2013 Annual Conference Agenda
APRIL 2, 2013
4:00 P.M.
– 8:00 P.M.
APRIL 3, 2013
7:00 A.M.
– 5:00 P.M.
7:00 A.M. – 8:00 A.M.
TUESDAY
8:00 A.M. – 8:15 A.M.
8:15 A.M. – 8:45 A.M.
PC1
PC2
8:45 A.M. – 9:15 A.M. PC3
ATTENDEE REGISTRATION
PRE-CONFERENCE WORKSHOPS
ATTENDEE REGISTRATION
CONTINENTAL BREAKFAST
WELCOME
Marjorie A. Speers, Ph.D., President and CEO, AAHRPP
INTRODUCTION TO THE AAHRPP ACCREDITATION
PHILOSOPHY AND PROCESS
Chair, AAHRPP Council on Accreditation
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
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2013 Annual Conference Agenda
9:15 A.M. – 10:15 A.M.
10:15 A.M. – 10:30 A.M.
10:30- NOON
12:00- 1:00 P.M.
Draft November 30, 2012 Page 2 of 20
PC4
PC5
SELF- ASSESSMENT PROCESS AND PRODUCT:
STRATEGIES 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
Services
The University of Texas Health Science Center at Houston
BREAK
OVERVIEW OF THE AAHRPP STANDARDS:
DOMAIN I
DOMAIN II
DOMAIN III
Wesley G. Byerly, Pharm.D.
Assistant Systemwide Compliance Officer - Research
Office of General Counsel
The University of Texas System
LUNCH
BREAK INTO TWO GROUPS: INITIAL ACCREDITATION AND
RENEWING ACCREDITATION

2013 Annual Conference Agenda
1:00 P.M. – 1:30 P.M.
1:30 P.M. - 2:30 P.M.
2:30 P.M
– 3:15 P.M.
3:15 P.M. - 3:30 P.M.
3:30 P.M. - 4:00 P.M.
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PCI1
PCI2
PCI3
PCI4
INITIAL ACCREDITATION
BREAKING DOWN THE RUMORS ABOUT ACCREDITATION
Wayne R. Patterson, Ph.D.
Associate Vice President for Research
Director, Office of Research Support
The University of Texas at Austin
PUTTING TOGETHER THE APPLICATION: ORGANIZING YOUR
POLICIES AND PROCEDURES
Barbara Santiago, B.A.
Director of Quality Improvement, AAHRPP
NAVIGATING THE STEP ONE PROCESS AND RESPONSE
Robert Hood, Ph.D.
Associate Director of Accreditation, AAHRPP
BREAK
MAXIMIZING THE AVAILABLE RESOURCES TO SIMPLIFY THE
APPLICATION PROCESS
Moira A Keane, M.A, C.I.P.
Consultant

2013 Annual Conference Agenda
4:00 P.M.
– 4:30 P.M.
4:30 P.M.
– 5:00 P.M.
1:00 P.M. – 1:45 P.M.
1:45 P.M. - 2:30 P.M.
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PCI5
PCI6
PCR
1
PCR
2
PREPARING FOR A SITE VISIT
Sujatha Sridhar, M.B.B.S., M.C.E.
Executive Director, Research Compliance, Education, and Support
Services
The University of Texas Health Science Center at Houston
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
MISTAKES TO AVOID ON RE-ACCREDITATION
David C. Clark, Ph.D
.
Associate Dean for Clinical Research
Medical College of Wisconsin
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

2013 Annual Conference Agenda
2:30 P.M – 3:15 P.M.
3:15 P.M. - 3:30 P.M.
3:30 P.M. - 4:00 P.M.
4:00 P.M.
– 4:30 P.M.
4:30 P.M.
– 5:00 P.M.
Draft November 30, 2012 Page 5 of 20
PCR
3
PCR
4
PCR
5
PCR
6
MANAGING THE UPDATING PROCESS
Martha F. Jones, M.A., C.I.P.
Executive Director of Human Studies
Washington University in St. Louis
BREAK
HANDLING THE MOST CHALLENGING STANDARDS
Robert Hood, Ph.D.
Associate Director of Accreditation, AAHRPP
LESSONS LEARNED FROM PREVIOUS EXPERIENCES
Candice A. Yekel, M.S., C.I.M.
Director, Office for Research Protections
The Pennsylvania State University
MAXIMIZING THE AVAILABLE RESOURCES TO SIMPLIFY THE
RE-ACCREDITATION PROCESS
Moira A Keane, M.A, C.I.P.
Consultant

2013 Annual Conference Agenda
APRIL 4, 2013
7:00 A.M. – 5:00 P.M.
7:00 A.M. – 5:00 P.M.
7:00 A.M. - 8:00 A.M.
THURSDAY
8:00 A.M. – 8:50 A.M.
Welcome
Opening
8:50 A.M. – 9:40 A.M. Plenary
9:40 A.M. – 10:00 A.M.
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Break
W1
ATTENDEE REGISTRATION
VISITING HOURS FOR EXHIBITORS
CONTINENTAL BREAKFAST
OPENING PLENARY
Marjorie A. Speers, Ph.D., AAHRPP
James Weyhenmeyer, Ph.D., Chair, AAHRPP Board of Directors
P1
INTERNATIONAL RESEARCH
BRIDGING BIOETHICS AND PRACTICE
Sergio Litewka, M.D.
University of Miami

2013 Annual Conference Agenda
10:00 A.M.
11:35 A.M.
– 11:30 A.M.
– 12:45 P.M.
Panel
Lunch
12:50 P.M.
– 1:40P.M.
Concurrent
Sessions
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
A1
BEYOND THE IRB: METRICS FOR THE WHOLE HRPP
Eifaang Li, D.V.M., M.P.H., C.I.P.
Cedars-Sinai Medical Center
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2013 Annual Conference Agenda
Draft November 30, 2012 Page 8 of 20
A2
A3
A4
STREAMLINING REVIEW THROUGH COLLABORATIONS AND
CONSORTIUM AGREEMENTS
Nichelle Cobb, Ph.D.
University of Wisconsin, Madison
Karen N. Hale, R.Ph., M.P.H.
The Ohio State University
RELATIONSHIP BUILDING THROUGH INTERNATIONAL
COLLABORATIVE RESEARCH
Shelley Bizilla
Indiana University
John Baumann, Ph.D.
Indiana University
David O. Ayuku, Ph.D.
Moi University
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

2013 Annual Conference Agenda
1:45 P.M. – 2:35 P.M.
Concurrent
Sessions
A5
A6
B1
B2
A SPONSOR’S PERSPECTIVE ON INTERNATIONAL
RESEARCH IN LOW RESOURCE COUNTRIES
Albert J Allen, M.D.
Eli Lilly
AAHRPP RECOMMENDATIONS ON REVIEWING RESEARCH
ON ADULTS WITH DIMINSHED DECISION-MAKING CAPACITY
Marjorie A. Speers, Ph.D.
AAHRPP
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
INTERPRETING AND LEARNING FROM OHRP
DETERMINATIONS
Kristina C. Borror, Ph.D.
Office of Human Research Protection
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2013 Annual Conference Agenda
2:40 P.M.
– 3:00 PM
Draft November 30, 2012 Page 10 of 20
Break
B3
B4
B5
B6
STRENGTHENING THE
RESEARCHERS’ ROLE IN THE HRPP
Francis DiMario, M.D.
Connecticut Children's Medical Center Corporation
SUCCEEDING AT COMMUNITY ENGAGEMENT
Mary Jane Welch, DNP, APRN, BC, CIP
Rush University Medical Center
Corey Ford, M.D., Ph.D.
The University of New Mexico Health Sciences Center
AAHRPP TOP 10 FINDINGS IN THE STEP 1 REVIEW
Robert Hood, Ph.D.
AAHRPP
THE NEURO-NEX MODEL OF IRB REVIEW
Pearl O’Rourke, M.D.
Partners HealthCare System

2013 Annual Conference Agenda
3:05 P.M.
– 3:55 P.M.
Concurrent
Sessions
C1
C2
C3
COLLECTING AND ANALYZING METRICS FOR QUALITY
IMPROVEMENT
K. Sue Haddock, Ph.D.
William Jennings Bryan Dorn Veterans Affairs Medical Center
Cheryl Byers, M.H.A., C.I.P.
University of South Florida
EXERCISING FLEXIBILITY IN APPLYING THE REGULATIONS
Susan Rose, Ph.D.
University of Southern California
Judy Birk, J.D.
University of Michigan
COMMON FINDINGS IN FDA INSPECTIONS OF IRBS AND
INVESTIGATORS
Gary Chadwick, Pharm.D., M.P.H., C.I.P.
University of Rochester
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2013 Annual Conference Agenda
4:00 P.M.
– 5:00 P.M.
Plenary
5:00 P.M.
– 6:00 P.M.
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Reception
C4
C5
C6
P3
RESEARCH INTEGRITY AND THE HRPP: COLLABORATIVE
EFFORTS IN HANDLING RESEARCH MISCONDUCT
ALLEGATIONS
Kristin H. West, J.D., M.S.
Emory University
REVIEWING MULTI-SITE RESEARCH CONDUCTED IN OTHER
COUNTRIES
Carrie Fisher, Ph. D.
Western IRB
RESULTS OF ORO INSPECTIONS
J.Thomas Puglisi, Ph.D. Invited
Department of Veterans Affairs
HOW CLOSELY DO INSTITUTIONAL REVIEW BOARDS
FOLLOW THE COMMON RULE
Paul S. Appelbaum, M.D.
Columbia University
RECEPTION AND POSTER PRESENTATIONS

2013 Annual Conference Agenda
APRIL 5, 2013
7:00 A.M.
– 3:00 P.M.
7:00 A.M.
– 1:00 P.M.
8:00 A.M.
9:05 A.M.
– 9:00 A.M.
– 9:55 A.M.
FRIDAY
Plenary
Concurrent
Sessions
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P4
D1
D2
ATTENDEE REGISTRATION
VISITING HOURS FOR EXHIBITORS
MANAGING INCIDENTAL FINDINGS AND RESEARCH RESULTS
IN GENOMIC RESEARCH: WHAT RESPONSIBILITIES SHOULD
BIOBANKS AND RESEARCHERS SHOULDER?
Jeffrey Kahn,Ph.D, M.P.H.
Johns Hopkins University
THE AMERICAN ANTHROPOLOGICAL ASSOCIATION REVISED
ETHICS CODE
Hugh Gusterson, Ph.D.
American Anthropological Association
AN UPDATE ON ACTIVITY OF THE S ECRETARY’S ADVISORY
COMMITTEE ON HUMAN RESEARCH PROTECTIONS
Gary Chadwick, Pharm.D., M.P.H., C.I.P.
University of Rochester

2013 Annual Conference Agenda
9:55 A.M. – 10:15 A.M.
Draft November 30, 2012 Page 14 of 20
Break
D3
D4
D5
D6
TRENDS IN INDEPENDENT IRB MODELS
Michael Woods
Schulman Associates
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
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
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

2013 Annual Conference Agenda
10:20 A.M. – 11:10 A.M.
Concurrent
Sessions
E1
E2
E3
GENOMIC RESEARCH AND HEALTH EQUITY
CONSIDERATIONS
Melody J. Slashinski, Ph.D., M.P.H.
Baylor College of Medicine
THE “IRBSHARE” MODEL FOR EFFICIENT REVIEW OF MULTI-
SITE RESEARCH
Gordon Bernard, M.D.
Vanderbilt University
IRB REVIEW OF REGISTRIES, DATABASES AND BIOBANKING
Camille Gerhardt J.D.
Quorum Review
E4
INTERNATIONAL ETHICS EDUCATION FOR GRADUATE
STUDENTS
Speaker to be Determined
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2013 Annual Conference Agenda
11:15 A.M. – 12:30 P.M.
12:35 P.M. –1:35 P.M.
Lunch
Plenary
E5
E6
P5
INFORMED CONSENT FOR WHOLE GENOME SEQUENCING: A
QUALITATIVE ANALYSIS OF PARTICIPANT EXPECTATIONS
AND PERCEPTIONS OF RISKS, BENEFITS, AND HARMS
Speaker to be Determined
CLARITY AND APPEAL OF A MULTIMEDIA INFORMED
CONSENT TOOL FOR BIOBANKING
Speaker to be Determined
NETWORKING LUNCH
PATERNALISM VS. PARTNERSHIP IN GENETIC RESEARCH
Rebecca Dresser Ph.D.
Washington University
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2013 Annual Conference Agenda
1:40 P.M. – 2:30 P.M.
Concurrent
Sessions
F1
F2
F3
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
THE INTERSECTION OF INSTITUTIONAL AND INVESTIGATOR
CONFLICT OF INTEREST
Lynn Zentner, J.D.
University of Minnesota
Jennifer L. Kunza
Washington University in St Louis
CROSS CULTURAL CHALLENGES IN OBTAINING CONSENT
Elena Chugunova
Pfizer H.C.P. Corporation
Ying-Chun Shen
National Taiwan University Hospital
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2013 Annual Conference Agenda
2:35 P.M.
– 2:55 P.M.
Break
F4
F5
F6
QUALITY IMPROVEMENT OF THE HRPP
Jose Perdomo, J.D
.
Miami
Children’s Hospital
Seil Jang
Samsung Medical Center
SYSTEM WIDE OVERSIGHT AND REGULATORY COMPLIANCE
Wesley Byerly, Pharm.D
University of Texas System
ETHICAL CHALLENGES IN PHASE ONE RESEARCH
Phil Bach
Celerion, Inc
Suzie Talbot, Invited
Dieux
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2013 Annual Conference Agenda
3:00 P.M.
– 3:50 P.M.
Concurrent
Sessions
G1
G2
G3
G4
G5
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
CONTRIBUTE COMMENTS ON METRICS TO AAHRPP STAFF
Marjorie A. Speers, Ph.D.
AAHRPP
RESERVED
STANDARD I.3. --WHAT AAHRPP EXPECTS IN
TRANSNATIONAL RESEARCH
Chair, AAHRPP Council on Accreditation
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
4:00 P.M. Adjourn
G6
RESEARCH WITH BANKED SPECIMENS
Robyn Shapiro J.D.
Drinker Biddle & Reath LLP
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