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- Monday, November 18, 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 PMContinental Breakfast to Welcome First-Time Attendees
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7:00 AM - 8:00 AMContinental Breakfast to Welcome First-Time Attendees
Location: Ballroom A -
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 -
8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:15 AM - 8:40 AMRemarks from PRIM&R’s Executive Director, Elisa A. Hurley, PhD
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8:15 AM - 8:40 AMRemarks from PRIM&R’s Executive Director, Elisa A. Hurley, PhD
Location: Veterans Memorial Auditorium -
8:40 AM - 9:45 AMKeynote Address by Janine Clayton MD, Associate Director for Research on Women’s Health; Director Office of Research on Women’s Health, NIH: It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women
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8:40 AM - 9:45 AMKeynote Address by Janine Clayton MD, Associate Director for Research on Women’s Health; Director Office of Research on Women’s Health, NIH: It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women
Location: Veterans Memorial Auditorium
Janine Austin Clayton, MD – NIHJanine Austin Clayton, MD – NIH ### 825084###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 - 11:30 AMConcurrent Plenary Sessions
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10:15 AM - 11:30 AMPanel I: Diverse Representation in Clinical Trials—Why Does It Matter and How Do We Move Forward?
Location: Ballroom B
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Denise Anne Dillard, PhD – Southcentral Foundation; Tesheia Johnson, MBA, MHS – Yale University; Paul Underwood, MD FACC – Boston Scientific CorporationBarbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard ### 10123###Moderator @@@ Denise Anne Dillard, PhD – Southcentral Foundation ### 824455###Panelist @@@ Tesheia Johnson, MBA, MHS – Yale University ### 829353###Panelist @@@ Paul Underwood, MD FACC – Boston Scientific Corporation ### 843651###Panelist -
10:15 AM - 11:30 AMPanel II: Using Social Behavioral Data to Provide Insight into Health-Related Experiences
Location: Veterans Memorial Auditorium
Kimberly M. Nelson, PhD, MPH – Boston University School of Public Health; Teresa Doksum, PhD, MPH – Abt Associates Inc.; Luke Gelinas, PhD – Advarra; Julie Slayton, JD, PhD – University of Southern CaliforniaKimberly M. Nelson, PhD, MPH – Boston University School of Public Health ### 825088###Moderator @@@ Teresa Doksum, PhD, MPH – Abt Associates Inc. ### 21633###Panelist @@@ Luke Gelinas, PhD – Advarra ### 420113###Panelist @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Panelist -
10:15 AM - 11:30 AMPanel III: What to Expect When We Sequence Expecting Moms
Location: Ballroom C
Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; Josephine M. Johnston, LLB, MBHL – The Hastings Center; Haley K. Sullivan – Duke University; Ingrid A. Holm, MD, MPH – Boston Children's HospitalJeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Moderator @@@ Josephine M. Johnston, LLB, MBHL – The Hastings Center ### 824512###Panelist @@@ Haley K. Sullivan – Duke University ### 829474###Panelist @@@ Ingrid A. Holm, MD, MPH – Boston Children's Hospital ### 844212###Panelist -
11:30 AM - 12:45 PMNetworking Luncheon
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11:30 AM - 12:45 PMNetworking Luncheon
Location: Exhibit Hall D -
11:30 AM - 12:45 PMSBER Network Luncheon
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11:30 AM - 12:45 PMSBER Network Luncheon
Location: Room 200
Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno; Linda E. Petree, BA, CIP – The University of New MexicoCecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker -
11:30 AM - 12:45 PMMeet the Author Luncheon and Book Signing: The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health
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11:30 AM - 12:45 PMMeet the Author Luncheon and Book Signing: The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health
Location: Ballroom A
Suzanne M. Rivera, PhD, MSW – Case Western Reserve University; Jonathan H. Marks, MA, BCL (University of Oxford equivalent to JD, LL.M.) – Pennsylvania State UniversitySuzanne M. Rivera, PhD, MSW – Case Western Reserve University ### 21648###Moderator @@@ Jonathan H. Marks, MA, BCL (University of Oxford equivalent to JD, LL.M.) – Pennsylvania State University ### 824595###Panelist -
12:15 PM - 12:35 PMIndustry Expert Theater: Overview of the CIP® Exam
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12:15 PM - 12:35 PMIndustry Expert Theater: Overview of the CIP® Exam
Location: Exhibit Hall C -
12:15 PM - 12:45 PMFederal Agency Office Hours
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12:15 PM - 12:45 PMFederal Agency Office Hours
Location: Exhibit Hall C -
12:15 PM - 12:45 PMMeet and Greet With Supporters and Exhibitors
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12:15 PM - 12:45 PMMeet and Greet With Supporters and Exhibitors
Location: Exhibit Hall C -
1:00 PM - 2:15 PMBreakout Session Series A
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1:00 PM - 2:15 PMA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. LouisIRB Operations Advanced Track
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus ### 10590###Speaker @@@ Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis ### 426680###Speaker -
1:00 PM - 2:15 PMA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of HealthFlexibility and Innovation in IRB Processes Track
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group ### 11068###Speaker @@@ Jonathan M. Green, MD, MBA – National Institutes of Health ### 420116###Speaker -
1:00 PM - 2:15 PMA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – ConsultantEducating and Training Track
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School ### 585128###Speaker @@@ Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc. ### 10675###Speaker @@@ Nancy A. Olson, JD – Consultant ### 11093###Speaker -
1:00 PM - 2:15 PMA03 - Ethics and Governance in Learning Healthcare Systems
Location: Room 102
Paul C. McLean – Center for Bioethics, Harvard Medical School; Nancy E. Kass, ScD – The Johns Hopkins University; Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of MedicineEmpirical Research Ethics Track
Paul C. McLean – Center for Bioethics, Harvard Medical School ### 824047###Speaker @@@ Nancy E. Kass, ScD – The Johns Hopkins University ### 10595###Speaker @@@ Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine ### 10030###Speaker -
1:00 PM - 2:15 PMA04 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 206
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug AdministrationFDA-Regulated Research Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker @@@ Donna L. Snyder, MD – Food and Drug Administration ### 587406###Speaker -
1:00 PM - 2:15 PMA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103
Rachel Zand, PhD – University of Toronto; Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public HealthGlobal Research Track
Rachel Zand, PhD – University of Toronto ### 171988###Speaker @@@ Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health ### 11119###Speaker -
1:00 PM - 2:15 PMA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310
Robert Hood – AAHRPP, Inc.; Scott J. Lipkin, DPM, CIP – Ankura ConsultingInstitutional Officials and HRPP Leadership Track
Robert Hood – AAHRPP, Inc. ### 251843###Speaker @@@ Scott J. Lipkin, DPM, CIP – Ankura Consulting ### 10598###Speaker -
1:00 PM - 2:15 PMA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309
George Gasparis, CIP – The PEER Consulting Group; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS); Judy Matuk, MS – HRP Consulting GroupIRB Basics Track
George Gasparis, CIP – The PEER Consulting Group ### 10676###Speaker @@@ Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Speaker @@@ Judy Matuk, MS – HRP Consulting Group ### 172024###Speaker -
1:00 PM - 2:15 PMA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; R. Peter Iafrate, PharmD – University of FloridaIRB Chairs Track
Francis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker -
1:00 PM - 2:15 PMA10 - Management of Incidental Findings (IFs) in Pragmatic Clinical Trials (PCTs)
Location: Room 201
Juli Bollinger, M.S. – Johns Hopkins University; Debra JH Mathews, PhD, MA – Johns Hopkins University Berman Institute of Bioethics; Stephanie Morain, PhD, MPH – Baylor College of Medicine; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins UniversityPharma/Biotech Perspectives Track
Juli Bollinger, M.S. – Johns Hopkins University ### 825085###Speaker @@@ Debra JH Mathews, PhD, MA – Johns Hopkins University Berman Institute of Bioethics ### 823745###Speaker @@@ Stephanie Morain, PhD, MPH – Baylor College of Medicine ### 429255###Speaker @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker -
1:00 PM - 2:15 PMA11 - Legal and Regulatory Changes: A Year in Review
Location: Room 302
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Michele Russell-Einhorn, JD – Advarra; Laura Odwazny, JD, MA – US DHHSLegal Considerations for HRPPs Track
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Speaker -
1:00 PM - 2:15 PMA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of HealthResearch involving Data and Biospecimens Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker -
1:00 PM - 2:15 PMA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203
Bruce G. Gordon, MD – University of Nebraska Medical Center; Corinne Rogers, MS, CIP – New York State Psychiatric InstitutePopulations Requiring Additional Protections Track
Bruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Speaker @@@ Corinne Rogers, MS, CIP – New York State Psychiatric Institute ### 10618###Speaker -
1:00 PM - 2:15 PMA14 - Staying on Top of It All—Practical Strategies for Implementing Postapproval Monitoring (PAM)
Location: Room 202
Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno; Andrea R. McDowell, PhD – Seattle UniversitySBER Track
Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker @@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker -
1:00 PM - 2:15 PMA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210
Megan Doerr, MS, LGC – Sage Bionetworks; Adarsh K. Gupta, DO, MS, FACOFP – Rowan University; Sara Meeder, CIP – Maimonides Medical CenterResearch Conducted in the Digital World Track
Megan Doerr, MS, LGC – Sage Bionetworks ### 427699###Speaker @@@ Adarsh K. Gupta, DO, MS, FACOFP – Rowan University ### 112619###Speaker @@@ Sara Meeder, CIP – Maimonides Medical Center ### 589958###Speaker -
1:00 PM - 2:15 PMA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Jim Kroll – National Science FoundationResponsible Conduct of Research Track
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Jim Kroll – National Science Foundation ### 824525###Speaker -
1:00 PM - 2:15 PMA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.; Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto RicoSmall Research Programs Track
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc. ### 11058###Speaker @@@ Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico ### 124835###Speaker -
1:00 PM - 2:15 PMA18 - Certificates of Confidentiality (CoCs)
Location: Room 111
Mary Ramirez, MA, CIP – University of Michigan; Adam C. Berger, PhD – NIH; Lyndi Lahl, RN, MS – National Institutes of HealthSBER Track
Mary Ramirez, MA, CIP – University of Michigan ### 420518###Speaker @@@ Adam C. Berger, PhD – NIH ### 855125###Speaker @@@ Lyndi Lahl, RN, MS – National Institutes of Health ### 875157###Speaker -
1:00 PM - 2:15 PMA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New HampshireSBER Track
Julie F. Simpson, PhD – University of New Hampshire ### 57933###Speaker @@@ Patricia B. Condon, PhD – University of New Hampshire ### 855130###Speaker -
1:00 PM - 2:15 PMA20 - Two Hats, One Head—When IRB Members Are Also Investigators
Location: Room 109
Stephanie Collins Reed, PhD – New York State Psychiatric Institute; Ilene F. Wilets, PhD, CIP – Program for the Protection of Human SubjectsEducating and Training Track
Stephanie Collins Reed, PhD – New York State Psychiatric Institute ### 112599###Speaker @@@ Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects ### 64126###Speaker -
1:00 PM - 2:15 PMA21 - An Introduction to the FDA and Their Regulations for the Non-Scientist IRB Member
Location: Room 108
Janet C. Donnelly, RAC – FDA; Patrick J. McNeilly, PhD – Food and Drug AdministrationFDA-Regulated Research Track
Janet C. Donnelly, RAC – FDA ### 10577###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
1:00 PM - 2:15 PMA22 - From Non-Exempt to Exempt and Back Again—Navigating Exemption 2iii
Location: Room 104
Petrice B. Longenecker, PhD, CIP – Uniformed Services University of the Health Sciences; Laura R. Brosch, RN, PhD – Uniformed Services University of the Health SciencesIRB Operations Advanced Track
Petrice B. Longenecker, PhD, CIP – Uniformed Services University of the Health Sciences ### 252194###Speaker @@@ Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences ### 10143###Speaker -
1:00 PM - 2:15 PMA23 - Making Limited Review Work Without Reinventing the Wheel
Location: Room 313
David A. Borasky, Jr., MPH, CIP – WCG; Teresa Doksum, PhD, MPH – Abt Associates Inc.IRB Operations Advanced Track
David A. Borasky, Jr., MPH, CIP – WCG ### 10124###Speaker @@@ Teresa Doksum, PhD, MPH – Abt Associates Inc. ### 21633###Speaker -
2:15 PM - 2:45 PMBeverage Break With the Supporters and Exhibitors
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2:15 PM - 2:45 PMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall C -
2:45 PM - 4:00 PMBreakout Session Series B
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2:45 PM - 4:00 PMB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – AdvarraFlexibility and Innovation in IRB Processes Track
Alexander M. Capron, LLB, MA (Hon). – University of Southern California ### 10125###Speaker @@@ Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center ### 57704###Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker -
2:45 PM - 4:00 PMB02 - Dear IRB, Please Tell Me What to Do and How to Avoid Mistakes
Location: Room 200
Ximena L. Levy, MD, MPH, CIP – Florida Atlantic University; Muhammad Waseem, MD, MS, CIP, CPI, CCRP – Lincoln Medical CenterEducating and Training Track
Ximena L. Levy, MD, MPH, CIP – Florida Atlantic University ### 824594###Speaker @@@ Muhammad Waseem, MD, MS, CIP, CPI, CCRP – Lincoln Medical Center ### 824687###Speaker -
2:45 PM - 4:00 PMB03 - Why Informed Consent Doesn't Work and Why the Revised Common Rule Won't Fix It
Location: Room 210
Quincy J. Byrdsong, EdD, CIP, CCRP – WellStar Health System; Stephanie S. Cargill, PhD – Saint Louis UniversityEmpirical Research Ethics Track
Quincy J. Byrdsong, EdD, CIP, CCRP – WellStar Health System ### 824449###Speaker @@@ Stephanie S. Cargill, PhD – Saint Louis University ### 11105###Speaker -
2:45 PM - 4:00 PMB04 - Investigational Device Exemptions (IDE) Mobile Medical Applications and IRB Review
Location: Room 311
Soma Kalb, PhD – US Food and Drug Administration; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc.FDA-Regulated Research Track
Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker @@@ Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration ### 838086###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker -
2:45 PM - 4:00 PMB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204
Susan Stayn, JD – Stanford University; Nicholas A. Wallace, JD – Ropes & Gray LLPGlobal Research Track
Susan Stayn, JD – Stanford University ### 11108###Speaker @@@ Nicholas A. Wallace, JD – Ropes & Gray LLP ### 821727###Speaker -
2:45 PM - 4:00 PMB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Michele Kennett, JD, MSN, CIP – University of MissouriInstitutional Officials and HRPP Leadership Track
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Speaker @@@ Michele Kennett, JD, MSN, CIP – University of Missouri ### 112633###Speaker -
2:45 PM - 4:00 PMB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309
Warren Capell, MD – University of Colorado Denver; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Linda E. Petree, BA, CIP – The University of New MexicoIRB Basics Track
Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker -
2:45 PM - 4:00 PMB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital; Barbara C. Engel, MD, PhD – Children's Hospital of PhiladelphiaIRB Chairs Track
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital ### 58254###Speaker @@@ Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia ### 420099###Speaker -
2:45 PM - 4:00 PMB09 - Taking the Plunge—Transitioning Studies to the Revised Common Rule
Location: Room 306
Lauren Hartsmith, JD – OHRP; John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Nathalia Henry, MS, CHRC, CIP – Northwestern UniversityIRB Operations Advanced Track
Lauren Hartsmith, JD – OHRP ### 263718###Speaker @@@ John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus ### 10590###Speaker @@@ Nathalia Henry, MS, CHRC, CIP – Northwestern University ### 586792###Speaker -
2:45 PM - 4:00 PMB10 - Right to Try—Legal, Ethical, and Implementation Issues
Location: Room 203
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Richard Klein – GE2P2 Global; Christine MacCracken, BSN, MSHEd – Janssen, Pharmaceutical Companies of Johnson & JohnsonPharma/Biotech Perspectives Track
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Richard Klein – GE2P2 Global ### 11087###Speaker @@@ Christine MacCracken, BSN, MSHEd – Janssen, Pharmaceutical Companies of Johnson & Johnson ### 824048###Speaker -
2:45 PM - 4:00 PMB11 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Room 202
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Michael J. Linke, PhD, CIP – University of Cincinnati College of MedicineLegal Considerations for HRPPs Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine ### 248446###Speaker -
2:45 PM - 4:00 PMB12 - Data and Biospecimens Across International Borders
Location: Room 102
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6; Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories; Marianne K. Henderson, MS, CPC – National Cancer Institute, NIH, DHHS; Edward E. Bartlett, PhD – Office for Human Research ProtectionsResearch involving Data and Biospecimens Track
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker @@@ Marianne K. Henderson, MS, CPC – National Cancer Institute, NIH, DHHS ### 868040###Speaker @@@ Edward E. Bartlett, PhD – Office for Human Research Protections ### 10663###Speaker -
2:45 PM - 4:00 PMB13 - Engaging the Principal Investigators of Tomorrow With Research Ethics Today: Is It Possible?
Location: Room 101
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; Leah R. Eisenberg, JD, MA – University of Arkansas for Medical SciencesResponsible Conduct of Research Track
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill ### 112598###Speaker @@@ Leah R. Eisenberg, JD, MA – University of Arkansas for Medical Sciences ### 57700###Speaker -
2:45 PM - 4:00 PMB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103
Lisa Denney, n/a – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical CenterQA/QI and Postapproval Monitoring Track
Lisa Denney, n/a – Stanford University ### 10319###Speaker @@@ Keren R. Dunn, CIP – Cedars-Sinai Medical Center ### 10320###Speaker -
2:45 PM - 4:00 PMB15 - The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 304
Ivor A. Pritchard, PhD – OHRPResearch Conducted in the Digital World Track
Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
2:45 PM - 4:00 PMB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University; Joseph Crossno, MS, CPIA – Central Michigan UniversityResponsible Conduct of Research Track
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University ### 261880###Speaker @@@ Joseph Crossno, MS, CPIA – Central Michigan University ### 597578###Speaker -
2:45 PM - 4:00 PMB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201
Melissa McGee, J.D. – University of New Hampshire; Heather H. Pierce, JD, MPH – Association of American Medical CollegesSmall Research Programs Track
Melissa McGee, J.D. – University of New Hampshire ### 824599###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker -
2:45 PM - 4:00 PMB18 - A Comparison of Human Subjects Protections Auditing Between Biomedical and Social-Behavioral Human Subjects Research
Location: Room 313
Narayan A. Escolin, MBS, CCRP – Rutgers University; Kate Sasamoto, JD – Office of Research Compliance Review, University of MichiganSBER Track
Narayan A. Escolin, MBS, CCRP – Rutgers University ### 824458###Speaker @@@ Kate Sasamoto, JD – Office of Research Compliance Review, University of Michigan ### 609545###Speaker -
2:45 PM - 4:00 PMB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300
Jyoti Angal, MPH CIP – Avera Research Institute; Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe); Anita B. Frederick, MS Management – Tribal Nations Research GroupPopulations Requiring Additional Protections Track
Jyoti Angal, MPH CIP – Avera Research Institute ### 420581###Speaker @@@ Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe) ### 420595###Speaker @@@ Anita B. Frederick, MS Management – Tribal Nations Research Group ### 418856###Speaker -
2:45 PM - 4:00 PMB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104
Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Laura Youngblood, MPH, CIP – Centers for Disease Control and PreventionFlexibility and Innovation in IRB Processes Track
Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention ### 10627###Speaker -
2:45 PM - 4:00 PMB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIHPharma/Biotech Perspectives Track
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 609692###Speaker @@@ Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH ### 112684###Speaker -
2:45 PM - 4:00 PMB22 - Ethical Considerations in Vaccine Development and Use
Location: Room 108
Walter L. Straus, MD, MPH – Merck Co., Inc.; Jennifer E. Gerber, MSc – Johns Hopkins Bloomberg School of Public Health; Jason L. Schwartz, PhD, MBE – Yale School of Public HealthPharma/Biotech Perspectives Track
Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker @@@ Jennifer E. Gerber, MSc – Johns Hopkins Bloomberg School of Public Health ### 824049###Speaker @@@ Jason L. Schwartz, PhD, MBE – Yale School of Public Health ### 824640###Speaker -
2:45 PM - 4:00 PMB23 - Flexible Strategies to Manage Unregulated Research in the Era of the Revised Common Rule
Location: Room 111
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus GroupFlexibility and Innovation in IRB Processes Track
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group ### 112600###Speaker -
4:00 PM - 5:00 PMBreakout Session Series B
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4:00 PM - 5:00 PMAER19 Welcome Reception Supported by CITI Program
Location: Exhibit Hall C -
4:10 PM - 4:30 PMIndustry Expert Theater: Overview and Demonstration of PRIM&R’s Ethical Research Oversight Course (EROC)
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4:10 PM - 4:30 PMIndustry Expert Theater: Overview and Demonstration of PRIM&R’s Ethical Research Oversight Course (EROC)
Location: Exhibit Hall C -
5:00 PM - 6:00 PMYoung Professionals Networking Reception
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5:00 PM - 6:00 PMYoung Professionals Networking Reception
Location: Trident Booksellers and Café (off-site)