University of Virginia
xx Basic areas of compliance risk for behavioral research xx Understanding of how behavioral researchers view compliance xx Opportunities to facilitate compliance for behavioral research
502 clinical Research fiscal compliance: Developing in‑house training
Angelique Dorsey, Research Compliance Director, MedStar Health
Rebecca Scott, Clinical Research Compliance Manager, UK Healthcare
xx Strategies for curriculum development xx Reaching your target audience xx Training Program Assessment
503 negotiating clinical trial agreements: the hospital’s perspective
David Vukadnovich, Senior Counsel, Catholic Healthcare West
xx Risk areas under Stark and kickback lawsxx Practical solutions for insurance and indemnification provisionsxx Two verses three party agreements/including PIs as parties to contracts
10:45 am – 11:00 am
Break
11:00 am – 12:15 pm
concuRRent BReakouts
601 Role of the compliance officer in Regulatory visits, audits and investigations
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
xx Address the distinct roles of counsel and the compliance officer of investigations xx Provide tools for conducting audits and investigations xx Define how audits and investigations are reported and built into ongoing
risk assessments
agenda
www.hcca-info.org | 888-580-8373 5
tuesday, october 20 (continued)11:00 am – 12:15 pm
concuRRent BReakouts (continueD)
602 the challenges of Research collaborationsKristen Rosati, Partner, Coppersmith Schermer & Brockelman PLC
James Moran, Director, Huron Consulting Group
xx Data and biospecimen sharing among research collaborators xx IRB review of multi-institutional research xx 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
xx Overview of the expansion and growth of CROs xx CROs for-profit business model xx IRB’s role to assess who is conducting research
2:00 pm – 4:00 pm
chRc exam (see details below)
CHRC Certification exam on-SiteDate: Tuesday, October 20, 2009Time: 2:00–4:00 pmPlace: �Hyatt Regency Minneapolis | Minneapolis, MNcost: $250 (HCCA Members) / $350 (Non-Members)You must be pre-registered to sit for the exam. To apply, download the application at HCCA’s Web site: www.hcca-info.org. Questions? E-mail [email protected]. Twenty CEUS are required to sit for the exam. Research Compliance Conference sessions qualify: each hour attended equals 1.2 CEUs (one clock hour equals 1.2 CCB/CHRC hours).
Healthcare Research Compliance CertificationThe certification in Healthcare Research Compliance (CHRC) is developed and managed by the Compliance Certification Board (CCB).
Enjoy the benefits of CHRC certification:Demonstrate professional standards and status for healthcare research compliance professionals • Heighten the credibility of compliance practitioners and the compliance programs staffed by these certified professionals • Ensure that each certified practitioner has the knowledge base necessary to perform the compliance function • Facilitate communication with other industry professionals, such as government officials and attorneys • Demonstrate the hard work and dedication necessary to succeed in the compliance field
For more information on how you can become a CHRC professional, please call 888-580-8373 or e-mail [email protected].
The CCB Research Compliance Certification exam is available in all 50 U.S. states. Join your peers and become Certified in Healthcare Research Compliance (CHRC).
Attend two of the following HCCA national Conferences
I will receive an additional $300 discount for attending two of the following conferences (see terms on page 5): 2009 Quality of Care Compliance Conference 2009 Physician Practice Compliance Conference
2009 Research Compliance Conference 2010 Managed Care Compliance Conference
Mail to: HCCA, 6500 Barrie Road, Suite 250, Minneapolis, MN 55435 FAX to: 952-988-0146 (including completed registration form with necessary billing information)
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Please note: should your credit card be miscalculated HCCA will charge your card the correct amount. No refunds will be given for “no-shows”or cancellations. You may send a substitute or receive a conference credit. Cancellation by telephone is NOT valid. Please fax written cancellations to 952-988-0146 or e-mail Patti Hoskin at [email protected]. Federal Tax ID No. 23-2882664 / Code: RC1009
SeSSion SelecTion: Please indicate below which sessions you would like to attend. This information will be used in planning. You are not obligated to attend selected sessions.
CLICK HERE TO REGISTER ONLINE NOW
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Millennium Hotel Minneapolis 1313 Nicollet Mall | Minneapolis, MN 55403 612-332-6000 or 800-522-8856
A special rate of $179 (single or double) per night has been arranged. Please make your reservations directly with the hotel and mention the HCCA’s Research Compliance Conference to receive the reduced rate. Reservations will be accepted at the group rate until 9/25/09, or until the group block is sold out, whichever comes first. Reservations received after this date or after the group block is filled will be accepted on space and rate availability. Cancellations must be made 24 hours prior to arrival (by 3:00 pm the day before).
airline Discount Conference attendees receive a 5% discount on AmericanAirlines. Your Authorization Code for this conference is: 58H9AS. Go to www.aa.com and after you have selected your flight(s) under the “Enter Passenger Details” tab, go to the “AA.com Promotion Code” field and enter in your Authorization Code.
Registration terms & conditionsgroup Discounts: Five or more individuals from the same company receive a $100 conference registration discount per person, based on membership status. Please complete a registration form for each attendee and fax or mail in simultaneously.
tax Deductibility: All expenses incurred during training to maintain or improve skills in your profession (including tuition, travel, lodging, and meals) may be tax deductible. Please consult your tax advisor.
cancellations/substitution: No refunds will be given for “no-shows”or cancellations. You may send a substitute or receive a conference credit. Cancellation by telephone is NOT valid. Please fax written cancellations to 952-988-0146 or e-mail Patti Hoskin at [email protected].
Dress code: Business casual dress is appropriate.
continuing education creditsaapc: This program has prior approval of the American Academy of Pro-fessional Coders (AAPC) for a maximum of 17.5 Continuing Education Units. Granting of this approval in no way constitutes endorsement by the Academy of the program, content or the program sponsor.
ache: This program has prior approval from the American College of Health-care Executives (ACHE) for 18 category II continuing education credits.
ca nuRsing ce: The Health Care Compliance Association is pre-approved by the California Board of Registered Nursing: Provider Number CEP 12990, for a maximum of 21.6 contact hour(s). The following states will accept CA Board of Nursing Contact Hours: Alabama, Alaska, Arkansas, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Texas, West Virginia, Wyo-ming. The following states do not have continuing education requirements: Arizona, Colorado, Connecticut, Georgia, Hawaii, Indiana, Maine, Missouri, Montana, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Vermont, Virginia, Washington, Wisconsin. The following states will NOT accept CA Board of Nursing contact hours: Delaware, Florida, New Jersey, Utah. Massachusetts and Mississippi nurses may submit CA Board of Nurs-ing contact hours to their state board, but approval will depend on review by the board. If your state is not listed, we are in the process of obtaining information regarding continuing education from your state. Please check our website for updates regarding nursing credits. Please contact the Accred-itation department at [email protected] with any questions you may have.
compliance certification Board (ccB): Certified in Healthcare Compliance (CHC), Certified Compliance & Ethics Professional (CCEP), Certified in Healthcare Research Compliance (CHRC): CCB has awarded a maximum of 21.6 CEUs for these accreditations in the following subject areas: Applica-tion of Management Practices for the Compliance Professional; Application of Personal and Business Ethics in Compliance; Written Compliance Poli-cies and Procedures; Designation of Compliance Officers and Committees; Compliance Training and Education; Communication and Reporting Mechanisms in Compliance; Enforcement of Compliance Standards and Discipline; Auditing and Monitoring for Compliance; Response to Com-pliance Violations and Corrective Actions; HIPAA Privacy Implementation and/or Complying with Government Regulations.
mcle/cle: The Health Care Compliance Association is a State Bar of Cali-fornia approved MCLE provider. An approximate recommended maximum of 18 clock hours may be awarded. For New York attorneys seeking MCLE credit for this event, please be advised that only sessions facilitated by attor-neys meet the New York State Bar Association’s standards for the awarding of MCLE credit. If you seek MCLE or CLE credit in other states, please contact the Accreditation department at the HCCA by phoning 888-580-8373 at least six weeks prior to the conference.
nasBa/cpe: The Health Care Compliance Association is registered with the National Association of State Boards of Accountancy (NASBA) as a spon-sor of continuing professional education on the National Registry of CPE sponsors: Sponsor Identification No: 105638. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit and may not accept one-half credits. To verify if your state board of accoun-tancy has adopted one-half credits, please visit our website at www.hcca-info.org/accountancycredits. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN 37219-2417. Website: www.nasba.org. A recommended maximum of 21.5 credits based on a 50-minute hour will be granted for the entire learning activity. This program addresses topics that are of a current concern in the compliance environment. An understanding of the USSG’s Seven Elements of an Effective Compliance Program and compliance terminology and acronyms are pre-requisites of this learning activity. This is an update, group-live activity. For more information regard-ing administrative policies such as complaints or refunds, call the HCCA at 888-580-8373.
Your Guide for Getting It RightHCCA’s New Research Compliance Guide
This indispensible reference tool covers the key areas a research compliance professional needs to know.
$149 for HCCA members/ $169 for nonmembers
for more information, visit www.hcca-info.org/books
6500 Barrie Road, suite 250minneapolis, mn 55435www.hcca‑info.org
ReseaRchCompliance Conference
ReseaRchCompliance Conference
October 18–20, 2009Minneapolis, MN | hyatt Regency Minneapolis
October 18–20, 2009Minneapolis, MN | hyatt Regency Minneapolis
