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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.
- Wednesday, November 20, 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 - 12:30 PMOn-Site Check-In Open
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7:00 AM - 12:30 PMOn-Site Check-In Open
Location: Pre-Function Hall C -
8:00 AM - 8:10 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:10 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:10 AM - 8:20 AMPRIM&R Membership Update
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8:10 AM - 8:20 AMPRIM&R Membership Update
Location: Veterans Memorial Auditorium -
8:20 AM - 8:30 AMPRIM&R CIP® Update
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8:20 AM - 8:30 AMPRIM&R CIP® Update
Location: Veterans Memorial Auditorium -
8:30 AM - 9:30 AMKeynote Address by Mary Elizabeth Williams, BA, Writer, Speaker, Consultant: Keeping the Humanity in Human Subjects Trials
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8:30 AM - 9:30 AMKeynote Address by Mary Elizabeth Williams, BA, Writer, Speaker, Consultant: Keeping the Humanity in Human Subjects Trials
Location: Veterans Memorial Auditorium
Mary Elizabeth Williams, BA – maryelizabethwilliams.netMary Elizabeth Williams, BA – maryelizabethwilliams.net ### 824690###Speaker -
9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
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9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall C -
9:30 AM - 10:00 AMBook Signing With Keynote Speaker Mary Elizabeth Williams, BA, Writer, Speaker, Consultant
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9:30 AM - 10:00 AMBook Signing With Keynote Speaker Mary Elizabeth Williams, BA, Writer, Speaker, Consultant
Location: Exhibit Hall C
Mary Elizabeth Williams, BA – maryelizabethwilliams.netMary Elizabeth Williams, BA – maryelizabethwilliams.net ### 824690###Speaker -
10:00 AM - 11:15 AMConcurrent Plenary Sessions
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10:00 AM - 11:15 AMPanel VII: From Fortnite to Facebook—Data Security and Breaches, Downstream Harms, and the (Precarious) Role of IRBs
Location: Ballroom B
Jacob Metcalf, PhD – Ethical Resolve, LLC; James R. Foulds, PhD – University of Maryland, Baltimore County; Stephen J. Rosenfeld, MD, MBA – Freeport Research SystemsJacob Metcalf, PhD – Ethical Resolve, LLC ### 425289###Panelist @@@ James R. Foulds, PhD – University of Maryland, Baltimore County ### 829349###Panelist @@@ Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Panelist -
10:00 AM - 11:15 AMPanel VIII: The Challenges of Studying Marijuana Use in the United States
Location: Ballroom C
Albert J. Allen, MD, PhD – Eli Lilly and Company; Benjamin C. Silverman, MD – Partners HealthCare System, Inc.; Juliette Roddy, PhD – University of Michigan Dearborn; Beth Watters, JD – Partners HealthCare System, Inc.Albert J. Allen, MD, PhD – Eli Lilly and Company ### 22648###Moderator @@@ Benjamin C. Silverman, MD – Partners HealthCare System, Inc. ### 824672###Panelist @@@ Juliette Roddy, PhD – University of Michigan Dearborn ### 828547###Panelist @@@ Beth Watters, JD – Partners HealthCare System, Inc. ### 856030###Panelist -
10:00 AM - 11:15 AMFive Repeat Breakout Sessions from AER19 Breakout Series A Through E
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10:00 AM - 11:15 AMRepeat Breakout Session (A9): The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 302
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 -
10:00 AM - 11:15 AMRepeat Breakout Session (B15): The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 306
Ivor A. Pritchard, PhD – OHRPResearch Conducted in the Digital World Track
Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (C3): Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Room 312
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 -
10:00 AM - 11:15 AMRepeat Breakout Session (D1): Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210
Cynthia S. Shindledecker, B.A., CIP – University of Michigan; Charles Brightbill, CIM, CIP – Geisinger Health SystemFlexibility and Innovation in IRB Processes Track
Cynthia S. Shindledecker, B.A., CIP – University of Michigan ### 25718###Speaker @@@ Charles Brightbill, CIM, CIP – Geisinger Health System ### 824373###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (E2): Strategies for IRB Member Education
Location: Room 304
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine; Toby L. Schonfeld, PhD – Prime Review BoardEducating and Training Track
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Toby L. Schonfeld, PhD – Prime Review Board ### 112660###Speaker -
11:15 AM - 11:30 AMBreak
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11:15 AM - 11:30 AM
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11:30 AM - 12:45 PMBreakout Session Series E
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11:30 AM - 12:45 PME01 - Innovations in IRB Evaluation and Improvement
Location: Room 210
Holly A. Taylor, PhD, MPH – NIH; Ilene F. Wilets, PhD, CIP – Program for the Protection of Human SubjectsFlexibility and Innovation in IRB Processes Track
Holly A. Taylor, PhD, MPH – NIH ### 57753###Speaker @@@ Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects ### 64126###Speaker -
11:30 AM - 12:45 PME02 - Strategies for IRB Member Education
Location: Room 304
Toby L. Schonfeld, PhD – Prime Review Board; Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of MedicineEducating and Training Track
Toby L. Schonfeld, PhD – Prime Review Board ### 112660###Speaker @@@ Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker -
11:30 AM - 12:45 PME03 - Integrating Empirical Research Ethics into IRB Decisions for Studies Involving Vulnerable Populations
Location: Room 104
Celia B. Fisher, PhD – Fordham University; Nicole M. Overstreet, PhD – Clark UniversityEmpirical Research Ethics Track
Celia B. Fisher, PhD – Fordham University ### 57702###Speaker @@@ Nicole M. Overstreet, PhD – Clark University ### 843744###Speaker -
11:30 AM - 12:45 PME04 - Assessing the Prospect of Direct Benefit in Early-Phase Pediatric Studies
Location: Room 202
Melanie Bhatnagar, MD – Food & Drug Administration; Donna L. Snyder, MD – Food and Drug Administration; Albert J. Allen, MD, PhD – Eli Lilly and CompanyFDA-Regulated Research Track
Melanie Bhatnagar, MD – Food & Drug Administration ### 824369###Speaker @@@ Donna L. Snyder, MD – Food and Drug Administration ### 587406###Speaker @@@ Albert J. Allen, MD, PhD – Eli Lilly and Company ### 22648###Speaker -
11:30 AM - 12:45 PME05 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures
Location: Room 302
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6; Derek Englis, MBA, EdS, CIP – Armed Forces Services Corp./Magellan Federal; Bussara Sukpanichnant, BS (Nursing), M.Ed., CIP – Armed Forces Research Institute of Medical Sciences (AFRIMS); Edward E. Bartlett, PhD – Office for Human Research ProtectionsGlobal Research Track
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Derek Englis, MBA, EdS, CIP – Armed Forces Services Corp./Magellan Federal ### 585129###Speaker @@@ Bussara Sukpanichnant, BS (Nursing), M.Ed., CIP – Armed Forces Research Institute of Medical Sciences (AFRIMS) ### 903008###Speaker @@@ Edward E. Bartlett, PhD – Office for Human Research Protections ### 10663###Moderator -
11:30 AM - 12:45 PME06 - Making Your HRPP Distinct and Organized in a Single IRB World
Location: Room 102
Ann Johnson, PhD, MPH, CIP – University of Utah; Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical CenterInstitutional Officials and HRPP Leadership Track
Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker -
11:30 AM - 12:45 PME07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309
Janet C. Donnelly, RAC – FDA; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of KentuckyIRB Basics Track
Janet C. Donnelly, RAC – FDA ### 10577###Speaker @@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Speaker -
11:30 AM - 12:45 PME08 - Meeting Management for IRB Chairs
Location: Room 300
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Robert H. Romanchuk, CCRC, CIP – Advarra, Inc.IRB Chairs Track
Francis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ Robert H. Romanchuk, CCRC, CIP – Advarra, Inc. ### 826173###Speaker -
11:30 AM - 12:45 PME09 - How IRBs Identify Research vs. Non-Research Risks—The Impact of the “Standard of Care” Concept
Location: Ballroom A
Sharon Ellison, PharmD – Duke University Health System, Inc.; Anthony E. Magit, MD, MPH – University of California, San DiegoIRB Operations Advanced Track
Sharon Ellison, PharmD – Duke University Health System, Inc. ### 10674###Speaker @@@ Anthony E. Magit, MD, MPH – University of California, San Diego ### 293357###Speaker -
11:30 AM - 12:45 PM
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11:30 AM - 12:45 PME11 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Room 312
Theresa J. Colecchia – Johns Hopkins University; Valerie H. Bonham, JD – Ropes & Gray LLPLegal Considerations for HRPPs Track
Theresa J. Colecchia – Johns Hopkins University ### 825253###Speaker @@@ Valerie H. Bonham, JD – Ropes & Gray LLP ### 11362###Speaker -
11:30 AM - 12:45 PME12 - Operationalizing Research Databases and Biobanks at Your Institution
Location: Room 200
Marylana Saadeh Helou, Esq. – Verrill LLP; R. Peter Iafrate, PharmD – University of Florida; Marianna J. Bledsoe, MA – International Society for Biological and Environmental RepositoriesResearch involving Data and Biospecimens Track
Marylana Saadeh Helou, Esq. – Verrill LLP ### 587399###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker @@@ Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker -
11:30 AM - 12:45 PME13 - Under the Influence—Capacity and Consent
Location: Room 203
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Health; Lara N. Sloboda, PhD – Dana Farber Cancer InsititutePopulations Requiring Additional Protections Track
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Health ### 420065###Speaker @@@ Lara N. Sloboda, PhD – Dana Farber Cancer Insititute ### 181613###Speaker -
11:30 AM - 12:45 PME14 - Impact of the Revised Common Rule on the Work of a QA/QI Program
Location: Room 311
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public HealthQA/QI and Postapproval Monitoring Track
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center ### 587396###Speaker @@@ Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health ### 187400###Speaker -
11:30 AM - 12:45 PME15 - The Regulatory and Ethical Implications of Melding Consumer "Big Data" With Medical "Big Data"
Location: Room 310
Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc.Research Conducted in the Digital World Track
Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker -
11:30 AM - 12:45 PME16 - IRBs and Conflict of Interest (COI) Oversight—Mind the Gaps
Location: Room 206
John R. Baumann, PhD – Indiana University; Scott J. Lipkin, DPM, CIP – Ankura Consulting; Shelby Moench, BA – Intermountain HealthcareResponsible Conduct of Research Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Scott J. Lipkin, DPM, CIP – Ankura Consulting ### 10598###Speaker @@@ Shelby Moench, BA – Intermountain Healthcare ### 187417###Speaker -
11:30 AM - 12:45 PME17 - Building Models for Hospital and Practice-Based Research Programs—Agony and Ecstasy
Location: Room 107
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health; Patricia Seymour, CCRC, MA, CIP – WCG ClinicalSmall Research Programs Track
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health ### 11610###Speaker @@@ Patricia Seymour, CCRC, MA, CIP – WCG Clinical ### 420598###Speaker -
11:30 AM - 12:45 PME18 - Beyond Auditing and Monitoring of the IRB Towards Quality Improvement
Location: Room 103
Cheryl L. Byers, MHA, CIP, CHRC – Moffitt Cancer Center and Research Institute; Mariette Marsh, MPA, CIP, CHPC – University of Arizona; Kristen Connal – The Fenway Institute at Fenway HealthQA/QI and Postapproval Monitoring Track
Cheryl L. Byers, MHA, CIP, CHRC – Moffitt Cancer Center and Research Institute ### 248450###Speaker @@@ Mariette Marsh, MPA, CIP, CHPC – University of Arizona ### 124813###Speaker @@@ Kristen Connal – The Fenway Institute at Fenway Health ### 829038###Speaker -
11:30 AM - 12:45 PME19 - Navigating Uncertainty—Developing Best Practices for Review of Research on the Edge
Location: Room 306
Jeffrey M. Cohen, PhD – Department of Bioethics, Clarkson University; Juliette Roddy, PhD – University of Michigan DearbornSBER Track
Jeffrey M. Cohen, PhD – Department of Bioethics, Clarkson University ### 11067###Speaker @@@ Juliette Roddy, PhD – University of Michigan Dearborn ### 828547###Speaker -
11:30 AM - 12:45 PME20 - Who's Minding the Store? Local Oversight of Research Without an IRB
Location: Room 201
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Hallie Kassan, MS, CIP – Northwell Health; Greg E. Manship, DBe, MDiv, CIP, CIM – OSF HealthCareInstitutional Officials and HRPP Leadership Track
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Hallie Kassan, MS, CIP – Northwell Health ### 57719###Speaker @@@ Greg E. Manship, DBe, MDiv, CIP, CIM – OSF HealthCare ### 10325###Speaker -
11:30 AM - 12:45 PME21 - Strategies for Conducting an Effective Local Context Review as a Relying Organization
Location: Room 101
Sarah Mumford, MBA, CIP – University of Utah; Kimberly K. Summers, PharmD – University of Texas Health San AntonioInstitutional Officials and HRPP Leadership Track
Sarah Mumford, MBA, CIP – University of Utah ### 826186###Speaker @@@ Kimberly K. Summers, PharmD – University of Texas Health San Antonio ### 420574###Speaker -
11:30 AM - 12:45 PME22 - Implementation of a System to Promote Compliance With 45 CFR 46.116(h)—Posting Consent Forms
Location: Room 313
Matthew Ogrodnik, MS, CIP – Boston Medical Center and Boston University Medical Campus; Lauren Hartsmith, JD – OHRPInstitutional Officials and HRPP Leadership Track
Matthew Ogrodnik, MS, CIP – Boston Medical Center and Boston University Medical Campus ### 426722###Speaker @@@ Lauren Hartsmith, JD – OHRP ### 263718###Speaker -
11:30 AM - 12:45 PME23 - Implementing Key Information in Multi-Site Research
Location: Room 108
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Jeanne Velders, JD, CIP – Washington University in St. Louis; Joan Affleck, M.A., M.B.A. – Merck & Co., Inc.IRB Operations Advanced Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Jeanne Velders, JD, CIP – Washington University in St. Louis ### 112676###Speaker @@@ Joan Affleck, M.A., M.B.A. – Merck & Co., Inc. ### 844800###Speaker -
12:45 PM - 2:30 PMClosing Session
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12:45 PM - 2:30 PMClosing General Session Luncheon—Designing Ethical Cars and Computing Clinicians: Research and the Ethics of Artificial Intelligence (AI) Programming
Location: Veterans Memorial Auditorium
Neal W. Dickert, MD, PhD – Emory University School of Medicine; Marshall Chin, MD, MPH – University of Chicago; David Magnus, PhD – Stanford University; Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) InternationalNeal W. Dickert, MD, PhD – Emory University School of Medicine ### 57694###Moderator @@@ Marshall Chin, MD, MPH – University of Chicago ### 859611###Panelist @@@ David Magnus, PhD – Stanford University ### 874905###Panelist @@@ Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) International ### 864327###Panelist