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2013 Annual Conference AgendaAPRIL 2, 2013 TUESDAY
4:00 P.M. – 8:00 P.M. ATTENDEE REGISTRATION
APRIL 3, 2013THURSDAYWEDNESDAY PRE-CONFERENCE WORKSHOPS
7:00 A.M. – 5:00 P.M. ATTENDEE REGISTRATION
7:00 A.M. – 8:00 A.M. CONTINENTAL BREAKFAST
8:00 A.M. – 8:15 A.M. PC1WELCOME
Marjorie A. Speers, Ph.D., President and CEO, AAHRPP
8:15 A.M. – 8:45 A.M. PC2
INTRODUCTION TO THE AAHRPP ACCREDITATION PHILOSOPHY AND PROCESS
Chair, AAHRPP Council on Accreditation
8:45 A.M. – 9:15 A.M. PC3
IDENTIFYING AND ENGAGING THE HRPP IN YOUR ORGANIZATION
Candice A. Yekel, M.S., C.I.M.Director, Office for Research Protections
The Pennsylvania State University
9:15 A.M. – 10:15 A.M. PC4 SELF- ASSESSMENT PROCESS AND PRODUCT:
Draft November 30, 2012 Page 1 of 19
2013 Annual Conference AgendaSTRATEGIES FOR SHARING THE WORK, SOLICITING INPUT,
AND PROMOTING BUY-IN
Sujatha Sridhar, M.B.B.S., M.C.E.Executive Director, Research Compliance, Education, and Support
ServicesThe University of Texas Health Science Center at Houston
10:15 A.M. – 10:30 A.M. BREAK
10:30- NOON PC5
OVERVIEW OF THE AAHRPP STANDARDS:DOMAIN IDOMAIN IIDOMAIN III
Wesley G. Byerly, Pharm.D.Assistant Systemwide Compliance Officer - Research
Office of General CounselThe University of Texas System
12:00- 1:00 P.M. LUNCH
BREAK INTO TWO GROUPS: INITIAL ACCREDITATION AND RENEWING ACCREDITATION
Draft November 30, 2012 Page 2 of 19
2013 Annual Conference AgendaINITIAL ACCREDITATION
1:00 P.M. – 1:30 P.M. PCI1
BREAKING DOWN THE RUMORS ABOUT ACCREDITATION
Wayne R. Patterson, Ph.D.Associate Vice President for ResearchDirector, Office of Research Support
The University of Texas at Austin
1:30 P.M. - 2:30 P.M. PCI2
PUTTING TOGETHER THE APPLICATION: ORGANIZING YOUR POLICIES AND PROCEDURES
Barbara Santiago, B.A. Director of Quality Improvement, AAHRPP
2:30 P.M – 3:15 P.M. PCI3
NAVIGATING THE STEP ONE PROCESS AND RESPONSE
Robert Hood, Ph.D. Associate Director of Accreditation, AAHRPP
3:15 P.M. - 3:30 P.M. BREAK
3:30 P.M. - 4:00 P.M. PCI4
MAXIMIZING THE AVAILABLE RESOURCES TO SIMPLIFY THE APPLICATION PROCESS
Moira A Keane, M.A, C.I.P.Consultant
4:00 P.M. – 4:30 P.M. PCI5 PREPARING FOR A SITE VISITDraft November 30, 2012 Page 3 of 19
2013 Annual Conference Agenda
Sujatha Sridhar, M.B.B.S., M.C.E.Executive Director, Research Compliance, Education, and Support
ServicesThe University of Texas Health Science Center at Houston
4:30 P.M. – 5:00 P.M. PCI6
RESPONDING TO DRAFT REPORTS AND PREPARING STATUS REPORTS
Scott J. Lipkin, D.P.M., F.A.C.F.A.S., C.I.P.Associate Vice President, Research
Lehigh Valley Health Network
RENEWING ACCREDITATION
1:00 P.M. – 1:45 P.M. PCR1
MISTAKES TO AVOID ON RE-ACCREDITATION
David C. Clark, Ph.D.Associate Dean for Clinical Research
Medical College of Wisconsin
1:45 P.M. - 2:30 P.M. PCR2
MAINTAINING INTEREST AND MOMENTUM IN YOUR HRPP
Karen N. Hale, R.Ph., M.P.H.Director, Office of Responsible Research Practices
The Ohio State University
Draft November 30, 2012 Page 4 of 19
2013 Annual Conference Agenda
2:30 P.M – 3:15 P.M. PCR3
MANAGING THE UPDATING PROCESS
Martha F. Jones, M.A., C.I.P.Executive Director of Human Studies
Washington University in St. Louis
3:15 P.M. - 3:30 P.M. BREAK
3:30 P.M. - 4:00 P.M. PCR4
HANDLING THE MOST CHALLENGING STANDARDS
Robert Hood, Ph.D. Associate Director of Accreditation, AAHRPP
4:00 P.M. – 4:30 P.M. PCR5
LESSONS LEARNED FROM PREVIOUS EXPERIENCES
Candice A. Yekel, M.S., C.I.M.Director, Office for Research Protections
The Pennsylvania State University
4:30 P.M. – 5:00 P.M. PCR6
MAXIMIZING THE AVAILABLE RESOURCES TO SIMPLIFY THE RE-ACCREDITATION PROCESS
Moira A Keane, M.A, C.I.P.Consultant
Draft November 30, 2012 Page 5 of 19
2013 Annual Conference Agenda
APRIL 4, 2013 THURSDAY
7:00 A.M. – 5:00 P.M. ATTENDEE REGISTRATION
7:00 A.M. – 5:00 P.M. VISITING HOURS FOR EXHIBITORS
7:00 A.M. - 8:00 A.M. CONTINENTAL BREAKFAST
8:00 A.M. – 8:50 A.M. WelcomeOpening W1
OPENING PLENARY
Marjorie A. Speers, Ph.D., AAHRPP
James Weyhenmeyer, Ph.D., Chair, AAHRPP Board of Directors
8:50 A.M. – 9:40 A.M. Plenary P1
INTERNATIONAL RESEARCHBRIDGING BIOETHICS AND PRACTICE
Sergio Litewka, M.D. University of Miami
9:40 A.M. – 10:00 A.M. Break
Draft November 30, 2012 Page 6 of 19
2013 Annual Conference Agenda
10:00 A.M. – 11:30 A.M. Panel P2
KEY CHALLENGES IN BUILDING CAPACITY AROUND THE GLOBE
David O. Ayuku, Ph.D.Moi University
K.L.Bairy, M.D., Ph.D.Manipal University
Byung-In Choe, M.B.A., LL.M., Ph.D. The Catholic University of Korea Catholic Medical Center
Charles Schmidt, M.D., Ph.D.Eurotrials
11:35 A.M. – 12:45 P.M. Lunch
12:50 P.M. – 1:40P.M. Concurrent Sessions A1
BEYOND THE IRB: METRICS FOR THE WHOLE HRPP
Eifaang Li, D.V.M., M.P.H., C.I.P.Cedars-Sinai Medical Center
A2 STREAMLINING REVIEW THROUGH COLLABORATIONS AND CONSORTIUM AGREEMENTS
Draft November 30, 2012 Page 7 of 19
2013 Annual Conference AgendaNichelle Cobb, Ph.D.
University of Wisconsin, Madison
Karen N. Hale, R.Ph., M.P.H.The Ohio State University
A3
RELATIONSHIP BUILDING THROUGH INTERNATIONAL COLLABORATIVE RESEARCH
Shelley BizillaIndiana University
John Baumann, Ph.D. Indiana University
David O. Ayuku, Ph.D.Moi University
A4
CONSIDERING CULTURE WHEN CREATING AN HRPP
Meixia Wang, Ph.D., M.D.Beijing You'an Hospital, Capital Medical University, China
Michel Toungouz Névessignsky, M.D.Erasme Hospital
A5 A SPONSOR’S PERSPECTIVE ON INTERNATIONAL RESEARCH IN LOW RESOURCE COUNTRIES
Draft November 30, 2012 Page 8 of 19
2013 Annual Conference AgendaAlbert J Allen, M.D.
Eli Lilly
A6
AAHRPP RECOMMENDATIONS ON REVIEWING RESEARCH ON ADULTS WITH DIMINSHED DECISION-MAKING CAPACITY
Marjorie A. Speers, Ph.D.AAHRPP
1:45 P.M. – 2:35 P.M. ConcurrentSessions B1
EFFECTIVE MANAGEMENT OF INDIVIDUAL CONFLICT OF INTEREST
Debra Thurley, J.D. The Pennsylvania State University
David Blake, Ph.D., J.D. Cedars-Sinai Medical Center
B2
INTERPRETING AND LEARNING FROM OHRP DETERMINATIONS
Kristina C. Borror, Ph.D. Office of Human Research Protection
B3STRENGTHENING THE RESEARCHERS’ ROLE IN THE HRPP
Francis DiMario, M.D.Connecticut Children's Medical Center Corporation
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2013 Annual Conference Agenda
B4
SUCCEEDING AT COMMUNITY ENGAGEMENT
Mary Jane Welch, DNP, APRN, BC, CIPRush University Medical Center
Corey Ford, M.D., Ph.D.The University of New Mexico Health Sciences Center
B5
AAHRPP TOP 10 FINDINGS IN THE STEP 1 REVIEW
Robert Hood, Ph.D.AAHRPP
B6
THE NEURO-NEX MODEL OF IRB REVIEW
Pearl O’Rourke, M.D.Partners HealthCare System
2:40 P.M. – 3:00 PM Break
3:05 P.M. – 3:55 P.M. ConcurrentSessions
C1 COLLECTING AND ANALYZING METRICS FOR QUALITY IMPROVEMENT
K. Sue Haddock, Ph.D.William Jennings Bryan Dorn Veterans Affairs Medical Center
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2013 Annual Conference Agenda
Cheryl Byers, M.H.A., C.I.P.University of South Florida
C2
EXERCISING FLEXIBILITY IN APPLYING THE REGULATIONS
Susan Rose, Ph.D. University of Southern California
Judy Birk, J.D.University of Michigan
C3
COMMON FINDINGS IN FDA INSPECTIONS OF IRBS AND INVESTIGATORS
Gary Chadwick, Pharm.D., M.P.H., C.I.P.University of Rochester
C4
RESEARCH INTEGRITY AND THE HRPP: COLLABORATIVE EFFORTS IN HANDLING RESEARCH MISCONDUCT
ALLEGATIONS
Kristin H. West, J.D., M.S.Emory University
C5 REVIEWING MULTI-SITE RESEARCH CONDUCTED IN OTHER COUNTRIES
Carrie Fisher, Ph. D.
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2013 Annual Conference AgendaWestern IRB
C6RESULTS OF ORO INSPECTIONS
J.Thomas Puglisi, Ph.D. InvitedDepartment of Veterans Affairs
4:00 P.M. – 5:00 P.M. Plenary P3
HOW CLOSELY DO INSTITUTIONAL REVIEW BOARDS FOLLOW THE COMMON RULE
Paul S. Appelbaum, M.D.Columbia University
5:00 P.M. – 6:00 P.M. Reception RECEPTION AND POSTER PRESENTATIONS
APRIL 5, 2013 FRIDAY
7:00 A.M. – 3:00 P.M. ATTENDEE REGISTRATION
7:00 A.M. – 1:00 P.M. VISITING HOURS FOR EXHIBITORS
8:00 A.M. – 9:00 A.M. Plenary P4 MANAGING INCIDENTAL FINDINGS AND RESEARCH RESULTS IN GENOMIC RESEARCH: WHAT RESPONSIBILITIES SHOULD
Draft November 30, 2012 Page 12 of 19
2013 Annual Conference AgendaBIOBANKS AND RESEARCHERS SHOULDER?
Jeffrey Kahn,Ph.D, M.P.H.Johns Hopkins University
9:05 A.M. – 9:55 A.M. ConcurrentSessions D1
THE AMERICAN ANTHROPOLOGICAL ASSOCIATION REVISED ETHICS CODE
Hugh Gusterson, Ph.D.American Anthropological Association
D2
AN UPDATE ON ACTIVITY OF THE SECRETARY’S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS
Gary Chadwick, Pharm.D., M.P.H., C.I.P.University of Rochester
D3
TRENDS IN INDEPENDENT IRB MODELS
Michael Woods Schulman Associates
D4 STREAMLINING IRB REVIEW FOR MULTISITE RESEARCH: RESULTS OF A RANDOMIZED, CONTROLLED TRIAL OF
CENTRAL VERSUS LOCAL IRB REVIEW
Daniel K. Nelson, M.S., C.I.P.The University of North Carolina at Chapel Hill
Draft November 30, 2012 Page 13 of 19
2013 Annual Conference Agenda
D5
ADOPTION OF NEW BEHAVIORAL SOCIAL SCIENCE LAW IN KOREA
Byung-In Choe, M.B.A., LL.M., Ph.D.The Catholic University of Korea Catholic Medical Center
D6
IRB REVIEW OF COMMUNITY-BASED PARTICIPATORY RESEARCH
Monika Markowitz, Ph.D., M.S.N., R.N., M.A.Virginia Commonwealth University
Elizabeth Ripley, M.D., M.S.Virginia Commonwealth University
9:55 A.M. – 10:15 A.M. Break
10:20 A.M. – 11:10 A.M. ConcurrentSessions E1
GENOMIC RESEARCH AND HEALTH EQUITY CONSIDERATIONS
Melody J. Slashinski, Ph.D., M.P.H.Baylor College of Medicine
E2 THE “IRBSHARE” MODEL FOR EFFICIENT REVIEW OF MULTI-SITE RESEARCH
Gordon Bernard, M.D.
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2013 Annual Conference AgendaVanderbilt University
E3
IRB REVIEW OF REGISTRIES, DATABASES AND BIOBANKING
Camille Gerhardt J.D.Quorum Review
E4INTERNATIONAL ETHICS EDUCATION FOR GRADUATE
STUDENTS
Speaker to be Determined
E5
INFORMED CONSENT FOR WHOLE GENOME SEQUENCING: A QUALITATIVE ANALYSIS OF PARTICIPANT EXPECTATIONS
AND PERCEPTIONS OF RISKS, BENEFITS, AND HARMS
Speaker to be Determined
E6 CLARITY AND APPEAL OF A MULTIMEDIA INFORMED CONSENT TOOL FOR BIOBANKING
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2013 Annual Conference AgendaSpeaker to be Determined
11:15 A.M. – 12:30 P.M. Lunch NETWORKING LUNCH
12:35 P.M. –1:35 P.M. Plenary P5
PATERNALISM VS. PARTNERSHIP IN GENETIC RESEARCH
Rebecca Dresser Ph.D.Washington University
1:40 P.M. – 2:30 P.M. Concurrent Sessions F1
THE NEW NCI MODEL FOR CENTRAL IRB REVIEW
Jeanne M. Adler, R.N., M.P.H., C.C.R.P.National Cancer Institute
Jacquelyn Goldberg J.D.National Cancer Institute
F2
THE INTERSECTION OF INSTITUTIONAL AND INVESTIGATOR CONFLICT OF INTEREST
Lynn Zentner, J.D.University of Minnesota
Jennifer L. KunzaWashington University in St Louis
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2013 Annual Conference Agenda
F3
CROSS CULTURAL CHALLENGES IN OBTAINING CONSENTElena Chugunova
Pfizer H.C.P. Corporation
Ying-Chun ShenNational Taiwan University Hospital
F4
QUALITY IMPROVEMENT OF THE HRPP
Jose Perdomo, J.D.Miami Children’s Hospital
Seil Jang Samsung Medical Center
F5
SYSTEM WIDE OVERSIGHT AND REGULATORY COMPLIANCE
Wesley Byerly, Pharm.DUniversity of Texas System
F6
ETHICAL CHALLENGES IN PHASE ONE RESEARCH
Phil BachCelerion, Inc
Suzie Talbot, InvitedDieux
Draft November 30, 2012 Page 17 of 19
2013 Annual Conference Agenda
2:35 P.M. – 2:55 P.M. Break
3:00 P.M. – 3:50 P.M. Concurrent Sessions G1
MAKING AND DOCUMENTING IRB DECISIONS: NON-COMPLIANCE AND UNANTICIPATED PROBLEMS
Ruth Mulnard D.N.Sc., R.N., C.N.R.N., C.I.P., F.A.A.N.University of California, Irvine
G2
CONTRIBUTE COMMENTS ON METRICS TO AAHRPP STAFF
Marjorie A. Speers, Ph.D.AAHRPP
G3 RESERVED
G4
STANDARD I.3. --WHAT AAHRPP EXPECTS IN TRANSNATIONAL RESEARCH
Chair, AAHRPP Council on Accreditation
G5
IRB REVIEW IN A GLOBAL CONTEXT
Renee Holt, R.N., J.D., M.P.H.Fred Hutchinson Cancer Center
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2013 Annual Conference Agenda
G6
RESEARCH WITH BANKED SPECIMENS
Robyn Shapiro J.D.Drinker Biddle & Reath LLP
4:00 P.M. Adjourn
Draft November 30, 2012 Page 19 of 19