admin.share.aahrpp.org Documents/Retired... · Web viewMANAGING INCIDENTAL FINDINGS AND RESEARCH RESULTS IN GENOMIC RESEARCH: WHAT RESPONSIBILITIES SHOULD BIOBANKS AND RESEARCHERS

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


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



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



APRIL 4, 2013 THURSDAY


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



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


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


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



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



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.


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. – 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


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



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.


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


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



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



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



G6

RESEARCH WITH BANKED SPECIMENS

Robyn Shapiro J.D.Drinker Biddle & Reath LLP

4:00 P.M. Adjourn
