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Click on an individual session to read more about it. To search the program by date, title, target audience, or to do a keyword search, click on "Conference Agenda" in the left hand navigation, and select the desired sort type.
- Tuesday, November 19, 2019
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7:00 AM - 6:00 PMA Capella Musical Performance
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7:00 AM - 8:00 AMA Capella Musical Performance
Location: Pre-Function Hall C/ Veterans Memorial Auditorium -
7:00 AM - 6:00 PMNetworking Breakfast
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7:00 AM - 8:00 AMNetworking Breakfast
Location: Exhibit Halls C and D -
7:00 AM - 5:00 PMOn-Site Check-In Open
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7:00 AM - 5:00 PMOn-Site Check-In Open
Location: Pre-Function Hall C -
7:15 AM - 7:35 AMIndustry Expert Theater: AER19 Poster Presentation
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7:15 AM - 7:35 AMIndustry Expert Theater: AER19 Poster Presentation—Accelerating Clinical Coordinator Excellence (ACCE): Building for Excellence, Success and Empowerment
Location: Exhibit Hall C
Abby Keeley, MS, CIP – Washington University School of Medicine in St. LouisAbby Keeley, MS, CIP – Washington University School of Medicine in St. Louis ### 255930###Speaker -
7:40 AM - 8:00 AMIndustry Expert Theater: SkyiRIS Research Network for the NIH Single IRB of Use
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7:40 AM - 8:00 AMIndustry Expert Theater: SkyiRIS Research Network for the NIH Single IRB of Use
Location: Exhibit Hall C
William Schroeder – iMedRISWilliam Schroeder – iMedRIS ### 906915###Speaker -
8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:05 AM - 8:10 AMPresentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University
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8:05 AM - 8:10 AMPresentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University
Location: Veterans Memorial Auditorium -
8:10 AM - 8:15 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Susan Z. Kornetsky, MPH, Boston Children's Hospital
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8:10 AM - 8:15 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Susan Z. Kornetsky, MPH, Boston Children's Hospital
Location: Veterans Memorial Auditorium -
8:15 AM - 8:40 AMRemarks from PRIMR’s Chair of Board of Directors, Heather H. Pierce, JD, MPH
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8:15 AM - 8:40 AMRemarks from PRIM&R’s Board of Directors Chair, Heather H. Pierce, JD, MPH
Location: Veterans Memorial Auditorium -
8:40 AM - 9:45 AMKeynote Address by Scott D. Halpern, MD, PhD, Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, University of Pennsylvania: Financial Incentives and Nudges for Research Participation—Undue, Unjust, or Uncertain?
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8:40 AM - 9:45 AMKeynote Address by Scott D. Halpern, MD, PhD, Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, University of Pennsylvania: Financial Incentives and Nudges for Research Participation—Undue, Unjust, or Uncertain?
Location: Veterans Memorial Auditorium
Scott D. Halpern, MD, PhD – University of Pennsylvania Perelman School of MedicineScott D. Halpern, MD, PhD – University of Pennsylvania Perelman School of Medicine ### 824498###Keynote Speaker -
9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
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9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall C -
10:15 AM - 12:45 PMBreakout Session Series C
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10:15 AM - 12:45 PMC01 - HRPP Innovation Showcase—Creative Approaches to IRB Challenges
Location: Room 203
Madelon V. Baranoski, PhD, CIP – Yale University; Jeri Burr, RN-BC, MS, CCRC, FACRP – University of Utah; Martha Jones, MA, CIP – Partners HealthCare System, Inc.; Christine Suver, PhD – Sage BionetworksFlexibility and Innovation in IRB Processes Track
Madelon V. Baranoski, PhD, CIP – Yale University ### 433404###Speaker @@@ Jeri Burr, RN-BC, MS, CCRC, FACRP – University of Utah ### 824448###Speaker @@@ Martha Jones, MA, CIP – Partners HealthCare System, Inc. ### 59861###Speaker @@@ Christine Suver, PhD – Sage Bionetworks ### 262889###Speaker -
10:15 AM - 12:45 PMC02 - I Love My Job!? Perspectives Throughout a Career in Human Research Protections
Location: Room 312
Tonya Ferraro, MEd – Boston Children's Hospital; Danielle A. Griffin, Ed.D., CIP – University of Houston; Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Ada Sue Selwitz, MA – University of KentuckyEducating and Training Track
Tonya Ferraro, MEd – Boston Children's Hospital ### 420587###Speaker @@@ Danielle A. Griffin, Ed.D., CIP – University of Houston ### 824496###Speaker @@@ Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention ### 10627###Speaker @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Speaker -
10:15 AM - 11:30 AMC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom A
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Nicholas A. Wallace, JD – Ropes & Gray LLP; Carol Juliet Weil, JD – National Cancer InstituteResearch involving Data and Biospecimens Track
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker @@@ Nicholas A. Wallace, JD – Ropes & Gray LLP ### 821727###Speaker @@@ Carol Juliet Weil, JD – National Cancer Institute ### 10624###Speaker -
10:15 AM - 11:30 AMC04 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB and Clinical Investigator Inspections
Location: Room 101
Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration; Jan L. Hewett, BSN, JD – Food & Drug AdministrationFDA-Regulated Research Track
Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration ### 824454###Speaker @@@ Jan L. Hewett, BSN, JD – Food & Drug Administration ### 43213###Speaker -
10:15 AM - 11:30 AMC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLPGlobal Research Track
Kristin J. Craun, MPH, CIP – University of California Los Angeles ### 114622###Speaker @@@ Michael A. DiMaio – Ropes & Gray LLP ### 825251###Speaker -
10:15 AM - 11:30 AMC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health San AntonioInstitutional Officials and HRPP Leadership Track
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Kimberly K. Summers, PharmD – University of Texas Health San Antonio ### 420574###Speaker -
10:15 AM - 12:45 PMC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public HealthIRB Basics Track
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University ### 609634###Speaker @@@ Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health ### 187400###Speaker -
10:15 AM - 12:45 PMC08 - IRB Chairs Forum—A Structured Discussion for IRB Chairs
Location: Room 200
Luke Gelinas, PhD – Advarra; R. Peter Iafrate, PharmD – University of Florida; Brenda J. Klement – Morehouse School of MedicineIRB Chairs Track
Luke Gelinas, PhD – Advarra ### 420113###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker @@@ Brenda J. Klement – Morehouse School of Medicine ### 824524###Speaker -
10:15 AM - 12:45 PMC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOMIRB Operations Advanced Track
Holly Bante, PhD, MPH – University of Cincinnati ### 824368###Speaker @@@ Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Hallie Kassan, MS, CIP – Northwell Health ### 57719###Speaker @@@ Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM ### 609637###Speaker -
10:15 AM - 11:30 AMC10 - A Case-Based Assessment of Post-Trial Access to Investigational Medicines
Location: Room 107
Karla Childers, MSJ – Johnson & Johnson; Ariella Kelman, MD – Genentech, a member of the Roche GroupPharma/Biotech Perspectives Track
Karla Childers, MSJ – Johnson & Johnson ### 418855###Speaker @@@ Ariella Kelman, MD – Genentech, a member of the Roche Group ### 420841###Speaker -
10:15 AM - 12:45 PMC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103
Kate Gallin Heffernan, JD – Verrill Dana LLP; Todd W. Rice, MD – Vanderbilt University Medical CenterLegal Considerations for HRPPs Track
Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Todd W. Rice, MD – Vanderbilt University Medical Center ### 821446###Speaker -
10:15 AM - 11:30 AMC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; P. Pearl O'Rourke, MD – Harvard Medical SchoolResearch involving Data and Biospecimens Track
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker @@@ P. Pearl O'Rourke, MD – Harvard Medical School ### 112647###Speaker -
10:15 AM - 12:45 PMC13 - IRB Review of Research With Children
Location: Room 309
Ran Goldman, MD – University of British Columbia; Bethany Johnson, JD, CIP – Indiana University; Andrew Neel, CIP – Indiana UniversityPopulations Requiring Additional Protections Track
Ran Goldman, MD – University of British Columbia ### 824461###Speaker @@@ Bethany Johnson, JD, CIP – Indiana University ### 609633###Speaker @@@ Andrew Neel, CIP – Indiana University ### 824618###Speaker -
10:15 AM - 11:30 AMC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202
Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of PittsburghQA/QI and Postapproval Monitoring Track
Stephanie deRijke, RN, MSN – Emory University ### 256471###Speaker @@@ Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh ### 10578###Speaker -
10:15 AM - 11:30 AMC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of MedicineResearch Conducted in the Digital World Track
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania ### 420145###Speaker @@@ Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Stephanie Morain, PhD, MPH – Baylor College of Medicine ### 429255###Speaker -
10:15 AM - 11:30 AMC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services; David J. Hudson, PhD – University of VirginiaResponsible Conduct of Research Track
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services ### 261881###Speaker @@@ David J. Hudson, PhD – University of Virginia ### 824510###Speaker -
10:15 AM - 11:30 AMC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate HealthSmall Research Programs Track
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare ### 42223###Speaker @@@ Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health ### 594020###Speaker -
10:15 AM - 11:30 AMC18 - Reaching the Masses—Ideas for Researcher Education
Location: Room 204
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Cecilia Brooke Cholka, MA, CIP – University of Nevada, RenoSBER Track
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker -
10:15 AM - 11:30 AMC19 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 104
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute; Matt D. Stafford, MPH – Boston Children's HospitalAdvanced Track (SBER)
Lara N. Sloboda, PhD – Dana Farber Cancer Insititute ### 181613###Speaker @@@ Matt D. Stafford, MPH – Boston Children's Hospital ### 57750###Speaker -
10:15 AM - 12:45 PMC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIHIRB Operations Advanced Track
Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Speaker @@@ Sariah Fuller – University of Utah ### 843617###Speaker @@@ Holly A. Taylor, PhD, MPH – NIH ### 57753###Speaker -
10:15 AM - 12:45 PMC21 - A Look into the Crystal Ball—The HRPP of the Future
Location: Room 310
John R. Baumann, PhD – Indiana University; Nichelle Cobb, PhD – University of Wisconsin-Madison; Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - LincolnInstitutional Officials and HRPP Leadership Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - Lincoln ### 825254###Speaker -
10:15 AM - 12:45 PMC22 - Scientific Aspects of Study Design—A Primer for Non-Scientists
Location: Room 108
Susan S. Fish, PharmD, MPH – Boston University School of Public Health; Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus GroupEducating and Training Track
Susan S. Fish, PharmD, MPH – Boston University School of Public Health ### 11071###Speaker @@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Speaker -
10:15 AM - 12:45 PMC23 - Exempt Human Subjects Research Case Studies— Implementing Changes to the Exemption Categories Under the Revised Common Rule
Location: Room 206
Christine DeLussey, MS, CIP – Children's Hospital of Philadelphia; Julie M. Eiserman, MA, CCRP – National Institutes of Health; Caitlin Alcorn, MPA, CIP – University of OregonIRB Operations Advanced Track
Christine DeLussey, MS, CIP – Children's Hospital of Philadelphia ### 830299###Speaker @@@ Julie M. Eiserman, MA, CCRP – National Institutes of Health ### 830300###Speaker @@@ Caitlin Alcorn, MPA, CIP – University of Oregon ### 840256###Speaker -
11:30 AM - 11:45 AMBreak
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11:30 AM - 11:45 AM
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11:45 AM - 12:05 PMIndustry Expert Theater: AER19 Poster Presentation
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11:45 AM - 12:05 PMIndustry Expert Theater: AER19 Poster Presentation—IRB Members' Assessment of Minimal Risk Procedures in Pregnancy
Location: Exhibit Hall C
Amina A. White, MD, MA – University of North Carolina at Chapel HillAmina A. White, MD, MA – University of North Carolina at Chapel Hill ### 847720###Speaker -
11:45 AM - 12:45 PMFederal Agency and Accrediting Body Dialogue Sessions
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11:45 AM - 12:45 PMA Dialogue With AAHRPP, Inc.
Location: Room 202
Mary L. Fields, BA (Psychology), CIP – Association for the Accreditation of Human Research Protection Programs; Robert Hood – AAHRPP, Inc.; Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP); Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc.; Kate Vulakovich – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP); Jemelle Williams – AAHRPPMary L. Fields, BA (Psychology), CIP – Association for the Accreditation of Human Research Protection Programs ### 284711###Speaker @@@ Robert Hood – AAHRPP, Inc. ### 251843###Speaker @@@ Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 641618###Speaker @@@ Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc. ### 10699###Speaker @@@ Kate Vulakovich – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 587411###Speaker @@@ Jemelle Williams – AAHRPP ### 857461###Speaker -
11:45 AM - 12:45 PMA Dialogue With DHHS Office for Civil Rights (OCR)
Location: Room 107
Marissa Gordon-Nguyen, JD, MPH – HHS; Linda Sanches, MPH – HHS; Nick Heesters, JD – HHSMarissa Gordon-Nguyen, JD, MPH – HHS ### 441562###Speaker @@@ Linda Sanches, MPH – HHS ### 879286###Speaker @@@ Nick Heesters, JD – HHS ### 879287###Speaker -
11:45 AM - 12:45 PMA Dialogue with DoD
Location: Room 313
Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences; Stephanie Bruce, CIP, CPIA – Department of Defense; John Lee Melton, PhD, CDR, MSC, USN – Department of NavyLaura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences ### 10143###Speaker @@@ Stephanie Bruce, CIP, CPIA – Department of Defense ### 255575###Speaker @@@ John Lee Melton, PhD, CDR, MSC, USN – Department of Navy ### 429110###Speaker -
11:45 AM - 12:45 PMA Dialogue With DOE
Location: Room 204
Cheri Hautala-Bateman – Department of Energy/National Nuclear Security Administration; James E. Morris – Department of Energy; Elizabeth P. White, MBA, MPH, CIP – United States Department of EnergyCheri Hautala-Bateman – Department of Energy/National Nuclear Security Administration ### 593731###Speaker @@@ James E. Morris – Department of Energy ### 824045###Speaker @@@ Elizabeth P. White, MBA, MPH, CIP – United States Department of Energy ### 10625###Speaker -
11:45 AM - 12:45 PMA Dialogue With FDA
Location: Ballroom C
Joanne R. Less, PhD – US Food and Drug Administration; Diane M. Maloney, JD – Food and Drug Administration; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Soma Kalb, PhD – US Food and Drug Administration; Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration; Patrick J. McNeilly, PhD – Food and Drug AdministrationJoanne R. Less, PhD – US Food and Drug Administration ### 10597###Speaker @@@ Diane M. Maloney, JD – Food and Drug Administration ### 10601###Speaker @@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker @@@ Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker @@@ Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration ### 824454###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
11:45 AM - 12:45 PMCarrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker
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11:45 AM - 12:45 PMA Dialogue With OHRP
Location: Ballroom B
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Julie Kaneshiro, MA – Office for Human Research Protections; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ivor A. Pritchard, PhD – OHRPLisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Julie Kaneshiro, MA – Office for Human Research Protections ### 11084###Speaker @@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
11:45 AM - 12:45 PMA Dialogue With ORI
Location: Room 109
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human ServicesYvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services ### 261881###Speaker -
11:45 AM - 12:45 PMA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111
Jason Gerson, PhD – Patient-Centered Outcomes Research InstituteJason Gerson, PhD – Patient-Centered Outcomes Research Institute ### 420114###Speaker -
11:45 AM - 12:45 PMA Dialogue With SACHRP
Location: Room 201
Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems; Nancy M.P King, JD – Wake Forest School of Medicine; Julia G. Gorey, JD – OHRP; David G. Forster, JD, MA, CIP – WIRB-Copernicus GroupStephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Speaker @@@ Nancy M.P King, JD – Wake Forest School of Medicine ### 586820###Speaker @@@ Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker -
11:45 AM - 12:45 PMA Dialogue With the VA
Location: Room 302
Kristina C. Borror, PhD – Veterans Health Administration; Cynthia L. Boudreaux, M.Ed – Department of Veterans Affairs; Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs; Mary M. Klote, MD, CIP – Veterans Health AdministrationKristina C. Borror, PhD – Veterans Health Administration ### 10668###Speaker @@@ Cynthia L. Boudreaux, M.Ed – Department of Veterans Affairs ### 824372###Speaker @@@ Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs ### 426712###Speaker @@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Speaker -
11:45 AM - 12:45 PMMeet and Greet With the Supporters and Exhibitors, View the AER19 Posters
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11:45 AM - 12:45 PMMeet and Greet With the Supporters and Exhibitors, View the AER19 Posters
Location: Exhibit Hall C -
11:45 AM - 12:45 PMPRIM&R’s Guide to Speaking at the AER Conference
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11:45 AM - 12:45 PMPRIM&R’s Guide to Speaking at the AER Conference
Location: Room 300
Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of MedicineMichelle M. Feige, MSW, LCSW-C – AAHRPP, Inc. ### 10675###Speaker @@@ Kelly Unsworth, MS, CCRP, CIP – University of Rochester ### 187438###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker -
11:45 AM - 12:45 PMThe Certified IRB Professional (CIP®) Credential—How Do I Get Started?
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11:45 AM - 12:45 PMThe Certified IRB Professional (CIP®) Credential—How Do I Get Started?
Location: Room 102
Lori Roesch, CIM, CIP – Children's Hospital of Wisconsin; Andrew Hedrick, MPA, CIP – The Ohio State University; David C. Matesanz, JD, CIP – Kaiser Permanente - Northern CaliforniaLori Roesch, CIM, CIP – Children's Hospital of Wisconsin ### 57742###Speaker @@@ Andrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Speaker @@@ David C. Matesanz, JD, CIP – Kaiser Permanente - Northern California ### 880506###Speaker -
12:10 PM - 12:30 PMIndustry Expert Theater: AER19 Poster Presentation
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12:10 PM - 12:30 PMIndustry Expert Theater: AER19 Poster Presentation—What Ethical Challenges Do Pragmatic Trials Pose for the Oversight of Human Subjects Research? An Interview Study With Key Stakeholders
Location: Exhibit Hall C
Stuart G. Nicholls, PhD – Clinical Epidemiology Program, Ottawa Hospital Research InstituteStuart G. Nicholls, PhD – Clinical Epidemiology Program, Ottawa Hospital Research Institute ### 847723###Speaker -
12:45 PM - 1:45 PMAttendee Open Lunch Period
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12:45 PM - 1:45 PM
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2:00 PM - 3:15 AMConcurrent Plenary Sessions
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2:00 PM - 3:15 PMPanel IV: Identifying and Avoiding the Conduct of Low Value Clinical Trials
Location: Ballroom B
John R. Baumann, PhD – Indiana University; Laura Odwazny, JD, MA – US DHHS; Eileen M. O'Reilly, MD – Memorial Sloan Kettering Cancer Center; Deborah Zarin, MD – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Medical School; Stephen J. Rosenfeld, MD, MBA – Freeport Research SystemsJohn R. Baumann, PhD – Indiana University ### 57670###Moderator @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Moderator @@@ Eileen M. O'Reilly, MD – Memorial Sloan Kettering Cancer Center ### 824620###Panelist @@@ Deborah Zarin, MD – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Medical School ### 10628###Panelist @@@ Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Panelist -
2:00 PM - 3:15 PMPanel V: Bioethics Turns 50—Reflections from The Hastings Center
Location: Ballroom C
Mildred Z. Solomon, EdD – The Hastings Center; Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine; Nancy M.P King, JD – Wake Forest School of Medicine; Alex John London, PhD – Carnegie Mellon University; Karen J. Maschke, PhD – The Hastings CenterMildred Z. Solomon, EdD – The Hastings Center ### 57748###Moderator @@@ Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine ### 10030###Panelist @@@ Nancy M.P King, JD – Wake Forest School of Medicine ### 586820###Panelist @@@ Alex John London, PhD – Carnegie Mellon University ### 418860###Panelist @@@ Karen J. Maschke, PhD – The Hastings Center ### 114629###Panelist -
2:00 PM - 3:15 PMConcurrent Plenary Sessions
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2:00 PM - 3:15 PMPanel VI: Studying Suicide and Subjects at Risk for Suicide—Identifying and Minimizing Risk to Promote Necessary Research
Location: Veterans Memorial Auditorium
David H. Strauss, MD – Columbia University; Celia B. Fisher, PhD – Fordham University; Samantha Marquez McKetchnie, LCSW – Massachusetts General HospitalDavid H. Strauss, MD – Columbia University ### 10147###Moderator @@@ Celia B. Fisher, PhD – Fordham University ### 57702###Panelist @@@ Samantha Marquez McKetchnie, LCSW – Massachusetts General Hospital ### 829354###Panelist -
3:15 PM - 3:45 PMBeverage Break With the Supporters and Exhibitors
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3:15 PM - 3:45 PMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall C -
3:45 PM - 5:00 PMBreakout Session Series D
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3:45 PM - 5:00 PMD01 - Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210
Charles Brightbill, CIM, CIP – Geisinger Health System; Cynthia S. Shindledecker, B.A., CIP – University of MichiganFlexibility and Innovation in IRB Processes Track
Charles Brightbill, CIM, CIP – Geisinger Health System ### 824373###Speaker @@@ Cynthia S. Shindledecker, B.A., CIP – University of Michigan ### 25718###Speaker -
3:45 PM - 5:00 PMD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's HospitalEducating and Training Track
Kelly Unsworth, MS, CCRP, CIP – University of Rochester ### 187438###Speaker @@@ Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital ### 10574###Speaker -
3:45 PM - 5:00 PMD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203
Julia G. Gorey, JD – OHRP; Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc.Populations Requiring Additional Protections Track
Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. ### 429992###Speaker -
3:45 PM - 5:00 PMD04 - FDA’s Oversight of ClinicalTrials.gov Requirements
Location: Room 309
Anthony Keyes, MBA, PMP – Johns Hopkins University; Patrick J. McNeilly, PhD – Food and Drug AdministrationFDA-Regulated Research Track
Anthony Keyes, MBA, PMP – Johns Hopkins University ### 586819###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
3:45 PM - 5:00 PMD05 - Export Controls
Location: Room 300
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Lisa A. Griffin, JD, MPH – Brigham and Women's Healthcare, Inc.Global Research Track
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University ### 261880###Speaker @@@ Lisa A. Griffin, JD, MPH – Brigham and Women's Healthcare, Inc. ### 114626###Speaker -
3:45 PM - 5:00 PMD06 - Complex Institutional Relationships—Going Beyond the Multi-site Model
Location: Room 202
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Sara Chandros Hull, PhD – NIH; Mary M. Klote, MD, CIP – Veterans Health Administration; Theresa M. Straut, RAC, CIP – US Army, Combat Capabilities Development Command, Army Research LaboratoryInstitutional Officials and HRPP Leadership Track
Kristin J. Craun, MPH, CIP – University of California Los Angeles ### 114622###Speaker @@@ Sara Chandros Hull, PhD – NIH ### 10593###Speaker @@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Speaker @@@ Theresa M. Straut, RAC, CIP – US Army, Combat Capabilities Development Command, Army Research Laboratory ### 609630###Speaker -
3:45 PM - 5:00 PMD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting GroupIRB Basics Track
Elizabeth A. Bankert, MA – Dartmouth College ### 57668###Speaker @@@ Lauren Hartsmith, JD – OHRP ### 263718###Speaker @@@ Cheryl A. Savini – The HRP Consulting Group ### 21651###Speaker -
3:45 PM - 5:00 PMD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of MedicineIRB Chairs Track
Francis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine ### 248446###Speaker -
3:45 PM - 5:00 PMD09 - Ensuring IRB Compliance in a Hybrid World—Strategies for Operating in a World Where Multiple Regulatory Frameworks Apply
Location: Room 310
Martha Jones, MA, CIP – Partners HealthCare System, Inc.; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of MedicineIRB Operations Advanced Track
Martha Jones, MA, CIP – Partners HealthCare System, Inc. ### 59861###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker -
3:45 PM - 5:00 PMD10 - Returning Research Results to Participants—Whose Job Is It?
Location: Room 201
Gianna McMillan, DBe – Loyola Marymount University; Carol Juliet Weil, JD – National Cancer Institute; Karla Childers, MSJ – Johnson & JohnsonPharma/Biotech Perspectives Track
Gianna McMillan, DBe – Loyola Marymount University ### 11611###Speaker @@@ Carol Juliet Weil, JD – National Cancer Institute ### 10624###Speaker @@@ Karla Childers, MSJ – Johnson & Johnson ### 418855###Speaker -
3:45 PM - 5:00 PMD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Emily M.Q Schriver, JD – The Ohio State University; Michael J. Vernick, JD – Hogan Lovells US LLPLegal Considerations for HRPPs Track
Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker @@@ Emily M.Q Schriver, JD – The Ohio State University ### 824639###Speaker @@@ Michael J. Vernick, JD – Hogan Lovells US LLP ### 828346###Speaker -
3:45 PM - 5:00 PMD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-StoutResearch involving Data and Biospecimens Track
Gretchen L. J Anding, MA – University of Wisconsin-Madison ### 418825###Speaker @@@ Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker -
3:45 PM - 5:00 PMD13 - Inclusion of Pregnant Women in Clinical Trials
Location: Room 101
Kristine Shields, MSN, DRPH – Shields Medical Writing and Consulting; Leyla Sahin, MD – FDAPopulations Requiring Additional Protections Track
Kristine Shields, MSN, DRPH – Shields Medical Writing and Consulting ### 824642###Speaker @@@ Leyla Sahin, MD – FDA ### 857460###Speaker -
3:45 PM - 5:00 PMD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardQA/QI and Postapproval Monitoring Track
Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Neala Lane, MS, CCRC – Indiana University ### 824565###Speaker @@@ Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 609692###Speaker -
3:45 PM - 5:00 PMD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom A
Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Laura Odwazny, JD, MA – US DHHSResearch Conducted in the Digital World Track
Luke Gelinas, PhD – Advarra ### 420113###Speaker @@@ Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard ### 10123###Speaker @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Speaker -
3:45 PM - 5:00 PMD16 - Responsible Conduct of Research (RCR) for Research Leaders—Integrating Research Administration for a Successful Collaborative Framework
Location: Room 107
John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc.; Jane Strasser – University of CincinnatiResponsible Conduct of Research Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker @@@ Jane Strasser – University of Cincinnati ### 824683###Speaker -
3:45 PM - 5:00 PMD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea R. McDowell, PhD – Seattle University; Rachel Zand, PhD – University of TorontoSmall Research Programs Track
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago ### 263607###Speaker @@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker @@@ Rachel Zand, PhD – University of Toronto ### 171988###Speaker -
3:45 PM - 5:00 PMD18 - Reviewing SBER—A Guide for the Non-Scientist, Unaffiliated IRB Member
Location: Room 108
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Amy Corneli, PhD, MPH – Duke UniversitySBER Track
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Amy Corneli, PhD, MPH – Duke University ### 112601###Speaker -
3:45 PM - 5:00 PMD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State UniversitySBER Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Montana Miller, PhD – Bowling Green State University ### 830142###Speaker -
3:45 PM - 5:00 PMD20 - Staying Current and Keeping Pace—A Primer for IRB Chairs
Location: Room 104
J. Andrew Bertolatus, MD – University of Iowa; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Kerry A. Agnitsch, PhD – Iowa State UniversityIRB Chairs Track
J. Andrew Bertolatus, MD – University of Iowa ### 112581###Speaker @@@ Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center ### 57704###Speaker @@@ Kerry A. Agnitsch, PhD – Iowa State University ### 855362###Speaker -
3:45 PM - 5:00 PMD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312
John A. Guidry, PhD – TRX Development Soutions; Matan Benyishay, MPP – AIDS Action Committee/Fenway Health; Dana J. Pardee, BS – The Fenway InstitutePopulations Requiring Additional Protections Track
John A. Guidry, PhD – TRX Development Soutions ### 112618###Speaker @@@ Matan Benyishay, MPP – AIDS Action Committee/Fenway Health ### 837945###Speaker @@@ Dana J. Pardee, BS – The Fenway Institute ### 850368###Speaker -
3:45 PM - 5:00 PMD22 - The Keys to Key Information—An Interactive Workshop
Location: Room 103
Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Jerry A. Menikoff, MD, JD – Office for Human Research ProtectionsIRB Operations Advanced Track
Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Jerry A. Menikoff, MD, JD – Office for Human Research Protections ### 11091###Speaker -
3:45 PM - 5:00 PMD23 - Challenges and Lessons for Implementing New Exemption 4(iii)—Secondary Research Involving Only Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule-Protected Identifiable Health Information
Location: Room 102
Kim Fowler, CIP, CIM – University of Georgia; Megan McFarland, MS, CIP, CCRP – Army Human Research Protections Office (AHRPO)Research involving Data and Biospecimens Track
Kim Fowler, CIP, CIM – University of Georgia ### 843740###Speaker @@@ Megan McFarland, MS, CIP, CCRP – Army Human Research Protections Office (AHRPO) ### 843741###Speaker -
5:00 PM - 6:00 PMFederal Agency Office Hours
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5:00 PM - 6:00 PMFederal Agency Office Hours
Location: Exhibit Hall C -
5:00 PM - 6:00 PMMeet the AER19 Poster Authors
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5:00 PM - 6:00 PMMeet the AER19 Poster Authors
Location: Exhibit Hall C -
5:00 PM - 6:00 PMNetworking Reception With the Supporters and Exhibitors
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5:00 PM - 6:00 PMNetworking Reception With the Supporters and Exhibitors
Location: Exhibit Hall C -
5:10 PM - 5:30 PMIndustry Expert Theater: AER19 Poster Presentation
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5:10 PM - 5:30 PMIndustry Expert Theater: AER19 Poster Presentation—Novice Researcher Confidence Before and After the Implementation of an Informed Consent Simulation Workshop Enlisting the Feedback of Former Research Volunteers
Location: Exhibit Hall C
Susan Garrow-Sloan, RN, BSN, CCRP – Baystate Health; Judith Pride, RN, MSHS, CCRC, CCRP, CIP – Baystate HealthSusan Garrow-Sloan, RN, BSN, CCRP – Baystate Health ### 864103###Speaker @@@ Judith Pride, RN, MSHS, CCRC, CCRP, CIP – Baystate Health ### 864102###Speaker -
5:35 PM - 5:55 PMIndustry Expert Theater: AER19 Poster Presentation
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5:35 PM - 5:55 PMIndustry Expert Theater: AER19 Poster Presentation—The Consent Language Explicit and Reasonable (CLEAR) Initiative
Location: Exhibit Hall C
Marilyn Eshikena, MS, CIP – Icahn School of Medicine at Mount SinaiMarilyn Eshikena, MS, CIP – Icahn School of Medicine at Mount Sinai ### 847719###Speaker