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2015 ANNUAL AAHRPP CONFERENCE
LOOKING BACK AND LOOKING FORWARD: COMPLIANCE, COLLABORATION AND COMMUNITY
MONDAY – MAY 18, 2015
REGISTRATION
4 p.m. – 8 p.m.
ATTENDEE REGISTRATION
Normandie
Lounge
TUESDAY – MAY 19, 2015
PRE-CONFERENCE WORKSHOP
7 a.m. – 8 p.m.
ATTENDEE REGISTRATION
7 a.m. – 8 a.m.
CONTINENTAL BREAKFAST
7 a.m. – 5 p.m.
VISITING HOURS FOR EXHIBITORS
8 a.m. – 8:15 a.m.
PC1
8:15 a.m. – 8:45 a.m.
PC2
8:45 a.m. – 9:15 a.m.
PC3
9:15 a.m. – 10:15 a.m.
PC4
10:15 a.m. – 10:30 a.m.
Break
10:30 a.m. – 11:30 a.m.
PC5
12:00 p.m. – 1:00 p.m.
Lunch
1:00 p.m. – 3:15 p.m.
PC6
3:15 p.m. – 3:30 p.m.
Break
3:30 p.m. – 4:30 p.m.
PC7
4:30 p.m.
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 H. Kiskaddon, J.D., AAHRPP
Michelle Kost, AAHRPP
HOW TO CONDUCT THE SELF-ASSESSMENT
Wesley Byerly, Pharm.D., University of Connecticut Health Center
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.S., Pennsylvania State University
Delia Wolf, M.D., J.D., M.S., Harvard School of Public Health
QUESTIONS AND ANSWERS
All Faculty
Normandie
Lounge
Grand
Ballroom
Normandie
Lounge
Grand
Ballroom
Grand
Ballroom
Grand
Ballroom
Grand
Ballroom
Normandie
Lounge
Grand
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Grand
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Grand
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Normandie
Lounge
Grand
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Grand
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WEDNESDAY – MAY 20, 2015
CONFERENCE I
7:00 a.m. – 5:00 p.m.
ATTENDEE REGISTRATION
7:00 a.m. – 8:00 a.m.
CONTINENTAL BREAKFAST
7:00 a.m. – 5:00 p.m.
VISITING HOURS FOR EXHIBITORS
8:00 a.m. – 9:00 a.m.
Welcome
Opening
W1
WELCOME
Jeffrey Wendel, M.B.A, Chair, AAHRPP Board of Directors
Normandie
Lounge
Grand
Ballroom
Normandie
Lounge
Grand
Ballroom
LOOKING BACK AND LOOKING FORWARD:
COMPLIANCE, COLLABORATION, AND COMMUNITY
Elyse I. Summers, J.D., AAHRPP
9:00 a.m. – 10:15 a.m.
Plenary
10:15 a.m. – 10:30 a.m.
Break
10:30 a.m. – 11:45 a.m.
Concurrent
Sessions
11:45 a.m. – 1:15 p.m.
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 Veterans Affairs
George Gasparis, B.S., PEER Consulting Group
Grand
Ballroom
Normandie
Lounge
Williford C
A1
UNIQUE ISSUES WHEN REVIEWING SBER
Wayne R. Patterson, Ph.D., 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
Williford B
A3
DEMYSTIFYING CONSENT REQUIREMENTS
Megan Kasimatis-Singleton, J.D., M.B.E., C.I.P., University of
Pennsylvania
Williford A
A4
QUALITY IMPROVEMENT: THE HRPP AND THE
ELECTRONIC SYSTEM
Candice Yekel, M.A., Pennsylvania State University
Sara Horn, C.I.P., Pennsylvania State University
Boulevard C
A5
MEETING THE ACCREDITATION STANDARDS: DOMAIN I
and III
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
Boulevard A
PRESENTATION OF CERTIFICATES OF
ACCREDITATION AND AWARDS
Grand
Ballroom
1:15 p.m. – 2:30 p.m.
2:45 p.m. – 4:00 p.m.
Concurrent
Sessions
Concurrent
Sessions
3:45 p.m. – 4:00 p.m.
Break
4:00 p.m. – 5:00 p.m.
Plenary
B1
ASSESSING AND ADDRESSING THE IMPACT OF
FINANCIAL CONFLICT OF INTEREST REGULATIONS
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
Williford B
B3
OBTAINING PERMISSION IN PEDIATRIC RESEARCH:
WHAT DOES “REASONABLY AVAILABLE” MEAN?
Daniel Nelson, M.S., U.S. Environmental Protection Agency
Williford A
B4
INTERNATIONAL PERSPECTIVE:
ACHIEVING A ROBUST HUMAN RESEARCH
PROTECTION PROGRAM
David Borasky, M.P.H., Copernicus Group IRB
B.I. Choe, Ph.D., Catholic University of Korea
Williford C
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., Washington University in St. Louis
Judy Birk, J.D., University of Michigan Health System
Boulevard C
C2
COLLABORATIONS: BIOBANKING AND LARGE DATA
SETS
Sue Rivera, Ph.D., Case Western Reserve University
Williford B
C3
WHAT WE MEAN BY ENGAGEMENT: PATIENTCENTERED RESEARCH
Cynthia Hahn, C.I.P., Northshore-LIJ Health System
Veronica Todaro, M.P.H., Parkinson’s Disease Foundation
Williford A
C4
EXPLORING IRB CONSIDERATIONS IN SOCIAL MEDIA
RESEARCH
Elizabeth Buchanan, Ph.D., University of Wisconsin, Stout
Williford C
C5
TOP 10 FINDINGS FROM 2014 APPLICATIONS AND SITE
VISITS
Sarah H. Kiskaddon, J.D., AAHRPP
Candice Yekel, M.A., Pennsylvania State University
C1
P2
FACING THE CHALLENGES OF REVIEWING
COMPARATIVE EFFECTIVENESS RESEARCH
Julie Kaneshiro, M.A., OHRP
Boulevard A
Boulevard A
Boulevard C
Grand
Ballroom
Grand
Ballroom
Ivor Pritchard, Ph.D., OHRP
RECEPTION AND POSTER PRESENTATIONS
5:00 p.m. – 6:00 p.m.
Normandie
Lounge
THURSDAY – MAY 21, 2015
CONFERENCE II
6:30 a.m.
3 K FUN RUN/WALK:
Run/walk past the Art Institute to the Bean and back by the
waterfront
Meet in
Hotel
Lobby
7:00 a.m. -1:00 p.m.
ATTENDEE REGISTRATION
7:00 a.m. – 8:00 a.m.
CONTINENTAL BREAKFAST
7:00 a.m. – 1:00 p.m.
VISITING HOURS FOR EXHIBITORS
Normandie
Lounge
Grand
Ballroom
Normandie
Lounge
Grand
Ballroom
8:00 a.m. – 9:00 a.m.
Plenary
P3
SHARING CLINICAL TRIAL DATA WITH RESEARCH
PARTICIPANTS: REGULATORY, OPERATIONAL, AND
ETHICAL CONSIDERATIONS
Barbara Bierer, M.D., Brigham and Women’s Hospital,
Harvard Medical School
9:15 a.m. – 10:30 a.m.
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
CONTROVERSIES IN PEDIATRIC RESEARCH: WORKING
THROUGH SUBPART D
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., AAHRPP
Susan Rose, Ph.D., U.S.C.
Williford A
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
Williford C
10:30 a.m. – 10:45 a.m.
Break
10:45 a.m. – 12:00 p.m.
Concurrent
Sessions
E1
MEETING STANDARDS IN HUMAN RESEARCH
PROTECTIONS: THE GLOBAL CHALLENGE
Delia Wolf, M.D., Harvard University
Boulevard A
Williford B
Boulevard C
Normandie
Lounge
Boulevard C
Ponni Subbiah, M.D., Global Med Strategies, LLC
Sarah H. Kiskaddon, J.D., AAHRPP (moderator)
E2
THE CONTINUING CHALLENGE OF QUALITY
IMPROVEMENT
K. Sue Haddock, Ph.D., R.N.,
WJB Dorn Veterans Affairs Medical Center
Williford B
Williford A
E3
VALID INFORMED CONSENT EDUCATION (VoICE)
PROJECT
Elizabeth Bankert, M.A., Dartmouth University
Williford C
E4
E5
12:00 p.m. – 1:00 p.m.
Lunch
1:00 p.m. – 2:00 p.m.
Plenary
P4
2:15 p.m. – 3:30 p.m.
Concurrent
Sessions
F1
ADVANCING THE HRPP CONCEPT: INTERNATIONAL
PERSPECTIVE
B.I. Choe, Ph.D., 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
NATIONAL IRB RELIANCE INITIATIVE: CURRENT
STATUS AND FORWARD PROGRESS
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
Boulevard A
Grand
Ballroom
Williford A
Grand
Ballroom
Boulevard A
F2
SINGLE IRB REVIEW: VIEW FROM THE INDEPENDENTS
Stephen Rosenfeld, M.D., M.B.A., Quorum Review IRB
David Forster, J.D., Western IRB
Lauri Carlile, M.S., C.I.P., Chesapeake IRB
Williford B
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., AAHRPP
Williford A
F4
LESSONS LEARNED FROM INTERNATIONAL AAHRPP
ACCREDITATIONS: CHINA AND TAIWAN [SESSION
PRESENTED IN MANDARIN]
Williford C
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
3:30 p.m.
Adjourn
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
Boulevard C