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2015 ANNUAL AAHRPP CONFERENCE
LOOKING BACK AND LOOKING FORWARD: COMPLIANCE, COLLABORATION AND COMMUNITY
Conference Agenda
May 19 – 21, 2015
Chicago, IL
MONDAY – MAY 18, 2015
REGISTRATION
4:00pm – 8:00pm
ATTENDEE REGISTRATION
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TUESDAY – MAY 19, 2015
PRE-CONFERENCE WORKSHOP
7:00am – 8:00am
ATTENDEE REGISTRATION
7:00am – 8:00am
CONTINENTAL BREAKFAST
7:00am – 5:00pm
VISITING HOURS FOR EXHIBITORS
8:00am – 8:15am
PC1
8:15am – 8:45am
PC2
8:45am – 9:15am
PC3
9:15am – 10:15am
PC4
10:15am – 10:30am
Break
10:30am – 11:30am
PC5
12:00pm – 1:00pm
Lunch
1:00pm – 3:15pm
PC6
3:15pm – 3:30pm
Break
3:30pm – 4:30pm
PC7
4:30pm
Adjourn
WELCOME
Elyse I. Summers, J.D., AAHRPP
OVERVIEW OF AAHRPP
Elyse I. Summers, J.D., AAHRPP
ACCREDITATION PROCESS
Wayne Patterson, Ph.D., University of Texas at Austin
Sarah Giannakopoulos, M.A., AAHRPP
HOW TO CONDUCT THE SELF-ASSESSMENT
Wesley Byerly, Pharm.D., University of Texas
Martha F. Jones, M.A., C.I.P., Washington University in St. Louis
WHAT TO EXPECT DURING AND AFTER THE SITE VISIT
John Baumann, Ph.D., University of Indiana
Judy Matuk, M.S., State University of New York at Stony Brook
REVIEW OF ACCREDITATION STANDARDS
Candice Yekel, M.A., The Pennsylvania State University
Delia Wolf, M.D., J.D., M.S., Harvard School of Public Health
QUESTIONS AND ANSWERS
All Faculty
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WEDNESDAY – MAY 20, 2015
CONFERENCE I
7:00am – 5:00pm
ATTENDEE REGISTRATION
7:00am – 8:00am
CONTINENTAL BREAKFAST
7:00am – 5:00pm
VISITING HOURS FOR EXHIBITORS
8:00am – 9:00am
Welcome
Opening
W1
WELCOME
Jeffrey Wendel, B.S., M.B.A, Chair, AAHRPP Board of
Directors
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LOOKING BACK AND LOOKING FORWARD:
COMPLIANCE, COLLABORATION AND COMMUNITY
Elyse I. Summers, J.D., AAHRPP
9:00am – 10:15am
Plenary
10:15am – 10:30am
Break
10:30am – 11:45am
Concurrent
Sessions
11:45am – 1:15pm
Lunch
P1
THEN AND NOW: HOW THE SUSPENSIONS BY OPRR
CHANGED THE IRB LANDSCAPE
David Clark, Ph.D., Medical College of Wisconsin
Michele Russell-Einhorn, J.D., Dana Farber Cancer Institute
Tom Puglisi, Ph.D., Department of Veteran’s Affairs
George Gasparis, B.S., PEER Consulting Group
A1
UNIQUE ISSUES WHEN REVIEWING SBER
Wayne R. Patterson, Ph.D., The University of Texas at Austin
Cynthia Monahan, M.B.A., C.I.P., Boston University
A2
NONCOMPLIANCE IN BIOMEDICAL RESEARCH:
SYSTEM FAILURE, QUALITY INDICATOR, OR WILLFUL
NEGLECT
Scott J. Lipkin, D.P.M., C.I.P., FTI Consulting
A3
DEMYSTIFYING CONSENT REQUIREMENTS
Megan Kasimatis-Singleton, J.D., M.B.E., C.I.P., University of
Pennsylvania
A4
QUALITY IMPROVEMENT: THE HRPP AND THE
ELECTRONIC SYSTEM
Candice Yekel, M.A., Pennsylvania State University
Sara Horn, C.I.P., Pennsylvania State University
A5
MEETING THE ACCREDITATION STANDARDS: DOMAIN I
Kathleen Lawry, M.S.S.A., C.I.P., C.I.M., Reliant Review
Martha F. Jones, M.A., C.I.P., Washington University in St.
Louis
PRESENTATIONS OF CERTIFICATES OF
ACCREDITATION AND AWARDS
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1:15pm – 2:30pm
2:45pm – 4:00pm
Concurrent
Sessions
Concurrent
Sessions
3:45pm – 4:00pm
Break
4:00pm – 5:00pm
Plenary
5:00pm – 6:00pm
B1
FINANCIAL COI: BEST PRACTICES
Heather Pierce, J.D., AAMC
B2
CREATING EFFICIENCIES THROUGH COLLABORATION:
NEURONEXT AND IRBSHARE
Pearl O’Rourke, M.D., Partners HealthCare System
Julie Ozier, M.H.L., Vanderbilt University
B3
OBTAINING PERMISSION IN PEDIATRIC RESEARCH:
WHAT DOES “REASONABLY AVAILABLE” MEAN?
Daniel Nelson, M.S., U.S. Environmental Protection Agency
B4
INTERNATIONAL PERSPECTIVE:
ACHIEVING A ROBUST HUMAN RESEARCH
PROTECTION PROGRAM
David Borasky, M.P.H., Copernicus Group IRB
B.I. Choe, Ph.D., The Catholic University of Korea
B5
MEETING THE ACCREDITATION
STANDARDS: DOMAIN II
Wesley Byerly, Ph.D., University of Connecticut Health
Center
John Baumann, Ph.D., Indiana University
FOCUSING ON THE REVIEW CRITERIA
IN THE IRB MEETING
Jonathan Green, M.D., University of Washington at St. Louis
Judy Birk, J.D., University of Michigan Health System
C1
C2
COLLABORATIONS: BIOBANKING AND LARGE DATA
SETS
Sue Rivera, Ph.D., Case Western Reserve University
C3
WHAT WE MEAN BY ENGAGEMENT: PATIENT
CENTERED RESEARCH
Cynthia Hahn, C.I.P., Northshore-LIJ Health System
Veronica Todaro, M.P.H., Parkinson’s Disease Foundation
C4
EXPLORING IRB CONSIDERATIONS IN SOCIAL MEDIA
RESEARCH
Elizabeth Buchanan, Ph.D., University of Wisconsin, Stout
C5
TOP 10 FINDINGS FROM 2014 APPLICATIONS AND SITE
VISITS
Sarah H Kiskaddon, J.D., AAHRPP
Candice Yekel, M.A, The Pennsylvania State University
P2
FACING THE CHALLENGES OF REVIEWING
COMPARATIVE EFFECTIVENESS RESEARCH
Julie Kaneshiro, M.A., OHRP
Ivor Pritchard, Ph.D., OHRP
RECEPTION AND POSTER PRESENTATIONS
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THURSDAY – MAY 21, 2015
CONFERENCE II
7:00am – 3:00pm
ATTENDEE REGISTRATION
7:00am – 8:00am
CONTINENTAL BREAKFAST
7:00am – 1:00pm
VISITING HOURS FOR EXHIBITORS
8:00am – 9:00am
Plenary
P3
SHARING DATA FROM CLINICAL TRIALS WITH
RESEARCH PARTICIPANTS
Barbara Bierer, M.D., Brigham and Women’s Hospital,
Harvard Medical School
9:15am – 10:30am
Concurrent
Sessions
D1
DOGS, CATS, AND DISGUST: REVIEW OF A COMMON
TYPE OF SOCIAL/BEHAVIORAL RESEARCH STUDY
Ivor Pritchard, Ph.D., OHRP
Julie Kaneshiro, M.A.,OHRP
D2
TEAMWORK IN THE TRENCHES: HOW TO
COLLABORATE ACROSS YOUR HRPP
Marley Thrasher, B.A., PRIM&R
D3
VULNERABLE POPULATIONS: SUBPART D AND
ABOVE MINIMAL RISK RESEARCH IN CHILDREN
Bruce Gordon, M.D., University of Nebraska Medical Center
Francis DiMario, M.D., Connecticut Children’s Medical Center
D4
JUST DO IT: WAIVERS AND FLEXIBILITY IN INFORMED
CONSENT
Michelle Feige, M.S.W., OHRP
Susan Rose, Ph.D., U.S.C.
D5
NEGOTIATING CONTRACTS THAT PROTECT HUMAN
RESEARCH PARTICIPANTS
David Forster, J.D., M.A.,WIRB
Cynthia W. Hahn, C.I.P., Northshore-LIJ Health System
10:30am – 10:45am
Break
10:45am – 12:00pm
Concurrent
Sessions
E1
MEETING STANDARDS IN HUMAN RESEARCH
PROTECTIONS: THE GLOBAL CHALLENGE
Delia Wolf, M.D., Harvard University
Ponni Subbiah, M.D., Global Med Strategies, LLC.
Sarah H. Kiskaddon, J.D., AAHRPP
E2
THE CONTINUING CHALLENGE OF QUALITY
IMPROVEMENT
K. Sue Haddock, Ph.D., R.N.,
WJB Dorn Veterans Affairs Medical Center
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E3
VALID INFORMED CONSENT EDUCATION (VoICE)
PROJECT
Elizabeth Bankert, M.A., Dartmouth University
E4
ADVANCING THE HRPP CONCEPT: INTERNATIONAL
PERSPECTIVE
B.I. Choe, Ph.D., The Catholic University of Korea
Ian Chen, M.D., LL.M., National Taiwan University Hospital,
Mohamed Sager, M.D., Ph.D., King Fahad Specialist
Hospital Dammam
E5
PREPARING FOR PARTICIPANT-LEVEL DATA SHARING:
REGULATORY MANDATES AND THE ROLE OF THE
HRPP
Barbara Bierer, M.D., Brigham and Women’s Hospital,
Harvard Medical School
NETWORKING LUNCH
[FLEX COALITION LUNCH]
CENTRAL IRBS: OPPORTUNITIES AND CHALLENGES—
REAL AND PERCEIVED
Pearl O’Rourke, M.D., Partners HealthCare System
UPDATE FROM OHRP
Ivor Pritchard, Ph.D., OHRP
Julie Kaneshiro, M.A., OHRP
12:00pm – 1:00pm
Lunch
1:00pm – 2:00pm
Plenary
P4
2:15pm – 3:30pm
Concurrent
Sessions
F1
3:30pm
Adjourn
F2
SINGLE IRB REVIEW: VIEW FROM THE INDEPENDENTS
David Forster, J.D., Western IRB
Lauri Carlile, M.S., C.I.P., Chesapeake IRB
F3
GLOBAL AND DOMESTIC EDUCATIONAL INITIATIVES
Sergio Litewka, M.D., M.P.H., University of Miami
Karen Hansen, B.A.., Fred Hutchinson Cancer Research
Center
Michelle Feige, M.S.W., OHRP
F4
LESSONS LEARNED FROM INTERNATIONAL AAHRPP
ACCREDITATIONS: CHINA AND TAIWAN [SESSION
PRESENTED IN MANDARIN]
Delia Wolf, M.D., J.D.,M.S., Harvard School of Public Health
(moderator)
Xiuqin Wang, M.D., Jiangsu Province Hospital, China
Hong-Nerng Ho, M.D., National Taiwan University Hospital
F5
INITIATIVES TO PROMOTE A CULTURE OF
COMPLIANCE AND FACILITATE THE ETHICAL
CONDUCT OF RESEARCH: BRIDGING THE GAP
BETWEEN RESEARCHERS AND THE IRB
Cathy Powers, M.B.A., C.R.R.C., C.I.P.
Ann & Robert H. Lurie Children’s Hospital of Chicago
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